Follow-up observation of rectal cancer patients with clinical complete response receiving non-operative and standard operative management after neo-adjuvant chemoradiotherapy

Abstract

Objective To investigate the feasibility of non-operative management (NOM) by comparing the therapeutic effects between NOM and total mesorectal excision (TME) for rectal cancer patients with clinical complete response (cCR) after neo-adjuvant chemoradiotherapy. Methods A total of 135 patients with stage Ⅱ/Ⅲ rectal cancer who obtained cCR after neo-adjuvant chemoradiotherapy in Sun Yat-sen University Cancer Center from 2006 to 2016 were recruited and assigned into the NOM (n=43) and standard operative management (SOM) groups (n=92). The local recurrence rate, accumulative local control (LC) rate after salvage therapy, disease-free survival (DFS), overall survival (OS) and sphincter preservation rate were statistically compared between two groups. Kaplan-Meier analysis and log-rank test were utilized to calculate the LC, OS and DFS.Chi-square test was performed to calculate the sphincter preservation rate. Results The mean follow-up duration was 39 months (range: 10-127 months). Of 135 patients, the local recurrence rate and distant metastasis rate were 3.7% and 11.1%, and the 3-year DFS and OS were 90.5% and 97.0%.In the NOM and SOM groups, the 3-year DFS were 87% and 93%, and the 5-year DFS were 73% and 87%(P=0.089). The 3-year OS were 98% and 99%, and the 5-year OS were 98% and 97%(P=0.578). In the NOM group, the local recurrence rate was 12%(n=5), 80% of patients received salvage treatment and the accumulative LC rate was calculated as 98%.In the SOM group, the local recurrence rate was 0, which was significantly lower than that in the NOM group (P=0.010). In the NOM group, the sphincter preservation rate was 93%, significantly higher compared with 70% in the SOM group (P=0.030). Conclusions It is feasible for rectal cancer patients with cCR to receive NOM following neo-adjuvant chemoradiotherapy. Partial locally recurrent patients can be healed by timely salvage therapy, thereby averting TME and relevant complications and enhancing the quality of life of rectal cancer patients. Key words: Rectal neoplasm; Neo-adjuvant chemoradiotherapy; Clinical complete response; Follow-up observation