国产仿制硼替佐米治疗多发性骨髓瘤的近期疗效及安全性观察

目的:探讨国产仿制蛋白酶体抑制剂硼替佐米治疗多发性骨髓瘤(MM)的近期疗效及安全性。方法:回顾性分析本中心2017年12月-2019年7月采用以国产仿制硼替佐米为基础的化疗方案并至少完成了2个周期化疗的MM患者共62例,其中初诊患者47例,疾病复发/进展的患者15例,中位年龄62岁。结果:诱导治疗后患者的贫血、肾功能、白蛋白及β2-微球蛋白水平迅速得到改善;至少完成4个周期化疗的患者共56例,总体有效率(ORR)为85.7%,达到非常好的部分缓解(VGPR)及以上治疗反应的患者为64.3%,完全缓解(CR)率为28.6%;完成全部诱导及巩固治疗的患者(9个周期化疗或4-6周期化疗+自体造血干细胞移植)共19例,其中疗效达VGPR以上的患者为84.2%,CR或者严格意义的完全缓解(sCR)的患者为57.9%。截止至2019年9月20日,本研究患者中位随访时间为300d,18个月的无进展生存(PFS)率和总生存(OS)率分别为62.1%和85.3%。与硼替佐米可能有关的不良反应以1-2级为主,最常见的血液学不良反应为血小板减少(27.4%),最常见的非血液学不良反应为周围神经病变(43.5%),其次为乏力(37.1%)。结论:以国产仿制硼替佐米为基础的联合化疗治疗多发性骨髓瘤,疾病缓解迅速,近期疗效、生存情况及安全性总体良好,远期疗效及生存情况将进一步随访观察。

Short-Term Efficacy and Safety Profile of Generic Bortezomib in the Treatment of Multiple Myeloma

Objective:To investigate the short-term efficacy and safety of generic bortezomib in the treatment of Chinese patients with multiple myeloma(MM).Methods:Clinical data of 62 MM patients(median age of 62 years)who had accepted at least 2 cycles of chemotherapy based on generic bortezomib in our center from December 2017 to July 2019 were retrospectively analyzed,including 47 newly diagnosed patients and 15 with disease recurrence or progression.Results:Anemia,renal dysfunction,hypoproteinemia and high level ofβ2-microglobulin were all improved rapidly after induction treatment.In 56 patients who had completed at least 4 cycles of chemotherapy,the overall response rate(ORR)was 85.7%,and 64.3%of the patients achieved very good partial response(VGPR)or better,and 28.6%achieved complete remission(CR)or better.In the 19 patients who had already completed all planned induction and consolidation treatment(9 cycles of chemotherapy or 4-6 cycles of chemotherapy plus autologous hematopoietic stem cell transplantation),84.2%achieved VGPR or better,and 57.9%achieved CR or stringent complete remission(sCR).Median follow-up time was 300 days with data cut-off date of September 20,2019,and the progression-free survival(PFS)rate and overall survival(OS)rate were 62.1%and 85.3%,respectively.The possible adverse reactions associated with bortezomib were grade 1-2,the most common hematologic adverse reaction was thrombocytopenia(27.4%),and the most common non-hematologic adverse reaction was peripheral neuropathy(43.5%),followed by asthenia(37.1%).Conclusion:The disease severity can be rapidly alleviated after generic bortezomib-based chemotherapy,and a favorable short-term efficacy and survival have been observed with a generally acceptable toxicity profile.However,the long-term outcomes will be examined through further follow-up.