|
|||||
|
|
Randomized trial of response-oriented individualized versus fixed-schedule induction chemotherapy with idarubicin and cytarabine in adult acute myeloid leukemia: the JALSG AML95 study |
|
| Authors: | 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 |
| Affiliation: | 1. Department of Hematology, Kanazawa University Graduate School of Medical Science, 13-1 Takara-machi, Kanazawa, 920-8641, Japan 2. Division of Hematology, Saiseikai Maebashi Hospital, Maebashi, Japan 3. Department of Hematology and Oncology, Nagoya University Graduate School of Medicine, Nagoya, Japan 4. Department of Hematology and Molecular Medicine Unit, Atomic Bomb Disease Institute, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan 5. Center for Hematopoietic Disorders, Ohta Nishinouchi Hospital, The Ohta Foundation, Kohriyama, Japan 6. Division of Hematology, Jichi Medical University, Shimotsuke, Tochigi, Japan 7. The First Department of Internal Medicine, Kansai Medical University, Moriguchi, Japan 8. Division of Hematology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan 9. Division of Hematology and Oncology, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Japan 10. Department of Medicine and Clinical Science, Gunma University Graduate School of Medicine, Maebashi, Japan 11. Department of Hematology and Rheumatology, Nihon University School of Medicine, Tokyo, Japan 12. Department of Hematology and Oncology, Mie University Graduate School of Medicine, Tsu, Japan 13. Department of Hematology, Kumamoto University School of Medicine, Kumamoto, Japan 14. Department of Hematology, Saitama Medical School, Hidaka, Japan 15. Department of Hematology, Kinki University School of Medicine, Osaka-Sayama, Japan 16. Oncology Center, Hamamatsu University School of Medicine, Hamamatsu, Japan 17. Aichi Cancer Center, Nagoya, Japan |
| Abstract: | A multicenter, prospective, randomized study was conducted to compare a response-oriented individualized remission induction therapy with a standard fixed-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) and 81.9% for the fixed 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 the fixed group (p = 0.496), and 7-year predicted event-free survival was 22% for the individualized group and 23% for the fixed group (p = 0.546). Thus, the present study could not demonstrate any advantage of a response-oriented individualized induction therapy over a fixed-schedule induction therapy in this protocol setting. |
| Keywords: | |
| 本文献已被 SpringerLink 等数据库收录！ | |