PMID- 20026804 OWN - NLM STAT- MEDLINE DCOM- 20100218 LR - 20220311 IS - 1527-7755 (Electronic) IS - 0732-183X (Linking) VI - 28 IP - 4 DP - 2010 Feb 1 TI - Azacitidine prolongs overall survival compared with conventional care regimens in elderly patients with low bone marrow blast count acute myeloid leukemia. PG - 562-9 LID - 10.1200/JCO.2009.23.8329 [doi] AB - PURPOSE: In a phase III randomized trial, azacitidine significantly prolonged overall survival (OS) compared with conventional care regimens (CCRs) in patients with intermediate-2- and high-risk myelodysplastic syndromes. Approximately one third of these patients were classified as having acute myeloid leukemia (AML) under current WHO criteria. This analysis compared the effects of azacitidine versus CCR on OS in this subgroup. PATIENTS AND METHODS: Patients were randomly assigned to receive subcutaneous azacitidine 75 mg/m(2)/d or CCR (best supportive care [BSC] only, low-dose cytarabine (LDAC), or intensive chemotherapy [IC]). RESULTS: Of the 113 elderly patients (median age, 70 years) randomly assigned to receive azacitidine (n = 55) or CCR (n = 58; 47% BSC, 34% LDAC, 19% IC), 86% were considered unfit for IC. At a median follow-up of 20.1 months, median OS for azacitidine-treated patients was 24.5 months compared with 16.0 months for CCR-treated patients (hazard ratio = 0.47; 95% CI, 0.28 to 0.79; P = .005), and 2-year OS rates were 50% and 16%, respectively (P = .001). Two-year OS rates were higher with azacitidine versus CCR in patients considered unfit for IC (P = .0003). Azacitidine was associated with fewer total days in hospital (P < .0001) than CCR. CONCLUSION: In older adult patients with low marrow blast count (20% to 30%) WHO-defined AML, azacitidine significantly prolongs OS and significantly improves several patient morbidity measures compared with CCR. FAU - Fenaux, Pierre AU - Fenaux P AD - Service d'Hematologie Clinique, Hospital Avicenne, Assistance Publique-Hopitaux de Paris (AP-HP), Universite Paris XIII, Bobigny, France. pierre.fenaux@avc.aphp.fr FAU - Mufti, Ghulam J AU - Mufti GJ FAU - Hellstrom-Lindberg, Eva AU - Hellstrom-Lindberg E FAU - Santini, Valeria AU - Santini V FAU - Gattermann, Norbert AU - Gattermann N FAU - Germing, Ulrich AU - Germing U FAU - Sanz, Guillermo AU - Sanz G FAU - List, Alan F AU - List AF FAU - Gore, Steven AU - Gore S FAU - Seymour, John F AU - Seymour JF FAU - Dombret, Herve AU - Dombret H FAU - Backstrom, Jay AU - Backstrom J FAU - Zimmerman, Linda AU - Zimmerman L FAU - McKenzie, David AU - McKenzie D FAU - Beach, C L AU - Beach CL FAU - Silverman, Lewis R AU - Silverman LR LA - eng PT - Clinical Trial, Phase III PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20091221 PL - United States TA - J Clin Oncol JT - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JID - 8309333 RN - 0 (Antimetabolites, Antineoplastic) RN - M801H13NRU (Azacitidine) SB - IM CIN - J Clin Oncol. 2010 Feb 1;28(4):521-3. PMID: 20026796 CIN - J Clin Oncol. 2010 Aug 1;28(22):e380-1. PMID: 20458054 MH - Aged MH - Aged, 80 and over MH - Antimetabolites, Antineoplastic/*therapeutic use MH - Antineoplastic Combined Chemotherapy Protocols/therapeutic use MH - Azacitidine/*therapeutic use MH - Blast Crisis/*pathology MH - Bone Marrow Cells/*pathology MH - Female MH - Follow-Up Studies MH - Humans MH - International Agencies MH - Leukemia, Myeloid, Acute/*drug therapy/*mortality MH - Leukocyte Count MH - Male MH - Maximum Tolerated Dose MH - Middle Aged MH - Neoplasm Staging MH - Prognosis MH - Survival Rate MH - Treatment Outcome EDAT- 2009/12/23 06:00 MHDA- 2010/02/19 06:00 CRDT- 2009/12/23 06:00 PHST- 2009/12/23 06:00 [entrez] PHST- 2009/12/23 06:00 [pubmed] PHST- 2010/02/19 06:00 [medline] AID - JCO.2009.23.8329 [pii] AID - 10.1200/JCO.2009.23.8329 [doi] PST - ppublish SO - J Clin Oncol. 2010 Feb 1;28(4):562-9. doi: 10.1200/JCO.2009.23.8329. Epub 2009 Dec 21.