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Efficacy and safety of domestic generic bortezomib (Xintai) in patients with newly-diagnosed multiple myeloma
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Citation of this paper:ZHANG Yi-an, ZHUANG Jing-li, WANG Zhi-mei, WEI Zheng, WANG Wei-guang, JI Li-li, CHEN Zhi-xiang, KE Yang, LIU Peng*.Efficacy and safety of domestic generic bortezomib (Xintai) in patients with newly-diagnosed multiple myeloma[J].Chinese Journal of Clinical Medicine,2019,26(2):224-228
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ZHANG Yi-an, ZHUANG Jing-li, WANG Zhi-mei, WEI Zheng, WANG Wei-guang, JI Li-li, CHEN Zhi-xiang, KE Yang, LIU Peng* Department of Hematology, Zhongshan Hospital, Fudan University, Shanghai, 200032, China 
Abstract:Objective:To evaluate the efficacy and safety of domestic generic bortezomib (Xintai) in the treatment of patients with newly-diagnosed multiple myeloma (MM). Methods:Patients with newly diagnosed MM were treated with Xintai for at least two cycles. Patients were treated with two-drug regimen of Xintai combined with dexamethasone (BD) or three-drug combination of cyclophosphamide plus BD regimen (VCD). The initial dose of Xintai was 1.3 mg/m2everyweek.The efficacy and safety were evaluated every two cycles. Results:From June 2018 to November 2018, 14 eligible patients were enrolled and followed until January 2019. At the end of 2-cycles, the overall response rate (ORR) of these 14 patients was 85.72%. Three had very good partial response (VGPR), 9 partial response (PR), 1 mild response (MR) and 1 progression disease (PD). Six patients were evaluable at the end of 4-cycles. All these 6 patients obtained VGPR and ORR was 100%. Adverse events were similar to the original drug. The main adverse events of hematological toxicity were mild decrease of platelet and lymphocyte counts. Meanwhile, diarrheal and constipation were the main non-hematological toxicities observed. Conclusions:The domestic generic bortezomib (Xintai) is effective and safe in the treatment of newly-diagnosed MM.
keywords:multiple myeloma  bortezomib  generic drug  efficacy  safety
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