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
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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