Zhang Zhenan, Jiang Tao, Wang Wensheng, Piao Daxun
Department of Colorectal Surgery, The First Affiliated Hospital of Harbin Medical University Thoracic Surgery, Harbin Children's Hospital, Harbin, Heilongjiang Province, China.
Medicine (Baltimore). 2017 Dec;96(48):e8698. doi: 10.1097/MD.0000000000008698.
This meta-analysis aimed to evaluate the safety and efficacy of regorafenib as a treatment for patients with advanced (metastatic and/or unresectable) gastrointestinal stromal tumor (AGIST) after developing resistance to imatinib and sunitinib.
A literature search of databases such as PubMed, Embase, and Cochrane library was conducted up to February 2017. The pooled percentages and the corresponding 95% confidence intervals (CIs) were calculated using the Stata 11.0 software.
Four studies involving 243 patients with AGIST were included. Results revealed that approximately 49% (95% CI 30-67), 14% (95% CI 5-23), and 41% (95% CI 21-61) of patients with AGIST showed clinical benefit (including complete response), partial response, and stable disease, respectively, after regorafenib treatment, which was given after failure with imatinib and sunitinib treatments. No complete response was found in the included studies. Pooled progression-free survival was 6.58 months (95% CI 4.62-8.54). Hypertension (20%; 95% CI 7-33), hand-foot skin reaction (22%; 95% CI 17-27), and hypophosphatemia (18%; 95% CI 5-41) were common grade ≥3 regorafenib-related adverse events in patients treated with regorafenib after failure with imatinib and sunitinib treatments.
Forty-nine per cent of patients with AGIST benefited after regorafenib treatment after the development of resistance to imatinib and sunitinib. More studies should be performed to improve the clinical survival of patients with AGIST. Close monitoring and appropriate management of grade ≥3 regorafenib-related adverse events should be considered during treatment.
本荟萃分析旨在评估瑞戈非尼用于对伊马替尼和舒尼替尼耐药后的晚期（转移性和/或不可切除）胃肠道间质瘤（AGIST）患者治疗的安全性和有效性。
截至2017年2月，对PubMed、Embase和Cochrane图书馆等数据库进行文献检索。使用Stata 11.0软件计算合并百分比及相应的95%置信区间（CI）。
纳入了四项涉及243例AGIST患者的研究。结果显示，在伊马替尼和舒尼替尼治疗失败后接受瑞戈非尼治疗的AGIST患者中，分别约有49%（95%CI 30 - 67）、14%（95%CI 5 - 23）和41%（95%CI 21 - 61）的患者显示出临床获益（包括完全缓解）、部分缓解和疾病稳定。纳入研究中未发现完全缓解病例。合并无进展生存期为6.58个月（95%CI 4.62 - 8.54）。高血压（20%；95%CI 7 - 33）、手足皮肤反应（22%；95%CI 17 - 27）和低磷血症（18%；95%CI 5 - 41）是伊马替尼和舒尼替尼治疗失败后接受瑞戈非尼治疗患者中常见的≥3级瑞戈非尼相关不良事件。
49%的AGIST患者在对伊马替尼和舒尼替尼耐药后接受瑞戈非尼治疗有获益。应开展更多研究以改善AGIST患者的临床生存情况。治疗期间应考虑对≥3级瑞戈非尼相关不良事件进行密切监测和适当处理。
