Zhang Jianwei, Chi Pan, Shi Lishuo, Cui Long, Gao Jinbo, Li Wanglin, Wei Hongbo, Cheng Longqing, Huang Zonghai, Cai Guangfu, Zhao Ren, Huang Zhongcheng, Zhou Hongfeng, Wei Yisheng, Zhang Hao, Zheng Jian, Huang Yan, Cai Yue, Zhou Zhiyang, Kang Liang, Huang Meijin, Wu Xiaojian, Peng Junsheng, Ren Donglin, Lan Ping, Wang Jianping, Deng Yanhong
Department of Oncology, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, People's Republic of China.
Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, People's Republic of China.
J Clin Oncol. 2025 Feb 20;43(6):633-640. doi: 10.1200/JCO-24-01676. Epub 2024 Dec 13.
We present 10-year results of the phase Ⅲ FOWARC trial, which evaluated the efficacy of modified infusional fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) with or without radiation compared with fluorouracil with radiation in patients with locally advanced rectal cancer. A total of 495 patients age 18-75 years with stage Ⅱ-Ⅲ rectal cancer were randomly assigned to three treatment arms: fluorouracil plus radiotherapy, mFOLFOX6 plus radiotherapy, or mFOLFOX6 alone, followed by surgery and adjuvant chemotherapy. With a median follow-up of 10 years, the 10-year disease-free survival (DFS) rates were 52.5%, 62.6%, and 60.5%, respectively ( = .56). The 10-year locoregional recurrence (LR) rates were 10.8%, 8.0%, and 9.6% ( = .57), and the 10-year overall survival (OS) rates were 65.9%, 72.3%, and 73.4% ( = .90). Subgroup analysis identified ypTNM stage as a significant prognostic factor for DFS, LR, and OS ( < .0001, < .006, < .0001, respectively). Patients achieving pathologic complete response had 10-year DFS, LR, and OS rates of 84.3%, 3.0%, and 92.4%, respectively. No significant difference was observed in long-term survival outcome between mFOLFOX6 with and without radiation and fluorouracil plus radiation. These results demonstrate that neoadjuvant mFOLFOX6 chemotherapy can be considered as a therapeutic option in LARC.
我们公布了Ⅲ期FOWARC试验的10年结果，该试验评估了改良的氟尿嘧啶、亚叶酸钙和奥沙利铂（mFOLFOX6）联合或不联合放疗与氟尿嘧啶联合放疗相比，在局部晚期直肠癌患者中的疗效。共有495例年龄在18至75岁之间的Ⅱ-Ⅲ期直肠癌患者被随机分配到三个治疗组：氟尿嘧啶加放疗、mFOLFOX6加放疗或单纯mFOLFOX6，随后进行手术和辅助化疗。中位随访10年，10年无病生存率（DFS）分别为52.5%、62.6%和60.5%（P = 0.56）。10年局部区域复发（LR）率分别为10.8%、8.0%和9.6%（P = 0.57），10年总生存率（OS）分别为65.9%、72.3%和73.4%（P = 0.90）。亚组分析确定ypTNM分期是DFS、LR和OS的重要预后因素（分别为P < 0.0001、P < 0.006、P < 0.0001）。达到病理完全缓解的患者10年DFS、LR和OS率分别为84.3%、3.0%和92.4%。mFOLFOX6联合或不联合放疗与氟尿嘧啶加放疗之间在长期生存结果上未观察到显著差异。这些结果表明，新辅助mFOLFOX6化疗可被视为局部晚期直肠癌（LARC）的一种治疗选择。
