Danthala Madhav, Gundeti Sadashivudu, Kuruva Siva Prasad, Puligundla Krishna Chaitanya, Adusumilli Praveen, Karnam Ashok Pillai, Bala Stalin, Konatam Meher Lakshmi, Maddali Lakshmi Srinivas, Digumarti Raghunadha Rao
Department of Medical Oncology, Nizam's Institute of Medical Sciences, Hyderabad, India.
Department of Medical Oncology, Nizam's Institute of Medical Sciences, Hyderabad, India.
Clin Lymphoma Myeloma Leuk. 2017 Jul;17(7):457-462. doi: 10.1016/j.clml.2017.05.006. Epub 2017 May 10.
The patent expiration of imatinib mesylate (Gleevec; Novartis) on February 1, 2016, has brought the focus back on generic versions of the drug, and an opportunity to provide a safe and cost-effective alternative. The objective of our study was to determine the molecular and cytogenetic responses, survival endpoints (event-free survival, failure-free survival, transformation-free survival, overall survival), and safety of innovator and generic brands of imatinib.
In this retrospective analysis, data from 1812 patients with chronic myeloid leukemia treated with frontline imatinib mesylate (innovator/generic) at a single institution between 2008 and 2014 is included. Of these, 445 were excluded owing to inadequate data and follow-up, and a further 156 were excluded as they were in either the accelerated phase or blast crisis at diagnosis. Thus, data from 1067 patients who were treated with Gleevec (Novartis), and 144 patients with Veenat (NATCO) were available for analysis, and included in the study.
There was no significant difference in event-free survival (P = .05), failure-free survival (P = .07), transformation-free survival (P = .12), or overall survival (P = .24) between the 2 groups. The frequency of reported nonhematologic adverse events and hematologic adverse events was comparable between the study groups.
The findings of the present study showed comparable efficacy and safety of the generic and innovator versions of imatinib in the treatment of patients with chronic myeloid leukemia.
甲磺酸伊马替尼（格列卫；诺华公司）于2016年2月1日专利到期，这使得人们重新关注该药物的仿制药版本，并提供了一个提供安全且具成本效益的替代方案的机会。我们研究的目的是确定伊马替尼原研药和仿制药的分子及细胞遗传学反应、生存终点（无事件生存期、无失败生存期、无转化生存期、总生存期）以及安全性。
在这项回顾性分析中，纳入了2008年至2014年间在单一机构接受一线甲磺酸伊马替尼（原研药/仿制药）治疗的1812例慢性髓性白血病患者的数据。其中，445例因数据不足和随访不充分而被排除，另有156例因诊断时处于加速期或急变期而被排除。因此，有1067例接受格列卫（诺华公司）治疗的患者以及144例接受维奈托克（纳科公司）治疗的患者的数据可供分析，并纳入本研究。
两组之间的无事件生存期（P = 0.05）、无失败生存期（P = 0.07）、无转化生存期（P = 0.12）或总生存期（P = 0.24）无显著差异。研究组之间报告的非血液学不良事件和血液学不良事件的发生率相当。
本研究结果表明，伊马替尼仿制药和原研药在治疗慢性髓性白血病患者方面具有相当的疗效和安全性。
