Chemoradiation and Local Excision Versus Total Mesorectal Excision for T2N0 Rectal Cancer: Comparison of Short- and Long-Term Outcomes From 2 Prospective Studies.

OBJECTIVE: Compare oncological long-term and short-term outcomes between patients with distal cT2NO rectal cancer treated with chemoradio-therapy 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 a 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% [confidence interval (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 2 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.