Jin Hongyu, Zhang Man, Jin Kun, Hu Chenggong
Department of Liver Surgery, Liver Transplantation Center, West China Hospital, Sichuan University, Chengdu.
Department of Gynecology and Obstetrics, West China Second University Hospital, Sichuan University; Key Laboratory of Obstetric & Gynecologic and Pediatric Disease and Birth Defects of Ministry of Education.
Medicine (Baltimore). 2021 Jan 22;100(3):e23956. doi: 10.1097/MD.0000000000023956.
The aim of this systematic review and meta-analysis is to evaluate the efficacy and safety of adjuvant targeted therapy by sunitinib combined with surgery in the treatment of advanced or metastatic renal cell carcinoma.
PubMed/Medline, Web of Science, Cochrane Library, ClinicalTrials.gov (http://www.ClinicalTrials.gov), China National Knowledge Infrastructure (CNKI) will be searched for clinical research articles related to the efficacy and safety of adjuvant therapy combined with surgery in the treatment of advanced and metastatic RCC. The identification, inclusion and exclusion flow charts will be conducted according to the PRISMA guidelines. The quality assessment will be done by Quadas-2 evaluation tool. Key parameters including OS in 10, 20, 30, and 40 months, PFS in 10, 20, and 30 months, objective response rate (ORR), stable disease (SD) rate, progressive disease (PD) rate, median OS and PFS, types of AEs and their occurrence rates, etc will be extracted. The evaluation of the efficacy and safety will be pooled by CMA.
This systematic review will provide evidence on the efficacy and safety of adjuvant therapy by sunitinib combined with surgery in treating advanced and metastatic RCC.
The study aims to generalize data concerning the response rate, OS, PFS and rates of adverse effects of the perioperative use of sunitinib in advanced and metastatic RCC patients. The evidence provided by this systematic review and meta-analysis will help guide the clinical decision making and enlighten the future management of advanced or metastatic RCC.
This protocol has been registered on the International Platform of Registered Systematic Review and Meta-analysis Protocols (INPLASY registration number: INPLASY2020110093; INPLASY DOI number: 10.37766/inplasy2020.11.0093 Available at: https://inplasy.com).
本系统评价和荟萃分析的目的是评估舒尼替尼联合手术辅助靶向治疗晚期或转移性肾细胞癌的疗效和安全性。
检索PubMed/Medline、Web of Science、Cochrane图书馆、ClinicalTrials.gov（http://www.ClinicalTrials.gov）、中国知网（CNKI），以查找与舒尼替尼联合手术辅助治疗晚期和转移性肾细胞癌的疗效和安全性相关的临床研究文章。将根据PRISMA指南制作识别、纳入和排除流程图。将采用Quadas-2评估工具进行质量评估。提取关键参数，包括10、20、30和40个月时的总生存期（OS）、10、20和30个月时的无进展生存期（PFS）、客观缓解率（ORR）、疾病稳定（SD）率、疾病进展（PD）率、中位OS和PFS、不良事件（AE）类型及其发生率等。将通过CMA对疗效和安全性进行汇总评估。
本系统评价将为舒尼替尼联合手术辅助治疗晚期和转移性肾细胞癌的疗效和安全性提供证据。
本研究旨在归纳有关舒尼替尼在晚期和转移性肾细胞癌患者围手术期使用的缓解率、OS、PFS和不良反应发生率的数据。本系统评价和荟萃分析提供的证据将有助于指导临床决策，并为晚期或转移性肾细胞癌的未来管理提供启示。
本方案已在国际注册系统评价和荟萃分析方案平台上注册（INPLASY注册号：INPLASY2020110093；INPLASY DOI编号：10.37766/inplasy2020.11.0093 可在：https://inplasy.com获取）
