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

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

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Journal
Journal of Clinical Oncology
Published
2024-12-13
DOI
https://doi.org/10.1200/jco-24-01676
Citations
19
Primary Topic
Colorectal Cancer Surgical Treatments
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article
Field-Weighted Citation Impact
5.37
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article

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

Yanhong Deng, Yisheng Wei, Long Cui, Yan Huang et al.
19 citations
Journal of Clinical Oncology
Colorectal Cancer Surgical Treatments
5.37
article

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

Yanhong Deng, Yisheng Wei, Long Cui, Yan Huang, Lishuo Shi, Junsheng Peng, Meijin Huang, Guangfu Cai, Zonghai Huang, Longqing Cheng, Liang Kang, Jianwei Zhang, Jianping Wang, Hao Zhang, Hongbo Wei, Pan Chi, Hongfeng Zhou, Xiaojian Wu, Jian Zheng, Jinbo Gao, Donglin Ren, Ren Zhao, Wanglin Li, Ping Lan, Yue Cai, Zhiyang Zhou, Zhongcheng Huang
article en
19 citations

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

Journal of Clinical OncologyVol. 43(6)
Fujian Medical University (CN), Sun Yat-sen University (CN), Shanghai Jiao Tong University (CN), XinHua Hospital (CN), Ruijin Hospital (CN), Second Affiliated Hospital of Guangzhou Medical University (CN), Sixth Affiliated Hospital of Sun Yat-sen University (CN), General Hospital of Guangzhou Military Command (CN), First People's Hospital of Foshan (CN), Guangzhou First People's Hospital (CN), Zhujiang Hospital (CN), Dongguan People’s Hospital (CN), Wuhan Union Hospital (CN), Third Affiliated Hospital of Sun Yat-sen University (CN), Hunan Provincial People's Hospital (CN), Guangdong Provincial People's Hospital (CN), Union Hospital (CN), State Key Laboratory of Oncology in South China, Guangzhou Medical University (CN)
Good health and well-being
Openalex Percentile: Top 3%
Colorectal Cancer Surgical Treatments
5.37
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