Neoadjuvant Chemotherapy With CAPOX Versus Chemoradiation for Locally Advanced Rectal Cancer With Uninvolved Mesorectal Fascia (CONVERT): Initial Results of a Phase III Trial

作者：Wei-Jian Mei, Xiaozhong Wang, Yunfeng Li, Yueming Sun, Chunkang Yang, Junzhong Lin, Zuguang Wu, Rui Zhang, Wei Wang, Yong Li, Yezhong Zhuang, Jian Lei, Xiangbin Wan, Yingkun Ren, Yong Cheng, Wenliang Li, Ziqiang Wang, Dongbo Xu, Xianwei Mo, Haixing Ju, Shengwei Ye, Jinglin Zhao, Hong Zhang, Yuanhong Gao, Zhifan Zeng, Weiwei Xiao, Xiaopeng Zhang, Xuan Zhang, Enzehua Xie, Yifei Feng, Jinghua Tang, Xiaojun Wu, Gong Chen, Li Li, Zhenhai Lu, De-Sen Wan, Jin‐Xin Bei, Zhizhong Pan, Peirong Ding · 发表于：Annals of Surgery · 年份：2022 · DOI：10.1097/sla.0000000000005780 · 被引用次数：86 · 研究领域：Colorectal Cancer Surgical Treatments、Colorectal and Anal Carcinomas、Pelvic floor disorders treatments

OBJECTIVE: To 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 DATA: nCRT 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. METHODS: Patients 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. RESULTS: Of 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 l...