Association between adjuvant chemotherapy and survival in patients with rectal cancer and pathological complete response after neoadjuvant chemoradiotherapy and resection.

He, Fang; Ju, Huai-Qiang; Ding, Yi; Jiang, Zhiqiang; Li, Zhenhui; Huang, Bo; Wang, Xiuhong; Zhao, Yuanyuan; Li, Yong; Qi, Bin; Luo, Wenguang; Zhang, Zijian; Pei, Qian; Chen, Haiyang; Liu, Shuai; Pang, Xiaolin; Zheng, Jian; Wang, Jianping; Ajani, Jaffer A; Wan, Xiang-Bo

BACKGROUND For patients with locally advanced rectal cancer (LARC), it is unclear whether neoadjuvant chemoradiotherapy-induced pathologic complete response (pCR) individuals would further benefit from adjuvant chemotherapy (ACT). METHODS The pCR individuals who received different ACT cycles were paired by propensity score matching. Overall survival (OS), disease-free survival (DFS), local recurrence-free survival (LRFS), and distant metastasis-free survival (DMFS) were calculated by Kaplan-Meier and log-rank test. RESULTS In total, 1041 pCR individuals were identified from 5567 LARC cases. Specifically, 303 pCR cases had no ACT treatment, and 738 pCR patients received fluoropyrimidine-based ACT (median, 4 cycles) treatment. After 1:3 propensity score matching, 297 cases without ACT treatment were matched to 712 cases who received ACT treatment. Kaplan-Meier analysis showed that pCR individuals treated with or without ACT had the similar 3-year outcome (OS, DFS, LRFS and DMFS) (all P > 0.05). Moreover, the pCR patients received different ACT cycle(s) (0 vs. 1-4 cycles, 0 vs. ≥5 cycles) had comparable 3-year OS, DFS, LRFS and DMFS (all P > 0.05). In stratified analysis, ACT treatment did not improve 3-year survival (OS, DFS, LRFS and DMFS) for the baseline high-risk (cT3-4/cN1-2) subgroup patients (all P > 0.05). CONCLUSION ACT, which did not improve survival, is unnecessary to neoadjuvant treatment-induced pCR LARC patients. TRIAL REGISTRATION 2019ZSLYEC-136 (24-6-2019).