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国产硼替佐米(昕泰)治疗初治多发性骨髓瘤的初步研究

Efficacy and safety of domestic generic bortezomib (Xintai) in patients with newly-diagnosed multiple myeloma

  • 摘要: 目的:初步评价国产硼替佐米(昕泰)治疗初治多发性骨髓瘤(multiple myeloma, MM)的有效性及安全性。方法:纳入确诊活动性MM,并接受昕泰治疗2个周期以上可评估疗效的初治患者。采用昕泰联合地塞米松的两药(BD)方案或两药基础上加用环磷酰胺的三药方案(VCD)。昕泰的起始剂量为每周1.3 mg/m2。每2周期评价疗效和安全性。结果:2018年6月至2018年11月,共纳入14例MM患者,随访至2019年1月。全部患者可行2周期疗效评估,其中3例为非常好的部分缓解(VGPR)、9例部分缓解(PR)、1例微小缓解(MR)、1例疾病进展(PD),总反应率(ORR)为85.7%。6例患者可行4周期疗效评估,均为VGPR,ORR为100%。不良事件与原研药类似。主要血液学毒性包括血小板及淋巴细胞计数降低;非血液学毒性主要为消化系统不良反应,腹泻与便秘较多见。结论:昕泰治疗初治MM具有良好的疗效及安全性。

     

    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.

     

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