Bowel function 14 years after preoperative short-course radiotherapy and total mesorectal excision for rectal cancer: report of a multicenter randomized trial.

BACKGROUND We investigated very long-term bowel function after total mesorectal excision (TME) with or without preoperative short-course radiotherapy (PRT) for rectal cancer, the risk factors for bowel dysfunction, and the association of bowel dysfunction with health-related quality of life (HRQL). PATIENTS AND METHODS In the TME trial (1996-1999), 1530 Dutch patients with rectal cancer were randomized to TME preceded by 5 × 5 Gy PRT or TME alone. A set of questionnaires was sent to the surviving patients (n = 583) in 2012. The questionnaires included the Low Anterior Resection Syndrome Score (LARS score), European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) and Colorectal Module (EORTC QLQ-CR29). The LARS score range was divided into "no LARS," "minor LARS," and "major LARS" categories in ascending severity of bowel dysfunction. The potential risk factors for major LARS were tested on multivariable analysis. The HRQL was compared between the LARS score categories. RESULTS Of the 478 respondents, 242 nonstoma patients were included in the present analysis. The median interval since treatment was 14.6 years, and the median age at the follow-up point was 75 years. Major LARS was reported by 46% of all patients (56% PRT plus TME vs. 35% TME). PRT (odds ratio [OR], 3.0; 99% confidence interval [CI], 1.3-6.9) and age ≤ 75 years at the follow-up point (OR, 2.4; 99% CI, 1.1-5.5) increased the risk of major LARS. Gender, tumor height, anastomotic leakage, type of anastomosis, interval since treatment, and comorbid diabetes were not significant. Patients with major LARS fared worse in many HRQL domains (P < .01; score difference > 5% of score range). CONCLUSION A considerable proportion of nonstoma patients endured major LARS years after TME. PRT and age ≤ 75 years at follow-up pose further risks of major LARS in addition to surgery. Major LARS is associated with reduced HRQL.