Patient-reported outcomes after neoadjuvant chemoradiotherapy for rectal cancer: a multicenter prospective observational study.

Objective: To prospectively describe patient-reported outcomes (PROs) after preoperative chemoradiotherapy (pCRT) for rectal cancer. Background: Little evidence is available on PROs after pCRT for rectal cancer. Patients and Methods: Patients with rectal cancer, candidates to receive pCRT, were enrolled in a multicenter prospective observational trial. Health-related quality of life was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and its colorectal cancer module (QLQ-CR38), and fecal incontinence and bowel function were evaluated using the fecal incontinence score questionnaire and a set of ad hoc questions. Questionnaires were filled out before CRT (to), 2 to 3 weeks after completion of CRT (t 1 ), and at 6 (t 2 ) and 12 months (t 3 ) after surgery. Primary analysis of selected scales included: global quality of life, physical functioning, social functioning, fatigue, body image, future prospective, and gender-related sexual problems. Results: Of 149 eligible patients, questionnaires were completed in 100%, 95%, 88% and 77% of cases at t 0 , t 1 , t 2 , and t 3 , respectively. At t 3 , 78% of patients reported stool fractionation and 72% sensation of incomplete defecation. Only 14% of patients had optimal continence. Physical/social functioning, fatigue, and body image showed a decrease just after pCRT and returned to baseline levels at 1 year after treatment. Global quality of life was stable over time. Male sexual problems were greatly impaired throughout the study period (P < 0.001) with major clinically meaningful changes between baseline and 1 year after treatment. Conclusions: These findings add to the body of evidence available regarding pCRT and help clinicians to make more informed treatment decisions.