Long-term outcome of neoadjuvant mFOLFOX6 with or without radiation versus fluorouracil plus radiation for locally advanced rectal cancer: A multicenter, randomized phase III trial.

Authors

null

Jianwei Zhang

Sixth Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China

Jianwei Zhang , Pan Chi , Ping Lan , Long Cui , Hongbo Wei , Ren Zhao , Zhongcheng Huang , Hao Zhang , Yue Cai , Jianping Wang , Yanhong Deng

Organizations

Sixth Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China, Fujian Medical University Union Hospital, Fuzhou, China, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China, The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guandong, China, Ruijin Hospital North, Shanghai Jiao Tong University School of Medcine, Shanghai, China, Hunan Provincial People's Hospital, Changsha, China, Dongguan Kang Hua Hospitcal, Dongguan, China, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China, The Sixth Affiliated Hospital of Sun Yat-Sen, Guangzhou, China

Research Funding

Other
Supported by National Key Clinical Discipline, China National Natural Science Foundation

Background: Pevisous results of phase III FOWARC trial demonstrated that mFOLFOX6, with or without radiation, did not significantly improve survival versus fluorouracil with radiation in patients with locally advanced rectal cancer at 3 yeas. Here, we presented the data of long-term disease free survival (DFS) and overall survival (OS). Methods: In this multicenter, phase III trial, patients with stage II/III rectal cancer were randomly assigned (1:1:1) to receive 5 cycles of infusional fluorouracil (leucovorin 400 mg/m2, fluorouracil 400 mg/m2, and fluorouracil 2.4 g/m2 over 48 hours) plus radiotherapy (46.0 to 50.4 Gy delivered in 23 to 25 fractions during cycles 2 to 4) followed by surgery and seven cycles of infusional fluorouracil adjuvant treatment, mFOLFOX6 plus radiotherapy, or four to six cycles of mFOLFOX6 followed by surgery and six to eight cycles of mFOLFOX6. Results: Totally, 495 patients were enrolled,165 pateints in each group. 445 patients underwent surgery. After a median follow-up of 9.5 years, DFS events were observed in 56, 54, and 55 patients in fluorouracil plus radiotherapy, mFOLFOX6 plusradiotherapy, and mFOLFOX6 goups. The 10-year DFS rate were 55.5%, 63.0% and 62.8% (P = 0.934 by the log-rank test). OS evets were reported in 39, 38, and 40 patientts in the 3 group. The 10-year OS rate was 66.2%, 73.2% and 73.0% (P = 0.919 by the log-rank test), respectively. Conclusions: With long-term follow up, no significant difference in was found in survival outcome between mFOLFOX6, with and without radiation. Comparing with fluorouracil plus radiation, mFOLFOX6 plus radiation also failed to improve long-term survival. Clinical trial information: NCT01211210.

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Abstract Details

Meeting

2023 ASCO Annual Meeting

Session Type

Oral Abstract Session

Session Title

Gastrointestinal Cancer—Colorectal and Anal

Track

Gastrointestinal Cancer—Colorectal and Anal

Sub Track

Colorectal Cancer–Local-Regional Disease

Clinical Trial Registration Number

NCT01211210

Citation

J Clin Oncol 41, 2023 (suppl 16; abstr 3505)

DOI

10.1200/JCO.2023.41.16_suppl.3505

Abstract #

3505

Abstract Disclosures