Kocaeli University Faculty of Medicine, Department of Hematology, Kocaeli, Turkey
Turk J Haematol. 2021 Aug 25;38(3):211-217. doi: 10.4274/tjh.galenos.2021.2020.0555. Epub 2021 May 5.
Constantly increasing health expenditures lead to the use of generic molecules and generic versions of bortezomib have been used for a long time. The aim of this study is to retrospectively examine the effectiveness, side effects, and reliability of generic bortezomib in newly diagnosed multiple myeloma (MM) patients.
The data of 95 patients who received four cycles of bortezomib as first- or second-line therapy in a single center were retrospectively recorded. Treatment responses, side effects, and progression-free survival (PFS) rates were calculated and compared.
Of the 95 patients, 42 used the original and 53 used the generic molecule. Epidemiological data, MM types, genetic risk groups, laboratory values at diagnosis, and bortezomib treatment lines (as a first line or second) were evaluated and there was no statistical difference between the two groups. When the response rates were evaluated according to International Myeloma Working Group criteria, there was no significant difference (p=0.42). Rates of partial response and higher responses were similar (81% vs. 79.2%, p=0.84). PFS rates were 42.8 months with the original and 37.8 months with the generic molecule (p=0.68). Side effects were seen in 44.2% of all patients, and the most common side effects were neuropathy, cytopenia, and infection. These rates were similar in the two groups (p=0.55).
Although this retrospective study is limited in scope, it is the first study comparing the original molecule of bortezomib with a generic version. There were no statistical differences between the two groups in terms of treatment responses, PFS, or side effects. However, large-scale evaluations will help obtain more data on this subject.
不断增加的卫生支出导致了对通用分子的使用，而硼替佐米的通用版本已经使用了很长时间。本研究的目的是回顾性检查新诊断多发性骨髓瘤（MM）患者中硼替佐米通用版本的疗效、副作用和可靠性。
回顾性记录了 95 名患者在单一中心接受 4 个周期硼替佐米一线或二线治疗的数据。计算并比较了治疗反应、副作用和无进展生存期（PFS）率。
95 例患者中，42 例使用原药，53 例使用仿制药。对流行病学数据、MM 类型、遗传风险组、诊断时的实验室值以及硼替佐米治疗线（一线或二线）进行了评估，两组间无统计学差异。根据国际骨髓瘤工作组标准评估反应率时，无显著差异（p=0.42）。部分缓解和更高缓解率相似（81%比 79.2%，p=0.84）。原药组和仿制药组的 PFS 率分别为 42.8 个月和 37.8 个月（p=0.68）。所有患者中出现副作用的比例为 44.2%，最常见的副作用是周围神经病、血细胞减少和感染。两组间这些副作用发生率相似（p=0.55）。
尽管这项回顾性研究范围有限，但它是首次比较硼替佐米原药和仿制药的研究。两组在治疗反应、PFS 或副作用方面无统计学差异。然而，大规模评估将有助于获得更多关于该主题的数据。
