Neoadjuvant Modified Infusional Fluorouracil, Leucovorin, and Oxaliplatin With or Without Radiation Versus Fluorouracil Plus Radiation for Locally Advanced Rectal Cancer: Updated Results of the FOWARC Study After a Median Follow-Up of 10 Years

Author(s): Jianwei Zhang, MD^1,2,3; Pan Chi, MD⁴; Lishuo Shi, MD, PhD^3,5; Long Cui, MD⁶; Jinbo Gao, MD⁷; Wanglin Li, MD⁸; Hongbo Wei, MD, PhD⁹; Longqing Cheng, MD¹⁰; Zonghai Huang, MD¹¹; Guangfu Cai, MD, PhD¹²; Ren Zhao, MD, PhD¹³; Zhongcheng Huang, MD¹⁴; Hongfeng Zhou, MD¹⁵; Yisheng Wei, MD, PhD¹⁶; Hao Zhang, MD¹⁷; Jian Zheng, MD^2,3,18; Yan Huang, MD^2,3,19; Yue Cai, MD^1,2,3; Zhiyang Zhou, MD, PhD^2,3,20; Liang Kang, MD, PhD^2,3,21; Meijin Huang, MD, PhD^2,3,21; Xiaojian Wu, MD, PhD^2,3,21; Junsheng Peng, MD, PhD^2,3,21; Donglin Ren, MD^2,3,21; Ping Lan, MD, PhD^2,3,21; Jianping Wang, MD, PhD^2,3,21; Yanhong Deng, MD, PhD^1,2,3;

Source: https://doi.org/10.1200/JCO-24-01676

Dr. Maen Hussein's Thoughts

FOLFOX is the way to go … as no significant difference was observed in the long-term survival outcome between mFOLFOX6 with and without radiation and fluorouracil plus radiation.

ABSTRACT

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 (P = .56). The 10-year locoregional recurrence (LR) rates were 10.8%, 8.0%, and 9.6% (P = .57), and the 10-year overall survival (OS) rates were 65.9%, 72.3%, and 73.4% (P = .90). Subgroup analysis identified ypTNM stage as a significant prognostic factor for DFS, LR, and OS (P < .0001, P < .006, P < .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.

Author Affiliations

¹Department of Oncology, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, People’s Republic of China; ²Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, People’s Republic of China; ³Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University, The State Key Laboratory of Oncology in South China, Guangzhou, People’s Republic of China; ⁴Department of Colorectal Surgery, Fujian Medical University Union Hospital, Fuzhou, People’s Republic of China; ⁵Clinical Research Center, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, People’s Republic of China; ⁶Xinhua Hospital, Shanghai Jiao Tong University, Shanghai, People’s Republic of China; ⁷Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; ⁸The First People’s Hospital, Guangzhou City, People’s Republic of China; ⁹The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, People’s Republic of China; ¹⁰The First People’s Hospital, Foshan City, People’s Republic of China; ¹¹Zhujiang Hospital, Nanfang University of Medical Science, Guangzhou, People’s Republic of China; ¹²Guangdong Provincial Peoples Hospital, Guangzhou, People’s Republic of China; ¹³Ruijin Hospital, Shanghai Jiao Tong University, Shanghai, People’s Republic of China; ¹⁴General Hospital, Hunan Province, Changsha, People’s Republic of China; ¹⁵Guangzhou General Hospital of Guangzhou Military Command, Guangzhou, People’s Republic of China; ¹⁶The Second Affiliated Hospital, Guangzhou Medical University, Guangzhou, People’s Republic of China; ¹⁷Kuanghua Hospital, Dongguan, People’s Republic of China; ¹⁸Department of Radiotherapy, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, People’s Republic of China; ¹⁹Department of Pathology, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, People’s Republic of China; ²⁰Department of Radiology, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, People’s Republic of China; ²¹Department of General Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, People’s Republic of China;

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Neoadjuvant Modified Infusional Fluorouracil, Leucovorin, and Oxaliplatin With or Without Radiation Versus Fluorouracil Plus Radiation for Locally Advanced Rectal Cancer: Updated Results of the FOWARC Study After a Median Follow-Up of 10 Years

Dr. Maen Hussein's Thoughts

ABSTRACT

Author Affiliations

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