Search

Background The prognosis of patients with relapsed/refractory acute myeloid leukemia (AML) following intensive chemotherapy (IC) is poor; furthermore, treatment options for these patients are limited. Few studies have assessed outcomes of azacitidine (AZA) in a relapsed/refractory setting.1–3 Response rates and survival in these studies have been variable. Methods The Austrian AZA Registry was initiated to gain a comprehensive view of the use, safety and efficacy of AZA in a broad range of ‘real-life’ AML patients. The sole inclusion criteria were the diagnosis of AML according to World Health Organization (WHO) criteria and treatment with ≥1 dose of AZA. Here, we assess clinical outcomes in patients with newly diagnosed AML (AZA 1st line) vs patients with relapsed/refractory AML following IC and/or low-dose chemotherapy/other disease-modifying therapy (AZA ≥2nd line). Results Baseline characteristics were generally comparable between patients treated with AZA 1st line (n=170) and AZA after IC (n=127), or AZA ≥2nd line (n=176), respectively (Figure 1). However, pre-treated patients had a significantly lower proportion of patients younger than 75 years (18.9 and 29.0 vs 59.4% for AZA after IC [p Median time from initial diagnosis to AZA treatment was shorter for patients treated with AZA 1st line than AZA after IC or ≥2nd line (0.5, 9.2 and 7.8 months, respectively). Median number of cycles was higher for patients who received AZA 1st line than AZA after IC or ≥2nd line (6 [range 1–46], 3 [range 1–27] and 3 [range 1–35], respectively). Time from AZA stop to death was 1.8 months for the AZA 1st line and ≥2nd line cohorts, and 2.1 months for patients receiving AZA after IC. There was no significant difference in overall response rate (ORR) according to International Working Group (IWG) 2003 criteria4 (complete response [CR] + CR with incomplete blood count recovery [CRi] + partial response [PR]) in patients treated with AZA 1st line compared with pre-treated patients (24.4 and 22.2 vs 35.9% for AZA after IC [p=0.139] and AZA ≥2nd line vs AZA 1st line [p=0.072], respectively; Figure 1). Furthermore, rates of hematologic improvement (HI) according to IWG 2006 criteria5 were also similar (53.2 and 51.0 vs 63.3% for AZA after IC [p=0.349] and AZA ≥2nd line vs AZA 1st line [p=0.250], respectively; p=0.463; Figure 1). When ORR and rate of HI were combined, the difference remained non-significant (Figure 1). Median overall survival (OS) was significantly higher with AZA 1st line than AZA after IC (12.8 vs 7.6 months, p=0.005) or ≥2nd line (12.8 vs 6.0 months, p0% (p=0.01), lactate dehydrogenase >225IU/L (p=0.012), and poor-risk cytogenetics (according Medical Research Council [MRC] criteria; p=0.011). Conclusion This study represents the largest cohort of relapsed/refractory AML patients treated with AZA, comprising almost four times as many patients (n=176) than the largest cohorts reported to date (n=47). Despite a shorter OS than patients treated with AZA 1st line, response rates in patients who received AZA as a ≥2nd line therapy were encouragingly high and similar to response rates of AZA 1st line patients. Median OS of 7.6 months in relapsed patients or those who are refractory to IC, which generally confers a dismal prognosis (median OS: ~3 months),6,7 is promising. Thus, salvage therapy with AZA is a treatment option for patients with relapsed/refractory AML, which should be further pursued in clinical trials. Figure 1 Figure 1. Figure 2 Figure 2. Disclosures Pleyer: Bristol-Myers Squibb: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; AOP Orphan Pharmaceuticals: Honoraria; Celgene: Consultancy, Honoraria. Off Label Use: Vidaza (azacitidine) is indicated for the treatment of adult AML patients who are not eligible for haematopoietic stem cell transplantation with 20–30 % blasts and multi-lineage dysplasia, according to WHO classification. This cohort also includes AML-patients with >30% bone marrow blasts.. Burgstaller:AOP Orphan Pharmaceuticals: Honoraria; Novartis: Honoraria; Mundipharma: Honoraria; Celgene: Consultancy. Stauder:Novartis: Research Funding; Ratiopharm: Honoraria, Research Funding; Celgene: Consultancy, Honoraria, Research Funding. Girschikofsky:Pfizer: Honoraria, Research Funding; Mundipharm: Consultancy, Honoraria. Pfeilstöcker:Novartis: Consultancy, Honoraria; Janssen-Cilag: Honoraria; Celgene: Consultancy, Honoraria. Lang:Celgene: Consultancy. Sperr:Phadia: Research Funding; Novartis: Honoraria; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. Valent:Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; BMS: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees. Greil:Sanofi Aventis: Honoraria; Roche: Honoraria; Pfizer: Honoraria, Research Funding; Boehringer-Ingelheim: Honoraria; Astra-Zeneca: Honoraria; Novartis: Honoraria; Genentech: Honoraria, Research Funding; Janssen-Cilag: Honoraria; Merck: Honoraria; Mundipharma: Honoraria, Research Funding; Eisai: Honoraria; Amgen: Honoraria, Research Funding; Celgene: Consultancy, Research Funding; Cephalon: Consultancy, Honoraria, Research Funding; Bristol-Myers-Squibb: Consultancy, Honoraria; GSK: Research Funding; Ratiopharm: Research Funding.

Background Recent phase III data indicate that azacitidine (AZA) is active, and well tolerated, in patients with acute myeloid leukemia (AML) and baseline white blood cell (WBC) counts of Methods In this retrospective study of the Austrian AZA Registry (N=346), we assessed outcomes in patients with WHO-AML who received ≥1 dose of AZA, according to baseline WBC count. Patients were divided according to WBC Results A comparison of baseline characteristics between the two groups revealed significantly higher levels of serum lactate dehydrogenase (LDH), peripheral blood (PB) and bone marrow (BM) blasts in patients with WBC ≥15G/L vs those with WBC In the 1st line setting, overall response rate (ORR) was similar in the WBC In contrast, in the ≥2nd line setting, ORR was significantly higher in the WBC Different baseline factors appeared to significantly impact OS in the 0% and LDH >225IU/L negatively affected OS, irrespective of treatment line. Adverse cytogenetics reached statistical significance for the whole 3, primarily in the AZA 1st line setting. Conclusions Previous retrospective studies have suggested that WBC ≥15G/L has a negative impact on OS in AML patients treated with AZA.2,3 This report is the first to describe the impact of WBC ( 1. Dombret H, et al. Oral presentation at EHA 2014. Abstract LB-2433 2. Thepot S, et al. Am J Hematol 2014;89:410–6 3. van der Helm LH, et al. Leuk Res 2013;37:877–82 4. Cheson BD, et al. J Clin Oncol 2003;21:4642–9 5. Cheson BD, et al. Blood 2006;108:419–25 Figure 1 Figure 1. Figure 2 Figure 2. Disclosures Pleyer: Celgene: Consultancy, Honoraria; AOP Orphan Pharmaceuticals: Honoraria; Novartis: Consultancy, Honoraria; Bristol-Myers Squibb: Consultancy, Honoraria. Off Label Use: Vidaza (azacitidine) is indicated for the treatment of adult AML patients who are not eligible for haematopoietic stem cell transplantation with 20–30 % blasts and multi-lineage dysplasia, according to WHO classification. This cohort also includes AML-patients with >30% bone marrow blasts.. Burgstaller:AOP Orphan Pharmaceuticals: Honoraria; Novartis: Honoraria; Mundipharma: Honoraria; Celgene: Consultancy. Stauder:Ratiopharm: Honoraria, Research Funding; Celgene: Consultancy, Honoraria, Research Funding; Novartis: Research Funding. Girschikofsky:Pfizer: Honoraria, Research Funding; Mundipharm: Consultancy, Honoraria. Pfeilstöcker:Janssen-Cilag: Honoraria; Novartis: Consultancy, Honoraria; Celgene: Consultancy, Honoraria. Lang:Celgene: Consultancy. Sperr:Phadia: Research Funding; Novartis: Honoraria; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. Valent:Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; BMS: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees. Greil:Amgen: Honoraria, Research Funding; Eisai: Honoraria; Mundipharma: Honoraria, Research Funding; Merck: Honoraria; Janssen-Cilag: Honoraria; Genentech: Honoraria, Research Funding; Novartis: Honoraria; Astra-Zeneca: Honoraria; Boehringer-Ingelheim: Honoraria; Pfizer: Honoraria, Research Funding; Roche: Honoraria; Sanofi Aventis: Honoraria; GSK: Research Funding; Ratiopharm: Research Funding; Celgene: Consultancy, Research Funding; Cephalon: Consultancy, Honoraria, Research Funding; Bristol-Myers-Squibb: Consultancy, Honoraria.

Background Approximately 10% of cases of acute myeloid leukemia (AML) arise following exposure to chemotherapy (treatment-related AML [tAML]). Compared to de novo AML patients, tAML patients have a poor prognosis, not least due to a higher proportion having adverse cytogenetics. Treatment options for tAML patients are limited and outcomes remain dismal. Median overall survival (OS) of 6.9 mo as of initial presentation, with 25% deaths within one month of diagnosis, was reported for a large cohort of tAML patients, with individualized treatments ranging from supportive care, to intensive chemotherapy (IC) and bone marrow (BM) transplantation.1 Few studies have assessed azacitidine (AZA) in patients with tAML, and those that have, did not report separate outcomes for this subgroup.2–4 Methods Here, we compare a subgroup of tAML patients (n=27) with patients with other World Health Organization (WHO)-AML subgroups (n=319) from the Austrian AZA Registry. The aim of the registry was to gain insight of the use, safety and efficacy of AZA in ‘real-world’ AML patients. The sole inclusion criteria were the diagnosis of WHO-AML and treatment with ≥1 dose of AZA. Results Baseline characteristics were compared between patients with tAML and WHO-AML: median age, gender, percentage with myelodysplatic syndrome (MDS)-related features, serum lactate dehydrogenase (LDH) level, and median peripheral blood and BM blasts were similar between both cohorts. However, tAML patients had poorer Eastern Cooperative Oncology Group Performance Status (ECOG PS) scores, more comorbidities, and a higher proportion of high-risk cytogenetics compared with WHO-AML patients. Of patients with tAML, 41% received AZA as 1st line therapy and 59% received AZA as ≥2nd line therapy. Baseline characteristics of these two subgroups were also comparable, except that tAML patients treated with AZA 1st line were older, had poorer ECOG PS and worse cytogenetics than ≥2nd line patients, which is in line with what would be expected from a cohort not deemed eligible for IC (Figure 1). Median number of AZA cycles was 4 (range 1–25) for tAML patients and 4 (range 1–46) for WHO-AML patients. Median time from AZA stop to death was 1.9 vs 1.8 mo for patients with tAML vs other WHO-AML subgroups. The overall response rate (ORR; International Working Group [IWG] 2003 criteria5) as well as the rate of hematologic improvement (HI; IWG 2006 criteria6) were similar for patients with tAML vs WHO-AML treated with AZA (complete response [CR] + CR with incomplete blood count recovery [CRi] + partial response [PR]: 22.2 vs 29.5%; and HI: 58.8 vs 57.7%, respectively; Figure 1). Median OS was similar for patients with tAML vs WHO-AML (8.9 vs 9.4 mo; p=0.147; Figure 1), but was longer for responders than non-responders in both groups of patients. Relapse-free survival was 7.7 vs 9.1 mo for patients with tAML vs WHO-AML. In univariate analyses, baseline factors that significantly affected OS for tAML patients were LDH >225IU/L (p Patients with tAML who received AZA 1st line achieved a significantly higher ORR than those who received AZA ≥2nd line (36.4 vs 12.5%; p Conclusions This represents the largest study reporting outcomes of tAML patients treated with AZA. Survival of tAML patients with AZA was comparable to that achieved in other WHO-AML subgroups, suggesting that AZA is a feasible treatment option for this poor prognostic subgroup. The OS data compare favorably to OS data reported for IC1 and are encouraging. Based on these ‘real-world’ data, randomized trials should assess AZA in tAML patients. 1. Smith SM, et al. Blood 2003;102:43–52 2. Bally C, et al. Leuk Res 2013;37:637–40 3. Fianchi L, et al. J Hematol Oncol 2012;5:44 4. Pleyer L, et al. Ann Hematol 2014; epub ahead of print 5. Cheson BD, et al. J Clin Oncol 2003;21:4642–9 6. Cheson BD, et al. Blood 2006;108:419–25 Figure 1 Figure 1. Figure 2 Figure 2. Disclosures Pleyer: Bristol-Myers Squibb: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; AOP Orphan Pharmaceuticals: Honoraria; Celgene: Consultancy, Honoraria. Off Label Use: Vidaza (azacitidine) is indicated for the treatment of adult AML patients who are not eligible for haematopoietic stem cell transplantation with 20–30 % blasts and multi-lineage dysplasia, according to WHO classification. This cohort also includes AML-patients with >30% bone marrow blasts.. Burgstaller:AOP Orphan Pharmaceuticals: Honoraria; Novartis: Honoraria; Mundipharma: Honoraria; Celgene: Consultancy. Stauder:Celgene: Consultancy, Honoraria, Research Funding; Ratiopharm: Honoraria, Research Funding; Novartis: Research Funding. Girschikofsky:Pfizer: Honoraria, Research Funding; Mundipharm: Consultancy, Honoraria. Pfeilstöcker:Janssen-Cilag: Honoraria; Novartis: Consultancy, Honoraria; Celgene: Consultancy, Honoraria. Lang:Celgene: Consultancy. Sperr:Phadia: Research Funding; Novartis: Honoraria; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. Valent:Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; BMS: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees. Greil:Sanofi Aventis: Honoraria; Roche: Honoraria; Pfizer: Honoraria, Research Funding; Boehringer-Ingelheim: Honoraria; Astra-Zeneca: Honoraria; Novartis: Honoraria; Genentech: Honoraria, Research Funding; Janssen-Cilag: Honoraria; Merck: Honoraria; Mundipharma: Honoraria, Research Funding; Eisai: Honoraria; Amgen: Honoraria, Research Funding; Celgene: Consultancy, Research Funding; Cephalon: Consultancy, Honoraria, Research Funding; Bristol-Myers-Squibb: Consultancy, Honoraria; GSK: Research Funding; Ratiopharm: Research Funding.

Background Few data exist reporting the incidence of World Health Organization (WHO)-defined acute myeloid leukemia (AML) subgroups in adults in Europe,1 but the incidence of AML with myelodysplastic-related features (MRF) may be higher than initially reported.2–4 Whether the presence of multilineage dysplasia has an independent prognostic impact in AML is still controversial.5,6 However, AML patients with preceding myelodysplastic syndrome (MDS)/myeloproliferative neoplasm and/or MDS-related cytogenetics (Medical Research Council [MRC]) have been shown to have poorer survival than AML-not otherwise specified (NOS).7 Previous studies of AML patients treated with azacitidine (AZA) included AML-MRF patients, but did not report on outcomes separately.3,4, 8–12 Methods Due to the lack of data assessing the prognostic impact of AML-MRF in elderly AML patients treated with AZA, we analyzed patients with AML-MRF from the Austrian AZA Registry, which was initiated to gain a comprehensive view of the safety and efficacy of AZA in ‘real-life’ patients. Similar to the approach taken by others who assessed the effect of AML-MRF irrespective of treatment modality,7 patients with AML and recurrent cytogenetic abnormalities (RCA), and treatment-related AML (tAML) based on the WHO 2008 classification13 were excluded, as these subsets have particularly good (AML-RCA) or dismal prognosis (tAML), respectively. Results The AML-MRF group comprised 217 patients (AZA 1st line, n=121; AZA ≥2nd line, n=96) and the AML-NOS group comprised 90 patients (AZA 1st line, n=33; AZA ≥2nd line, n=57). Baseline characteristics were comparable except AML-MRF patients had worse Hematopoietic Cell Transplant Comorbidity Index (HCT-CI) scores and a higher proportion of high-risk cytogenetics (Figure 1). The latter is expected as most high-risk cytogenetic abnormalities are defined as MDS-related.13 Median time from diagnosis to AZA start was 6 months for AZA ≥2nd line. The median number of AZA cycles was 4 (range 1–35) for AML-MRF patients and 4.5 (range 1–46) for AML-NOS patients. The overall response rate (ORR)14 was similar for AML-MRF vs AML-NOS patients (complete response [CR] + CR with incomplete blood count recovery [CRi] + partial response [PR]: 29.0 vs 33.3%, respectively; p=0.586). Rates of hematologic improvement15 were similar for AML-MRF vs AML-NOS patients (57.9 vs 57.4%; p=0.964). Median duration of response was 7.0 vs 5.5 mo, respectively. ORR was similar for AML-MRF and AML-NOS patients irrespective of AZA treatment line (Figure 1). Median overall survival (OS) for AML-MRF vs AML-NOS patients was 9.4 vs 9.7 mo for the total cohort (p=0.490; Figure 2), and 13.1 vs 10.8 mo for patients treated with AZA 1st line. For responding patients, median OS, response duration and relapse-free survival were numerically longer for AML-MRF than AML-NOS patients within the total cohort (17.1 vs 12.6; 7.0 vs 5.5; and 9.8 vs 8.5 mo), and even more so in the AZA 1st line cohort (19.7 vs 12.6; 7.4 vs 3.9; and 10.5 vs 7.9 mo). In univariate analyses, baseline factors that significantly negatively impacted OS in AML-MRF patients treated with AZA were peripheral blood blasts >0% (p=0.025), Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≥2 (p=0.004), >3 comorbidities (p=0.004), and poor cytogenetics (p=0.001). Notably, none of these factors showed statistical significance for AML-NOS patients. Conclusions This represents the first and largest report comparing outcomes of AML-MRF vs AML-NOS patients treated with AZA. Outcomes of AML-MRF patients were similar to patients with other AML-NOS subgroups. AZA seems a feasible treatment option for these patients despite the reported poor prognostic impact of MRF. 1. Sant M, et al. Blood 2010;116:3724–34 2. Quintas-Cardama A, et al. Blood 2012;120:4840–5 3. Pleyer L, et al. Ann Hematol 2014 [Epub ahead of print] 4. Thepot S, et al. Am J Hematol 2014;89:410–6 5. Wandt H, et al. Blood 2008;111:1855–61 6. Gahn B, et al. Leukemia 1996;10:946–51 7. Miesner M, et al. Blood 2010;116:2742–51 8. van der Helm L, et al. Leuk Res 2013;37:877–82 9. Gavillet M, et al. Haematologica 2012;97:1929–31 10. Maurillo L, et al. Cancer 2012;118:1014–22 11. Ivanoff S, et al. Am J Hematol 2013;88:601–5 12. Al-Ali HK, et al. Leuk Lymphoma 2011;53:110–7 13. Swerdlow SH, et al. IARC press 2008 14. Cheson BD, et al. J Clin Oncol 2003;21:4642–9 15. Cheson BD, et al. Blood 2006;108:419–25 Figure 1 Figure 1. Figure 2 Figure 2. Disclosures Pleyer: Bristol-Myers Squibb: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; AOP Orphan Pharmaceuticals: Honoraria; Celgene: Consultancy, Honoraria. Off Label Use: Vidaza (azacitidine) is indicated for the treatment of adult AML patients who are not eligible for haematopoietic stem cell transplantation with 20–30 % blasts and multi-lineage dysplasia, according to WHO classification. This cohort also includes AML-patients with >30% bone marrow blasts. Burgstaller:AOP Orphan Pharmaceuticals: Honoraria; Novartis: Honoraria; Mundipharma: Honoraria; Celgene: Consultancy. Stauder:Novartis: Research Funding; Ratiopharm: Honoraria, Research Funding; Celgene: Consultancy, Honoraria, Research Funding. Girschikofsky:Pfizer: Honoraria, Research Funding; Mundipharm: Consultancy, Honoraria. Pfeilstöcker:Janssen-Cilag: Honoraria; Novartis: Consultancy, Honoraria; Celgene: Consultancy, Honoraria. Lang:Celgene: Consultancy. Sperr:Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Honoraria; Phadia: Research Funding. Valent:Novartis: Membership on an entity's Board of Directors or advisory committees; BMS: Membership on an entity's Board of Directors or advisory committees; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees. Greil:Sanofi Aventis: Honoraria; Roche: Honoraria; Pfizer: Honoraria, Research Funding; Boehringer-Ingelheim: Honoraria; Astra-Zeneca: Honoraria; Novartis: Honoraria; Genentech: Honoraria, Research Funding; Janssen-Cilag: Honoraria; Merck: Honoraria; Mundipharma: Honoraria, Research Funding; Eisai: Honoraria; Amgen: Honoraria, Research Funding; Celgene: Consultancy, Research Funding; Cephalon: Consultancy, Honoraria, Research Funding; Bristol-Myers-Squibb: Consultancy, Honoraria; GSK: Research Funding; Ratiopharm: Research Funding.

Background Several studies, including retrospective analyses of patient registries1,2 and a subanalysis of the phase III MDS-AZA-001 trial3 suggest that poor-risk cytogenetics negatively impact overall survival (OS) in patients with myelodysplastic syndrome (MDS) and World Health Organization (WHO)-defined acute myeloid leukemia (AML) treated with azacitidine (AZA). There are few data available to indicate whether AZA has improved clinical activity vs conventional care in AML patients with adverse cytogenetics. However, in a subanalysis of MDS-AZA-001 (MDS and AML [20–30% bone marrow blasts]) patients with –7/–7q abnormalities had better OS with AZA than low-dose cytarabine (21.4 vs 3.5 months, respectively) supporting significant activity of AZA in patients with adverse cytogenetics.4 Methods In this retrospective study of the Austrian AZA Registry (N=346), we compared patients with WHO-AML and intermediate- (n=228) vs high-risk (n=74) cytogenetics according to Medical Research Council (MRC) criteria. Outcomes were also assessed with respect to AZA treatment line. Results The intermediate-risk cytogenetics group comprised 228 patients (AZA 1st line, n=109; AZA ≥2nd line, n=119), and the high-risk cytogenetics group comprised 74 patients (AZA 1st line, n=39; AZA ≥2nd line, n=35; Figure 1). Comparison of baseline characteristics of both groups revealed significant differences with regard to prevalence of males and Eastern Cooperative Oncology Group Performance Status (ECOG PS) >2 for patients with high-risk cytogenetics receiving AZA 1st line, but not in those receiving AZA ≥2nd line. Peripheral blood blasts were present in a significantly larger proportion of high- than intermediate-risk patients (Figure 1). In patients who received AZA 1st line, median number of AZA cycles was 6 for both the intermediate- and high-risk cytogenetic groups (range: 1–46 and 1–25, respectively). Median time from diagnosis to AZA start was 7.6 months for AZA ≥2nd line. Median time from AZA stop to death was In the whole cohort, the overall response rate (ORR) according to International Working Group (IWG) 2003 criteria5 was similar for patients with intermediate- and high-risk cytogenetics (complete response [CR] + CR with incomplete blood count recovery [CRi] + partial response [PR]: 32.0 vs 20.3%; p=0.106; Figure 1). Rates of hematologic improvement (HI) according to IWG 2006 criteria6 were also not significantly different (54.4 vs 75.6; p=0.063), and when ORR and HI were combined, the difference remained non-significant (47.4 vs 46.0%; p=0.885; Figure 1). Median OS was consistently higher in patients with intermediate- than high-risk cytogenetics (9.8 vs 5.4 months for the total cohort; p=0.046 [Figures 1 and 2a]; 13.5 vs 9.5 months for AZA 1st line [not significant]; and 7.6 vs 3.5 months for AZA ≥2nd line; p=0.005 [Figure 1]). However, median OS for responding patients (CR/CRi/PR/HI) was similar for patients with intermediate- and high-risk cytogenetics, irrespective of treatment line (19.9 vs 19.3 months for all responders; 20.5 vs 21.7 months for AZA 1st line; and 18.5 vs 15.0 months for AZA ≥2nd line). Furthermore, presence of a monosomal karyotype had a significant negative impact on OS (Figure 2b). None of the baseline factors analyzed had an impact on OS in patient subgroups with intermediate- or high-risk cytogenetics, except number of comorbidities >3. Conclusions Here, we compared outcomes of 302 WHO-AML patients with intermediate- vs high-risk cytogenetics treated with AZA. In line with recent data of MDS patients,1 baseline cytogenetics did not seem to have a significant effect on response to AZA. However, in agreement with other studies of AZA in MDS/WHO-AML patients,1–3 high-risk cytogenetics had a negative impact on survival compared with intermediate-risk cytogenetics in WHO-AML treated with AZA. 1. Sebert M, et al. Oral presentation at ASH 2013. Abstract 389 2. Thepot S, et al. Am J Hematol 2014;89:410–6 3. Fenaux P, et al. J Clin Oncol 2010;28:562–9 4. Fenaux P, et al. Br J Haematol 2010;149:244–9 5. Cheson BD, et al. J Clin Oncol 2003;21:4642–9 6. Cheson BD, et al. Blood 2006;108:419–25 Figure 1 Figure 1. Figure 2 Figure 2. Disclosures Pleyer: AOP Orphan Pharmaceuticals: Honoraria; Novartis: Consultancy, Honoraria; Bristol-Myers Squibb: Consultancy, Honoraria; Celgene: Consultancy, Honoraria. Off Label Use: Vidaza (azacitidine) is indicated for the treatment of adult AML patients who are not eligible for haematopoietic stem cell transplantation with 20–30 % blasts and multi-lineage dysplasia, according to WHO classification. This cohort also includes AML-patients with >30% bone marrow blasts.. Burgstaller:AOP Orphan Pharmaceuticals: Honoraria; Novartis: Honoraria; Mundipharma: Honoraria; Celgene: Consultancy. Stauder:Novartis: Research Funding; Ratiopharm: Honoraria, Research Funding; Celgene: Consultancy, Honoraria, Research Funding. Girschikofsky:Pfizer: Honoraria, Research Funding; Mundipharm: Consultancy, Honoraria. Pfeilstöcker:Janssen-Cilag: Honoraria; Novartis: Consultancy, Honoraria; Celgene: Consultancy, Honoraria. Lang:Celgene: Consultancy. Sperr:Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Honoraria; Phadia: Research Funding. Valent:Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; BMS: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees. Greil:Sanofi Aventis: Honoraria; Roche: Honoraria; Pfizer: Honoraria, Research Funding; Boehringer-Ingelheim: Honoraria; Astra-Zeneca: Honoraria; Novartis: Honoraria; Genentech: Honoraria, Research Funding; Janssen-Cilag: Honoraria; Merck: Honoraria; Mundipharma: Honoraria, Research Funding; Eisai: Honoraria; Amgen: Honoraria, Research Funding; Celgene: Consultancy, Research Funding; Cephalon: Consultancy, Honoraria, Research Funding; Bristol-Myers-Squibb: Consultancy, Honoraria; GSK: Research Funding; Ratiopharm: Research Funding.