Huang Shang-Yi, Chen Tsai-Yun, Kuo Ching-Yuan, Chen Yeu-Chin, Lin Sheng-Fung, Chang Ming-Chih, Lv Xinzhu, Yang Betty, Chang Cheng-Shyong
National Taiwan University Hospital, Taiwan.
National Cheng Kung University Hospital, Taiwan.
Oncol Rev. 2019 Jan 18;13(1):377. doi: 10.4081/oncol.2019.377. eCollection 2019 Jan 14.
Bortezomib is a proteasome inhibitor, approved for treating newly diagnosed and relapsed multiple myeloma (MM). This realworld, multicenter, observational, non-interventional study of bortezomib was designed to collect and analyze prospective data in Taiwanese patients with relapsed or refractory MM. The primary endpoints included clinical effectiveness outcomes (disease response, disease progression [PD], time-to-response, time-toprogression, response duration, and overall survival [OS]). Secondary endpoints were safety and healthcare resource utilization. Total 100 patients (median [range] age 64.9 [37.0-85.5] years) were enrolled; 47 patients completed the study. Of the withdrawn patients (n=53), there were 48 deaths (PD-related death: n=35, adverse events [AEs]-related: n=12, other reason: n=1), and 5 due to loss to follow-up. Four patients in Cycle 1, 6 patients each in Cycle 2 and 5, 7 in Cycle 3, 10 patients in Cycle 4, 5 patients in Cycle 6, and 3 patients each in Cycle 7 and 8 achieved overall response during the study. Time-to-response was 4.68 months (95%CI: 3.2, NE) and response duration was 10.08 months (95%CI: 2.3, 28.6). Median OS was 9.8 months (95%CI: 3.8, 13.7), and median time-to-progression was 11.3 months (95%CI: 6.2, 20.2). Most common non-hematological AEs were diarrhea (n=32) and hypoesthesia (n=25); most common hematological AE was thrombocytopenia (n=18). Efficacy and safety profile of bortezomib in Taiwanese patients with MM was similar to global and other Asian population. Study provides a critical insight on use of bortezomib in realworld clinical practice, which can be helpful for Taiwanese healthcare providers' decision-making processes.
硼替佐米是一种蛋白酶体抑制剂，已被批准用于治疗新诊断和复发的多发性骨髓瘤（MM）。这项针对硼替佐米的真实世界、多中心、观察性、非干预性研究旨在收集和分析台湾复发或难治性MM患者的前瞻性数据。主要终点包括临床有效性结果（疾病反应、疾病进展[PD]、反应时间、进展时间、反应持续时间和总生存期[OS]）。次要终点是安全性和医疗资源利用情况。共纳入100例患者（中位[范围]年龄64.9[37.0 - 85.5]岁）；47例患者完成了研究。在退出研究的患者（n = 53）中，有48例死亡（与PD相关的死亡：n = 35，与不良事件[AEs]相关的：n = 12，其他原因：n = 1），5例因失访。在研究期间，第1周期有4例患者、第2和5周期各有6例患者、第3周期有7例患者、第4周期有10例患者、第6周期有5例患者以及第7和8周期各有3例患者实现了总体缓解。反应时间为4.68个月（95%CI：3.2，无上限），反应持续时间为10.08个月（95%CI：2.3，28.6）。中位OS为9.8个月（95%CI：3.8，13.7），中位进展时间为11.3个月（95%CI：6.2，20.2）。最常见的非血液学不良事件是腹泻（n = 32）和感觉减退（n = 25）；最常见的血液学不良事件是血小板减少（n = 18）。硼替佐米在台湾MM患者中的疗效和安全性与全球及其他亚洲人群相似。该研究为硼替佐米在真实世界临床实践中的应用提供了关键见解，有助于台湾医疗服务提供者的决策过程。
