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引用次数: 0
摘要
本研究的目的是评价瑞非尼与地努妥昔单抗联合化疗治疗中国晚期神经母细胞瘤儿童的疗效和安全性。年龄小于16岁的组织学诊断为晚期神经母细胞瘤的患者被纳入并随机分组，以1:1的比例接受瑞非尼加最佳支持治疗或迪努妥昔单抗加化疗加最佳支持治疗。肿瘤反应评估按照国际神经母细胞瘤反应标准进行。对不良事件也进行了评估。瑞非尼比接受地努妥昔单抗联合化疗的患者的总生存期和无进展生存期更长(总生存期:中位32.3个月对27.2个月;风险比= 0.45;95% CI 0.11-0.13, p<0.001;无进展生存期:分层风险比= 0.48;95% ci 0.11-0.14;p < 0.01)。此外，与地努妥昔单抗组相比，瑞非尼组患者的总体缓解率更高。Regorafenib在中国晚期神经母细胞瘤儿童中似乎有效且具有可管理的安全性。
Efficacy and safety of regorafenib versus dinutuximab with chemotherapy in Chinese children with neuroblastoma
The objective of the present study was to evaluate the efficacy and safety of regorafenib in comparison with dinutuximab with chemotherapy in Chinese children with advanced neuroblastoma. The patients aged less than 16 years who were histologically diagnosed with advanced neuroblastoma were enrolled and randomized to receive either regorafenib plus best supportive care or dinutuximab plus chemotherapy plus best supportive care in a 1:1 ratio. The tumor response assessment was made in accordance with modified international neuroblastoma response criteria. Adverse events were also assessed. Regorafenib showed prolonged overall survival and progression-free survival than who received dinutuximab plus chemotherapy (overall survival: median 32.3 months versus 27.2 months; hazard ratio = 0.45; 95% CI 0.11-0.13, p<0.001; progression-free survival: stratified hazard ratio = 0.48; 95% CI 0.11-0.14; p<0.01). Moreover, the overall response rate was greater in patients treated with regorafenib as compared to dinutuximab group. Regorafenib appears efficacious and has a manageable safety profile in Chinese children with advanced neuroblastoma.
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Bangladesh Journal of Pharmacology (Bangladesh J Pharmacol) is an open access, video component, peer-reviewed journal of the Bangladesh Pharmacological Society (BDPS).
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