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1
Castro Marin, Antonio, Federico Baris, Elia Romanini, Milena Lambri, Giuseppe Montevecchi, and Fabio Chinnici. "Physico-Chemical and Sensory Characterization of a Fruit Beer Obtained with the Addition of Cv. Lambrusco Grapes Must." Beverages 7, no. 2 (June 3, 2021): 34. http://dx.doi.org/10.3390/beverages7020034.
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In 2015, Italian Grape Ale (IGA) beers have been included as a new provisional sub-category of special-type fruit beers by the Beer Judge Certification Program, including those products whose brewing process is carried out in presence of determined quantities of grape must. However, information on the effects of these additions on the composition of final beers are still scarce. This work is hence focused on the chromatic, volatile, phenolic and sensory characterization of IGA beers obtained with the addition of grape musts during brewing process. To this aim, different amounts of must (5, 10 and 20%) from cv. Lambrusco red grapes were added to a lager wort before primary fermentation. Beers were then characterized by HPLC-MS, GC-MS and sensory analysis in order to determine phenolic and aroma compounds along with their sensory attributes. Results confirmed the addition of must from cv. Lambrusco grapes capable to enrich beers in color, acids, phenolic (up to 7-folded increased) and volatile compounds, while giving complexity to beers. These results, which were confirmed by a trained sensory panel, are among the very first insights on the impact of red grape must in brewing, both from a compositional and sensory point of view.
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Ferrandino, Vittoria, and Valentina Sgro. "Associazionismo industriale e corporativismo: l’American Chamber of Commerce in Italy nell’epoca fascista = Industrial association and corporatism: The American chamber of commerce in Italy during the fascism age." Pecvnia : Revista de la Facultad de Ciencias Económicas y Empresariales, Universidad de León, no. 19 (February 2, 2016): 103. http://dx.doi.org/10.18002/pec.v0i19.3584.
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<p>Il contributo in oggetto si propone di approfondire i rapporti tra le corporazioni e i gruppi industriali italiani da un’ottica particolare, quella dell’associazionismo che si concretizza con l’American Chamber of Commerce in Italy, instituita nel 1915 per agevolare le relazioni commerciali tra Italia e Stati Uniti. La grave crisi economica del 1930 e del 1931 e, poco dopo, le gravissime restrizioni portate agli scambi con l’estero dal programma autarchico del Governo fascista, influirono notevolmente sullo sviluppo della Camera. L’autorità dell’istituzione venne a diminuire, i rapporti con gli Stati Uniti si fecero più rari e il numero dei soci diminuì notevolmente.<strong> </strong>Alle corporazioni furono affidate le autorizzazioni sui nuovi impianti, la costituzione delle compagnie per la valorizzazione dell’Africa orientale italiana, il controllo sulle iniziative economiche nelle colonie, la collaborazione col fisco nella determinazione e nell’applicazione dei tributi ed infine il controllo sul commercio estero e sulle valute. Di conseguenza, la funzione che lo Stato avrebbe dovuto esercitare servendosi delle corporazioni finì col ricadere nelle mani dei grandi industriali, che le dominavano attraverso i loro rappresentanti. Da un lato, quindi, vi erano le corporazioni, che garantivano piena libertà ai gruppi industriali, avallandone le scelte; dall’altro lato, invece, vi erano le autorità governative che riconoscevano i limiti di competenza e d’intervento di quelle istituzioni e la necessità di una migliore definizione degli obiettivi.</p><p>This contribution aims to examine the relationship between corporations and the Italian industrial groups from a particular perspective, which is that of associations through the American Chamber of Commerce in Italy, established in 1915 to facilitate the commercial relations between Italy and the United States. The economic crisis of 1930 and 1931 and, shortly after, the very serious restrictions on foreign trade of the Fascist government program influenced significantly on the Chamber’s development. The authority of the institution was to decline, the relations with the United States became more and more rare and the number of members decreased considerably. Corporations obtained the authorizations on new systems, the establishment of companies for the development of the Italian East Africa, the control on economic initiatives in the colonies, the cooperation with the tax authorities in the determination and application of taxes, and finally control over foreign trade and currencies. So the function that the State should have exercised using the corporations ended up falling into the hands of big businessmen, who ruled through their representatives. Therefore, Corporations guaranteed full freedom to industry groups supporting them, and government authorities recognized the competence and intervention limits of those institutions and the need for a better definition of the objectives.</p>
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Djorovic, Danijela, and Natasa Lalic-Vucetic. "Some peculiarities of Italian language instruction at primary school age." Zbornik Instituta za pedagoska istrazivanja 42, no. 1 (2010): 150–64. http://dx.doi.org/10.2298/zipi1001150d.
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Instruction of Italian language at primary school level has not been studied more comprehensively in our expert and scientific literature so far, since Italian has been studied as a compulsory foreign language in Serbian schools since the school year 2001/2002. This paper discusses some peculiarities of learning and teaching a foreign language, with emphasis on the socio-cultural aspect and functional usage of the language as the primary task of instruction. The paper presents the results of one part of a larger empirical research that studies the attitude of primary school students towards learning Italian as a foreign language. The goal of the research refers to identifying the competences that students acquire by learning this language and the possibility of applying the linguistic knowledge and skills in real-life situations of students' interaction with the members of other culture, as well as identifying learning difficulties. The sample comprised 185 fifth grade students and 110 seventh grade students from three primary schools where the Italian language has been studied the longest. Research findings indicate that there is an initial positive attitude towards learning Italian and the sensitivity for extralinguistic and cultural elements of instruction of foreign language. Students pointed out to the need for a more active participation in instruction and selection of teaching contents, for more modern approaches to learning, and for a larger degree of applicability of linguistic knowledge and skills in real-life situations.
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Bracarda, Sergio, Giuseppe Di Lorenzo, Donatello Gasparro, Paolo Marchetti, Francesco Boccardo, Andrea Martoni, Giacomo Carteni, et al. "Preliminary safety results of an Italian early-access program (EAP) with cabazitaxel plus prednisone (CbzP) in patients with docetaxel-refractory metastatic castration-resistant prostate cancer (mCRPC)." Journal of Clinical Oncology 30, no. 5_suppl (February 10, 2012): 253. http://dx.doi.org/10.1200/jco.2012.30.5_suppl.253.
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253 Background: A significant number of docetaxel (D) refractory mCRPC patients (pts) have a life expectancy of > 15 months and ask for additional efficacious treatments. In the phase 3 TROPIC trial treatment of mCRPC patients with CbzP who progressed during or after docetaxel resulted in a statistically significant overall survival benefit compared with mitoxantrone / prednisone (Lancet 2010). This survival benefit supported establishment of a global early access program (EAP), allowing pts with mCRPC to have access to the drug prior to its commercial availability. Here we describe preliminary safety results from the EAP in Italy. Methods: We report here the data of the first 16 mCRPC patients (out of the 123 enrolled by 19 Italian centers until Sept 2011 in EAP) treated with Cbz (25mg/m2 Q3W) plus P(10mg bid). Results: Pts were median age 73.5 years (>75 years 38%), ECOG PS-0 81.3% and had received a median of 7 prior cycles of D (median cumulative D dose 562.5mg). Median time from last D dose to inclusion was 7.1 months. Overall, 62.5% (10 Pts) had 2 or more metastatic sites (bone 94%, regional/distant lymph nodes 25% and 44%, lung 12.5%, other sites 19%). A limited number of relevant adverse events (AE) were observed. All grade AEs were seen in 14/16 pts (81.3%), with 4/16 pts experiencing grade 3/4 leukopenia, 8/16 pts grade 3 - 4 neutropenia, one patient with febrile neutropenia and one with hypertransaminasaemia. Grade 1-2 asthenia and fatigue were experienced respectively by 2 pts. No grade 3 / 4 diarrhea, vomiting or constipation were observed and no AEs results in death. All pts received at least 2 cycles of CbzP (2÷5) and only one patient permanently discontinued treatment (disease progression). Conclusions: This preliminary analysis of Italian pts enrolled in the EAP provides real world safety data and suggests a good safety profile of cabazitaxel even in heavily pretreated pts, which is in agreement with Italian experience in TROPIC. Results of the entire Italian cohort with a longer follow-up will be presented.
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Ciavattini, Andrea, Giovanni Delli Carpini, Lorenzo Moriconi, Nicolò Clemente, Nina Montik, Rosa De Vincenzo, Anna Del Fabro, et al. "Effect of age and cone dimensions on cervical regeneration: an Italian multicentric prospective observational study." BMJ Open 8, no. 3 (March 2018): e020675. http://dx.doi.org/10.1136/bmjopen-2017-020675.
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ObjectivesTo evaluate cervical regeneration at 6 months following excisional treatment for high-grade cervical intraepithelial neoplasia (CIN), and to investigate the effect of cone dimensions, age of patients and technique of excision on the efficacy of the regeneration process.DesignProspective observational multicentric study.SettingThree tertiary care and research centres.ParticipantsAmong the 197 eligible women of childbearing age, older than 25 years of age, undergoing for the first time a loop electrosurgical excision procedure or carbon dioxide laser cervical excision for a high-grade CIN at the colposcopy-directed cervical punch biopsy, and with a final diagnosis of high-grade CIN, 165 completed the 6-month follow-up and were included in the analysis.Primary outcome measuresThe cervical length and volume regeneration (%) after 6 months from procedure were determined by three-dimensional ultrasound, and the correlation of regeneration with cone dimensions, age and excision technique was evaluated.ResultsThe mean±SD cervical length regeneration at 6 months was 89.5%±6.3% and the mean±SD cervical volume regeneration was 86.3%±13.2%. At the multivariate analysis, a significant and independent inverse correlation between excised cone length and cervical regeneration emerged (r=−0.39, P<0.001). A significantly negative trend in length regeneration at 6 months from procedure with an increasing class of cone length was found (P<0.001). No significant association was found in relation with patient age at the time of procedure or with the technique of excision.ConclusionsCervical length regeneration at 6 months from excisional treatments is negatively affected by an increasing cone length but not from the age of the patient or the technique of excision. While still achieving equal clinical efficacy, it is crucial to contain cone dimensions, in order to favour a greater length regeneration, reducing the cervical harm and the potential future obstetric complications.
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Di Persio, Luca, and Michele Marchesan. "Forecasting Energy Market Contracts by Ambit Processes: Empirical Study and Numerical Results." International Scholarly Research Notices 2014 (October 29, 2014): 1–10. http://dx.doi.org/10.1155/2014/879892.
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In the present paper we exploit the theory of ambit processes to develop a model which is able to effectively forecast prices of forward contracts written on the Italian energy market. Both short-term and medium-term scenarios are considered and proper calibration procedures as well as related numerical results are provided showing a high grade of accuracy in the obtained approximations when compared with empirical time series of interest.
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Frassoldati, Antonio, Sandro Barni, Domenico Amoroso, and Elena Collovà. "Attitude of Italian oncologists toward fertilty preservation in patients with early breast cancer." Journal of Clinical Oncology 31, no. 15_suppl (May 20, 2013): e11547-e11547. http://dx.doi.org/10.1200/jco.2013.31.15_suppl.e11547.
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e11547 Background: Patient’s desire for fertility preservation is a frequently underestimated problem in oncology clinical practice. Even if several different approaches have been suggested to maintain fertility in early stage breast cancer patients undergoing adjuvant chemotherapy, few women undergo to such procedures or are referred to a specialized team. Methods: Between April and July 2011, an electronic questionnaire regarding the treatment attitude in early breast cancer in premenopausal women was submitted to Italian oncologists, and 611 (female 52%, age range 25-65, 81% from general hospitals, 19% from research institute) filled in the questionnaire. Among the items, we explored also the issue of fertility preservation in women candidate for adjuvant chemotherapy and hormones. We compared the survey results (examined according to sex, age, working institution and geographic origin) with the recommendations available from guidelines of oncology and gynecology societies. Results: A pregnancy test before starting chemotherapy is considered mandatory only by 49.5% of oncologists, independently from age and type of treatment. In order to maintain fertility, several guidelines recommend eggs or embrio freezing, whereas the use of LHRH-analogs is recommended only in the contex of research trials. In our survey, the eggs freezing is considered the preferred method by 24,8% of Italian oncologists only, while 6% suggest cryopreservation of ovarian tissue. Embrio freezing is preferred by <1% of oncologist. However, the majority of Italian oncologists considers the administration of LHRH-analog the treatment of choice to maintain fertility (independently from the hormone receptor status of the tumor in 83% of cases). No significant differences as by type of institution, geographic location, and physician’s age has been observed. Conclusions: The use of LHRH-analog is the preferred method by Italian oncologists for fertility preservation. A recent analysis of literature regarding the use of LHRH-analogs by Italian Society for Medical Oncology using the GRADE method suggest an important role of this drugs, even if not yet conclusive for their efficacy (level of evidence 1+, Recommendation “slightly positive”).
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Suenaga, Mitsukuni, Marta Schirripa, Shu Cao, Wu Zhang, Dongyun Yang, Lisa Salvatore, Sara Lonardi, et al. "Genetic variants of genes in CCL5/CCR5 pathway to predict regorafenib-induced hand-foot skin reaction in patients with refractory metastatic colorectal cancer: A report of ethnic difference." Journal of Clinical Oncology 35, no. 4_suppl (February 1, 2017): 615. http://dx.doi.org/10.1200/jco.2017.35.4_suppl.615.
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615 Background: CCL5/CCR5 pathway is involved in VEGF-A production and a recent study reported that serum CCL5 levels predict onset of hand-foot skin reaction (HFSR) due to regorafenib. We therefore tested whether genetic polymorphisms in the CCL5/CCR5 pathway predict onset of HFSR in patients with refractory metastatic colorectal cancer (mCRC) receiving regorafenib. Methods: Two independent cohorts treated with regorafenib were included in this study: a training cohort from Japan with 79 patients (median age 62 years, male 47%); and a testing cohort from Italy with 150 patients (median age 62 years, male 54%). Single nucleotide polymorphisms (SNPs) of genes in CCL5/CCR5 pathway ( CCL5, CCR5, PRCKD, CCL3, CCL4, KLF13, HIF1A) were selected for analyses using PCR-based direct sequencing. Adverse events were graded according to the CTCAE version 4.0. Comparisons of variants’ and adverse events’ distributions across two cohorts, and association between SNPs and adverse events were analyzed using contingency tables and Fisher’s exact test. Results: Grade 3 ≤ HFSR was more frequent in Japanese patients compared with Italian patients (32.9% vs. 16.0%, P= 0.004). The frequency of homozygous variant in CCL5 SNPs varied between Japanese and Italian patients (G/G variant in rs2280789, 21.5% vs. 1.3%, P< 0.001; T/T variant in rs3817655, 22.8% vs. 2.7%, P< 0.001). In the training cohort, patients with the G/G variant in rs2280789 had a higher incidence of grade 3 ≤ HFSR compared to those with any A allele (53% vs. 27%, P= 0.078); and the T/T variant in rs3817655 was significantly associated with onset of grade 3 ≤ HFSR compare to any A allele (56% vs. 26%, P= 0.026). These findings were not confirmed in the testing cohort, and no significant differences for toxicities were observed in the other candidate SNPs. Conclusions: Germline CCL5 polymorphisms in the CCL5/CCR5 pathway may serve as predictor of onset of severe HFSR in refractory mCRC patients receiving regorafenib. The different percentage of homozygote of CCL5 SNPs confers the ethnic difference in developing severe HFSR between Italian and Japanese patients.
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Donfrancesco, R., A. Marano, D. Calderoni, D. Mugnaini, F. Thomas, M. Di Trani, M. Innocenzi, and B. Vitiello. "Prevalence of severe ADHD: an epidemiological study in the Italian regions of Tuscany and Latium." Epidemiology and Psychiatric Sciences 24, no. 6 (September 15, 2014): 525–33. http://dx.doi.org/10.1017/s2045796014000523.
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Background.The rate with which attention deficit/hyperactivity disorder (ADHD) is diagnosed varies widely across countries, suggesting that cultural factors influence the clinical interpretation of child behaviour. This study estimated the point prevalence of severe ADHD among elementary and middle-school Italian children.Method.An epidemiological sample of 2016 children attending 2nd–8th grade in the Italian regions of Tuscany and Latium was selected based on census distribution of the school-age population. Teachers completed the Italian version of the ADHD Rating Scale for Teachers (SDAI). For children with at least six inattention symptoms and/or at least six hyperactivity/impulsivity symptoms rated ‘very often’ by the teachers, the parents completed the Italian ADHD Rating Scale for Parents (SDAG). Children with documented ADHD symptoms at both school and home received a complete psychiatric interview with the Kiddie Schedule for Affective Disorders and Schizophrenia-present and lifetime version (K-SADS-PL).Results.Of the 1887 assessed children, 4.45% (95% CI 3.58–5.51) met the ADHD cut-off on teacher ratings, 1.43% (0.96–2.12) had ADHD symptoms endorsed by both teacher and parent, and 1.32% (0.87–1.97) were further confirmed by the psychiatric evaluation. The male:female ratio was 7:1. The inattentive type accounted for about half of the ADHD cases.Conclusions.When applying stringent criteria for both severity and pervasiveness of symptoms, it is estimated that about 1.3% of the Italian elementary and middle-school children suffer from severe ADHD.
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Terranova, Michael D. "The Greater Wonder of God's Subjection in John Donne's Holy Sonnet “Why are wee by all Creatures waited on?”." Ben Jonson Journal 24, no. 2 (November 2017): 205–22. http://dx.doi.org/10.3366/bjj.2017.0194.
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In his deceptively simple, but really extremely rich, sonnet, “Why are wee by all Creatures waited on?”, John Donne uses all the tools of prosody available to him and plays with the English and Italian forms of the sonnet to give a rich meditation on the order of creation, the history of salvation, and the relationship of nature and grace. He begins with what seems an irenic scholastic discussion, asking why humans are able to subjugate elements and animals which are purer and stronger than they. In the third quatrain, however, he shifts to a deep moral plaint. At the same time, he interweaves the philosophical idea of the Great Chain of Being with the theological distinction between nature and grace. He does so by employing both the Italian and the English sonnet forms simultaneously. The Italian sonnet poses and then resolves the question about the order of nature, while the English sonnet takes the question of the order of nature up into the question of the order of redemption. In the final couplet, he goes beyond both the metaphysical question and the moral plaint by turning the reader's attention to the Incarnation, in which God subjects Himself to both that which is lower and that which is worse than Himself. In doing so Donne transforms the images he evokes in a poem surprisingly devoid of his typical metaphysical conceits into one sustained conceit which elicits in the reader a humble awe before the Divine condescension.
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Asaftei, Sebastian Dorin, Nadia Puma, Anna Paioli, Marco Petraz, Carlo Morosi, Marta Podda, Angela Tamburini, et al. "Front-Line Window Therapy with Temozolomide and Irinotecan in Patients with Primary Disseminated Multifocal Ewing Sarcoma: Results of the ISG/AIEOP EW-2 Study." Cancers 13, no. 12 (June 18, 2021): 3046. http://dx.doi.org/10.3390/cancers13123046.
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Purpose: The main objective was to evaluate the activity and tolerability of TEMIRI as a front-line treatment in primary disseminated Ewing sarcoma (PDMES) using the RECIST 1.1 criteria. The secondary objectives included the assessment of toxicity and the performance status/symptom changes. Methods: Between 2012 and 2018, patients with PDMES received two courses of temozolomide 100 mg/sqm/day + irinotecan 50 mg/sqm/day for 5 days every 3 weeks as an amendment to the Italian Sarcoma Group/Associazione Italiana EmatoIogia ed Oncologia Pediatrica (ISG/AIEOP) EW-2 protocol (EUDRACT#2009-012353-37, Vers. 1.02). Results: Thirty-four patients were enrolled. The median age at diagnosis was 19 years (range 3–55). After TEMIRI, the RECIST response was as follows: a partial response in 20 (59%) patients, stable disease in 11 (32%), and disease progression in 3 (9%). The ECOG/Lansky score was improved in 25/34 (73.5%) cases, and a reduction or disappearance of pain was observed in 31/34 patients (91%). The incidence of grade 3–4 toxicity was 3%. The 3-year event-free survival (EFS) and overall survival (OS) were 21% (95% CI 6–35%) and 36% (95% CI: 18–54%), respectively. Conclusion: the smooth handling and encouraging activity demonstrated by up-front TEMIRI did not change the EFS in PDMES, so this result suggests the need for the further evaluation of the efficacy of TEMIRI in combination with conventional treatments in non-metastatic patients.
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Agasisti, Tommaso, Patrizia Falzetti, and Mara Soncin. "School principals' managerial behaviours and students' achievement." International Journal of Educational Management 34, no. 5 (April 4, 2020): 937–51. http://dx.doi.org/10.1108/ijem-11-2018-0350.
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PurposeThis research investigates the impact of managerial practices implemented by Italian school principals on students' outcomes, using micro-data provided by the National Evaluation Committee for Education (INVALSI) for 2013/14 school year.Design/methodology/approachEmploying an educational production function, the authors regress a set of student and school's characteristics, enriched by information from a questionnaire filled by school principals to estimate student's score at grade 8 (last year of junior secondary school), also taking into account student's prior achievement (at grade 6 – first year of junior secondary school).FindingsIndicators about managerial practices have positive coefficients, but low statistical significance. Stronger associations between management variables and test scores are detected for low-SES schools.Originality/valueThe research presented here is particularly innovative in the Italian context, where little evidence exists about the impact of managerial skills in education, though institutional reforms are leading towards a strengthening of school principal's leadership role. In this paper, the authors move a first step by describing managerial practices and their diffusion in different schools and geographical areas within the country. The authors focus the attention on the role of managerial practices (what principals do) and not on the managerial skills (what principals are able to do).
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Tremolada, Marta, Livia Taverna, and Sabrina Bonichini. "Which Factors Influence Attentional Functions? Attention Assessed by KiTAP in 105 6-to-10-Year-Old Children." Behavioral Sciences 9, no. 1 (January 8, 2019): 7. http://dx.doi.org/10.3390/bs9010007.
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This research revealed the children with difficulties in attentional functions among healthy children attending primary school and aimed to identify the possible sociodemographic factors, such as the child’s age, gender, and school grade, that could influence attentive performance. The participants were 105 children aged 6–10 years (M age = 8.6; SD = 1.04), attending primary schools. Family economic condition was mostly at a medium level (63.5%), and parents most frequently had 13 years of schooling. The computerized test KiTAP was administered to children to assess their attentional functions. Results showed a higher frequency of omissions and false alarms and a reduced speed in alertness, go/no-go, and sustained attention tasks compared to Italian norms. Hierarchical regression analyses were run with school grade, gender, and current age as independent variables and mean reaction times (and standard deviation), number of omissions, and false alarms as dependent ones. The results showed that male gender and attending a lower grade impacted on lower attentional performance in several subtests. Girls showed the best performances in tests of distractibility and impulsive reaction tendencies, while higher school grade positively influenced divided and sustained attention. These results could be useful to identify children with major attentional difficulties, and some recommendations for future studies and the implementation of attention empowerment programmes are proposed.
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Spina, Michele, Stefano Luminari, Flavia Salvi, Francesco Passamonti, Alberto Fabbri, Umberto Vitolo, Maria Giuseppina Cabras, et al. "Low Toxicity Profile of the Combination of Bendamustine Plus Rituximab (BR) in Elderly FRAIL Patients with Newly Diagnosed DLBCL." Blood 124, no. 21 (December 6, 2014): 4429. http://dx.doi.org/10.1182/blood.v124.21.4429.4429.
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Abstract Introduction: R-CHOP is the gold standard for the treatment of elderly patients with DLBCL. However, unfit and frail patients frequently do not qualify for CHOP-based chemotherapy. Alternatives are an urgent medical need. Bendamustine plus rituximab (BR) has been established as a standard treatment of indolent lymphomas and preliminary data have shown a promising activity in DLBCL, both in the relapsing and upfront setting. Methods: Within the Fondazione Italiana Linfomi (FIL), we started a phase II study (R-BENDA frail study, EUDRACT2011-001421-24) in elderly patients (>70 years) with a newly diagnosed DLBCL not suitable for R-CHOP-based chemotherapy. All patients were evaluated according to ADL, IADL and CIRS-G and were considered FRAIL if the following criteria were meet: in patients aged 70-80 ADL<4 or IADL<5 or one grade 3 comorbidity or >8 grade 2 comorbidities; in patients older than 80 years ADL>5 or IADL>6 or 5-8 grade 2 comorbidities. Patients received bendamustine at a dose of 90 mg/m2 daily on days 1 and 2 of each 28-day cycle along with rituximab on day 1 for up to 6 cycles. Results: From February 2012 to February 2014, 49 patients were enrolled in 24 Italian centers. The majority (57%) were male and 57% had stage III-IV with 41% elevated LDH. The median age was 82. Overall, 83% of the planned cycles were delivered without dose reduction or delay; grade 3/4 neutropenia was reported in 25% of cycles followed by anemia 21%, and thrombocytopenia 20%. One case of febrile neutropenia was observed. Grade 3-4 non-hematological toxicity was mild and reported in 6% of cycles including 3 episodes of cardiovascular events and 7 other cases of different toxicities (one creatinine increase, one fatigue, one bleeding, one peripheral neurotoxicity, one hyponatriemia, one hyperglycemia and one liver toxicity). Two deaths during treatment have been observed (cardiac failure and sudden death). At the interim analysis (23 patients) the overall response rate was 56% with a complete response rate of 39%. Conclusions: Combination therapy with BR demonstrates low toxicity profile in this high risk population. The promising results on activity can encourage clinicians to considered BR for the treatment of FRAIL elderly patients with DLBCL not eligible for R-CHOP. Disclosures No relevant conflicts of interest to declare.
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Sanfilippo, Roberta, Vittoria Colia, Elena Fumagalli, Rossella Bertulli, Carlo Morosi, Maria Luisa Carcangiu, Domenica Lorusso, Francesco Raspagliesi, Angelo Paolo Dei Tos, and Paolo Giovanni Casali. "Sensitivity to chemotherapy of low-grade endometrial stromal sarcoma (LGESS) versus high-grade endometrial stromal sarcoma (HGESS)." Journal of Clinical Oncology 35, no. 15_suppl (May 20, 2017): 11072. http://dx.doi.org/10.1200/jco.2017.35.15_suppl.11072.
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11072 Background: LGESS and HGESS are rare uterine neoplasms of endometrial stromal origin. The activity of hormonal therapy in LGESS is reported, whilst no data are available in HGESS. The activity of chemotherapy is unknown in both. We focused on LGESS and HGESS to explore their sensibility to chemotherapy Methods: Cases diagnosed with LGHSS and HGESS from 1997 at Istituto Nazionale Tumori, Milan, or within the Italian Rare Cancer Network (RTR), were reviewed. Results: We identified 39 patients (pts), 28 with LGESS (median age:43) and 11 (median age: 54) with HGESS. Seventeen LGESS pts received systemic therapy for advanced disease (1-5 lines). Eight received an aromatase inhibitor, with 2 PR, 5 SD and 2 PD; 8 received oral progestins, with 4 PR, 5 SD and 2 PD. Nine patients (6/9 in first line, 1/9 in second line and 1/9 in third line) received antracyclines +/- ifosfamide and were evaluable for response: 2 had a CR, 4 a PR and 3 a SD. Median PFS was 7,6 months. Five patients received high-dose ifosfamide (HDIFX), obtaining 2 PR and 3 SD. Five pts received trabectedin, with 1 PR, 3 SD and 1 PD. All eleven pts with HGESS received systemic therapy for advanced disease (1-5 lines). Three patients received oral progestins, with PD. Ten pts received an antracycline-based combination chemotherapy and were evaluable for response: 5 had SD and 5 had PD. Median PFS was 3 months. Four pts received HDIFX and all progressed. Four pts received gemcitabine-based chemotherapy, obtaining 1 SD and 3 PD. Five pts received trabectedin, obtaining 1 SD and 4 PD. One pt received Pazopanib, with a PR lasting 5 months. Conclusions: In this series of endometrial stromal tumor pts treated with medical therapy, chemotherapy with antracycline-based combinations resulted in some objective responses in LGESS, while it was essentially inactive in HGESS. An observational clinical study is ongoing to expand this series.
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Bigozzi, Lucia, Chiara Malagoli, Chiara Pecini, Sara Pezzica, Claudio Vezzani, and Giulia Vettori. "Attention Components and Spelling Accuracy: Which Connections Matter?" Children 8, no. 7 (June 24, 2021): 539. http://dx.doi.org/10.3390/children8070539.
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Attention and working memory are cross-domain functions that regulate both behavioural and learning processes. Few longitudinal studies have focused on the impact of these cognitive resources on spelling skills in the early phase of learning to write. This longitudinal study investigates the contributions of attention and working memory processes to spelling accuracy and handwriting speed in 112 primary school children (2nd, 3rd, and 4th grade; age range: 7.6–9.4 years) learning to write in the Italian transparent orthography. Standardised batteries were used to assess their attention and working memory skills, as well as their spelling. Homophone and non-homophone errors were measured, as they may involve different attentional and working memory processes. The results showed that, for 2nd grade children, selective attention shifting, planning, and inhibition predicted non-homophone errors, whereas sequential working memory predicted homophone errors and writing speed was explained by planning and selective attention. In 3rd grade, only homophone errors were predicted by planning and inhibition. No significant relationships were found in 4th grade, nor in the transition across grades. Dynamic and diversified roles of attentional and working memory processes in predicting different writing skills in early primary school years emerged, with a gradual decrease in the attention–writing relationship with age.
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Capussotti, Giulia, and Chiara Meluzzi. "Egg and Jerry." Journal of Speech Sciences 9 (September 9, 2020): 31–48. http://dx.doi.org/10.20396/joss.v9i00.14968.
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In this paper we present a sociolinguistic research conducted on Italian schoolchildren learning English as LS. Following on from renowned researchers, we focused on a less studied population, that is school-aged monolingual children. Our participants consist in 15 students of a 4th grade class at a primary school in Pavia, all aged around 9 y.o, 7 boys and 8 girls. All children do not present any recorded cognitive problems and they are all Italian L1 speakers with little or no use of other languages at home, and English learnt as LS since the beginning of primary school at age 6. We recorded all children performing a task of re-narration of a “Tom & Jerry” cartoon, firstly in Italian and then, after one week, in English. The corpus consist of about 2h 45’ of recordings, transcribed and annotated in ELAN. Lexical knowledge in English was also tested through a questionnaire before the recordings. The results were analyzed both qualitatively and, partly, quantitatively. During qualitative analysis, two elements were observed: (1) general tendencies in speakers general behavior and (2) differences in the relationship between syntactic-conversational system and gesture system in relation to L1/L2. The quantitative analysis show a difference in the use of beats gestures and iconic ones between L1 and LS, but also between boys and girls.
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Francis, Leslie J., Olga Breskaya, and Ursula McKenna. "Attitudes toward Civil Human Rights among Italian Students of Sociology: The Effects of Religion and Theology." Religions 11, no. 12 (December 1, 2020): 643. http://dx.doi.org/10.3390/rel11120643.
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Connecting with and building on the research tradition established by The International Empirical Research Programmes in Religion and Human Rights, this study explores the power of two measures shaped within empirical theology (the Theology of Religions Index that distinguishes seven ways in which religions may be viewed and the New Indices of God Images that distinguishes between the God of Grace and the God of Law) to predict individual differences in attitude toward civil human rights among students of sociology under the age of thirty who had lived in Italy all their lives, after taking into account the effect of baptismal status (Catholic or not Catholic) and frequency of mass attendance. Data provided by 1046 participants demonstrated that more positive attitudes toward civil human rights are associated with being male, with not being baptised Catholic, with not attending mass, and with the God of Grace, but not with the God of Law. Five of the positions identified within the framework of the theology of religions are significant predictors of attitude toward civil human rights: the most positive attitude is associated with atheism and the least positive attitude is associated with exclusivism.
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Tarella, Corrado, Manuela Zanni, Michele Magni, Fabio Benedetti, Tiziano Barbui, Mario Boccadoro, Katia Patti, et al. "Benefit of Rituximab Addition to High-Dose Programs with Autograft for B-Cell Lymphoma: A Multicenter GITIL Survey on 957 Patients." Blood 108, no. 11 (November 16, 2006): 207. http://dx.doi.org/10.1182/blood.v108.11.207.207.
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Abstract Background: The outcome of B-cell lymphoma has definitely improved since the introduction of the anti-CD20 Rituximab, which can be effectively combined into conventional chemotherapy regimens. Rituximab can also be added to high-dose chemotherapy programs with autograft. However, the clinical benefit of combining Rituximab and autograft-based programs has not been proved yet. This issue is addressed in the present study. Patients and Methods: Data have been retrospectively collected on 957 B-cell lymphoma patients receiving a high-dose sequential (HDS) chemotherapy program, at 10 Italian Centers associated to GITIL (Gruppo Italiano Terapie Innovative nei Linfomi). Although the HDS schedule has been introduced almost 20 yrs. ago, most patients were treated in the last decade. They received most frequently either the HDS scheme adapted for follicular lymphoma (Tarella C et al. Leukemia 2000) or the hd-Ara-C-supplemented scheme developed for mantle-cell and diffuse large cell lymphoma (Magni M et al, Blood 2000; Cuttica A et al., Cancer 2003); overall, Rituximab was added to HDS (R+) in 483 (50.5%) patients, the remaining 474 (49.5%) received Rituximab-free HDS (R−). All patients entered the HDS-protocols due to high-risk prognostic features, their median age was 49 yrs. (range 17–70). The series included 403 patients (232 R+) with low-grade and 554 (251 R+) with intermediate/high grade B-cell lymphoma subtypes; HDS was delivered to 542 (259 R+) patients at diagnosis and to 415 (224 R+) at first or subsequent relapse. Results: at a median follow-up of 5 yrs, the 5-yr Overall Survival (OS) and Event-free Survival (EFS) projections were 66% and 55%, respectively, with a significantly better outcome for patients treated at diagnosis (5-yr OS: 72%, EFS: 61%) compared to patients at relapse (5-yr OS: 56%, EFS: 45%). In all instances, Rituximab addition was associated with significant improvements; in particular, the 5-yr EFS projections were:patients at diagnosis: 68% for R+ vs. 57% for R−;patients at relapse: 59% for R+ vs. 34% for R−;low-grade subtypes: 65% for R+ vs. 41% for R− (Figure 1A);intermediate/high-grade subtypes: 64% for R+ vs. 52% for R− (Figure 1B). In the Cox multivariate survival analysis, two factors had a significant impact on the EFS, i.e. relapse status at HDS (HR: 1.74, c.i.: 1.43–2.13) and Rituximab addition to HDS (HR: 0.60, c.i.: 0.49–0.75). Conclusions: the addition of Rituximab to high-dose programs with autograft may improve response and long-term outcome in high-risk B-cell lymphoma patients. Figure 1. EFS according to Rituximab [R] administration, in (A) low-grade and (B) intermediate/high-grade, B-cell lymphoma patients treated with a HDS program Figure 1. EFS according to Rituximab [R] administration, in (A) low-grade and (B) intermediate/high-grade, B-cell lymphoma patients treated with a HDS program
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Rossi, Francesca, Giulia Bellini, Livio Luongo, Iolanda Manzo, Salvatore Tolone, Chiara Tortora, Maria Ester Bernardo, et al. "Cannabinoid Receptor 2 as Antiobesity Target: Inflammation, Fat Storage, and Browning Modulation." Journal of Clinical Endocrinology & Metabolism 101, no. 9 (June 13, 2016): 3469–78. http://dx.doi.org/10.1210/jc.2015-4381.
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Abstract Context: Obesity is associated with a low-grade inflammatory state and adipocyte (ADP) hyperplasia/hypertrophy. Obesity inhibits the “browning” of white adipose tissue. Cannabinoid receptor 2 (CB2) agonists reduce food intake and induce antiobesity effect in mice. A common missense CB2 variant, Q63R, causes CB2-reduced function. Objective: To evaluate the influence of CB2 receptor on the modulation of childhood obesity and of ADP activity and morphology. Design: CB2-Q63R variant was analyzed in obese Italian children. The effects of an inflammatory stimulus and those of drugs selectively acting on CB2 were investigated on in vitro ADPs obtained from mesenchymal stem cells of adult healthy donors or from sc adipose biopsies of adult nonobese and obese subjects. Setting: Department of Women, Child and General and Specialist Surgery of the Second University of Naples. Patients or Other Participants: A total of 501 obese Italian children (age 11 ± 2.75). Twelve healthy bone marrow donors (age 36.5 ± 15); and 17 subjects, 7 lean (age 42 ± 10) and 10 obese (age 37.8 ± 12) underwent sc adipose tissue biopsies. Main Outcome Measures: Effects of CB2 stimulation on adipokine, perilipin, and uncoupling protein-1 expression. Results: The less-functional CB2-R63 variant was significantly associated with a high z-score body mass index. CB2 blockade with AM630 reverse agonist increased inflammatory adipokine release and fat storage and reduced browning. CB2 stimulation with JWH-133 agonist reversed all of the obesity-related effects. Conclusion: CB2 receptor is a novel pharmacological target that should be considered for obesity.
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Piazzolla, Francesca, Maria Luisa Amodio, Sandra Pati, and Giancarlo Colelli. "Evaluation of Quality and Storability of “Italia” Table Grapes Kept on the Vine in Comparison to Cold Storage Techniques." Foods 10, no. 5 (April 26, 2021): 943. http://dx.doi.org/10.3390/foods10050943.
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The aim of the study was to compare the quality of table grapes (cv. Italia) held on the vine compared to grapes stored in cold rooms with or without modified-atmosphere packaging (MAP). The grapes were harvested from 12 plants in 2 vineyards in the same area, differing for the age of the plant. Four- and a fourteen-year-old vines were cultivated with the “Apulia tendone” system. After the first harvest, grapes were divided into small clusters and used for storage treatments in air and in MAP. Samples of 400 g were packaged in polypropylene (PP) trays sealed with a polypropylene/polyamide (PP/PA) film with 20% CO2 in air. MAP and control samples were then stored in the same cold room at 0 °C. Initially and after 8, 21, and 28 days, grapes stored in air and MAP were compared to fresh harvested grapes, stored on the plants. Quality attributes included color, texture, maturity index, phenols, antioxidant activity, sugars, organic acids, sensory parameters, and volatile compounds. The results obtained demonstrated that grapes held on the plant and in MAP showed better quality in terms of appearance scores compared to grapes stored in air. In particular, the application of high CO2 contributed to reduce the deterioration rate of the clusters, minimizing weight loss, and delaying degradation processes, and this particularly for grapes from the 14-year-old vine, where grapes held on the plant degraded faster than grapes in the younger vines. Most volatile compounds did not change their concentration with the storage treatment, except for ethyl acetate and ethanol, which increased in MAP at the end of storage, and to some compound responsible for green odor. In conclusion, keeping the grapes on the plant can be considered a good agronomic practice to preserve the quality, whereas MAP can be applied to better maintain postharvest quality of the product throughout storage and distribution.
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Patti, Caterina, A. Zullo, L. Tedeschi, F. Di Raimondo, C. Hassan, U. Recine, M. Bibas, et al. "Clinical and Endoscopic Presentation of Primary Gastric Lymphoma: An Italian Multicenter Study." Blood 106, no. 11 (November 16, 2005): 4664. http://dx.doi.org/10.1182/blood.v106.11.4664.4664.
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Abstract Background. The stomach is the most frequent site of intestinal lymphomas. However, few data are available on the clinical-endoscopic presentation of gastric lymphoma as well as on possible differences in clinical pattern and endoscopic features between low-grade (LG) and high-grade (HG) lymphomas. In this study, we evaluated such aspects on consecutive primary gastric lymphoma patients observed in the last 12 years (1993–2004) in four Italian Hospitals (1 North, 2 Centre, 2 South). Methods. Clinical, histological, and endocospic records of consecutive patients diagnosed with LG or HG gastric lymphoma were retrieved and accurately evaluated. Symptoms were categorized as “alarm” (anaemia/melaena/heamorrage, persistent vomiting, weight loss) or “no alarm” (epigastric/abdominal pain, heartburn, dyspepsia/bloating). The endoscopic findings were classified as “normal” (no macroscopic lesions) or “abnormal” (ulcer, erosions, nodular pattern, hypertrophic folds, polypoid mass). Statistical analysis was carried out by using the Chi squared test. Results. During the study period, 143 patients with primary gastric lymphoma were detected. Overall, 61 patients were observed in the first 6 years and 82 in the last 6 years. The main results of the study are summarized in the table 1. Conclusions. The incidence of primary gastric lymphoma seems to be increasing. The overall prevalence of alarm symptoms is quite low, and they may be absent in near 75% of LG lymphoma patients. Moreover, contrarily to HG, LG lymphoma may present as a normal endoscopic finding and it is more frequently associated with H. pylori infection. At diagnosis, HG lymphoma is more frequently detected in an advanced stage as compared to LG lymphoma. Overall (143 patients) LG lymphoma (73 patients) HG lymphoma (70 patients) P value Age (mean ± SD) yrs 59.5 ± 14.2 59.4 ± 13.3 59.7 ± 15.1 0.4 Sex (M /F) 83/60 44/29 39/31 0.6 Alarm symptoms 57 (40%) 19 (26%) 38 (54%) 0.0009 Normal endoscopy 15 (10%) 15 (20%) 0 (0%) 0.0004 H. pylori infection 66 (73%) 47 (86%) 27 (39%) <0.0001 Stage (IA />IA) 78/65 58/15 20/50 <0.0001
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Luksch, Roberto, Giuseppe Maria Milano, Francesco Barretta, Alessandra Longhi, Emanuela Palmerini, Nadia Puma, Sebastian Dorin Asaftei, et al. "Efficacy of dose intensification in induction therapy for localized Ewing sarcoma: Italian Sarcoma Group (ISG) and Associazione Italiana Ematologia ed Oncologia Pediatrica (AIEOP) ISG/AIEOP EW-1 study." Journal of Clinical Oncology 39, no. 15_suppl (May 20, 2021): 11501. http://dx.doi.org/10.1200/jco.2021.39.15_suppl.11501.
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11501 Background: The role of dose intensification of chemotherapy in Ewing sarcoma (ES) is under evaluation in prospective trials. This is a controlled, randomized phase III study evaluating the impact on event-free survival (EFS) of two arms at different intensity of induction therapy in localized ES at onset. Methods: Newly diagnosed localized ES patients aged 2-40 were eligible. They were randomized to receive 4-courses induction therapy - 1 every 21 days - either with a standard arm (arm A) as per ISG/SSGIII protocol (Ferrari S, et at, Ann Oncol. 2011;22(5):1221) or with an intense arm B, consisting of vincristine 1,5mg/sqm+ doxorubicin 80mg/sqm+ifosfamide 9g/sqm for each course. After induction, patients underwent surgery and/or radiotherapy,followed by an adaptive treatment. Good responders received standard courses chemotherapy: arm A pts received 9 courses, while arm B pts received 5 courses. Poor responders in both arms received 4 courses followed by high-dose busulfan/melphalan+autologous stem cell rescue. The primary outcome measure was EFS for the 2 arms in the intention-to-treat population. Kaplan-Meier curves compared with log-rank test and Cox model were performed to assess differences between study arms. A secondary outcome was toxicity differences, assessed by means of the Fisher’s exact test. Initial sample size was 230 pts, type I error rate 5%, power 80%. Results: Between 2009 and 2019, 234 patients were randomized (arm A-115; arm B-119). M:F ratio was 1.8; median age 14 years (range 2-40); tumour site extremity in 55%, axial/pelvis in 45%; tumour volume < 200ml in 31% and ≥200ml in 69%. A good response was obtained in 56% in arm A and 60% in arm B. Median follow-up was 68 months. EFS was not significantly different between arms; HR: 0.85; 95% CI: 0,51-1,41, 5-year EFS (95% CI) was 73% (64-82%) in arm A and 75% (67-83%) in arm B ( p = 0.526). Good responders in arm A and in arm B and poor responders in arm B had comparable results: 5-year EFS (95% CI) was 80% (71-91%), 77% (67-88%), and 72% (59-86%), respectively, while poor responders in arm A showed a worse, not statistically significant (p = 0.164) performance (63%; 50-78%). Subgroup analyses showed similar outcome for age, tumour site and volume in both arms. Hematological, gastrointestinal, and cardiovascular grade ≥3 toxicities were more pronounced in arm B (p < 0.05). Conclusions: Intense induction therapy with arm B did not improve 5-year EFS when compared with the standard arm A. The higher toxicity observed in arm B than in arm A was counterbalanced, in good responders, by a similar outcome with a shorter treatment plan. For poor responders, with almost 30 patients per arm event-free and with < 48-month FUP, better 5-year EFS in arm B than in arm A was observed but needs further observation. Clinical trial information: NCT02063022.
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Cantisani, Giuseppe, and Giulia Del Serrone. "Procedure for the Identification of Existing Roads Alignment from Georeferenced Points Database." Infrastructures 6, no. 1 (December 24, 2020): 2. http://dx.doi.org/10.3390/infrastructures6010002.
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The aim of this research is to look for an automated, economical and fast method able to identify the elements of an existing road layout, whose original geometric design could date back to distant ages and could have undergone major modifications over the years. The analysis has been directed towards the Italian two-lane rural roads; the national public company ANAS made available its graph, obtained from high-performance surveys, that represents about 90% of these roads’ network. The graph is made up of a collection of georeferenced points but does not recognize or describe the geometric elements making up the roadway. Consequently, it has been necessary to design and develop an original procedure, subsequently implemented in a programming platform, able to identify the characteristics of the several parts, which constitute the reference axes of the existing roads. This research focuses on the horizontal geometry assessing the coherence, consistency and homogeneity of the roads’ layout, through the ex post application of the regulatory model for the design verification. If road sections are identified in which some conditions are not significantly met, further investigation should be conducted in order to ensure road safety and to plan any road upgrading activities.
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Mecucci, Cristina, Andrea Roncadori, Roberta La Starza, Francesco Arcioni, Alessandro Levis, Valeria Santini, Giuliana Alimena, et al. "Lenalidomide in Myelodysplastic Syndromes with 5q Deletion. Results From the Italian National Cancer Registry." Blood 120, no. 21 (November 16, 2012): 3850. http://dx.doi.org/10.1182/blood.v120.21.3850.3850.
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Abstract Abstract 3850 Background: Lenalidomide (LEN) is available in Italy for patients with intermediate-1- and low-risk myelodysplastic syndromes (MDS) associated with 5q deletion (5q-) since October 2008, based on a local disposition of the Italian Drug Agency (AIFA) issued according to a national law (Law 648/96). LEN is an oncological drug subject to intensive monitoring and, when it is prescribed in MDS, physicians are requested to enter the patient into a registry, which is entirely web-based. Methods: This observational, retrospective, multicenter study (registered at www.clinicaltrials.govasNCT01347944) has enrolled patients at 40 centres of 43 authorized in Italy. The study was approved by the ethic committee of each participating institution. The purpose was to analyse data available in the Registry and to integrate them with additional clinical and laboratory findings by filling up new e-forms in all cases with MDS and 5q- receiving LEN from October 31st, 2008 until the present. Diagnosis, treatment, follow-up and re-evaluation of patients were considered. Results: Study population included patients pre-treated and not pre-treated, with or without the integration form at the end of treatment. Pre-treated were defined as patients who were given LEN (from 1 to 12 cycles, median 3) before entering the AIFA registry. 158 patients (42 pre-treated and 116 not pre-treated) were eligible for this preliminary analysis. Median age was 75 (range, 38–89 years); 6 patients were younger than 50. There were 108 females (68.35%) and 50 males (31.6%) (table). Hematological findings evaluated at diagnosis were: hemoglobin (<8.5g/dL, 43% and >8.5g/dL, 57%), macrocytosis (MCV >98 fL, 54.4%), platelet count (<140×109/L, 24.7%; between 140 and 400×109/L, 56.3%; >400×109/L, 19%). Median white blood cell count was 4× 103/L with 54% neutrophils. Bone marrow blasts ≤5% were found in 75.9% of cases. The 5q- was detected by conventional cytogenetics in 131/158 cases (82.9%): it was isolated in 110 cases, associated with one additional in 15, and in complex karyotypes in 6. In 2 cases with normal karyotype and in 25 cases with failed cytogenetics the 5q- was demonstrated by fluorescence in situ hybridization (FISH). These cases could not be grouped as isolated or non-isolated. Patients received LEN at a daily dose of 10mg or 5 mg for 21 of 28 days as the starting dose. The dose and schedule was adjusted mainly based on blood count and hematological toxicity. Median time on treatment was 15.5 months (range, 1–45). Major and minor criteria for hematological and cytogenetic response are under evaluation. Transfusion independence at 6 months was reached in 77/103 cases (74.75%). Hematological toxicity could be evaluated in 148 cases. A total of 555 neutropenia events (36% grade 3 and 12.9% grade 4) and 422 thrombocytopenia events (10.9% grade 3 and 6.16% grade 4) were seen. Among 69 evaluable cases, 11 (15.9%) developed acute myeloid leukemia. In this group the median age was 72 (range, 62–85) and there were 4 males and 7 females. The median number of LEN cycles was 6 (range, 2–31). The median time from diagnosis of MDS was 34 months (range, 4–68). Chromosome 5q- at diagnosis was demonstrated by conventional cytogenetics in 8 cases (6 isolated and 2 with one additional change) and by FISH in 3. Comments: The Italian Drug Agency (AIFA) Registry provided us with a large series of MDS cases with 5q- to investigate appropriatness of LEN prescription and management. As expected LEN was successful to obtain transfusion independence in this patient population. Hematological toxicity was manageable. The number of cases with leukemic evolution is in line with data reported in the literature. These cases will be further investigated. Disclosures: Mecucci: CELGENE: Research Funding.
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Palassini, Elena, Stefano Ferrari, Paolo Verderio, Antonino De Paoli, Javier Martin Broto, Vittorio Quagliuolo, Alessandro Comandone, et al. "Feasibility of Preoperative Chemotherapy With or Without Radiation Therapy in Localized Soft Tissue Sarcomas of Limbs and Superficial Trunk in the Italian Sarcoma Group/Grupo Español de Investigación en Sarcomas Randomized Clinical Trial: Three Versus Five Cycles of Full-Dose Epirubicin Plus Ifosfamide." Journal of Clinical Oncology 33, no. 31 (November 1, 2015): 3628–34. http://dx.doi.org/10.1200/jco.2015.62.9394.
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Purpose We report on feasibility of preoperative chemotherapy with or without radiation therapy (RT) in the context of a phase III randomized clinical trial involving localized, high-risk, soft tissue sarcomas. Patients and Methods Of 321 eligible patients, 161 were randomly assigned to three preoperative cycles of epirubicin 120 mg/m2 plus ifosfamide 9 g/m2, and 160 were randomly assigned to three preoperative plus two postoperative cycles. Among them, 303 patients were included in this analysis; 169 were male and 134 were female, with a median age of 48 years (range, 15 to 79 years). One hundred fifty-two patients received concurrent RT preoperatively at a total dose of 44 to 50 Gy. Preoperative chemotherapy-related hematologic toxicity and early postoperative complications were reported. The influence of RT, age, and sex on hematologic grade 3 or 4 toxicities and wound complications was analyzed. Chemotherapeutic dose intensity (DI) was analyzed. Results Among the patients, 61.4%, 22.4%, and 23.8% experienced, grade 4 leucopenia, grade 3 or 4 anemia, and grade 3 or 4 thrombocytopenia, respectively. Respective rates were 66.4%, 24.3%, and 31.6% when RT was added preoperatively, and 56.3%, 20.5%, and 15.9% when preoperative chemotherapy was administered alone. Patient age affected grade 3 or 4 thrombocytopenia. Grade 4 leucopenia and grade 3 or 4 anemia presented 2.5 times more frequently in female patients than in male patients. Wound complications were observed in 13.5% of patients: 17% with preoperative RT and 10% without. Chemotherapeutic DI was greater than 90%, even in patients receiving preoperative RT and in patients age 65 years or older. Conclusion This preoperative chemotherapy is feasible and can also be proposed for selected elderly patients. Grade 3 or 4 hematologic toxicity was common, but DI was excellent. Concurrent preoperative RT is safe, although an increased rate of grade 4 thrombocytopenia and limited increase in wound complications may be observed.
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De Santis, S., V. Donato, M. R. Migliorino, B. Tedesco, S. Condo, and F. De Marinis. "Stage III non small lung cancer (NSCLC): Docetaxel (D), gemcitabine (G), and cisplatin (C) as induction chemotherapy, an Italian phase I study." Journal of Clinical Oncology 25, no. 18_suppl (June 20, 2007): 18201. http://dx.doi.org/10.1200/jco.2007.25.18_suppl.18201.
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18201 Background: Based on the several clinical trials, combined modality therapy became the standard of care for patients with stage III NSCLC “unresectable” with good performance status (Kathy S. Albain, Educational Book ASCO 2006, 453–461; Thomas E. Stinchcombe, Oncologist 2006, 11, 809–823). The most effective induction chemotherapy has yet to be determined. The objective of this prospective phase I study was to define the maximum tolerated dose (MTD), and to evaluate the activity and safety of one of the third generation triplets as a full dose neoadjuvant regimen in patients (pts) with unresectable Stage III NSCLC. Methods: In this study, chemotherapy-naïve pts with stage IIIA-N2 bulky and IIIB (except malignant pleural effusion) NSCLC were eligible. Inclusion into the trial and treatment decisions were done by multidisciplinary panel involving surgeons, medical oncologists and radiotherapists. All drugs were given intravenously on days 1 and 8, and repeated every 3 weeks up to 2 cycles followed by concurrent chemoradiation. D (30–35 mg/m2) was given first, followed by C (35 mg/m2) and G (1000 mg/m2). Results: From Jan ‘06 to Jul ‘06 twelve eligible pts were enrolled, 10/2 m/f gender; median age 63 (50–72), 1 patient with ECOG PS 0, 11 pts with PS 1; 5 pts with stage IIIA-N2 bulky, 7 pts with stage IIIB NSCLC; nine pts were smokers. All pts were evaluable for toxicity. Toxicity grade 3–4 by CTC criteria was: grade 3 neutropenia in 2/3 patients and grade 3 thrombocytopenia in 1/3 patients on the second dose level of chemotherapy (i.e. docetaxel 35 mg/m2), and was considered dose-limiting. Of 9 pts treated at the MTD (i.e. docetaxel 30 mg/m2), only 1 patient developed grade 4 neutropenia and 1 patient grade 3 thrombocytopenia; 3 patients (30%) had grade 2 neutropenia and grade 2 stomatitis. Of 12 evaluable pts for response, after induction chemotherapy eighty-three percent of patients (9/12 pts) had an objective response and 16,6% (2/9 pts) stable disease. Phase II is continuing for larger patient accrual. Conclusions: The recommended doses for further phase II studies are D (30 mg/m2) followed by C (35 mg/m2) and G (1000 mg/m2) every 3 weeks. This regimen is well tolerated and effective, and appears to be an excellent choice for stage III NSCLC. No significant financial relationships to disclose.
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Musto, Pellegrino, Stefano Luminari, Amalia De Renzo, Marcello Persico, Emilio Iannitto, Matteo Dell’Olio, Daniele Vallisa, et al. "Diffuse Large B-Cell Lymphomas (DLBCL) with Hepatitis-C Virus (HCV) Infection: Incidence, Clinical Outcome and Preliminary Results of Antiviral Treatments (AVT) after Chemotherapy." Blood 108, no. 11 (November 1, 2006): 2442. http://dx.doi.org/10.1182/blood.v108.11.2442.2442.
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Abstract A possible relationship between HCV and some sub-types of low-grade lymphomas (in particular, immunocytomas and nodal/extranodal marginal lymphomas) has been suggested. In these patients, AVT has shown to be effective in inducing neoplastic regression without chemotherapy (CT). In the present study we aimed to define epidemiological, clinical and therapeutic issues in DLBCL with concomitant HCV infection. We evaluated the incidence of HCV infection in 881 consecutive Italian patients with DLBCL (676 of whom collected by GISL - Gruppo Italiano Studio Linfomi, and 205 by ISS - Istituto Superiore di Sanità), in whom HCV determination was available. We found that 105 out of them (11.9%) were HCV+ve. We also looked at the clinical outcome of 61 patients, who had complete clinical and laboratory work-up and long term follow-up. With respect to a cohort of comparable historical controls without HCV infection, HCV+ve DLBCL showed older age (62 vs 48 years, p < 0.03), more frequently signs of liver damage (59% vs 8%, p < 0.001) and presence of monoclonal gammopathy (17% vs 3%, p < 0.05), increased rate of autoimmune disorders (19% vs 3 %, p < 0.02) and extranodal localizations (65.3% vs 35%, p < 0.04), including, in particular, liver, spleen, and other unusual sites (esophagous, vagina), often as primitive disease. First line CT for HCV+ve DLBCL. mainly consisted of classic/modified CHOP+/−rituximab or PROMACE-CytaBOM regimens. Response rate (complete + partial remission) was not different, approaching 60% in both groups. Six-year overall survival (OS) was also similar (62% for HCV+ve and 65% for HCV−ve DLBCL, p 0.67). However, during the first two years, there was a worse trend for HCV+ve patients with increased ALT levels, high viral load (> 800.000 IU RNA viral copies) and evidence of active hepatitis or cirrhosis at liver biopsy. Finally, we evaluated the possible role of AVT given after standard CT in HCV+ve DLBCL. Preliminary data available from 37 patients who have received at least three months of interferon (alpha or pegylated) +/− ribavirin in remission phase, indicate that such a sequential treatment is feasible, may induce complete virus clearance and may be associated with prolonged remission duration, without affecting, however, OS. In conclusion, about 12% of Italian patients with DBLCL have concomitant HCV infection and show some distinctive clinical and biological characteristics. In absence of liver dysfunction, these subjects should receive standard treatments as their HCV−ve counterparts. Monitoring of viral load and liver biopsy appears also to be useful for an appropriate management. A sequence of standard CT followed by AVT is a feasible approach which warrants to be further investigated.
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Guarino, Stefano, Enrico Mastrostefano, Massimo Bernaschi, Alessandro Celestini, Marco Cianfriglia, Davide Torre, and Lena Rebecca Zastrow. "Inferring Urban Social Networks from Publicly Available Data." Future Internet 13, no. 5 (April 26, 2021): 108. http://dx.doi.org/10.3390/fi13050108.
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The definition of suitable generative models for synthetic yet realistic social networks is a widely studied problem in the literature. By not being tied to any real data, random graph models cannot capture all the subtleties of real networks and are inadequate for many practical contexts—including areas of research, such as computational epidemiology, which are recently high on the agenda. At the same time, the so-called contact networks describe interactions, rather than relationships, and are strongly dependent on the application and on the size and quality of the sample data used to infer them. To fill the gap between these two approaches, we present a data-driven model for urban social networks, implemented and released as open source software. By using just widely available aggregated demographic and social-mixing data, we are able to create, for a territory of interest, an age-stratified and geo-referenced synthetic population whose individuals are connected by “strong ties” of two types: intra-household (e.g., kinship) or friendship. While household links are entirely data-driven, we propose a parametric probabilistic model for friendship, based on the assumption that distances and age differences play a role, and that not all individuals are equally sociable. The demographic and geographic factors governing the structure of the obtained network, under different configurations, are thoroughly studied through extensive simulations focused on three Italian cities of different size.
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Cozzi, Gabriele, Gennaro Musi, Matteo Ferro, Pierpaolo Prestianni, Roberto Bianchi, Garelli Giulia, Mistretta Francesco Alessandro, Stefano Luzzago, Elisabetta Pennacchioli, and Ottavio de Cobelli. "Robot-assisted inguinal lymphadenectomy: preliminary experience and perioperative outcomes from an Italian referral center." Therapeutic Advances in Urology 12 (January 2020): 175628722091338. http://dx.doi.org/10.1177/1756287220913386.
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Background: Inguinal lymphadenectomy remains the gold standard for the treatment of inguinal lymph node metastases from penile carcinoma, melanoma, Merkel cell carcinoma, and squamous cell carcinoma (SCC). This procedure is associated with significant complications. In order to reduce morbidity, minimally invasive approaches have been described. We report our preliminary experience with robot-assisted inguinal lymphadenectomies (RAIL). Methods: RAIL was performed according to the Sotelo technique. When indicated, a robot-assisted pelvic lymphadenectomy (RAPLND) was performed. We recorded age, sex, comorbidities, baseline oncologic diagnosis, operative time, hospital stay, lymph node yield, complications, time to drain removal, and oncologic outcomes. Results: From December 2016 to February 2019, 13 patients underwent RAIL. Median age was 65 years (range: 31–85 years). Primary malignancy was melanoma in five patients, Merkel cell carcinoma in four, dermal duct tumor in one, penile cancer in two, and SCC in one. RAIL was monolateral in 12 cases and bilateral in 1 case. A total of 10 monolateral RAPLNDs were performed; median operative time was 279 min (range: 169–320). Median lymph nodes yield was 11 (range: 2–24) for monolateral RAIL and 9 for monolateral RAPLND (range 2–24). Median hospital stay was 4 days (range: 2–5). No procedure was converted to open. Median follow up was 16 months (range: 5–31). Five Clavien-Dindo grade I complications were recorded. Median time to drain removal was 32.5 days (range 7–65). Three recurrences and two cancer-related deaths were recorded. Conclusions: RAIL is feasible and associated with a short hospital stay, with little incidence of perioperative complications.
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Gentile, Massimo, Stefania Ciolli, Stefano Molica, Nicola Di Renzo, Carmine Selleri, Maria Rosaria Villa, Maria Rosaria De Paolis, et al. "Bendamustine in Combination with Rituximab for Previously Untreated Chronic Lymphocytic Leukemia (CLL) Patients: An Italian Retrospective Multicentre Study." Blood 124, no. 21 (December 6, 2014): 1985. http://dx.doi.org/10.1182/blood.v124.21.1985.1985.
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Abstract BACKGROUND: The combination schedule of rituximab, fludarabine and cyclophosphamide is considered the standard therapy for fit and young untreated chronic lymphocytic leukemia (CLL) patients. However, although this therapy improves progression free survival (PFS) and overall survival (OS), it has been associated with increased toxicity: 76% of the patients experienced at least one grade 3 or 4 event. Recently, encouraging clinical results in terms of safety and efficacy have been obtained using bendamustine in combination with rituximab (R-B) in untreated CLL patients. PURPOSE: We performed a multicentre retrospective study to assess safety and efficacy of R-B in a large group of untreated CLL patients. METHODS: One hundred and thirty six untreated CLL patients were recruited from 16 Italian Institutions and included in the present analysis. The median age was 69 years (range 43–85), with 49.3% of patients older than 70 years; 53.7% of cases were male. All patients had active disease as defined by the NCI-WG, and 27.2% were at Binet stage C. FISH data, available in 86/136 cases, identified a del(17p) in 5.1% of the patients and del(11q) in 5.9%. Sixty-four patients (47.1%) had a creatinine clearance ≤70 mL/min. Fifty-six % of cases showed a WHO performance status (PS) of I-II and 61% a CIRS comorbidity index >0. RESULTS: Among the 136 patients, 90 cases (66.2%) received B at the dosage of 90 mg/m2 on day 1 and 2 every 28 days, the remaining 46 cases received B at the dosage of 70 or 80 mg/m2. R was administered at the dosage of 375 mg/m2 on day 1 of all cycles in 59.6% of cases, while 40.4% received 375 mg/m2 on day 1 of the first cycle and 500 mg/m2 on day 1 of the other cycles. A total of 725 cycles were administered with a median number of 6 cycles per patient. Eighteen patients (13.2%) required early discontinuation of therapy before the sixth cycle for serious infections (n=7), persistent hematological toxicity (n=5), grade 4 dermatological toxicity (n=3), withdrawal of consent (n=2), hypersomnia and depression (n=1). Grade 3 or 4 adverse events for neutropenia, thrombocytopenia, and anemia were documented in 25.8%, 25.8%, and 16.2% of patients, respectively. Grade 3 or 4 severe infections occurred in 6.6% of patients. The overall response rate (ORR) was 93.4%, 48 patients (35.3%) achieved a complete response (CR), 79 (58.1%) a partial response (PR), 8 (5.9%) a stable disease (SD) and in 1 patient (0.7%) no response assessment was performed due to death prior to terminating therapy. In the high-risk group with del17p, 5/7 (71.4%) cases achieved a PR and 2 a SD. Age >70 years (P=0.026) and del17p (P=0.007) were the only two parameters significantly associated with a lower response rate, while del11q and unmutated IGHV, as well as creatinine clearance <70 ml/min, elevated β2-microglobulin, PS and CIRS CI >0 did not seem to impact on achievement of response. The only parameter predictive of the probability of achieving a CR was an age <70 years (P=0.03). When the analysis was restricted to cases with available FISH data, excluding patients with del17p, biological (CD38, ZAP-70, IGHV mutational status, FISH risk) and clinical parameters (age, β2-microglobulin, LDH, PS, CIRS CI, and creatinine clearance) did not significantly impact on the probability of achieving a response or on quality of response. After a median follow-up of 14 months, 2-year PFS was 87% and 2-year OS 84.5% (14 deaths occurred). Eight of 14 deaths were CLL-related (infections in 6 cases and disease progression in 2). CONCLUSIONS: The clinical practice of the Italian centers taking part in the study confirms that chemoimmunotherapy with R-B was an effective and well-tolerated treatment for untreated CLL patients. In patients with del17p the therapy appears to be less efficacious. Disclosures Off Label Use: Bendamustine in diffuse large B-cell lymphoma. Zinzani:Genentech, inc.: Membership on an entity's Board of Directors or advisory committees.
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Zaniboni, Alberto, Carlo Antonio Barone, Maria Chiara Banzi, Francesca Bergamo, Livio Blasi, Roberto Bordonaro, Maria Di Bartolomeo, et al. "Italian results of the PRECONNECT study: safety and efficacy of trifluridine/tipiracil in metastatic colorectal cancer." Future Oncology 17, no. 18 (June 2021): 2315–24. http://dx.doi.org/10.2217/fon-2020-1278.
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The international PRECONNECT Phase IIIb study demonstrated safety and efficacy of trifluridine/tipiracil in the management of patients with metastatic colorectal cancer. Post-hoc analyses in a national context are important because of the differences in disease management across countries. Post-hoc safety and efficacy analyses in the PRECONNECT Italian patient subset were conducted. Patients' quality of life was assessed from baseline to end of treatment. In Italy, 161 patients were enrolled. The median age was 64 years, with a performance status of 0–1. The most common hematological drug-related adverse events ≥grade 3 were neutropenia (41.0%) and anemia (13.7%). The median progression-free survival was reached at 3.0 months, with a disease control rate of 28.6%. The Quality of Life Questionnaire Core 30 score improved in 25.4% of the patients. Safety, efficacy and quality of life results confirmed trifluridine/tipiracil as a feasible and favorable treatment option for metastatic colorectal cancer patients.
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Smorti, Andrea, Anne McKeough, Enrica Ciucci, Michael Pyryt, Nicki Wilson, Alex Sanderson, and Tak Fung. "What shapes narrative thought?" Narrative Inquiry 17, no. 2 (December 31, 2007): 329–47. http://dx.doi.org/10.1075/ni.17.2.09smo.
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The primary aims of the study were to investigate the narrative strategies used by Italian and Canadian youth on progressive (improving interactions) and regressive (degenerating interactions) stories and to investigate potential differences in story interpretation across the two countries. Two hundred and six participants, matched for age, gender and SES, were selected from fifth and seventh grade classrooms in Calgary, Canada, and Florence, Italy. Participants were presented with six stories of social interaction between peers, in which the protagonist performed an act that differed markedly from his/her habitual behavior towards a classmate, and asked to describe events that led to the discrepant act and to interpret the social attitude of the protagonist. The results showed that participants used different narrative strategies on the two story types. Moreover, country of residence shaped the children’s narrative interpretations.
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Auletta, Andrea F., Simone Cupellaro, Luigi Abbate, Elena Aiello, Pamela Cornacchia, Claudia Norcia, and Carla Sogos. "SCORS-G and Card Pull Effect of TAT Stories: A Study With a Nonclinical Sample of Children." Assessment 27, no. 6 (June 17, 2018): 1368–77. http://dx.doi.org/10.1177/1073191118781014.
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Previous research has shown that stimulus pull is one of the contributory factors influencing Thematic Apperception Test (TAT) responses. In recent years, there has been a resurgence of studies examining this. In particular, the Social Cognition and Object Relations Scale–Global Rating Method (SCORS-G) has been employed to examine stimulus pull in adult clinical and nonclinical samples. The present study is the first attempt to examine this issue in a nonclinical sample of children. Ninety-eight children from Italian elementary (1st to 5th grade) and middle (6th to 8th grade) schools provided narratives to six TAT cards (1, 2, 3BM, 4, 8BM, and 16). Some important findings with regard to variance within scales replicate prior findings from other studies. Furthermore, some findings regarding the specific nature of pull for particular TAT cards (1, 2, 3BM, and 4) replicate prior work. Given that Cards 8BM and 16’s SCORS-G stimulus properties have not been previously studied, the pull of these cards is explored. Last, SCORS-G differences/similarities across these two age groups are highlighted. Suggestions for further research in this field are also provided, particularly concerning the use of SCORS-G and TAT for clinical assessment.
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Marsigalia, Bruno, Renato Giovannini, and Emanuela Palumbo. "Family cumulative knowledge and firm’s financial performance: An empirical investigation of the wine companies’ governance." Corporate Governance and Sustainability Review 3, no. 1 (2019): 8–17. http://dx.doi.org/10.22495/cgsrv3i1p1.
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Family business is one of the most common governance systems worldwide and it is very successful in industries with strong cultural traditions, as the wine business. The literature still disagrees on whether the familiar corporate structure increases performance or not. Our empirical paper aims to investigate the effect of a long-term company culture in terms of economic performance and firm value. Is it possible to track the cumulative knowledge (passed from father to son) into firm economic returns? Using a qualitative and a quantitative research approach, the survey tests the hypothesis that the more experienced companies (higher firm age) will perform better than the others considering a set of performance indicators on a four years pattern (from firm value to EVA and VAIC). Comparing firm longevity with the performance indicators, but also monitoring many other corporate governance or ownership indicators, on a panel dataset of the top Italian wine companies, developing the statistical models of regression and correlation to verify the relationship between performance indicators and a set of corporate governance/ownership variables. This methodology results in a deep analysis of the Italian wine business, that also describes the family buy-out strategy and the cooperative ownership structure (which could be considered somehow a micro-families aggregative model). Proper family firms represent 42% of the panel, with more than 200 years of experience, a larger presence of women on board, a higher average age of the directors and a higher propensity to the production of grapes. Moreover, they have the greatest longevity and perform better than the other two groups, non-family firms and cooperatives.
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Ruda, Roberta, Luca Bertero, Elisa Trevisan, Andrea Pace, Carmine Maria Carapella, Cristina Dealis, Manuela Caroli, Marina Faedi, Chiara Bomprezzi, and Riccardo Soffietti. "Phase II trial of dose-dense temozolomide as initial treatment for progressive low-grade oligodendroglial tumors: A multicentric study of the Italian Association of Neuro-Oncology (AINO)." Journal of Clinical Oncology 30, no. 15_suppl (May 20, 2012): 2037. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.2037.
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2037 Background: Standard temozolomide has been shown to be active in progressive low grade gliomas after surgery, whereas few data are available on the impact of dose dense regimens. Thus, we developed a phase II single arm multicenter study to evaluate the efficacy and toxicity of a regimen of dose dense temozolomide in progressive low grade oligodendroglial tumors. Methods: The inclusion criteria of the study were as follows: 1)biopsy-proven supratentorial WHO grade II oligodendroglioma and oligoastrocytoma; 2)progressive disease, clinically (epileptic seizures)or radiologically; 3)measurable disease on MRI (at least 1 cm); 4)age ≥18 years; 5)Karnofsky Performance Status ≥70. Temozolomide was administered at 150mg/m2 1 week on/1 week off up to a maximum of 18 cycles or unacceptable toxicity. The primary end-point was response rate (RR) according to RANO criteria, whereas secondary end-points were clinical benefit in terms of reduction of epileptic seizures ≥50%, progression-free survival (PFS), quality of life and toxicity. Results: From January 2005 until December 2010 60 patients (median age 39 and median KPS 80) have been accrued and are now evaluable for response. Response rates on T2/FLAIR images were as follows: CR 0/60, PR 21/60 (35%), MR 14/60 (23%), SD 21/60 (35%) and PD 4/60 (7%). The clinical benefit was significant in 29/34 patients (85%). As for toxicity 5/60 (8%) patients stopped treatment for lymphopenia grade IV, whereas 11/31 patients (35%) were switched to the standard regimen of temozolomide. PET with methionine was added to MRI in 17 patients: in 10/17 (59%) a disappearance or a significant reduction of uptake was observed, being the reduction of seizures better correlated with the response on PET rather than that on MRI. 1p/19q codeletion was not associated with either the response or the clinical benefit, whereas the analysis of MGMT methylation and IDH1 mutations are ongoing. Thirty-nine (65%) patients are still free of tumor progression. Conclusions: Dose-dense TMZ seems to be active, especially in terms of clinical benefit, but the myelotoxicity could be a concern.
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Marucci, Eleonora, Beau Oldenburg, and Davide Barrera. "Do teachers know their students? Examining teacher attunement in secondary schools." School Psychology International 39, no. 4 (August 2018): 416–32. http://dx.doi.org/10.1177/0143034318786536.
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Using survey data from 457 Italian sixth grade secondary school students ( M age = 11.9, SD = 0.7, 46% girls) and 58 of their teachers ( M age = 45.7, SD = 9.4, 92.8% female) this study examined the extent to which secondary school teachers were attuned to their students. More specifically, we investigated the extent to which teachers were aware of which students were highly liked, disliked, prosocial, aggressive, or engaged in risky behavior. For each of these five dimensions, teacher attunement was measured by comparing teacher’s nominations to the proportion of received peer nominations per student. Then, a general teacher attunement score was constructed by calculating the mean of these five scores. Descriptive analyses showed a moderate teacher attunement, which was highest for prosocial behavior and lowest for risk behavior. It was investigated whether certain teachers had a higher attunement than others. Our analyses showed that teacher attunement was positively associated with the amount of time teachers spent with their students and with their experience as a teacher. Furthermore, attunement was negatively associated with classroom size.
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Sant, Milena, Gemma Gatta, Fulvia Valente, Alessandro Barchielli, Valerio Ramazzotti, Lidia Serventi, and Stefano Rosso. "The Itacare Study." Tumori Journal 83, no. 1 (January 1997): 17–24. http://dx.doi.org/10.1177/030089169708300106.
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ITACARE is a collaborative study on the survival of Italian cancer patients diagnosed in the period 1978–1989. The study involves 11 Italian population-based cancer registries (CRs) (Firenze, Forlì-Ravenna, Genova, Latina, Modena, Parma, Ragusa, Torino, Varese, the childhood CR of Piedmont and the colorectal CR of Modena), and its principal aim is to identify and analyze possible differences between the areas covered by the CRs. This article describes the ITACARE database. Ten percent of the Italian population is covered by the participating CRs, most of which are located in the northern part of the country. All malignant cancer sites (classified by ICD-9) except skin cancers were included. For bladder cancers, papillomas and transitional cell tumours grade 1 and 2 were also included. Survival data on over 100,000 cases were collected. The principal information variables were sex, date of birth, diagnosis and end of follow-up, life status, ICD-9 code for tumour site, diagnosis modality (clinical, cytologic confirmation, histologic confirmation), ICD-0 morphology code, and tumour stage (grouped into broad categories). Follow-up is active in all registries. All cases were checked systematically for errors and inconsistencies, following which about 0.2% of cases were excluded from the analyses. The percentage of cases microscopically verified, which is an indicator of diagnostic accuracy and data reliability, was higher among patients under 65 years of age (90%), breast cancer patients (92%) and cases covered by the Varese, Torino and Forlì-Ravenna CRs (more than 82%). The percentage of cases known by death certificate only (an indicator of the completeness and quality of registration) was about 3% of total cases and was higher among older patients (4%). Province-specific mortality, used to compute relative survival from cancer (i.e., survival adjusted for competing causes of death), varied according to period of diagnosis, sex and area: the highest mortality was among women of the Ragusa CR (Sicily) and men in northern CRs. Overall mortality decreased during the period, more markedly in the north and among women.
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Ricci, B., G. Coppola, A. Capobianco, and L. Ziccardi. "Penetrating Keratoplasty in a Newborn: Case Report and Analysis of Current Surgical Trends in Italy." European Journal of Ophthalmology 18, no. 2 (March 2008): 290–93. http://dx.doi.org/10.1177/112067210801800220.
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Purpose The aims of this study were to describe bilateral penetrating keratoplasty (PK) in a newborn and to analyze the data of PKs performed in Italy during the 5-year period 1999–2003 in children under 4 years of age. Methods A male newborn had PK at age 3 months and 5 months for near-blindness secondary to severe congenital corneal clouding in both eyes. The infant's explanted corneas were subjected to histochemical and ultrastructural analyses. Data regarding the number of PKs performed in Italy on 0–4-year-olds were obtained from the Web site of the Italian Ministry of Health. Results The postoperative courses were uncomplicated, and 42 months of follow-up data show bilateral graft transparency and substantial improvement in visual acuity despite high-grade myopia and nystagmus. At the ultrastructural level, the main alterations involved the endothelial cells and Descemet membrane. A total of 45 PKs were performed in Italy on patients 0–4 years old from 1999 through 2003; only nine involved babies under 1 year of age. Conclusions In babies with congenital corneal opacities, early PK can reduce severe amblyopia. However, the risk of intra- and postoperative complications in PK is high. Based on the 42-month follow-up, the anatomic and functional results achieved in the current patient are satisfactory despite the presence of nystagmus and postoperative high-grade myopia. This study shows that PKs are rarely performed, in Italy, in children aged 0–4 years, and very few are done during the first year of life.
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Muka, Rina, and Irida Hoti. "FIRST AND SECOND LANGUAGE LEARNING THROUGH TEXTBOOKS IN ALBANIAN SCHOOLS (COMPARATIVE OVERVIEW OF ALBANIAN AND ENGLISH LANGUAGE TEXTBOOKS)." Knowledge International Journal 28, no. 7 (December 10, 2018): 2319–24. http://dx.doi.org/10.35120/kij28072319r.
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The language acquired from the childhood is the language spoken in the family and in the place of living. This language is different from one pupil to another, because of their social, economical conditions. By starting the school the pupil faces first the ABC book and then in the second grade Albanian language learning through the Albanian language textbook. By learning Albanian language step by step focused on Reading, Writing, Speaking and Grammar the pupil is able to start learning the second language on the next years of schooling. So, the second language learning in Albanian schools is related to the first language learning (mother tongue), since the early years in primary school. In our schools, the second language (English, Italian) starts in the third grade of the elementary class. On the third grade isn’t taught grammar but the pupil is directed toward the correct usage of the language. The textbooks are structured in developing the pupil’s critical thinking. The textbooks are fully illustrated and with attractive and educative lessons adequate to the age of the pupils. This comparative study will reflect some important aspects of language learning in Albanian schools (focused on Albanian language - first language and English language - second language), grade 3-6. Our point of view in this paper will show not only the diversity of the themes, the lines and the sub-lines but also the level of language knowledge acquired at each level of education. First, the study will focus on some important issues in comparing Albanian and English language texts as well as those which make them different: chronology and topics retaken from one level of education to another, so by conception of linear and chronological order will be shown comparatively two learned languages (mother tongue and second language). By knowing and learning well mother tongue will be easier for the pupil the foreign language learning. The foreign language (as a learning curriculum) aims to provide students with the skills of using foreign language written and spoken to enable the literature to recognize the achievements of advanced world science and technology that are in the interest of developing our technique. Secondly, the study will be based on the extent of grammatical knowledge, their integration with 'Listening, Reading, Speaking and Writing' as well as the inclusion of language games and their role in language learning. The first and second language learning in Albanian schools (grade III-VI) is based on similar principles for the linearity and chronology of grammatical knowledge integrated with listening, reading, writing and speaking. The different structure of both books help the pupils integrate and use correctly both languages. In the end of the sixth grade, the pupils have good knowledge of mother tongue and the second language and are able to write and speak well both languages.
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Muka, Rina, and Irida Hoti. "FIRST AND SECOND LANGUAGE LEARNING THROUGH TEXTBOOKS IN ALBANIAN SCHOOLS (COMPARATIVE OVERVIEW OF ALBANIAN AND ENGLISH LANGUAGE TEXTBOOKS)." Knowledge International Journal 28, no. 7 (December 10, 2018): 2319–24. http://dx.doi.org/10.35120/kij29082319r.
Full textAbstract:
The language acquired from the childhood is the language spoken in the family and in the place of living. This language is different from one pupil to another, because of their social, economical conditions. By starting the school the pupil faces first the ABC book and then in the second grade Albanian language learning through the Albanian language textbook. By learning Albanian language step by step focused on Reading, Writing, Speaking and Grammar the pupil is able to start learning the second language on the next years of schooling. So, the second language learning in Albanian schools is related to the first language learning (mother tongue), since the early years in primary school. In our schools, the second language (English, Italian) starts in the third grade of the elementary class. On the third grade isn’t taught grammar but the pupil is directed toward the correct usage of the language. The textbooks are structured in developing the pupil’s critical thinking. The textbooks are fully illustrated and with attractive and educative lessons adequate to the age of the pupils. This comparative study will reflect some important aspects of language learning in Albanian schools (focused on Albanian language - first language and English language - second language), grade 3-6. Our point of view in this paper will show not only the diversity of the themes, the lines and the sub-lines but also the level of language knowledge acquired at each level of education. First, the study will focus on some important issues in comparing Albanian and English language texts as well as those which make them different: chronology and topics retaken from one level of education to another, so by conception of linear and chronological order will be shown comparatively two learned languages (mother tongue and second language). By knowing and learning well mother tongue will be easier for the pupil the foreign language learning. The foreign language (as a learning curriculum) aims to provide students with the skills of using foreign language written and spoken to enable the literature to recognize the achievements of advanced world science and technology that are in the interest of developing our technique. Secondly, the study will be based on the extent of grammatical knowledge, their integration with 'Listening, Reading, Speaking and Writing' as well as the inclusion of language games and their role in language learning. The first and second language learning in Albanian schools (grade III-VI) is based on similar principles for the linearity and chronology of grammatical knowledge integrated with listening, reading, writing and speaking. The different structure of both books help the pupils integrate and use correctly both languages. In the end of the sixth grade, the pupils have good knowledge of mother tongue and the second language and are able to write and speak well both languages.
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Mazzei, Maria Antonietta, Giulio Bagnacci, Francesco Gentili, Andrea Nigri, Veronica Pelini, Carla Vindigni, Francesco Giuseppe Mazzei, et al. "Gastric Cancer Maximum Tumour Diameter Reduction Rate at CT Examination as a Radiological Index for Predicting Histopathological Regression after Neoadjuvant Treatment: A Multicentre GIRCG Study." Gastroenterology Research and Practice 2018 (2018): 1–10. http://dx.doi.org/10.1155/2018/1794524.
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Aim. To investigate the role of maximum tumour diameter (D-max) reduction rate at CT examination in predicting histopathological tumour regression grade (TRG according to the Becker grade), after neoadjuvant chemotherapy (NAC), in patients with resectable advanced gastric cancer (AGC). Materials and Methods. Eighty-six patients (53 M, mean age 62.1 years) with resectable AGC (≥T3 or N+), treated with NAC and radical surgery, were enrolled from 5 centres of the Italian Research Group for Gastric Cancer (GIRCG). Staging and restaging CT and histological results were retrospectively reviewed. CT examinations were contrast enhanced, and the stomach was previously distended. The D-max was measured using 2D software and compared with Becker TRG. Statistical data were obtained using “R” software. Results. The interobserver agreement was good/very good. Becker TRG was predicted by CT with a sensitivity and specificity, respectively, of 97.3% and 90.9% for Becker 1 (D-max reduction rate > 65.1%), 76.4% and 80% for Becker 3 (D-max reduction rate < 29.9%), and 70.8% and 83.9% for Becker 2. Correlation between radiological and histological D-max measurements was strongly confirmed by the correlation index (c.i.= 0.829). Conclusions. D-max reduction rate in AGC patients may be helpful as a simple and reproducible radiological index in predicting TRG after NAC.
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Gadducci, Angiolo, Stefania Cosio, Paolo Zola, Benedetta Sostegni, Luca Fuso, and Enrico Sartori. "Prognostic Factors and Clinical Outcome of Patients With Recurrent Early-Stage Epithelial Ovarian Cancer: An Italian Multicenter Retrospective Study." International Journal of Gynecologic Cancer 23, no. 3 (March 2013): 461–68. http://dx.doi.org/10.1097/igc.0b013e318286665b.
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ObjectiveThe objective of this study was to assess the clinical outcome of patients with recurrent early-stage ovarian cancer.MethodsThe hospital records of 87 patients were reviewed. The median follow-up of survivors from recurrence was 87.6 months.ResultsThe 25%, 50%, and 75% quantiles of time to recurrence were 15, 25, and 44 months, respectively. The pelvis was the most common site of failure (39.1%), followed by abdomen (18.3%) and retroperitoneal nodes (18.3%). Treatment at recurrence consisted of chemotherapy in 46 patients, surgery plus chemotherapy in 29, surgery in 3, surgery plus radiotherapy in 2, and other therapies in 7. A macroscopically complete cytoreduction was obtained in 29 (85.2%) of the 34 patients who underwent secondary surgery. Five- and 7-year survival rates after recurrence were 34.3% and 29.6%. By log-rank test, survival after recurrence was related to patient age (≤60 vs >60 years; P = 0.001), time to recurrence (>15 vs ≤15 months; P = 0.049), site of recurrence (retroperitoneum vs pelvis vs other; P = 0.004), and surgery at recurrence (yes vs not; P = 0.001), but not to substage, histotype, grade, prior adjuvant chemotherapy, examination that detected recurrence, and chemotherapy at recurrence. On multivariate analysis, patient age (hazard ratio, 1.836; 95% confidence interval, 1.060-3.180) and surgical treatment at recurrence (hazard ratio, 1.972; 95% confidence interval, 1.084–3.587) were independent prognostic variables for survival after recurrence.ConclusionsPatient age and surgery at recurrence were independent prognostic variables for patients with recurrent early-stage ovarian cancer. When feasible, salvage surgery appears to give a survival advantage in this clinical setting.
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Sinicrope, F., P. Benatti, N. R. Foster, S. Marsoni, G. Monges, R. Labianca, G. A. Yothers, S. Gallinger, and D. J. Sargent. "Detecting deficient DNA mismatch repair in stage II and III colon cancers." Journal of Clinical Oncology 29, no. 4_suppl (February 1, 2011): 419. http://dx.doi.org/10.1200/jco.2011.29.4_suppl.419.
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419 Background: Deficient DNA mismatch repair (MMR) results in microsatellite instability (MSI) that is detected in ∼15% of sporadic colon cancers. MMR status has been shown to provide prognostic and predictive information. We developed a model to predict MMR deficiency using clinically available data, and thereby facilitate the selection of patient tumors for MMR testing. Methods: Data were utilized from stage II and III colon carcinoma patients (n = 2016) who participated in 5-fluorouracil-based adjuvant studies (NCCTG, FFCD, NCIC, GIVIO, NSABP) and an Italian cohort. MMR status in tumors had been determined by MSI testing or by immunohistochemistry for hMLH1 and hMSH2 proteins. Logistic regression and a recursive partitioning and amalgamation analysis was used to identify factors (histologic grade, gender, tumor site, stage, age, lymph node status, T-stage) predictive of MMR status. Results: Of the cancers, 357 (17.7%) showed deficient MMR. Tumor site was the most important predictor of MMR status followed by histologic grade, then stage (II vs. III) and then gender. Distal tumors had a low likelihood of deficient MMR (5% rate overall), whereas proximal tumors had a greater likelihood of deficient MMR (30%). For patients with proximal tumors, the addition of histologic grade and stage increased the prediction of deficient MMR (Table). Using tumor site, histologic grade, and stage, the logistic regression model showed excellent discrimination (c-statistic = 0.80). Conclusions: Routine clinicopathological data can facilitate the identification of MMR deficient cases. Tumor site and histologic grade were the strongest predictors of MMR deficiency. Within proximal, poorly differentiated tumors, stage was highly predictive. These findings suggest that our model can assist in selecting sporadic colon cancers for MMR testing for use in clinical decision-making, especially for stage II patients. [Table: see text] [Table: see text]
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Menegazzi, Paola, Luisa Barzon, Giorgio Palù, Elisa Reho, and Luigi Tagliaferro. "Human Papillomavirus Type Distribution and Correlation with Cyto-Histological Patterns in Women from the South of Italy." Infectious Diseases in Obstetrics and Gynecology 2009 (2009): 1–4. http://dx.doi.org/10.1155/2009/198425.
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Human papillomavirus (HPV) type-specific distribution was evaluated in genital samples collected from 654 women from the South of Italy undergoing voluntary screening and correlated with cyto-histological abnormalities. HPV DNA was detected in 45.9% of the samples, 41.7% of which had multiple infection and 89.0% had high-risk HPV infection. The prevalence of HPV infection and the rate of multiple infections decreased with age, suggesting natural selection of HPV types with better fitness. In line with other Italian studies, the most common HPV types were HPV-6 and HPV-16, followed by HPV-51, HPV-31, HPV-53, and HPV-66, in women with both normal and abnormal cytology. Cervical intraepithelial lesions grade 2 or 3 were associated with high-risk HPV-16, HPV-18, HPV-31, and HPV-51 infection. These data indicate that prophylactic HPV vaccination is expected to reduce the burden of HPV-related cervical lesions in this population, but also suggest the potential utility of new vaccines with larger type coverage.
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Carella, A. M., S. Nati, G. Fraternali Orcioni, M. Petrini, S. Galimberti, U. Vitolo, N. Cascavilla, and P. L. Zinzani. "90y Ibritumomab Tiuxetan as Initial Treatment for Follicular Lymphoma (ZEUS Protocol). An Italian Cooperative Study Group." Blood 112, no. 11 (November 16, 2008): 3061. http://dx.doi.org/10.1182/blood.v112.11.3061.3061.
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Abstract Background: Approximately 80% of patients with Follicular Lymphoma present with disseminated disease, which is consider incurable with standard treatment. Monoclonal antibodies labeled with radionuclides can potentially deliver cytocidal doses of radiation to all sites of disseminated disease. Anti-CD20 radioimmunotherapy has resulted effective in patients who have had relapse after chemotherapy or who have refractory. More recently, radioimmunotherapy (131I-Tositumomab) has been tested also in previously untreated patients with very good results (Kaminsky et al. NEJM, 2005;352:441). Methods: This study is an open-label, prospective, phase II evaluation of efficacy and safety of a single course of 90Y-ibritumomab tiuxetan at a standard dose of 15 MBq/kg (or 0.4 mCi/kg) in untreated follicular NHL patients. From February 2007, 27 patients with stage III–IV FL received at diagnosis a single course of treatment with 90Y Ibritumomab Tiuxetan (registered as Zevalin). The drug for this study has been suppored by Bayer-Italy. Fifteen patients have enough follow-up for a first evaluation. Eligibility criteria were as follows: CD20 positive follicular lymphoma grade 1 or 2; an age of at least 18 years; no prior therapy, Ann Harbor stage III or IV; at least one bidimensional measurable lesion; involvement of 25% or less of the marrow by lymphoma on trephine biopsy and an absolute neutrophil and platelet count of >1.500×103/ml and 100.000×103/ml, respectively. Results: Ninety-three percent (14/15 patients) of the patients had any response, and 73% (11/15 patients) had a complete remission. The use of PCR to detect rearrangement of the BCL2 gene was positive at diagnosis in 7/11 remitters patients; six out of these 7 patients developed molecular response and are in continuous complete remission 4–18 months (median, 9 months) after therapy. After a median follow-up of 10 months (range, 4–18 months), 14 patients (93%) are alive, of whom 10 patients in continous complete remission. One remitter patient died of brain stroke; the cause of death was not linked to Zevalin. No patient required hematopoietic growth factors. By week 4, seven patients developed grade 3 thrombocytopenia and 5 of them required platelet transfusions. Until now, no patient developed signs of MDS. Conclusion: One single dose of 90Y Ibritumomab Tiuxetan as initial treatment can induce clinical and molecular remission in patients with advanced untreated follicular lymphoma; moreover, hematological toxicity was low and quickly reversible.
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Fontanella, Marco, Innocenzo Rainero, Salvatore Gallone, Elisa Rubino, Chiara Rivoiro, Walter Valfrè, Diego Garbossa, Chiara Nurisso, Alessandro Ducati, and Lorenzo Pinessi. "Lack of association between the apolipoprotein E gene and aneurysmal subarachnoid hemorrhage in an Italian population." Journal of Neurosurgery 106, no. 2 (February 2007): 245–49. http://dx.doi.org/10.3171/jns.2007.106.2.245.
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Object The results of genome-wide scan studies have suggested the presence of a genetic risk factor for aneurysmal subarachnoid hemorrhage (SAH) on chromosome 19 (at 19p13). The apolipoprotein E (APOE) gene is located in this chromosomal region and encodes a protein that exerts several neuroprotective and neurotrophic functions in the brain. The purpose of this study was to evaluate whether a particular allele or genotype of the APOE gene would modify the occurrence or the clinical features of SAH. Methods Genomic DNA was extracted from 146 patients with aneurysmal SAH and 222 age- and sex-matched healthy controls and genotyped for the triallelic polymorphism of the APOE gene (ε2, ε3, and ε4). Allele and genotype frequencies were compared between patients and controls. The clinical characteristics of the disease were compared according to the different APOE genotypes. Allele and genotype frequencies of the APOE gene polymorphism were nearly identical in cases and controls. Patients carrying the APOE ε4 allele had a significantly higher Hunt and Hess grade on admission (p = 0.0014). There was no significant relationship between any of the other clinical characteristics and the APOE genotype. Conclusions The authors’ data do not support the hypothesis that genetic variations within the APOE gene are associated with aneurysmal SAH. However, the APOE gene influences the disease phenotype and may be regarded as a disease modifier gene.
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Mauro, Francesca Romana, Alessandra Tedeschi, Alfonso Piciocchi, Marina Motta, Emilia Iannella, Lucia Farina, Lydia Scarfo, et al. "Outcome of Patients with Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) and/or 17p Deletion/TP53 Mutations Treated with Ibrutinib According to a Named Patient Program (NPP) in Italy: Preliminary Analysis of a Real Life Retrospective Study." Blood 128, no. 22 (December 2, 2016): 2038. http://dx.doi.org/10.1182/blood.v128.22.2038.2038.
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Abstract Introduction. Observational studies from patients treated outside controlled clinical trials offer real life information and are relevant to understand whether data derived from prospective trials are reproducible in the clinical practice. A retrospective observational study was carried out by the GIMEMA (Gruppo Italiano Malattie EMatologiche dell'Adulto) group in order to evaluate the clinical characteristics and outcome of patients with chronic lymphocytic leukemia (CLL) treated with ibrutinib in Italy within a Named Patient Program (NPP). The NPP was intended to offer free and early drug access to CLL patients until ibrutinib became available on the Italian market. Methods. Patients included in the NPP program had refractory or relapsed (R/R) disease with progression within 24 months after prior chemo-immunotherapy, and/or 17p deletion/TP53 mutations. Patients were also required to have an ECOG performance status ≤2; serum creatinine ≤2 times, liver enzymes ≤3 times and total bilirubin ≤1.5 times the upper limit of normal. Key exclusion criteria were: the need of a concomitant treatment with a strong CYP3A inhibitor or warfarin, an allogeneic stem cell transplantation within the past 6 months or an ongoing active infection. All patients included in the program received ibrutinib orally as a single agent at the standard dose of 420 mg daily. Clinical data of 110 patients included in the NPP program between January 2014 and November 2014 have so far been collected and analyzed using the Research Electronic Data Capture (REDCap) system. Patients were managed at 20 Italian centers and received at least one dose of ibrutinib. Clinical data were reported by the treating physicians. Results. The median age of patients was 69.9 years (range 49.8-83.3); 53% were in Rai stage III-IV, 32% in stage II and 15% in stage 0-I. Sixty-two percent of patients had relapsed disease, 38% were refractory to prior treatment. The presence of a 17p deletion and/or TP53 mutations was recorded in 51 R/R patients. Eighty-six percent of patients had an unmutated IGHV gene profile. The median number of prior treatments was 3 and included allogeneic stem cell transplantation in 4 cases. Two or more comorbidities were reported in 57 patients (52%) and included atrial fibrillation (AF) in 10 (9.1%) and hypertension in 40 (36.4%). After a median follow-up of 12.1 months (range, 1.6-24.6), 87 patients (79%) were still on ibrutinib. A response to ibrutinib was reported in 98/110 patients (89.1%). The best recorded response was a CR/CRi in 19 patients (17.3%), while a PR was reported in 79 patients (72%; PR-L 21.1%). Similar response rates were observed in patients with unmutated IGHV genes (91.9%) and in those with 17p deletion/TP53 mutations (90.3%). At 12 months, the progression-free survival (PFS) and overall survival (OS) were 92.9% (95%CI: 87.9-98.2) and 95.2% (95%CI: 91.1-99.4), respectively. PFS at 12 months of patients who achieved a response was 96.3%, 98.9% in unmutated IGHV patients, 90.7% in those with 17p deletion/TP53 mutations. Five patients (4.5%) died during the NPP program (1 patient each for sepsis, heart failure, ileus perforation, cancer, unknown cause). Adverse events (AE) were recorded in 75 patients (68.2%); in 47 (42.7%) they were grade ≥3. Any grade AEs recorded in ≥5% of patients were: infections (35%; grade ≥3, 22%), granulocytopenia (18.8%; grade ≥3, 17.2%), bleeding (15.5%; grade ≥3, 2.7%), fever of unknown origin or febrile neutropenia (12%; grade ≥3, 5.4%), AF (10.9%; grade ≥3, 4.5%), diarrhoea (8.3; grade ≥3, 2%), hypertension (7.2%; grade ≥3, 5.4%). A new event of AF occurred in 1/10 patients with a prior history of AF. Warfarin was required in 1 patient with AF and this was the reason for ibrutinib discontinuation. Conclusions. The results of the first interim analysis of this retrospective, real life study confirms that ibrutinib, as a single agent, is an effective treatment for patients with poor-prognosis CLL. Our data also suggest that ibrutinib given to unselected patients, in a compassionate-use program, shows a clinical activity and a safety profile comparable to those reported in prospective trials. Data collection is ongoing in order to complete the analysis of this large NPP cohort in Italy. Disclosures Marasca: Roche: Honoraria; Gilead: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Pfizer: Honoraria. Coscia:Karyopharm: Research Funding; ROCHE: Honoraria, Other: Advisory board; Janssen: Honoraria; Gilead: Honoraria; Mundipharma: Honoraria. Zinzani:Abbvie: Membership on an entity's Board of Directors or advisory committees; Roche: Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees; MorphoSys: Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees; Celegene: Membership on an entity's Board of Directors or advisory committees. Molica:Jansen: Membership on an entity's Board of Directors or advisory committees; Abbvie: Membership on an entity's Board of Directors or advisory committees; Roche Italy: Membership on an entity's Board of Directors or advisory committees; Gilead Sciences: Speakers Bureau. Orlandi:Ariad: Honoraria; BMS: Honoraria; Novartis: Honoraria. Ghia:Gilead: Consultancy, Honoraria, Research Funding, Speakers Bureau; Janssen: Consultancy, Honoraria, Speakers Bureau; Abbvie: Consultancy, Honoraria; Adaptive Biotechnology: Consultancy; Roche: Honoraria, Research Funding. Foà:Amgen: Consultancy, Speakers Bureau; Janssen: Consultancy, Speakers Bureau; Roche: Consultancy, Speakers Bureau; Gilead: Consultancy, Speakers Bureau; Celgene: Consultancy, Speakers Bureau; BMS: Consultancy; Genentech: Consultancy; Pfizer: Speakers Bureau; Ariad: Speakers Bureau.
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Loupakis, Fotios, Chiara Cremolini, Gianluca Masi, Sara Lonardi, Vittorina Zagonel, Patrizia Trenta, Gianluca Tomasello, et al. "FOLFOXIRI plus bevacizumab (bev) versus FOLFIRI plus bev as first-line treatment of metastatic colorectal cancer (MCRC): Results of the phase III randomized TRIBE trial." Journal of Clinical Oncology 31, no. 4_suppl (February 1, 2013): 336. http://dx.doi.org/10.1200/jco.2013.31.4_suppl.336.
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336 Background: First-line FOLFOXIRI demonstrated superior activity and efficacy compared to FOLFIRI. Moreover, the outcome is improved by the addition of bev to first-line doublets. A phase II study of FOLFOXIRI/bev showed promising activity and manageable toxicities. The present trial compared FOLFOXIRI/bev to FOLFIRI/bev as first-line treatment in unresectable mCRC. Methods: Eligibility criteria included: measurable and unresectable mCRC, age 18-75 years, no prior chemotherapy for advanced disease. Patients (pts) were randomized to either FOLFIRI/bev (bev 5 mg/kg, irinotecan 180 mg/sqm, l-LV 200 mg/sqm, 5FU bolus 400 mg/sqm, 5FU infusion 2400 mg/sqm over 48h q2w, arm A) or FOLFOXIRI/bev (bev 5 mg/kg, irinotecan 165 mg/sqm, oxaliplatin 85 mg/sqm, l-LV 200 mg/sqm, 5FU infusion 3200 mg/sqm over 48h q2w, arm B). Treatment was planned for a maximum of 12 cycles followed by maintenance with bev and 5FU until progression. Primary endpoint was progression-free survival (PFS). Results: Between July 2008 and May 2011, 508 pts were randomized among 35 italian centers. Pts characteristics were (arm A/arm B): median age 60/61 yrs, ECOG PS 1-2 11%/10%, synchronous metastases 81%/79% multiple sites of disease 74%/70%. At a median follow-up of 20.9 months 391 pts have progressed. The study met its primary endpoint: FOLFOXIRI/bev significantly increased PFS (median 9.5 vs 11.9 months, HR 0.72 [95%CI:0.59-0.87], p=0.001). Response rate was also significantly increased (53% vs 64%, p=0.015). Main per patient toxicities were (arm A/arm B): grade 3-4 diarrhea 10%/18%, grade 3-4 vomiting 3%/4%, grade 3-4 stomatitis 4%/8%, grade 3-4 peripheral neurotoxicity 0%/5%, grade 3-4 neutropenia 20%/49%, febrile neutropenia 6%/8%, hypertension 2%/4%, thromboembolic events 7%/7%, bleeding 1%/1%. Deaths within 60 days were 3% and 4%. Conclusions: FOLFOXIRI/bev significantly increases PFS and response rate compared to FOLFIRI/bev. Chemotherapy- and bev-related toxicities occur with the expected incidence. Clinical trial information: NCT00719797.
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Bassi, Simona, Fausto Castagnetti, Marilina Amabile, Barbara Giannini, Daniela Cilloni, Barbara Izzo, Antonio De Vivo, et al. "Imatinib in the Treatment of CML Patients ≥ 65 Years Old in Late Chronic Phase: Results of a Phase II Study of the GIMEMA CML Working Party." Blood 104, no. 11 (November 16, 2004): 2935. http://dx.doi.org/10.1182/blood.v104.11.2935.2935.
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Abstract Older age constitutes a poor prognostic variable in CML patients: the negative effect of age on long-term survival has been consistently observed with most effective therapeutic modalities, both drug therapies (busulfan, hydroxyurea and interferon) and allogeneic transplant. In particular, older patients treated with interferon experienced much more adverse events than younger ones. In part their poorer prognosis was probably due to poor treatment compliance and few older patients have been included in prospective studies of interferon. Actually, imatinib is the first-line treatment for CML: its efficacy is very high and it seems to be well tolerated across age groups. We performed a sub-analysis of the effects of age on response and tolerance within the phase II trial of the italian GIMEMA CML Working Party (serial n.CML/002/STI571), which included 284 late chronic phase patients, treated with imatinib (400 mg daily) after interferon failure. Following the WHO, who defines “old” a patient ≥ 65 years, we analyzed the safety and efficacy of imatinib by age group: 226/284 patients (80%) were < 65 years (extr. 17–64) and 58/284 (20%) were ≥ 65 years (extr. 65–85 yrs) old. No significant differences between the two age groups were present at enrollment. Table 1 shows the responses and incidence of hematologic and non-hematologic adverse events (AEs). As expected, older patients experienced more AEs, both hematologic and non-hematologic. In part this significantly poorer tolerance probably justifies the lower response rates, both hematologic and cytogenetic. However, the overall survival was not different between the two age groups: with a median observation time of 33 months, the overall survival curves were superimposed (91%). Moreover, the rate of progression to accelerated/blastic phase was the same (10%). This study demonstrates that imatinib is greatly effective in older CML patients in late chronic phase (53% of MCR and 36% of CCR) and allows a good long-term survival. It is conceivable that treating old CML patients at the onset of the disease, as already shown by Jorge Cortes et al (Cancer2003;98:1105), could translate into response rates as the ones of younger patients. Responses and adverse events ≥ 65 (n. 58) ≤ 65 (n226) p value Complete Hematologic response 91% 99% 0,001 Major Cytogenetic Response 53% 74% 0,003 Complete Cytogenetic Response 36% 57% 0,001 Grade III Hematologic AEs 72% 50% 0,002 Grade III+IV Hematologic AEs 86% 60% 0,0001 Grade II non Hematologic AEs 83% 68% 0,0001 Grade III + IV non Hematologic AEs 29% 10% 0,0001