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Int J Hematol (2010) 91:276283 DOI 10.1007/s12185-009-0480-5
ORIGINAL ARTICLE
Randomized trial of response-oriented individualized versus xed-schedule induction chemotherapy with idarubicinand cytarabine in adult acute myeloid leukemia:the JALSG AML95 study
Shigeki Ohtake Shuichi Miyawaki Hitoshi Kiyoi Yasushi Miyazaki Hirokazu Okumura Shin Matsuda
Tadashi Nagai Yuji Kishimoto Masaya Okada Masatomo Takahashi Hiroshi Handa Jin Takeuchi
Shinichi Kageyama Norio Asou Fumiharu Yagasaki Yasuhiro Maeda Kazunori Ohnishi
Tomoki Naoe Ryuzo Ohno
Received: 11 May 2009 / Revised: 11 December 2009 / Accepted: 21 December 2009 / Published online: 7 January 2010 The Japanese Society of Hematology 2010
Abstract A multicenter, prospective, randomized study was conducted to compare a response-oriented individualized remission induction therapy with a standard xed-schedule induction therapy, using idarubicin (IDR) and cytarabine (Ara-C), in adult patients with acute myeloid leukemia (AML). Newly diagnosed patients with AML of age less than 65 were randomly assigned to receive either of the two schedules. Both groups received IDR (12 mg/m2)
for 3 days and Ara-C (100 mg/m2) for 7 days. In the individualized group, if the bone marrow on day 8 did not become hypocellular with less than 15% blasts, patients received additional IDR for one more day and Ara-C for 2 or 3 more days. Patients achieving complete remission (CR) received the same post-remission therapy. The CR rate was 79.4% for the individualized group (n = 209) and81.9% for the xed group (n = 221) (p = 0.598). At a median follow-up of 81 months, 7-year predicted overall survival was 37% for the individualized group and 39% for
For the Japan Adult Leukemia Study Group (JALSG).
S. Ohtake (&) H. Okumura
Department of Hematology, Kanazawa University Graduate School of Medical Science, 13-1 Takara-machi, Kanazawa 920-8641, Japane-mail: [email protected]
S. MiyawakiDivision of Hematology, Saiseikai Maebashi Hospital, Maebashi, Japan
H. Kiyoi T. Naoe
Department of Hematology and Oncology, Nagoya University Graduate School of Medicine, Nagoya, Japan
Y. MiyazakiDepartment of Hematology and Molecular Medicine Unit, Atomic Bomb Disease Institute, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan
S. MatsudaCenter for Hematopoietic Disorders,Ohta Nishinouchi Hospital, The Ohta Foundation, Kohriyama, Japan
T. NagaiDivision of Hematology, Jichi Medical University, Shimotsuke, Tochigi, Japan
Y. KishimotoThe First Department of Internal Medicine, Kansai Medical University, Moriguchi, Japan
M. OkadaDivision of Hematology, Department of Internal Medicine, Hyogo College of...