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

Détails

ID Serval
serval:BIB_EFBD423076BB
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Titre
Azacytidine for acute myeloid leukemia in elderly or frail patients: a phase II trial (SAKK 30/07).
Périodique
Leukemia and Lymphoma
Auteur(s)
Passweg J.R., Pabst T., Blum S., Bargetzi M., Li Q., Heim D., Stussi G., Gregor M., Leoncini L., Meyer-Monard S., Brauchli P., Chalandon Y.
Collaborateur(s)
Swiss Group for Clinical Cancer Research (SAKK)
ISSN
1029-2403 (Electronic)
ISSN-L
1026-8022
Statut éditorial
Publié
Date de publication
2014
Volume
55
Numéro
1
Pages
87-91
Langue
anglais
Notes
Publication types: Journal ArticlePublication Status: ppublish PDF: Original Article: Clinical
Résumé
Abstract 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.
Pubmed
Web of science
Création de la notice
24/01/2014 19:20
Dernière modification de la notice
10/07/2019 6:26
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