Health-related quality of life 14 years after preoperative short-term radiotherapy and total mesorectal excision for rectal cancer: Report of a multicenter randomised trial

Abstract Background Preoperative short-term radiotherapy (PRT) in combination with total mesorectal excision (TME) has shown to improve local control in rectal cancer treatment, however without a survival benefit and at the cost of increased morbidity. The current study investigates the long-term health-related quality of life (HRQL) of patients 14 years after treatment in the Dutch TME trial. Methods In the TME trial (1996–1999) 1530 Dutch patients with rectal cancer were treated with TME and randomly assigned to PRT (5 × 5 Gy). In 2012 HRQL was evaluated in surviving patients ( n  = 606) using a questionnaire combining EORTC QLQ-C30, EORTC QLQ-CR29 and additional questions. Findings Results were obtained from 478 patients (82%), with a median follow up of 14 years. PRT + TME patients without stoma reported more faecal leakage and higher stool frequency, resulting in increased need of pads. Furthermore, irradiated males reported more erection problems. However, radiotherapy did not have negative effects on overall functioning. Compared with Dutch population, patients in both treatment arms reported a small decrease in overall functioning and males reported less sexual activity, interest and enjoyment and more erection difficulties. Irradiated females reported more vaginal dryness and more pain at intercourse compared with Dutch population. Interpretation Long-term HRQL evaluation shows that treatment-related symptoms are still present 14 years after treatment for rectal cancer. Radiotherapy increased bowel dysfunction in patients without stoma. Compared with the Dutch population, both groups reported increased sexual dysfunction. Despite these treatment-related symptoms, there was no difference in overall functioning and global health between TME and PRT + TME.