Feng Yan-Ru, Zhu Yuan, Liu Lu-Ying, Wang Wei-Hu, Wang Shu-Lian, Song Yong-Wen, Wang Xin, Tang Yuan, Liu Yue-Ping, Ren Hua, Fang Hui, Zhang Shi-Ping, Liu Xin-Fan, Yu Zi-Hao, Li Ye-Xiong, Jin Jing
Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China.
Department of Radiation Oncology, Zhejiang Cancer Hospital, Hangzhou, China.
Oncotarget. 2016 May 3;7(18):25576-84. doi: 10.18632/oncotarget.8226.
The aim of this study is to present an interim analysis of a phase III trial (NCT00714077) of postoperative concurrent capecitabine and radiotherapy with or without oxaliplatin for pathological stage II and III rectal cancer. Patients with pathologically confirmed stage II and III rectal cancer were randomized to either radiotherapy with concurrent capecitabine (Cap-RT group) or with capecitabine and oxaliplatin (Capox-RT group). The primary endpoint was 3-year disease-free survival rate (DFS). The 3-year DFS rate was 73.9% in the Capox-RT group and 71.6% in the Cap-RT group (HR 0.92, p = 0.647), respectively. No significant difference was observed in overall survival, cumulative incidence of local recurrence and distant metastasis between the two groups (p > 0.05). More grade 3-4 acute toxicity was observed in the Capox-RT group than in the Cap-RT group (38.1% vs. 29.2%, p = 0.041). Inclusion of oxaliplatin in the capecitabine-based postoperative regimen did not improve DFS but increased toxicities for pathological stage II and III rectal cancer in this interim analysis.
本研究旨在对一项III期试验（NCT00714077）进行中期分析，该试验针对病理分期为II期和III期的直肠癌患者，术后采用卡培他滨与放疗联合或不联合奥沙利铂治疗。病理确诊为II期和III期直肠癌的患者被随机分为两组，一组接受卡培他滨同步放疗（卡培他滨-放疗组），另一组接受卡培他滨与奥沙利铂同步放疗（卡培他滨-奥沙利铂-放疗组）。主要终点为3年无病生存率（DFS）。卡培他滨-奥沙利铂-放疗组和卡培他滨-放疗组的3年DFS率分别为73.9%和71.6%（风险比0.92，p = 0.647）。两组在总生存期、局部复发累积发生率和远处转移方面均未观察到显著差异（p > 0.05）。卡培他滨-奥沙利铂-放疗组观察到的3-4级急性毒性反应比卡培他滨-放疗组更多（38.1%对29.2%，p = 0.041）。在此中期分析中，对于病理分期为II期和III期的直肠癌患者，在基于卡培他滨的术后治疗方案中加入奥沙利铂并未改善DFS，但增加了毒性反应。
