Добірка наукової літератури з теми "Finsider"

Abstract Introduction Although plenty of data exists on efficacy and safety of CLL drugs, their impact on patients' Health-Related Quality of Life (HRQoL) is largely unknown (1-2). Documentation of drug safety via traditional use of adverse events (AE) in hematology is limited if not complemented with Patient-Reported Outcomes (PRO) measures (3-4). Incorporation of HRQoL PROs is now essential to better evaluate risk-benefit of new therapeutic approaches and it is also highly valued by regulatory stakeholders (5). Most PRO data currently available for CLL patients (pts) came from randomized controlled trial settings (6-7), hence limiting generalizability of findings to CLL real-life patients. CHOICE study was designed to investigate CLL patients' QoL and preference towards different treatment profiles through a Discrete Choice Experiment (DCE) methodology in Italy. Due to the timelines of the study, which started in February 2020, the related data offer an insight into patients' perception and worries during the first wave of the COVID-19 pandemic. Methods This cross sectional, multi-center, observational study included CLL patients, treatment naïve during the watch & wait period (W&W) or already TREATED (around 50% each, controlled at site level), who signed the informed consent for study participation. Exclusion criteria were inability to take oral drugs, cognitive disorders that could impair the comprehension of the questionnaires and concomitant treatment for other malignancies. Patients were asked to fill in the following HRQoL questionnaires: EQ-5D-5L, EORTC QLQ-C30 and QLQ CLL-16, as well as a DCE questionnaire, (described elsewhere). Each questionnaire was completed by the patient on a tablet - using an App specifically developed for the study. Results 401 pts were enrolled in Italy in 16 hematology centers (Feb - July 2020); 199 W&W and 196 TREATED pts completed the questionnaires and were included in the evaluable population. Main patients' characteristics are shown in Table 1. 73.7% of TREATED pts were ON-treatment (30.8% were in 1st-line, 69,2% in further lines) and 26.3% were OFF-treatment; the majority of pts (55,6%) were currently treated with a target therapy (Table1). The EQ-5D-5L questionnaire showed no significant differences between groups. In both groups more than 80% of pts reported low values (1 or 2, indicating no or small impact) on all items. Median VAS was 75 for the TREATED group and 80 for the W&W group (0-100; higher scores indicate higher QoL). QLQ C-30 / CLL-16 scores had very similar results between TREATED and W&W pts suggesting a limited impact of CLL on pts QoL. The median (IQR) QoL Scale was 83.3 (67- 83) for TREATED and 83.3 (67- 92) for W&W pts (0-100; all functional scales had high scores, that represent a better level of functioning; all symptoms' scales had low values, representing a less important symptomatology or problem, Figure 1). The main symptoms reported were fatigue, insomnia, pain, and dyspnea, while the main worry was for "future health" (Figure 1). Distribution of data was statistically different between the 2 groups only for the Role functioning Scale (p=0.024) and the Social Functioning Scale (p=0.003) of QLQ-C30 and for the Infection Scale (p<0.001) of QLQ CLL-16, always with slightly but significantly better results for the W&W group. Conclusions CHOICE study helps to understand the CLL patients' mindset and feeling in the light of the COVID-19 pandemic impact on health care for this category of pts, highlighting their preferences and worries in a large cohort of pts in Italy, allowing a comparison between TREATED and W&W pts. The main limitation of the study was its cross-sectional design, which does not allow us to evaluate any change in QoL neither with respect to the impact of the pandemic, nor to the effects of the treatment, if any. CLL pts showed a good QoL, as confirmed by both EQ-5D-5L and EORTC QLQ C-30 / CLL-16 scores, with very similar results between TREATED and W&W pts (although slightly better results in the W&W vs TREATED group). The results of the present study are consistent with previous reports, and fatigue was the most reported symptom, while worry for future health was the most relevant score in CLL-16 questionnaire. Hospital accesses reduction that was detected during the pandemic might have influenced patients' response, as well as the extreme attention towards the danger of infections, and might have impacted patients' perception on future health. Figure 1 Figure 1. Disclosures Tedeschi: Beigene: Honoraria, Speakers Bureau; AstraZeneca: Honoraria, Speakers Bureau; AbbVie: Honoraria, Speakers Bureau; Janssen: Honoraria, Speakers Bureau. Gozzetti: Janssen: Honoraria; AbbVie: Honoraria. Reda: Beigene: Consultancy; Astra Zeneca: Consultancy; Abbvie: Consultancy; Janssen: Consultancy. Gualberti: AbbVie: Current Employment. Malgieri: AbbVie: Current Employment. Finsinger: AbbVie: Current Employment.

Abstract Introduction: All the available CLL therapies differ for relevant aspects as duration of response, mode of administration, treatment duration and adverse events: the CHOICE study was designed to investigate CLL patients' Quality of Life (QoL) and preferences towards different treatment attributes through a Discrete Choice Experiment (DCE) in Italy. Due to the timeline of the study, started in Feb2020, the collected data offer an insight of patients' perception and attitude during the 1 st wave of the COVID-19 pandemic, as opposed to other DCE results available in CLL (1-2). Methods: This cross-sectional multi-center observational study enrolled patients (pts) with CLL, WATCH&WAIT (W&W) or already TREATED (around 50% each, controlled at site level), who signed the informed consent for study participation. Exclusion criteria were inability to take oral drugs, cognitive disorders that could impair questionnaire's comprehension and concomitant therapy for other malignancies. Pts were asked to fill in 3 QoL questionnaires: EQ-5D-5L, EORTC QLQ-C30, QLQ CLL-16, described elsewhere. DCE Questionnaire was composed of 9/10 blocks (for W&W/TREATED, respectively) each composed of 8 comparisons between 2 profiles with the following attributes: "Treatment and relevant duration", "PFS", "Possibility of infections", "Possible occurrence of organ damage", "Possible occurrence of diarrhea", with levels specified in Fig1. Each patient (pt) was centrally assigned to 1 block of 8 comparisons. Each pt could ask questionnaire explanations to the medical staff but self-completed it on an App specifically developed for the study. Results: 401 pts were enrolled in Italy across 16 centers (Feb-Jul 2020),199 W&W and 198 TREATED pts completed the DCE questionnaire and were included in the evaluable population. Main pts' characteristics are shown in Table 1. 73.7% of TREATED pts were ON-treatment (30.8% in 1st-line, 69.2% in further lines) and 26.3% were OFF-treatment. DCE results showed that W&W pts rated as most important the 'Possibility of infections' (relative importance, RI=36.2%), followed by 'Treatment and Relevant duration' (RI=28.0%), 'PFS' (RI=16.9%), while 'Possible occurrence of organ damage' (RI=12.5%) and 'Possible occurrence of Diarrhea' (RI=6.4%) had lower impact on the preference (Fig 1A). DCE in TREATED pts showed that they gave more importance to 'Treatment and relevant duration' (RI =33.3%) followed by 'Possibility of infections' (RI =28.8%). The RI of the other attributes was lower: 'Possible occurrence of organ damage' (RI =19.4%), 'PFS' (RI =9.8%), 'Possible occurrence of diarrhea' (RI =8.7%, Fig 1B). A sub-analysis stratifying pts from Northern regions (more impacted during the 1 st wave of the pandemic) and Center-Southern regions showed that in W&W pts from North Regions the attribute with a higher impact is 'Treatment and Relevant duration' (RI=40.3%) followed by 'Possibility of infection' (RI=27.2%), while in W&W pts from Central-Southern area, the attribute with a higher impact is 'Possibility of infection' (RI=43.4%) followed by 'Possible occurrence of Organ damage' (RI=21.6%). In TREATED pts no difference between the 2 groups has been shown and the results are consistent with the total population. Conclusions: CHOICE study was planned to understand CLL patients' preferences towards different treatment attributes, but the results have been impacted by the concurrent COVID-19 pandemic. In contrast to previously published DCEs (1-2), where PFS was the most important attribute, in the CHOICE study pts put much more emphasis on their concerns about possible infections: this could be due to the influence of the 1 st Covid-19 pandemic wave, with the relevant feeling of uncertainty, also due to the great attention that media has dedicated to the issue of infection in general, especially for vulnerable individuals such as CLL pts. The limitation in hospital access during the 1 st wave and the overall need of personal protection (masks usage) and social distancing might have influenced patients' responses too. The "infodemic" and the uncertainty had probably such a strong effect on patient's feelings, that PFS was no longer the most important attribute being substituted by the fear of hospitals access and infections. We thereby suggest that the pandemic had a great impact not only on the conduct of the study but also on patients' perception of their disease, if not properly reassured. Figure 1 Figure 1. Disclosures Molica: Astrazeneca: Honoraria; Abbvie: Consultancy, Honoraria; Janssen: Consultancy, Honoraria. Laurenti: AbbVie: Consultancy, Honoraria, Research Funding; Gilead: Honoraria; Roche: Honoraria, Research Funding; Janssen: Consultancy, Honoraria; AstraZeneca: Consultancy, Honoraria; BeiGene: Honoraria. Ghia: Gilead: Consultancy, Research Funding; Celgene/Juno/BMS: Consultancy, Honoraria; BeiGene: Consultancy, Honoraria; ArQule/MSD: Consultancy, Honoraria; AstraZeneca: Consultancy, Honoraria, Research Funding; Acerta/AstraZeneca: Consultancy, Honoraria, Research Funding; AbbVie: Consultancy, Honoraria, Research Funding; Janssen: Consultancy, Honoraria, Research Funding; Roche: Consultancy, Honoraria; Sunesis: Research Funding. Coscia: Gilead: Honoraria; Janssen: Honoraria, Other, Research Funding; AstraZeneca: Honoraria; AbbVie: Honoraria, Other. Cuneo: AstraZeneca: Consultancy, Speakers Bureau; Janssen: Consultancy, Speakers Bureau; Gilead: Consultancy, Speakers Bureau; AbbVie: Consultancy, Speakers Bureau. Gaidano: Beigene: Honoraria; Janssen: Honoraria, Speakers Bureau; AstraZeneca: Honoraria; AbbVie: Honoraria, Speakers Bureau; Incyte: Honoraria. Mauro: Takeda: Consultancy, Speakers Bureau; Gilead: Consultancy, Research Funding, Speakers Bureau; Roche: Consultancy, Speakers Bureau; Janssen: Consultancy, Speakers Bureau; AstraZeneca: Consultancy, Speakers Bureau; AbbVie: Consultancy, Speakers Bureau. Pane: AbbVie; Amgen; Novartis: Other: Travel, accommodation, expenses; AbbVie; Amgen; Novartis, GSK, Incyte: Speakers Bureau; Novartis Pharma SAS;: Research Funding; AbbVie; Amgen; Novartis, GSK , Incyte: Consultancy. Gualberti: AbbVie: Current Employment. Iannella: AbbVie: Current Employment. Finsinger: AbbVie: Current Employment. Caira: AbbVie: Current Employment. Sportoletti: AstraZeneca: Consultancy, Honoraria; Janssen: Consultancy, Honoraria; AbbVie: Consultancy, Honoraria.

Il presente lavoro indaga l'evoluzione della siderurgia pubblica italiana - ossia del gruppo Finsider e delle sue successive evoluzioni - dall'entrata in vigore del Mercato comune europeo alla definitiva privatizzazione delle imprese a partecipazione statale. Fondata nel 1937 per gestire le attività siderurgiche acquisite da Iri a seguito dell'operazione di salvataggio delle grandi banche di interesse nazionale, nel secondo dopoguerra Finsider venne rilanciata con un ambizioso programma di investimenti, il cosiddetto "Piano Sinigaglia". Il quadro all'interno del quale il gruppo pubblico si trovava ad operare subì una modificazione sostanziale a partire dal 1951, quando anche l'Italia decise di partecipare alla costituzione della Comunità europea del carbone e dell'acciaio (Ceca). Da quel momento un'industria storicamente beneficiaria di politiche protezioniste si trovò a dover competere con le realtà ben più avanzate del nord Europa. Questo evento ha condizionato significativamente la successiva evoluzione della siderurgia italiana, in generale, e di quella pubblica, in particolare. L'adesione dell'Italia alla Ceca ha posto in essere una sorta di "vincolo esterno" col quale la dirigenza della siderurgia pubblica è stata costantemente tenuta a fare i conti nel corso dei successivi decenni. La considerazione data a questo elemento è ciò che maggiormente contraddistingue la lettura proposta in questo lavoro rispetto alla letteratura precedente sul tema. La creazione del mercato unico è avvenuta in presenza di un significativo divario di partenza fra le siderurgie comunitarie. In quanto late comer l'Italia ha mostrato a lungo uno squilibrio fra livelli relativamente arretrati di capacità produttiva e di efficienza e una dinamica della domanda più vivace rispetto al resto della Comunità; contestualmente, negli altri paesi dell'area il settore ha raggiunto presto un grado di relativa maturità, evidenziato da una latente situazione di sovracapacità, esplosa negli anni '70. Da queste differenze sono derivate le dinamiche strutturali che hanno caratterizzato il mercato siderurgico comunitario nel corso del trentennio successivo all'istituzione della Ceca: in particolare, l'Italia è stata sistematicamente costretta a fronteggiare importanti flussi di importazioni dal resto della Comunità, più intensi nelle fasi di flessione congiunturale. A questa sfida Finsider cercò di rispondere seguendo due direttrici non sempre convergenti: da una parte, adeguando la struttura produttiva esistente ai livelli di efficienza vigenti presso i concorrenti europei e, dall'altra, ampliando la capacità produttiva per soddisfare il crescente fabbisogno interno. Ne derivarono, fra la fine degli anni '50 e l'inizio dei '70, almeno due imponenti cicli di investimenti (creazione e raddoppio dello stabilimento di Taranto, ampliamento degli altri siti). A fronte degli sforzi realizzati dalle aziende Finsider, non vi fu tuttavia un'adeguata copertura finanziaria da parte dell'azionista pubblico; oltretutto, le unità del gruppo furono interessate dalla lunga stagione di conflittualità operaia degli anni '70. L'ampio ricorso ad indebitamento per finanziare i piani di sviluppo, le difficoltà incontrate e gli errori commessi nella realizzazione degli stessi e nella successiva gestione degli impianti costituirono, in una situazione di mercato resa quanto mai tesa dalla crisi degli anni '70, i fattori da cui si originarono in buona parte le perdite che interessarono in misura crescente la siderurgia pubblica in quel frangente. Tale scenario subì un'accelerazione nel decennio successivo, a seguito di una recessione dei consumi ancora più intensa e di profonde mutazioni delle politiche monetarie a livello globale e dei rapporti di cambio (rivalutazione del dollaro e costituzione dello Sme - Sistema monetario europeo). Finsider si trovò così a scontare un progressivo degrado del rapporto costi/ricavi. Sul fronte dei costi, il nuovo corso della valuta statunitense determinò il rincaro delle materie prime, mentre il repentino incremento del costo del denaro - in Italia particolarmente significativo a causa della politica perseguita da Banca d'Italia - incise sulla voluminosa massa di debiti del gruppo generando una crescita esponenziale degli oneri finanziari. Sul piano dei ricavi, la sfavorevole situazione di mercato fu accentuata dalla rivalutazione reale che in quel frangente la Lira maturò rispetto alle altre valute comunitarie a causa dei meccanismi di funzionamento dello Sme. In queste circostanze gli unici piani su cui la dirigenza Finsider aveva margini di manovra erano, da una parte, l'efficientamento degli impianti e delle pratiche operative e, dall'altra, i rapporti con la manodopera. Nonostante i progressi maturati in queste direzioni, il gruppo subì perdite enormi, la cui copertura fu resa possibile solo dal massiccio intervento finanziario delle autorità pubbliche. Gli "aiuti di Stato" percepiti da Finsider furono oggetto della disciplina inaugurata nel frattempo dalla Commissione europea per fronteggiare la crisi dell'intera siderurgia comunitaria. Essi vennero così vincolati a robusti tagli di capacità produttiva e alla progressiva privatizzazione di parti del gruppo. La struttura della siderurgia pubblica subì in questo modo un significativo ridimensionamento, che tuttavia non ne scongiurò il fallimento. La Finsider venne messa in liquidazione nel 1987 e le sue attività principali furono trasferite a una nuova azienda pubblica, Ilva. Il definitivo smantellamento, allo scorcio degli anni '80, della complessa struttura di regolamentazione del mercato imposta dalle autorità europee all'inizio del decennio pose gli operatori del settore in una situazione di aperta concorrenza quando ancora la situazione di sovracapacità in cui si era dibattuta fino ad allora la siderurgia europea non era stata del tutto superata. In questo contesto si attivò un processo di selezione spontanea caratterizzato da due tendenze fondamentali: da una parte, le realtà più avanzate presero a praticare politiche commerciali aggressive per scalzare i concorrenti più deboli; dall'altra, andarono maturando processi di concentrazione di amplissima portata. La dirigenza di Ilva cercò di affrontare tali circostanze esprimendo un'azione non del tutto coerente: limitando le vendite per non esporsi ai ribassi di prezzo determinati dall'atteggiamento ostile dei concorrenti e, al contempo, acquisendo partecipazioni in società commerciali per ampliare le rispettive quote di mercato. Tale strategia fallì: gli investimenti sostenuti per acquisire un maggiore controllo a valle della produzione in assenza di coperture adeguate produssero un rilevante incremento dell'indebitamento proprio mentre i tassi di interesse vigenti nel nostro paese raggiungevano picchi storici. Contestualmente a Ilva non riuscì di concretizzare ipotesi di alleanze o acquisizioni con grandi gruppi esteri. La nuova crisi che colpì la siderurgia pubblica andò ad inscriversi in una delle fasi più turbolente della storia economica d'Italia. A partire dalla fuoriuscita dallo Sme, nel settembre 1992, il sistema economico italiano maturò modificazioni radicali. In particolare, prese le mosse un processo di privatizzazione di vastissima portata. La siderurgia ne fu pienamente coinvolta: su impulso delle autorità comunitarie il governo italiano procedette alla rapida dismissione delle partecipazioni statali nel settore. Fra 1992 e 1996 Ilva fu segmentata in quattro società (Acciaierie Piombino, Ilva laminati piani, Acciai speciali Terni e Dalmine), cedute a loro volta ad altrettanti gruppi privati (rispettivamente Lucchini, Riva, Krupp e Rocca). In questo modo la siderurgia italiana arrivava alle porte del nuovo millennio con una struttura di gran lunga più frammentaria rispetto a quella emersa nel frattempo presso gli altri paesi europei, dove imponenti processi di concentrazione avevano dato vita a società in grado di dominare il mercato comunitario.
This work analyzes the evolution of Italian public steel industry - namely, Finsider group and its subsequent evolutions - from the implementation of European Common Market (ECM) to the privatization of the public firms of the sector. Finsider was founded in 1937 in order to manage the line of business in steel sector acquired by IRI after the bailout of the biggest national banks; in the second post world war Finsider was restructured through an ambitious plan of investments, the "Piano Sinigaglia". The framework in which the public management had to operate was subject to a deep modification since 1951, when Italy decided to participate in the constitution of the European Community of Coal and Steel (ECCS). From then, the sector, usually benefited from protectionist policies, had to compete with more and more advanced competitors of Northern Europe. This event strongly affected the subsequent evolution of Italian steel industry, particularly for what concerns the public one. The participation of Italy to the ECCS became a "vincolo esterno", an element that public management constantly had to manage. The key role given to this factor differentiate this work from the previous literature on the topic. There were important gaps among ECCS steel industries when the common market was created. As a late comer, and compared to other ECCS countries, Italy had for a long time a limited productive capacity and efficiency, and a very dynamic demand. At the same time, in these countries, the steel industries became mature, with a latent problem of overcapacity, that exploded during the 70s. These differences explain the structural dynamics that characterized the ECCS steel market in the three decades after the creation of ECCS. In particular, Italy was constantly under the pressure of import from others ECCS countries, especially during downturns. Finsider handled this challenge with two strategies: on the one hand, it started a revamping of plants to adequate themselves at the efficiency level of other European countries; on the other hand, it augmented the productive capacity to respond to an increasing domestic consumption. This led to two important wave of investment, from the 50s to the beginning of 70s, (building and revamping of steel plant in Taranto, revamping of other plants). Despite this efforts, the State didn't provide adequate financial resources; moreover, the plants of the group was interested by the working class struggle that characterized the 70s in Italy. The debts contracted to finance development programs, the difficulties and the mistakes in their implementation and into the inadequate management of these plants, in addition to the market tensions of the 70s led to the important losses of public steel company in that period. In the successive decades, this scenario was exacerbated by a stronger reduction in consumption levels, together with important changes in monetary and exchange rate policies (revaluation of the dollar and creation of European Monetary System - EMS). Then, Finsider faced a constant deterioration of the ratio costs/revenues. For what concerns costs, it experimented an increase of the prices of raw materials due to the revaluation of the dollar, while the rapid increase of interest rate, due to the Banca d'Italia policies, generated a sharp increase of finance charge. For what concerns revenues, the negative trends were emphasized by the revaluation in real terms of Lira, caused by mechanisms that characterized the EMS. In this situation, the Finsider management had only few opportunities: first, the increase in the level of efficiency of plants and productive process; second, the changes in industrial relations. Despite achievements, the group faced important losses, that was granted by a massive public intervention. This intervention was under the scrutiny of European Commission, that regulated State aids to face the crises of the whole steel sector in ECCS. Important reduction of productive capacity and a progressive privatization in the steel industry were imposed. As a consequence, public steel sector was sensibly reduced; despite this, Finsider was liquidated in 1987 and its main lines of business were transferred to a new public firm, Ilva. At the end of the 80s, the deregulation of the steel market in Europe led to a situation of strong competition for players; meanwhile, the problems of overcapacity that characterized the European steel market until that moment were still unresolved. In this context a spontaneous selection process took place, described by two main trends: on the one hand, the most competitive companies implemented aggressive commercial policies to eliminate the weaker competitors; on the other hand, strong concentration processes began. The Ilva management tried to face this situation with a not completely coherent strategy: limiting the sales in order to reduce the impact of the fall in prices generated by the behaviour of competitors, and at the same time, acquiring shares in trading companies to increase its market shares. This strategy was unsuccessful: the investments oriented to increase vertical integration, without proper financial resources, generated an increase in indebtedness, exactly when a peak in interest rate was registered in Italy. At the same time, Ilva didn't realized any alliance or acquisition of foreign competitors. The new crisis hit the public steel industry in one of the most critical periods of Italian economic history. Since the exit from the EMS, in 1992, the Italian economic system carried out radical changes. In particular, an important process of privatization began. The steel industry was totally involved by this process: under the impulse of European Commission the Italian government rapidly dismissed the public shares in this sector. From 1992 to 1996 Ilva was divided into four parts (Acciaierie Piombino, Ilva laminati piani, Acciai speciali Terni e Dalmine), that were sell to as many private companies (respectively, Lucchini, Riva, Krupp e Rocca). In that way, the Italian steel industry at the beginning of the new millennium was characterized by a higher degree of fragmentation when compared to other European countries. In fact, in these countries, very important processes of concentration generated big companies, able to dominate the European market.