Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.
The Study Center of the German Surgical Society (SDGC), University of Heidelberg, Im Neuenheimer Feld 130.3, 69120, Heidelberg, Germany.
Syst Rev. 2018 Jan 22;7(1):11. doi: 10.1186/s13643-018-0678-9.
Neoadjuvant (chemo-)radiation has proven to improve local control compared to surgery alone, but this improvement did not translate into better overall or disease-specific survival. The addition of oxaliplatin to fluoropyrimidine-based neoadjuvant chemoradiotherapy holds the potential of positively affecting survival in this context since it has been proven effective in the palliative and adjuvant setting of colorectal cancer. Thus, the objective of this systematic review is to assess the efficacy, safety, and quality of life resulting from adding a platinum derivative to neoadjuvant single-agent fluoropyrimidine-based chemoradiotherapy in patients with Union for International Cancer Control stage II and III rectal cancer.
MEDLINE, Web of Science, and Cochrane Central Register of Controlled Trials will be systematically searched to identify all randomized controlled trials comparing single-agent fluoropyrimidine-based chemoradiotherapy to combined neoadjuvant therapy including a platinum derivative. Predefined data on trial design, quality, patient characteristics, and endpoints will be extracted. Quality of included trials will be assessed according to the Cochrane Risk of Bias Tool, and the GRADE recommendations will be applied to judge the quality of the resulting evidence. The main outcome parameter will be survival, but also treatment toxicity, perioperative morbidity, and quality of life will be assessed.
The findings of this systematic review and meta-analysis will provide novel insights into the efficacy and safety of combined neoadjuvant chemoradiotherapy including a platinum derivative and may form a basis for future clinical decision-making, guideline evaluation, and research prioritization.
PROSPERO CRD42017073064.
新辅助（化疗-放疗）已被证明可改善局部控制率，优于单独手术，但这种改善并未转化为更好的总体或疾病特异性生存率。在氟嘧啶为基础的新辅助放化疗中加入奥沙利铂具有在这种情况下影响生存的潜力，因为它已被证明在结直肠癌的姑息和辅助治疗中有效。因此，本系统评价的目的是评估在 Union for International Cancer Control 分期 II 和 III 期直肠癌患者中，将铂衍生物加入新辅助单药氟嘧啶为基础的放化疗中，对疗效、安全性和生活质量的影响。
系统检索 MEDLINE、Web of Science 和 Cochrane 中央对照试验注册中心，以确定所有比较单药氟嘧啶为基础的放化疗与联合新辅助治疗（包括铂衍生物）的随机对照试验。将提取关于试验设计、质量、患者特征和终点的预定义数据。根据 Cochrane 偏倚风险工具评估纳入试验的质量，并应用 GRADE 建议判断产生证据的质量。主要结局参数将是生存率，但也将评估治疗毒性、围手术期发病率和生活质量。
本系统评价和荟萃分析的结果将为联合新辅助放化疗（包括铂衍生物）的疗效和安全性提供新的见解，并可能为未来的临床决策、指南评估和研究重点提供依据。
PROSPERO CRD42017073064。
