A randomized, postremission comparison of four courses of standard-dose consolidation therapy without maintenance therapy versus three courses of standard-dose consolidation with maintenance therapy in adults with acute myeloid leukemia

Autor: Yoshiaki Ogawa, Norio Asou, Sumihisa Honda, Fumiharu Yagasaki, Yuji Kishimoto, Masatomo Takahashi, Shin Matsuda, Nobuhiko Emi, Hisashi Sakamaki, Ryuzo Ohno, Yasushi Miyazaki, Shuichi Miyawaki, Kinuko Mitani, Shigeki Ohtake, Takafumi Matsushima
Rok vydání: 2005
Předmět:
Zdroj: Cancer. 104:2726-2734
ISSN: 0008-543X
DOI: 10.1002/cncr.21493
Popis: BACKGROUND A major concern in the treatment of patients with acute myeloid leukemia (AML) is how to prevent disease recurrences. Although intensive consolidation therapy has proven useful, the effectiveness of maintenance therapy remains controversial. METHODS Seven hundred eighty-nine patients ages 15–64 (median: 45 yrs) with de novo AML received induction therapy, which consisted of cytosine arabinoside (at a dose of 100 mg/m2 on Days 1–7) and idarubicin (at a dose of 12 mg/m2 on Days 1–3). The patients who achieved complete remission (CR) were then randomized into groups that received either four courses of standard-dose consolidation therapy without maintenance (Arm A) or three courses of standard-dose consolidation and six courses of maintenance therapy (Arm B). RESULTS In total, 78.7% of patients achieved CR. The 5-year overall survival (OS) rate for the 789 eligible patients was 46.9%, and the disease-free survival (DFS) rate for the 621 patients who achieved CR was 32.9%. The 5-year OS rate for Arm A was 52.4%, and 58.4% for Arm B (P = 0.599). The 5-year DFS rate for the patients who achieved CR was 35.8% in Arm A and 30.4% in Arm B (P = 0.543). In analyzing the data according to the risk groups, no statistical difference was observed either in the 5-year OS rate or in the 5-year DFS rate between the 2 arms. CONCLUSIONS In the current study, the Japan Adult Leukemia Study Group's conventional postremission therapy (three courses of standard-dose consolidation and six courses of maintenance therapy) was replaced successfully by a shorter duration of four courses of standard-dose consolidation therapy without the need for additional maintenance therapy. Cancer 2005. © 2005 American Cancer Society.
Databáze: OpenAIRE