• Wei-Jian Mei, Xiao-Zhong Wang, Yun-Feng Li, Yue-Ming Sun, Chun-Kang Yang, Jun-Zhong Lin, Zu-Guang Wu, Rui Zhang, Wei Wang, Yong Li, Ye-Zhong Zhuang, Jian Lei, Xiang-Bin Wan, Ying-Kun Ren, Yong Cheng, Wen-Liang Li, Zi-Qiang Wang, Dong-Bo Xu, Xian-Wei Mo, Hai-Xing Ju, Sheng-Wei Ye, Jing-Lin Zhao, Hong Zhang, Yuan-Hong Gao, Zhi-Fan Zeng, Wei-Wei Xiao, Xiao-Peng Zhang, Xuan Zhang, E Xie, Yi-Fei Feng, Jing-Hua Tang, Xiao-Jun Wu, Gong Chen, Li-Ren Li, Zhen-Hai Lu, De-Sen Wan, Jin-Xin Bei, Zhi-Zhong Pan, and Pei-Rong Ding.
• Department of Colorectal Surgery.
• Ann. Surg. 2023 Apr 1; 277 (4): 557564557-564.

ObjectiveTo compare neoadjuvant chemotherapy (nCT) with CAPOX alone versus neoadjuvant chemoradiotherapy (nCRT) with capecitabine in locally advanced rectal cancer (LARC) with uninvolved mesorectal fascia (MRF).Background DatanCRT is associated with higher surgical complications, worse long-term functional outcomes, and questionable survival benefits. Comparatively, nCT alone seems a promising alternative treatment in lower-risk LARC patients with uninvolved MRF.MethodsPatients between June 2014 and October 2020 with LARC within 12 cm from the anal verge and uninvolved MRF were randomly assigned to nCT group with 4 cycles of CAPOX (Oxaliplatin 130 mg/m2 IV day 1 and Capecitabine 1000 mg/m2 twice daily for 14 d. Repeat every 3 wk) or nCRT group with Capecitabine 825 mg/m² twice daily administered orally and concurrently with radiation therapy (50 Gy/25 fractions) for 5 days per week. The primary end point is local-regional recurrence-free survival. Here we reported the results of secondary end points: histopathologic response, surgical events, and toxicity.ResultsOf the 663 initially enrolled patients, 589 received the allocated treatment (nCT, n=300; nCRT, n=289). Pathologic complete response rate was 11.0% (95% CI, 7.8-15.3%) in the nCT arm and 13.8% (95% CI, 10.1-18.5%) in the nCRT arm ( P =0.33). The downstaging (ypStage 0 to 1) rate was 40.8% (95% CI, 35.1-46.7%) in the nCT arm and 45.6% (95% CI, 39.7-51.7%) in the nCRT arm ( P =0.27). nCT was associated with lower perioperative distant metastases rate (0.7% vs. 3.1%, P =0.03) and preventive ileostomy rate (52.2% vs. 63.6%, P =0.008) compared with nCRT. Four patients in the nCT arm received salvage nCRT because of local disease progression after nCT. Two patients in the nCT arm and 5 in the nCRT arm achieved complete clinical response and were treated with a nonsurgical approach. Similar results were observed in subgroup analysis.ConclusionsnCT achieved similar pCR and downstaging rates with lower incidence of perioperative distant metastasis and preventive ileostomy compared with nCRT. CAPOX could be an effective alternative to neoadjuvant therapy in LARC with uninvolved MRF. Long-term follow-up is needed to confirm these results.Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.

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