Chemoradiation and Local Excision versus Total Mesorectal Excision for T2N0 Rectal Cancer: Comparison of Short- and Long-Term Outcomes from Two Prospective Studies.

Objective Compare oncological long-term and short-term outcomes between patients with distal cT2N0 rectal cancer treated with chemoradiotherapy and local excision (CRT+LE) and patients treated with total mesorectal excision (TME). Summary background data Previous studies showed that CRT+LE is equivalent to TME in local tumor control and survival for T2N0 rectal cancer. Methods Seventy-nine patients with cT2N0 rectal adenocarcinoma treated with CRT+LE in the ACOSOG Z6041 trial were compared to cohort of 79 patients with pT2N0 tumors treated with upfront TME in the Dutch TME trial. Survival, short-term outcomes, and health-related quality of life (HRQOL) were compared between groups. Results Three patients (4%) in the CRT+LE group required abdominoperineal resection, compared with 31 (40%) in the TME group. Forty TME patients (51%) required a permanent stoma. CRT-related toxicity occurred in 43% of the CRT+LE patients; however, TME patients had a higher rate of complications requiring reoperation (1 vs. 9%; p = 0.03). Five-year disease-free survival (88.2% [CI, 77.7-93.9%] vs. 88.3% [CI, 78.7-93.7%]; p = 0.88) and overall survival (90.3% [CI, 80.8-95.3%] vs. 88.4% [CI, 78.9-93.8%]; p = 0.82) were similar in the two groups. Compared to baseline, overall HRQOL decreased in the CRT+LE group and improved in the TME group. In both groups, patients with sphincter preservation had worse HRQOL scores 1 year after surgery. Conclusions In patients who underwent CRT+LE, oncological outcomes were similar to those of patients who underwent TME, with fewer complications requiring reoperation but significant CRT toxicity. Although overall HRQOL decreased in the CRT+LE group and improved in TME patients, when considering anorectal function, results were worse in both groups.