Scientific article
Open access

Azacytidine for acute myeloid leukemia in elderly or frail patients: a phase II trial (SAKK 30/07)

Published inLeukemia & lymphoma, vol. 55, no. 1, p. 87-91
Publication date2014

This phase II trial treated elderly or frail patients with acute myeloid leukemia (AML) with single-agent subcutaneous azacytidine at 100 mg/m(2), on 5 of 28 days for up to six cycles. Treatment was stopped for lack of response, or continued to progression in responders. The primary endpoint was response within 6 months. A response rate ≥ 34% was considered a positive trial outcome. From September 2008 to April 2010, 45 patients from 10 centers (median age 74 [55-86] years) were accrued. Patients received four (1-21) cycles. Best response was complete response/complete response with incomplete recovery of neutrophils and/or platelets (CR/CRi) in eight (18%; 95% confidence interval [CI]: 8-32%.), 0 (0%) partial response (PR), seven (16%) hematologic improvement, 17 (38%) stable disease. Three non-responding patients stopped treatment after six cycles, 31 patients stopped early and 11 patients continued treatment for 8-21 cycles. Adverse events (grade ≥ III) were infections (n = 13), febrile neutropenia (n = 8), thrombocytopenia (n = 7), dyspnea (p = 6), bleeding (n = 5) and anemia (n = 4). Median overall survival was 6 months. Peripheral blood blast counts, grouped at 30%, had a borderline significant association with response (p = 0.07). This modified azacytidine schedule is feasible for elderly or frail patients with AML in an outpatient setting with moderate, mainly hematologic, toxicity and response in a proportion of patients, although the primary objective was not reached.

Citation (ISO format)
PASSWEG, Jakob et al. Azacytidine for acute myeloid leukemia in elderly or frail patients: a phase II trial (SAKK 30/07). In: Leukemia & lymphoma, 2014, vol. 55, n° 1, p. 87–91. doi: 10.3109/10428194.2013.790540
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Article (Published version)
ISSN of the journal1026-8022

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