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

Passweg, Jakob R.; Pabst, Thomas; Blum, Sabine; Bargetzi, Mario; Li, Qiyu; Heim, Dominik; Stussi, Georg; Gregor, Michael; Leoncini, Leda; Meyer-Monard, Sandrine; Brauchli, Peter; Chalandon, Yves; Swiss Group for Clinical Cancer Research, SAKK (2013). Azacytidine for acute myeloid leukemia in elderly or frail patients: A phase II trial (SAKK 30/07). Leukemia & lymphoma, 55(1), pp. 87-91. London: Informa Healthcare 10.3109/10428194.2013.790540

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Abstract This phase II trial treated elderly or frail AML patients with single agent subcutaneous azacytidine at 100 mg/m(2), on 5 of 28 days for up to 6 cycles. Treatment was stopped for lack of response, or continued to progression in responders. Primary endpoint was response within 6 months. A response rate >34% was considered a positive trial outcome. From 9/2008-4/2010, 45 patients from 10 centres (median age 74 (55-86) years) were accrued. Patients received 4 (1-21) cycles. Best response was CR/CRi in 8 (18%; 95% CI: 8%-32%.), 0 (0%) PR, 7 (16%) hematologic improvement, 17 (38%) stable disease. Three nonresponding patients stopped treatment after 6 cycles, 31 patients had stopped early and 11 patients continued treatment for 8-21 cycles. Adverse events (grade >III) were infections (13), febrile neutropenia (14), thrombocytopenia (7), dyspnea (6), bleeding (5) and anemia (4 patients). 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 AML patients in an outpatient setting with moderate, mainly hematologic, toxicity and response in a proportion of patients, although the primary objective was not reached.

Item Type:

Journal Article (Original Article)

Division/Institute:

08 Faculty of Science > Department of Mathematics and Statistics > Institute of Mathematical Statistics and Actuarial Science
04 Faculty of Medicine > Department of Haematology, Oncology, Infectious Diseases, Laboratory Medicine and Hospital Pharmacy (DOLS) > Clinic of Medical Oncology

UniBE Contributor:

Pabst, Thomas and Li, Qiyu

Subjects:

300 Social sciences, sociology & anthropology > 360 Social problems & social services
500 Science > 510 Mathematics

ISSN:

1042-8194

Publisher:

Informa Healthcare

Language:

English

Submitter:

Lutz Dümbgen

Date Deposited:

04 Oct 2013 14:36

Last Modified:

10 Dec 2014 11:40

Publisher DOI:

10.3109/10428194.2013.790540

PubMed ID:

23547838

Web of Science ID:

000295160600805

URI:

https://boris.unibe.ch/id/eprint/14274 (FactScience: 221150)

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