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

• Published in: Blood Vol. 117; no. 8; pp. 2366 - 2372
• Main Authors: Miyawaki, Shuichi, Ohtake, Shigeki, Fujisawa, Shin, Kiyoi, Hitoshi, Shinagawa, Katsuji, Usui, Noriko, Sakura, Toru, Miyamura, Koichi, Nakaseko, Chiaki, Miyazaki, Yasushi, Fujieda, Atsushi, Nagai, Tadashi, Yamane, Takahisa, Taniwaki, Masafumi, Takahashi, Masatomo, Yagasaki, Fumiharu, Kimura, Yukihiko, Asou, Norio, Sakamaki, Hisashi, Handa, Hiroshi, Honda, Sumihisa, Ohnishi, Kazunori, Naoe, Tomoki, Ohno, Ryuzo
• Format: Journal Article
• Language: English
• Published: Washington, DC Elsevier Inc 24-02-2011; Americain Society of Hematology
• Subjects: Adolescent; Adult; Antimetabolites, Antineoplastic; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Cytarabine - administration & dosage; Cytarabine - therapeutic use; Dose-Response Relationship, Drug; Hematologic and hematopoietic diseases; Humans; Leukemia, Myeloid, Acute - drug therapy; Leukemia, Myeloid, Acute - mortality; Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis; Leukocyte Count; Medical sciences; Middle Aged; Remission Induction; Survival Analysis; Treatment Outcome; Young Adult; Human; Antineoplastic agent; Acute myelogenous leukemia; Hematology; Malignant hemopathy; Consolidation treatment; Standards; Chemotherapy; Randomization; Treatment; Cytarabine; Antimetabolic; Adult; Pyrimidine nucleoside; High dose; Comparative study; Cancer
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood-2010-07-295279

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/m2 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 × 109/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.