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Regorafenib in glioblastoma recurrence: how to deal with conflicting ‘real-life’ experiences?

机译:雷戈非尼在胶质母细胞瘤复发中的作用:如何应对冲突的现实生活体验?

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摘要

To date, treatment options for glioblastoma recurrence are scarce. Based on efficacy data from randomized clinical trials, the nitrosourea compound CCNU (lomustine) is considered standard treatment after temozolomide failure. Treatment with lomustine in recurrent glioblastoma yields median overall survival (mOS) ranging from 8.6–9.8 months and median progression-free survival (mPFS) from 1.5–2.7 months. In a recently published open-label, randomized, phase II trial (REGOMA trial) of patients with first glioblastoma recurrence, regorafenib was found superior to lomustine with mOS of 7.4 months in regorafenib-treated patients as opposed to 5.6 months in lomustine treated patients. The radiographically assessed disease control rate (defined as complete/partial response or stable disease) was 44% in the regorafenib arm and 20% in the lomustine control arm. A yet unanswered question is whether regorafenib is going to replace lomustine as standard treatment should regorafenib superiority be confirmed in a planned randomized phase III trial.
机译:迄今为止,胶质母细胞瘤复发的治疗选择很少。根据来自随机临床试验的功效数据,亚硝基脲类化合物CCNU(洛莫司汀)被视为替莫唑胺治疗失败后的标准治疗方法。洛莫司汀治疗复发性胶质母细胞瘤的中位总生存期(mOS)为8.6–9.8个月,中位无进展生存期(mPFS)为1.5–2.7个月。在最近发表的一项开放性,随机,II期胶质母细胞瘤复发患者的II期试验中(REGOMA试验),在雷戈非尼治疗的患者中,瑞戈非尼的mOS为7.4个月,优于瑞莫司汀,而在洛莫斯汀治疗的患者中,瑞戈非尼的mOS为7.4个月。影像学评估的疾病控制率(定义为完全/部分缓解或稳定的疾病)在瑞戈非尼组为44%,在洛莫司汀对照组为20%。一个尚待解决的问题是,如果在一项计划中的随机III期临床试验中确认瑞格非尼的优越性,瑞格非尼是否将替代洛莫司汀作为标准治疗药物。

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