Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.
Colorectal Dis. 2016 Aug;18(8):763-72. doi: 10.1111/codi.13381.
Previous randomized controlled trials and meta-analyses have demonstrated the ineffectiveness of fluorouracil-based adjuvant chemotherapy for patients with rectal cancer who have undergone neoadjuvant chemoradiotherapy and subsequent surgery. The role of oxaliplatin/fluorouracil-based adjuvant chemotherapy in such patients is unknown. We performed a meta-analysis to evaluate the efficacy of oxaliplatin/fluorouracil-based adjuvant chemotherapy based on a comparison with fluorouracil-based adjuvant chemotherapy for patients with rectal cancer.
A literature search of MEDLINE, Embase, Web of Science, Cochrane Library and ClinicalTrials.gov was performed to identify eligible studies. The primary end-point of interest was disease-free survival (DFS). The secondary end-points were overall survival, compliance and the incidence of Grade 3 or 4 toxicity.
The literature search identified four randomized controlled trials that met the inclusion criteria for the meta-analysis, and 2793 patients with pathological TNM or clinical TNM Stage II or III disease were included. The meta-analysis showed that oxaliplatin/fluorouracil-based adjuvant chemotherapy was associated with a significantly improved DFS (hazard ratio 0.85; 95% CI 0.73-0.98; P = 0.03), comparable compliance (OR 1.18; 95% CI 0.95-1.46; P = 0.13) and a higher incidence of vomiting or nausea (OR 2.47; 95% CI 1.21-5.05; P = 0.01). No significant differences were observed between the groups with respect to overall survival and the incidence of leucopaenia, anaemia, thrombocytopaenia and diarrhoea.
Adjuvant oxaliplatin/fluorouracil-based chemotherapy can improve the DFS of patients after neoadjuvant chemoradiotherapy and radical surgery, compared with adjuvant fluorouracil-based chemotherapy. Data of the longer-term survival outcome are needed.
先前的随机对照试验和荟萃分析表明，对于接受新辅助放化疗和随后手术的直肠癌患者，氟尿嘧啶为基础的辅助化疗无效。奥沙利铂/氟尿嘧啶为基础的辅助化疗在这类患者中的作用尚不清楚。我们进行了一项荟萃分析，以评估奥沙利铂/氟尿嘧啶为基础的辅助化疗与氟尿嘧啶为基础的辅助化疗相比在直肠癌患者中的疗效。
对 MEDLINE、Embase、Web of Science、Cochrane Library 和 ClinicalTrials.gov 进行文献检索，以确定符合纳入标准的研究。主要观察终点是无病生存率（DFS）。次要观察终点是总生存率、依从性和 3 级或 4 级毒性的发生率。
文献检索确定了四项符合荟萃分析纳入标准的随机对照试验，共纳入 2793 例病理 TNM 或临床 TNM Ⅱ期或Ⅲ期疾病患者。荟萃分析显示，奥沙利铂/氟尿嘧啶为基础的辅助化疗与显著改善的 DFS（风险比 0.85；95%可信区间 0.73-0.98；P=0.03）相关，具有相似的依从性（比值比 1.18；95%可信区间 0.95-1.46；P=0.13）和更高的呕吐或恶心发生率（比值比 2.47；95%可信区间 1.21-5.05；P=0.01）。两组在总生存率和白细胞减少、贫血、血小板减少和腹泻的发生率方面无显著差异。
与氟尿嘧啶为基础的辅助化疗相比，新辅助放化疗和根治性手术后，奥沙利铂/氟尿嘧啶为基础的辅助化疗可提高患者的 DFS。需要更多关于长期生存结果的数据。
