Yanhong Deng, Ping Lan, Lei Wang, Jian Zheng, Yan Huang, Zhiyang Zhou, Yue Cai, Liang Kang, Meijin Huang, Junsheng Peng, Donglin Ren, and Jianping Wang, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases; Weiqing Chen, Medical Statistics of Sun Yat-sen University; Jie Cao, Guangzhou First People's Hospital; HongboWei, The Third Affiliated Hospital of Sun Yat-sen University; Zonghai Huang, Zhujiang Hospital of Southem Medical University; Guanfu Cai, Guangdong General Hospital; Hongfeng Zhou, General Hospital of Guangzhou Military Command PLA; Yisheng Wei, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou; Pan Chi, Fujian Medical University Union Hospital, Fuzhou; Long Cui, Xin Hua Hospital of Shanghai Jiao Tong University School of Medicine; Ren Zhao, Rui Jin Hospital of Shanghai Jiao Tong University School of Medicine, Shanghai; Daoda Chen, Union Hospital Tongji Medical College of Huazhong University of Science and Technology, Wuhan; Xiang Peng, The First People's Hospital, Foshan; Zhongcheng Huang, Hunan Provincial People's Hospital, Changsha; Lin Xu, The First Affiliated Hospital of Xiamen University, Xiamen; and Hao Zhang, Dongguan Kanghua Hospital, Dongguan, China.
J Clin Oncol. 2016 Sep 20;34(27):3300-7. doi: 10.1200/JCO.2016.66.6198. Epub 2016 Aug 1.
PURPOSE: Total mesorectal excision with fluorouracil-based preoperative chemoradiotherapy and postoperative chemotherapy is a standard treatment of locally advanced rectal cancer. This study investigated the addition of oxaliplatin with and without preoperative radiotherapy. METHODS: In this multicenter, open-label, phase III trial, we randomly assigned (1:1:1) Chinese adults (age 18 to 75 years) with locally advanced stage II/III rectal cancer to three treatments: five 2-week cycles of infusional fluorouracil (leucovorin 400 mg/m(2), fluorouracil 400 mg/m(2), and fluorouracil 2.4 g/m(2) over 48 h) plus radiotherapy (46.0 to 50.4 Gy delivered in 23 to 25 fractions during cycles 2 through 4) followed by surgery and seven cycles of infusional fluorouracil, the same treatment plus intravenous oxaliplatin 85 mg/m(2) on day 1 of each cycle (modified FOLFOX6 [mFOLFOX6]), or four to six cycles of mFOLFOX6 followed by surgery and six to eight cycles of mFOLFOX6. Random assignment was performed by using computer-generated block randomization codes. The primary end point was 3-year disease-free survival. Secondary end points of histopathologic response and toxicity are reported. RESULTS: A total of 495 patients were enrolled from June 2010 to February 2015; 475 were evaluable (fluorouracil-radiotherapy, n = 155; mFOLFOX6-radiotherapy, n = 157; mFOLFOX6, n = 163). In the fluorouracil-radiotherapy, mFOLFOX6-radiotherapy, and mFOLFOX6 groups, the rate of pathologic complete response (pCR) was 14.0%, 27.5%, and 6.6%, and downstaging (ypStage 0 to 1) was achieved by 37.1%, 56.4%, and 35.5% of patients, respectively. Higher toxicity and more postoperative complications were observed in patients who received radiotherapy. CONCLUSION: mFOLFOX6-based preoperative chemoradiotherapy results in a higher pCR rate than fluorouracil-based treatment. Perioperative mFOLFOX6 alone had inferior results and a lower pCR rate than chemoradiotherapy but led to a similar downstaging rate as fluorouracil-radiotherapy, with less toxicity and fewer postoperative complications.
目的：在术前氟尿嘧啶为基础的放化疗和术后化疗的基础上进行全直肠系膜切除术是局部晚期直肠癌的标准治疗方法。本研究调查了奥沙利铂联合和不联合术前放疗的作用。
方法：在这项多中心、开放标签、III 期临床试验中，我们将中国成年人（18 至 75 岁）随机分为三组，局部晚期 II/III 期直肠癌患者：五周期的氟尿嘧啶输注（亚叶酸 400mg/m²，氟尿嘧啶 400mg/m²，氟尿嘧啶 2.4g/m²持续 48 小时）联合放疗（46.0 至 50.4Gy，在第 2 至 4 周期的 23 至 25 个分次中给予），随后进行手术，以及七周期的氟尿嘧啶输注，相同的治疗加静脉注射奥沙利铂 85mg/m²（每周期第 1 天）（改良 FOLFOX6 [mFOLFOX6]），或四至六周期的 mFOLFOX6 后进行手术，以及六至八周期的 mFOLFOX6。通过使用计算机生成的分块随机化代码进行随机分组。主要终点是 3 年无病生存率。报告了组织病理学反应和毒性的次要终点。
结果：从 2010 年 6 月至 2015 年 2 月共纳入 495 例患者；475 例可评估（氟尿嘧啶放疗组，n=155；mFOLFOX6 放疗组，n=157；mFOLFOX6 组，n=163）。在氟尿嘧啶放疗组、mFOLFOX6 放疗组和 mFOLFOX6 组中，病理完全缓解（pCR）率分别为 14.0%、27.5%和 6.6%，分别有 37.1%、56.4%和 35.5%的患者降期（ypStage0 至 1）。接受放疗的患者毒性和术后并发症更多。
结论：mFOLFOX6 为基础的术前放化疗比氟尿嘧啶为基础的治疗产生更高的 pCR 率。单纯围手术期 mFOLFOX6 治疗效果低于放化疗，但 pCR 率较低，降期率与氟尿嘧啶放疗相似，毒性和术后并发症较少。
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