Academic literature on the topic '(477.43)"19" (043.3/.5)'

ObjectivesThis is the first Europe-wide study aiming to describe the medication use in Neonatal Intensive Care Units and to analyse the factors that might influence the prescription pattern.MethodsA pan-European one day point-prevalence study was conducted in 2012 where all of the prescriptions for hospitalised neonates were recorded. A trade name, manufacturer, active pharmaceutical ingredients (API), strength, galenic form and route of administration were registered.ResultsAltogether 2173 prescriptions were administered to 726 neonates from 21 countries, of whom 66% (477/726) were preterm, 12% (84/726) extremely preterm. There was inverse correlation between gestational age (GA) and median number of prescriptions per neonate (group median 2/IQR 1–4, extremely preterm 4/3–6, very preterm 3/2–5, late preterm 2/1–3, full-term 2/1–3). Median number of prescriptions per neonate was highest in the eastern region, among extremely preterm neonates (median=6.5/IQR 6–8.5). Highest prescription rate was for alimentary medicines (93/per 100 admissions), systemic antiinfectives (79/100) and medicines for blood (71/100). Antiinfectives were most frequently prescribed in the southern region (103/100). Multivitamins were most frequently used medications in most regions (western 74, southern 31, northern 31/100), except in eastern region (5/100). Most commonly prescribed API-s were multivitamins (32/100), caffeine (19/100), gentamicin (18/100), amino acids (18/100) and colecalciferol (15/100). Most frequently prescribed medications among extremely preterm neonates were caffeine (60/100), among very preterms multivitamins and caffeine (45 and 43/100), among late preterms multivitamins (44/100) and among full-terms phytomenadione (26/100) and gentamicin (24/100).ConclusionsOur study revealed the most commonly used medications in neonates. Higher prescription rate among preterm neonates calls for further analysis of the suitability and safety of medications for infants with lower GA.

TPS600 Background: This phase III post-NC trial evaluates if CWRNRT post-Mx or whole breast irradiation (WBI) with RNRT after BCS significantly reduces the IBCR-FI rate in pts with PPAx nodes that are pathologically negative after NC. Secondary aims are OS, LRR-FI, DR-FI, DFS-DCIS, second primary cancer, and comparison of RT effect on cosmesis in reconstructed Mx pts. Correlative science examines RT effect by tumor subtype, molecular outcome predictors for residual disease, and predictors for the degree of reduction in loco-regional recurrence. Methods: Clinical T1-3, N1 IBC PPAx nodes (FNA or core needle biopsy) pts complete ≥8 weeks of NC (anthracycline and/or taxane). HER2+ pts receive anti-HER2 therapy. Following NC, BCS or Mx, sentinel node biopsy (≥2 nodes) and/or Ax dissection with histologically negative nodes is performed. ER/PR and HER-2neu status before NC is required. Pts may receive appropriate adjuvant systemic therapy. Radiation credentialing with a facility questionnaire/case benchmark is required. Random assignment for Mx pts is to no CWRNRT or CWRNRT and for BCS pts to WBI or WBI+RNRT. Statistics: 1,636 pts are to be enrolled over 5 yrs (definitive analysis at 7.5 yrs). Study is powered at 80% to test that RT reduces the annual hazard rate of events for IBCR-FI by 35% for an absolute risk reduction of 4.6% (5-yr cumulative rate). Intent-to-treat analysis with 3 interim analyses (43, 86, and 129 events) and a 4th/final analysis at 172 events. Pt-reported outcomes focusing on RT effect will be provided by 736 pts before random assignment and at 3, 6, 12, and 24 mos. Accrual as of 2-7-19 is 1,164 (71.1%). Contacts: Protocol: CTSU member website https://www.ctsu.org . Questions: NRG Oncology Pgh Clin Coord Dpt: 1-800-477-7227 or ccd@nsabp.org . Pt entry: OPEN at https://open.ctsu.org or the OPEN tab on CTSU member website. Support: U10 CA-2166; -180868, -180822; 189867; Elekta NCT01872975 Clinical trial information: NCT01872975.

Abstract Background Although ESCrE are a global challenge, data on ESCrE in low- and middle-income countries are limited. In particular, colonization data are critical for larger antibiotic resistance efforts. We characterized the colonization prevalence of ESCrE in various settings in Botswana. Methods This study was conducted in 3 hospitals and 6 clinics located in 3 districts in Botswana. In each hospital, we conducted surveillance of adult patients. Adult clinic patients were also randomly selected for participation. Finally, we enrolled community subjects by inviting each enrolled clinic subject to refer up to 3 adults. Each adult clinic or community subject was also allowed to refer their children. All subjects had rectal swabs obtained which were inoculated onto chromogenic media for preliminary identification of ESCrE. Final identification and susceptibility testing were performed using MALDI-TOF MS and VITEK-2, respectively. Genotyping was done for identification of extended-spectrum beta-lactamase (ESBL) genes. Results Enrollment occurred from 1/15/20-9/4/20 but paused from 4/2/20-5/21/20 due to a countrywide COVID lockdown. Of 5,088 subjects approached, 2,469 (49%) participated. Enrollment by subject type was: hospital – 469 (19%); clinic – 959 (39%); community adult – 477 (19%); and community child – 564 (23%). Of 2,469 subjects, the median (interquartile range) age was 32 years (19-44) and 1,783 (72%) were female. 759 (31%) subjects were colonized with at least one ESCrE; 130 subjects were colonized with multiple strains. E. coli (n=663) and K. pneumoniae (n=121) were most common. ESCrE colonization prevalence was 43% for hospital subjects, 31% for clinic subjects, 24% for adult community subjects, and 26% for child community subjects (p< 0.001)). ESCrE prevalence varied significantly across regions (Figure 1) and was significantly higher pre-lockdown vs post-lockdown (Figure 2). CTX-M was the most common ESBL gene (Figure 3). Figure 1. ESCrE Colonization - Study Sites Figure 2. ESCrE Colonization - Temporal Trends Figure 3. ESCrE Genotypic Analyses Conclusion ESCrE colonization was common in both healthcare and community settings in Botswana. Colonization prevalence varies by region and clinical setting and decreased following a countrywide lockdown. These findings provide important clues regarding potential drivers of ESCrE that might serve as targets for intervention. Disclosures Robert Gross, MD, MSCE, Pfizer (Other Financial or Material Support, Serve on DSMB for drug unrelated to HIV) Ebbing Lautenbach, MD, MPH, MSCE, Merck (Other Financial or Material Support, Member of Data and Safety Monitoring Board (DSMB))

This is a descriptive type of cross sectional study among 477 family heads as respondents. It is aimed to identify morbidity pattern, duration of illness among households' members and also to determine treatment seeking behavior during illness. The socio-demographic characteristics of the respondents are points of investigations. It reveals from the findings that the mean age of the respondents is 35.16 years. They are mostly female (66%) and married (90%). Only 30% respondents are illiterate, 69% respondents are found from nuclear family. The study shows 73% respondents family are suffering from illness during last two months and majority sufferers (19%) and (44%) were less than 5years and more than 31 years old respectively. However, male sufferers were more among <5 years (9.63%) and female sufferers more (26.84%) among >31 years old. Moreover about 43% respondents' family members are suffering for more than 4 weeks and about 29% less than 01 week. On the other hands, Fever, Cough and Pain are found prominent sign/symptoms among 38%, 28% and 29% sufferers respectively. Common cold, Arthritis and Diarrhoea are found as diagnosis among 53.5%, 22.5% & 8.5% respondents' family members respectively. Nevertheless majority 56% are seeking treatment from MBBS doctors. The study findings highlight awareness program among family heads and adult sufferer towards preventing infectious and chronic diseases as well as to undertake modern scientific treatment. Improved surveillance system in the locality may be considered for early detection of cases to treat accordingly to avoid complications. DOI: http://dx.doi.org/10.3329/akmmcj.v3i2.11686 AKMMC J 2012: 3(2): 06-10

7050 Background: Treatment of older pts with AML is often complicated by comorbidities and pts with comorbidities are often underrepresented in clinical trials. The HCT-CI, which was developed in pts receiving allogeneic SCT, has been applied to pts receiving induction therapy for AML in an effort to assist in therapeutic and investigational decisions (Kantarjian 2006; Etienne 2007; Giles 2007). HCT-CI scores have been shown to be predictive of early death and survival in pts ≥ 60 years receiving induction therapy for AML, with early death rates of 3%, 11%, and 29% for pts with HCT-CI scores of 0, 1–2, and ≥ 3, respectively (Giles 2007). Methods: 140 pts age ≥ 60 with poor risk de novo AML from two phase II studies were scored for comorbidity by HCT-CI. In these studies, poor risk was defined by the presence of at least one risk factor: age ≥ 70, ECOG PS = 2, unfavorable cytogenetics, or cardiac, pulmonary, or hepatic dysfunction. All pts received induction therapy with 600 mg/m2 laromustine as a single 30–60 min infusion. A second induction cycle could be administered to pts with PR or hematologic improvement. Pts with CR or CRp were able to receive consolidation with laromustine 400 mg/m2 (Study CLI-033) or araC 400 mg/m2/day CIV for 5 days (Study CLI-043). Results: HCT-CI score was 0 in 7 (5%) pts, 1–2 in 19 (14%), and ≥ 3 in 114 (81%). The median HCT-CI score was 5 (range 0–13). The most common comorbidities were cardiac (42%), severe pulmonary (39%), infection (35%), and arrhythmia (31%). 52 (37%) of all pts achieved a CR/CRp; 39/114 (34%) of pts with HCT-CI score ≥ 3 achieved a CR/CRp. Deaths within 30 days of first induction were observed in 0/7 pts with HCT-CI score 0, 4/19 (21%) with score 1–2, and 16/114 (14%) with score ≥ 3. Overall survival at 12 months was 43%, 14%, and 21% for pts with HCT-CI scores of 0, 1–2, and ≥ 3, respectively. Conclusions: The majority (81%) of these older poor risk AML pts treated with laromustine had a HCT-CI score ≥ 3, confirming the poor risk nature of this patient group. The induction death rate for pts treated with laromustine and with HCT-CI score ≥ 3 was lower than that reported for a group of pts with HCT-CI score ≥ 3 treated with standard induction chemotherapy (14% vs 29%; Giles 2007). [Table: see text]

Abstract Iron overload, a potentially serious consequence of multiple blood transfusions, can be effectively managed with chelation therapy. Deferasirox, an investigational once-daily oral chelator, has been evaluated in a 1 year study of iron-overloaded adult and pediatric patients (n=184) with transfusion-dependent anemia including β-thalassemia, myelodysplastic syndromes (MDS) and Diamond-Blackfan anemia (DBA). Patients were stratified into four daily dose groups (5, 10, 20 and 30 mg/kg) according to baseline liver iron concentration (LIC; 2–3, &gt;3–7, &gt;7–14 and &gt;14 mg Fe/g dw, respectively). Iron balance was determined for all patients, based on transfusional iron intake and chelator-induced iron excretion, derived from the change in LIC during the study (Table 1). Patient characteristics, LIC, serum ferritin and iron excretion/intake ratio during deferasirox treatment β-thalassemia (n=85) DBA (n=30) MDS (n=47) Other anemias (n=22) *Mean ± SD Age*, years 24.7 ± 10.0 16.1 ± 10.3 65.1 ± 12.5 35.8 ± 22.9 Body weight, kg 51.1 ± 14.1 39.1 ± 18.7 70.4 ± 12.5 56.1 ± 18.5 Deferasirox dose*, mg/kg 23.8 ± 7.2 23.6 ± 7.4 20.0 ± 8.3 21.9 ± 6.5 Iron intake*, mg/kg/day 0.35 ± 0.12 0.40 ± 0.11 0.28 ± 0.14 0.31 ± 0.19 &lt;0.3, n (%) 28 (33) 6 (20) 25 (53) 10 (45) 0.3–0.5, n (%) 49 (58) 19 (63) 20 (43) 7 (32) &gt;0.5, n (%) 8 (9) 5 (17) 2 (4) 5 (23) Serum ferritin*, ng/mL Baseline 4321 ± 2881 3245 ± 2439 3343 ± 1978 3144 ± 1850 Absolute change −386 ± 1626 −118 ± 1373 −268 ± 2053 −750 ± 1517 LIC*, mg Fe/g dw (n=76) (n=26) (n=28) (n=17) Baseline 19.3 ± 10.9 18.8 ± 10.7 15.6 ± 11.9 15.1 ± 6.2 Absolute change −4.7 ± 8.6 −1.6 ± 6.5 −5.7 ± 6.3 −3.7 ± 6.3 Iron excretion/intake ratio 1.5 ± 0.90 1.1 ± 0.46 1.7 ± 0.93 1.6 ± 1.48 Transfusion requirements and iron intake during the study varied widely between diseases. However, LIC and serum ferritin decreases were consistently achieved in all patient groups. More than one-third (38%) of patients, most of whom had MDS or other anemias, had an iron intake rate &lt;0.3 mg/kg/day (average: 0.2 mg/kg/day; corresponding to 5.6 ml RBC/kg/month). In these patients, deferasirox at 10 and 20 mg/kg reduced LIC. Overall, an iron intake- and dose-related response pattern was observed for both LIC and serum ferritin (Figure 1). Effect of deferasirox dose and iron intake on changes in serum ferritin and LIC over 1 year Effect of deferasirox dose and iron intake on changes in serum ferritin and LIC over 1 year According to these results, deferasirox demonstrates the ability to stabilize and effectively decrease body iron levels at doses of 10, 20 and 30 mg/kg/day, depending on the degree of iron intake. In conclusion, dosing of chelation therapy should be guided by a patient’s transfusion requirements and the treatment goal, which is either to maintain or reduce body iron.

Abstract Introduction: BP of PV presents with dyserythropoiesis, including ring sideroblasts, and bilineage dysplasia in most cases. Clonal evolution or acquisition of new cytogenetic clone(s) plays a critical role in progression to BP of PV. SF3B1 mutation is associated with 75% of MDS with ring sideroblasts (RS). We hypothesized that an increase in ring sideroblast counts is an early event in the BP evolution. We postulate that genomic lesions other than in splicing factors genes are implicated in RS development in PV during BP evolution. Methods: We identified all cases in the last 14 years (2004 - 2018) with a diagnosis of PV in the MDACC files. We collected demographic, clinical, morphological, cytogenetic, and NGS information from 61 patients who developed BP progression from PV. We did an assessment and scoring of all bone marrow (BM) samples available at BP evolution. Results: A total of 61/477 (13%) patients with diagnosis of BP of PV were identified. Median age at BP diagnosis was 67 yrs. (32-82). This included 34 (56%) men and 27 (44%) women. At BP presentation, median BM blast percentage was 28%; 51 (84%) patients had BM dysplasia; 35 patients (69%) with dyserythropoiesis, 22 (43%) cases showed bilineage dysplasia. At BP, 43 pts had complex CG, 9 were were normal karyotype, 3 had double and 5 had single abnormalities. Prussian blue stain for Iron evaluation was available in 54 patients (89%); 24 patients (44%) had 0% RS; 19 patients (35%) had 1-14% RS; and 11 pts (20%) had >15% RS. Mutation analysis for splicing factor was performed on 13 patients. Of these, 2 patients with >15% RS had SRSF2 mutation and 1 patient with 6% RS had SF3B1 mutation. The other patients were wild type for SF3B1, SRSF2, U2AF1 (5 patients: >15% RS, 2 patients: 1-14% RS and 3 patients: 0% RS). Twenty-four (39%) patients had BM available before the BP diagnosis; median time between first BM at MDACC and BP BM diagnosis was 35 months (range, 1-135). At Baseline BM assessment, median BM blast was 3%; 13 (54%) patients had BM dysplasia. Prussian blue stain for Iron evaluation was available in 13 pts (55%): 10 pts (77%) had 0% RS and 3 pts (23%) had 1, 3, and 60% RS, respectively. To evaluate the level of RS during disease evolution we identified 10/26 pts who had at least 1 BM sample available between the first BM and the BP. 5/10 pts were in spent phase with increased blast, multilineage dysplasia and complex CG (RS: 6%, 25%, 0%, 1% and 50%) median time between samples 5 months. 4/10 pts had 1-4% blast, isolated dyserythropoiesis and normal diploid CG (RS: 12%, 5%, 2% and 0%). The median time between samples was 56 months. The last pt. had 0% blast, no dysplasia, del(20q) on CG and no RS. Pt. developed BP of PV 41 months after this follow up sample. Ten pts with PV chronic phase and were used as control group, median follow up of 14,5 yr. None of the patients had RS at baseline or at last follow up BM. Median time between samples 6 yrs. RS increase during PV evolution were statistically significant more frequent in pts who develop BP than in pts who remain in chronic phase of PV (7/10 vs. 0/10. P=0.003) Conclusion: Splicing factor gene mutation is infrequent in BP of PV despite the presence of dyserythropoiesis and frequent RS in 55% of patients. When present , RS may identify disease evolution and correlate with the disease phase of PV before BP. Dyserythropoiesis and the acquisition of RS is an early event BP of PV that precede other markers of disease progression like CG. Disclosures No relevant conflicts of interest to declare.

Abstract Abstract 4093 Introduction: Relapse remains a major cause of mortality after allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with hematological diseases. During the last decade, many improvements have been achieved in the understanding of the disease- and patient-related conditions in order to obtain the optimal allogeneic effect but the relapse is still representative which leaded to the development of different chemo- and immuno-therapy strategies. Aims: To evaluate at a first time the different pre- and post-transplantation factors impacting the relapse occurrence after allo-HSCT, and at a second time, to evaluate factors impact the survival post-relapse including the different treatment options. Material and methods: We have retrospectively studied the occurrence of relapse in 345 patients, 198 (57%) males and 147 (43%) females with a median age of 43 years (range17–66) who received allo-HSCT at our institution for hematological malignancies between years 2000 and 2011; 205 (59%) from siblings donors and 140 (41%) form unrelated donors. At transplantation, there were 148 (43%) patients in first complete response or first chronic phase (CR1/CP1), 66 (19%) in CR2/CP2 and 131 (38%) < CR2/CP2. Two hundred and six (60%) patients received a full intensity conditioning and 139 (40%) a reduced intensity one. The different patients and transplantations characteristics are detailed in Table 1. Results: After HSCT, 336 (97%) patients engrafted. The cumulative incidence of acute GVHD≥2 at 3 months was 35% (95%CI 32–37); the cumulative incidence of extensive and limited chronic GVHD at one year was the same 15% (95%CI 13–17). After a median follow-up of 11.4 months (range 4–129), the median overall survival (OS) for the whole population was 19 months (range 12–33) with a 2-years probability of 47% (95%CI 42–53). Eighty eight (25.5%) patients relapsed with a cumulative incidence at one and two years of 19% (95%CI 17–21) and 22% (95%CI 20–24) respectively. Characteristics of relapsed patients are described in Table 1. After relapse, 65 (74%) patients were treated [21 (32%) received donor lymphocyte infusion (DLI) alone, 21 (32%) chemotherapy alone, 14 (22%) DLI + chemotherapy and 9 (14%) received other treatment] and 23 (26%) were not treated due to deadly relapse. The median OS from relapse was 4 months (range 3–5) and the one year probability of OS in patients who relapsed was 21% (95%CI 14–31). The multivariate analysis studying the impact of different variables on the occurrence of relapse showed a negative impact of disease status [<CR/CP: HR=3.9 (2.4–6.7), p=0.0001], a negative impact of CMV status [D+R-: HR=2.4 [1.2–4.7], p=0.009] and a protective impact of cGVHD [HR=0.37 (0.2–0.6), p=0.0002]. The multivariate analysis studying the pre- and post-relapse variables on the survival after relapse showed a positive impact of ABO incompatibility [Major ABO incompatibility: HR=0.39 (0.16–0.9), p=0.03], a negative impact of disease status [<CR/CP: HR=2.4 (1.3–4.4), p=0.003] and a positive survival outcome in patients receiving DLI with or without chemotherapy [HR=0.5 (0.3–0.8), p=0.005]. Conclusion: We showed that relapse after allo-HSCT in hematological malignancies is still a significant issue, disease status at HSCT and CMV matching worsen its occurrence while cGVHD can be protective. Survival rate after relapse is still very low reflecting the difficulty to find an optimal treatment, disease status at transplantation seem to have a long term effect while the use of DLI with or without chemotherapy can offer better results. In addition to the new chemotherapy molecules, immunotherapy should be used in order to enhance the graft-versus-leukemia effect not only after relapse, but also early in presence of a minimal residual disease. Disclosures: No relevant conflicts of interest to declare.

Abstract Background: Autologous hematopoietic progenitor cells (auto-HC) can be mobilized either by hematopoietic growth factors (GF) alone or cytotoxic chemotherapy + GF (CC+GF). The latter is associated with higher CD34+ yields, but is associated with increased costs and risks of infection and hospitalization. In patients with multiple myeloma (MM) undergoing Auto-HCT, it is uncertain whether mobilization with CC+GF affects post transplant outcomes. Methods: We conducted a retrospective analysis of patients with MM undergoing their first AHPCT following high dose melphalan (≥140 mg/m2) between 2007 and 2012 in US and Canada and registered with the Center for International Blood and Marrow Transplant Research (CIBMTR). Patients who had a planned subsequent allogeneic transplant, received VAD or similar induction therapy, had disease progression prior to transplant, or were mobilized with plerixafor were excluded from the analysis. The primary endpoint was progression-free survival (PFS) and the main secondary end-points were transplant-related mortality (TRM), relapse and overall survival (OS). Results: There were 519 patients in GF and 449 in CC+GF with median follow-up of 42 and 46 months respectively. The most common mobilizing CC regimen was single agent cyclophosphamide (71%). GF and CC+GF groups were similar but there were more patients in GF with only one prior line of therapy, lenalidomide exposure and CR at the time of transplant and more patients in CC+GF with low HCT co-morbidity index, prior thalidomide exposure and planed second autologous transplant (Table 1). Median number of days for auto-HC collection was 2 (IQR 1-3) in GF and 1 (IQR 1-3) in CC+GF (P<0.001). There were fewer days between collection and transplant (median 16 vs. 18, P<0.001) and fewer CD34+ cells (x 106/kg) infused at transplant (median 3.9, IQR=3.1-4.8, vs. 5.1, IQR 3.5-6.9, P<0.001) in GF than in CC+GF. Kinetics of neutrophil engraftment (> 0.5 x 109/L) was similar between groups (13 vs. 13 days, P=0.69) while platelet engraftment (> 20 x 109/L) was faster in CC+GF (median 19 vs. 18 days, P=0.006). There was no difference between groups in number of hospitalization days (14 vs. 14, P=0.7). In univariate analysis, there was no significant difference between the two groups in OS, PFS, or TRM. In multivariate analysis, stage III at diagnosis and Karnofsky status <90 but not modality of mobilization were associated with worse PFS. Similarly HCT-CI >2, Stage III at diagnosis and immunoglobulin isotype (IgG/IgA/Others), but not mobilization were associated with OS. Adjusted 3-years PFS was 43% (95% C.I. 38-48) in GF and 40% (95% C.I. 35-45) in CC+GF, P=0.33 (Figure). Adjusted 3-years OS was 82% (95% C.I. 78-86) vs 80% (95% C.I. 75-84), P=0.43 and adjusted 5-year OS was 62% (95C.I. 54-68) vs. 60% (95% C.I. 52-67), P=0.76, for GF and CC+GF respectively (Figure). Conclusions: MM patients undergoing AHPCT have similar outcomes irrespective of the use of cytotoxic chemotherapy mobilization. We found no evidence that chemotherapy mobilization contributes to disease control in MM. Table Characteristics of patients and treatments GF CC+GF P N=519 N=449 Lines of therapy <0.001 1 382 (74) 265 (59) 2 113 (22) 136 (30) >2 24 (5) 48 (11) Prior therapy <0.001 Thalidomide+Bortezomb+-Steroid 74 (14) 92 (20) Lenalidomide+Bortezomb+-Steroid 121 (23) 48 (11) Thaildomide+-Steroid 85 (16) 106 (24) Bortezomib+-Steroid 132 (25) 136 (30) Lenalidomide+-Steroid 107 (21) 67 (15) Disease status at HCT 0.05 CR 84 (16) 48 (11) PR 407 (78) 378 (84) MR/NR/SD 28 (5) 23 (4) HCT-CI 0.006 0 227 (44) 227 (51) 1-2 147 (29) 134 (30) >2 145 (28) 88(20) Time from diagnosis to HCT <0.001 <6 mo 221 (43) 140 (31) 6-12 mo 298 (57) 309 (69) Year of HCT 0.03 2007-2008 289 (56) 272 (61) 2009-2010 105 (20) 100 (22) 2011-2012 125 (24) 77 (17) Melphalan dose 0.40 140-180 mg/m2 71 (14) 70 (16) >180 mg/m2 448 (86) 379 (84) Transplant type 0.02 Single transplant 417 (80) 331 (74) Multiple Transplants Planned 2ndAuto (0-6 mo) 42 (8) 63 (14) Planned 2ndAuto (>6 mo) 5 (1) 6 (1) Use of maintenance agent 198 (38) 176 (39) 0.29 Figure 1 Figure 1. Disclosures Costa: Sanofi: Honoraria.

Abstract Abstract 3099 Background: Despite the fact that allogeneic SCT currently offers patients with high risk AML the best chance of cure, we've aimed to investigate the outcome of AML patients who have undergone ASCT in our center, considered as one of spanish reference hospital in SCT, and the parameters that have been able to influence in relapse rate (RR), overall survival (OS) and relapse free survival (RFS). Methods: Retrospective study in 121 AML patients who have undergone ASCT between 1988 and 2010. The analysis has been performed in 95 patients (50 male and 45 female) by excluding 26 acute promyelocitic leukemias (APL): 62 patients until 1999 and 33 since 2000. Median age was 45 [18–74] and median lecocyte count, 17250/μL [1000–318000]. 90% were “de novo” AML and 92% were in first complete remission (1°CR). Cytogenetic risk was as follows: 64% intermediate, 29% high and 7% low. Conditioning regimens were oral BuCy (62%), CyTBI (24%) and intravenous BuCy (12%). Stem cell source was bone marrow (BM) in 46 patients (48%), but the use of peripheral blood (PB) was generalized since 1997. Colony-stimulating factors were used in 52% of total patients. Median time from last treatment was 94 days [30–285]. Results: The median follow-up of this study was 125 months [0–216]. OS at 1, 3 and 5 years were 59%, 46% and 44%. RFS at 1, 3 and 5 years were 60%, 49% and 48%. There was no relapse after 5 years from ASCT. Early mortality (before day +100) was 12% (9 in 11 patients between 1988 and 1999) and late mortality was 47% (34 in 45 patients because of relapse, with no significant difference between 1988–1999 and 2000–2010). Secondary malignancies incidence was 13% (5 in 6 patients suffered from haematologic neoplasms: 4 MDS at 43, 89, 90 and 97 months and 1 Follicular Lymphoma at 50 months), median age of these patients was slightly higher (53, 5 years old) and none of them had received TBI. Multivariable analysis showed that RFS at 5 years was influenced by: disease status at ASCT (55% if 1°CR vs 0% if ≥2°CR/PR/refractory disease, p<0, 0001), leucocyte count at diagnosis (p<0, 0001, without a significant cut-off), ethiologic classification (53% if “de novo” AML vs 19% if secondary AML, p=0, 002), age of recipient (60% if younger than 40 years old vs 45% if older, p=0, 031) and year of ASCT (62% if 2000–2010 vs 44% if 1988–1999, p=0, 043). Other parameters as stem cell source, conditioning regimen or cytogenetic risk had no significance in univariable analysis. Relapse was influenced by the presence of minimal residual disease (MRD) at time of ASCT (p=0, 03, with available data in 47 patients, only since 1997) and by a CD34 cells count higher than 3 × 106/kg (p=0, 04, with available data in 49 patients, only in case of PB as stem cell source). Conclusions: ASCT is an effective procedure of cure in AML patients (global RFS of 48% at 5 years), even in high cytogenetic risk (38% with no significant difference), offering its best outcomes in young patients diagnosed of “de novo” AML without hyperleucocytosis, who have undergone the transplantation in 1°CR since 2000. Disclosures: No relevant conflicts of interest to declare.