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Randomized Controlled Trial
. 2011 Feb 24;117(8):2366-72.
doi: 10.1182/blood-2010-07-295279. Epub 2010 Dec 29.

A randomized comparison of 4 courses of standard-dose multiagent chemotherapy versus 3 courses of high-dose cytarabine alone in postremission therapy for acute myeloid leukemia in adults: the JALSG AML201 Study

Shuichi Miyawaki  1 , Shigeki Ohtake, Shin Fujisawa, Hitoshi Kiyoi, Katsuji Shinagawa, Noriko Usui, Toru Sakura, Koichi Miyamura, Chiaki Nakaseko, Yasushi Miyazaki, Atsushi Fujieda, Tadashi Nagai, Takahisa Yamane, Masafumi Taniwaki, Masatomo Takahashi, Fumiharu Yagasaki, Yukihiko Kimura, Norio Asou, Hisashi Sakamaki, Hiroshi Handa, Sumihisa Honda, Kazunori Ohnishi, Tomoki Naoe, Ryuzo Ohno
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Randomized Controlled Trial

A randomized comparison of 4 courses of standard-dose multiagent chemotherapy versus 3 courses of high-dose cytarabine alone in postremission therapy for acute myeloid leukemia in adults: the JALSG AML201 Study

Shuichi Miyawaki et al. Blood. .
Free article

Abstract

We conducted a prospective randomized study to assess the optimal postremission therapy for adult acute myeloid leukemia in patients younger than 65 years in the first complete remission. A total of 781 patients in complete remission were randomly assigned to receive consolidation chemotherapy of either 3 courses of high-dose cytarabine (HiDAC, 2 g/m(2) twice daily for 5 days) alone or 4 courses of conventional standard-dose multiagent chemotherapy (CT) established in the previous JALSG AML97 study. Five-year disease-free survival was 43% for the HiDAC group and 39% for the multiagent CT group (P = .724), and 5-year overall survival was 58% and 56%, respectively (P = .954). Among the favorable cytogenetic risk group (n = 218), 5-year disease-free survival was 57% for HiDAC and 39% for multiagent CT (P = .050), and 5-year overall survival was 75% and 66%, respectively (P = .174). In the HiDAC group, the nadir of leukocyte counts was lower, and the duration of leukocyte less than 1.0 × 10(9)/L longer, and the frequency of documented infections higher. The present study demonstrated that the multiagent CT regimen is as effective as our HiDAC regimen for consolidation. Our HiDAC regimen resulted in a beneficial effect on disease-free survival only in the favorable cytogenetic leukemia group. This trial was registered at www.umin.ac.jp/ctr/ as #C000000157.

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