Liao Rong-Qiong, Lin Xiao-Jing, Li Xiang-Long, Ni Xun, Luo Wen-Feng, Zhao Pan, Chen Jing, Wei Jin, Zou Xing-Li
Department of Hematology, The Affiliated Hospital of North Sichuan Medical College, Nanchong 637000, Sichuan Province, China.
Department of Hematology, The Affiliated Hospital of North Sichuan Medical College, Nanchong 637000, Sichuan Province, China,E-mail:
Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2021 Feb;29(1):137-144. doi: 10.19746/j.cnki.issn.1009-2137.2021.01.022.
To investigate the short-term efficacy and safety of generic bortezomib in the treatment of Chinese patients with multiple myeloma (MM).
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.
Anemia, renal dysfunction, hypoproteinemia and high level of β -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%).
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.
探讨国产硼替佐米治疗中国多发性骨髓瘤（MM）患者的短期疗效及安全性。
回顾性分析2017年12月至2019年7月在我中心接受至少2个周期基于国产硼替佐米化疗的62例MM患者（中位年龄62岁）的临床资料，其中新诊断患者47例，疾病复发或进展患者15例。
诱导治疗后贫血、肾功能不全、低蛋白血症及β2微球蛋白水平均迅速改善。56例完成至少4个周期化疗的患者，总缓解率（ORR）为85.7%，64.3%的患者达到非常好的部分缓解（VGPR）或更好，28.6%达到完全缓解（CR）或更好。19例已完成所有计划诱导和巩固治疗（9个周期化疗或4 - 6个周期化疗加自体造血干细胞移植）的患者中，84.2%达到VGPR或更好，57.9%达到CR或严格完全缓解（sCR）。中位随访时间为300天，数据截止日期为2019年9月20日，无进展生存期（PFS）率和总生存期（OS）率分别为62.1%和85.3%。与硼替佐米相关的可能不良反应为1 - 2级，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%）。
基于国产硼替佐米的化疗后疾病严重程度可迅速缓解，观察到良好的短期疗效和生存期，毒性反应总体可接受。然而，长期结果将通过进一步随访进行观察。
