Bortezomib plus dexamethasone vs thalidomide plus dexamethasone for relapsed or refractory multiple myeloma |
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Authors: | Shinsuke Iida Masashi Wakabayashi Kunihiro Tsukasaki Kenichi Miyamoto Dai Maruyama Kazuhito Yamamoto Yoshifusa Takatsuka Shigeru Kusumoto Junya Kuroda Kiyoshi Ando Yoshitaka Kikukawa Yasufumi Masaki Miki Kobayashi Ichiro Hanamura Hiroaki Asai Hirokazu Nagai Kazuyuki Shimada Norifumi Tsukamoto Yoshiko Inoue Kensei Tobinai |
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Institution: | 1. Department of Hematology and Oncology, Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG‐LSG), Nagoya City University Hospital, Nagoya, Japan;2. JCOG Data Center/Operations Office, National Cancer Center, Tokyo, Japan;3. Department of Hematology, Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG‐LSG), National Cancer Center Hospital East, Kashiwa, Japan;4. Department of Hematology, Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG‐LSG), National Cancer Center Hospital, Tokyo, Japan;5. Department of Hematology and Cell Therapy, Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG‐LSG), Aichi Cancer Center Hospital, Nagoya, Japan;6. Department of Hematology, Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG‐LSG), Imamura General Hospital, Kagoshima, Japan;7. Division of Hematology and Oncology, Department of Medicine, Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG‐LSG), Kyoto Prefectural University, Kyoto, Japan;8. Department of Hematology and Oncology, Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG‐LSG), Tokai University of School of Medicine, Isehara, Japan;9. Department of Hematology, Rheumatology and Infectious Diseases, Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG‐LSG), Kumamoto University Hospital, Kumamoto, Japan;10. Department of Hematology and Immunology, Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG‐LSG), Kanazawa Medical University, Kahoku, Japan;11. Department of Hematology and Oncology, Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG‐LSG), Japanese Red Cross Nagoya Daini Hospital, Nagoya, Japan;12. Division of Hematology, Department of Internal Medicine, Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG‐LSG), Aichi Medical University, Nagakute, Japan;13. First Department of Internal Medicine, Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG‐LSG), Ehime University Hospital, Toon, Japan;14. Department of Hematology, Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG‐LSG), National Hospital Organization Nagoya Medical Center, Nagoya, Japan;15. Department of Hematology and Oncology, Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG‐LSG), Nagoya University Graduate School of Medicine, Nagoya, Japan;16. Oncology Center, Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG‐LSG), Gunma University Hospital, Maebashi, Japan;17. Department of Hematology, Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG‐LSG), National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan |
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Abstract: | A randomized phase II selection design study (JCOG0904) was carried out to evaluate the more promising regimen between bortezomib (Bor) plus dexamethasone (Dex; BD) and thalidomide (Thal) plus Dex (TD) in Bor and Thal‐naïve patients with relapsed or refractory multiple myeloma (RRMM). Patients ≥20 and <80 years old with a documented diagnosis of symptomatic multiple myeloma (MM) who received one or more prior therapies were randomized to receive BD (Bor 1.3 mg/m2) or TD (Thal 200 mg/d). In both arms, 8 cycles of induction (3‐week cycle) were followed by maintenance phase (5‐week cycle) until disease progression, unacceptable toxicity, or patient refusal. The primary end‐point was 1‐year progression‐free survival (PFS). Forty‐four patients were randomized and assigned to receive BD and TD (n = 22, each group). At a median follow‐up of 34.3 months, the 1‐year PFS in the BD and TD arms were 45.5% (95% confidence interval (CI), 24.4%‐64.3%) and 31.8% (95% CI, 14.2%‐51.1%), respectively, and the overall response rates were 77.3% and 40.9%, respectively. The 3‐year overall survival (OS) was 70.0% (95% CI, 44.9%‐85.4%) in the BD, and 48.8% (95% CI, 25.1%‐69.0%) in the TD arm. Among grade 3/4 adverse events, thrombocytopenia (54.5% vs 0.0%) and sensory peripheral neuropathy (22.7% vs 9.1%) were more frequent in BD when compared with the TD arm. Patients treated with BD had better outcomes than those treated with TD with regard to 1‐year PFS and 3‐year OS. Thus, BD was prioritized over TD for further investigations in Bor and Thal‐naïve RRMM patients. (Clinical trial registration no. UMIN000003135.) |
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Keywords: | bortezomib dexamethasone randomized phase II study relapsed or refractory multiple myeloma thalidomide |
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