Late patient-reported toxicity after preoperative radiotherapy or chemoradiotherapy in nonresectable rectal cancer: results from a randomized Phase III study

Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):1017-24. doi: 10.1016/j.ijrobp.2010.07.007. Epub 2010 Oct 6.

Abstract

Purpose: Preoperative chemoradiotherapy (CRT) is superior to radiotherapy (RT) in locally advanced rectal cancer, but the survival gain is limited. Late toxicity is, therefore, important. The aim was to compare late bowel, urinary, and sexual functions after CRT or RT.

Methods and materials: Patients (N = 207) with nonresectable rectal cancer were randomized to preoperative CRT or RT (2 Gy × 25 ± 5-fluorouracil/leucovorin). Extended surgery was often required. Self-reported late toxicity was scored according to the LENT SOMA criteria in a structured telephone interview and with questionnaires European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30), International Index of Erectile Function (IIEF), and sexual function-vaginal changes questionnaire (SVQ).

Results: Of the 105 patients alive in Norway and Sweden after 4 to 12 years of follow-up, 78 (74%) responded. More patients in the CRT group had received a stoma (73% vs. 52%, p = 0.09). Most patients without a stoma (7 of 12 in CRT group and 9 of 16 in RT group) had incontinence for liquid stools or gas. No stoma and good anal function were seen in 5 patients (11%) in the CRT group and in 11 (30%) in the RT group (p = 0.046). Of 44 patients in the CRT group, 12 (28%) had had bowel obstruction compared with 5 of 33 (15%) in the RT group (p = 0.27). One-quarter of the patients reported urinary incontinence. The majority of men had severe erectile dysfunction. Few women reported sexual activity during the previous month. However, the majority did not have concerns about their sex life.

Conclusions: Fecal incontinence and erectile dysfunction are frequent after combined treatment for locally advanced rectal cancer. There was a clear tendency for the problems to be more common after CRT than after RT.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adenocarcinoma / pathology
  • Adenocarcinoma / therapy
  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Agents / therapeutic use
  • Chemoradiotherapy / adverse effects*
  • Diagnostic Self Evaluation
  • Fecal Incontinence / epidemiology
  • Female
  • Fluorouracil / therapeutic use
  • Follow-Up Studies
  • Humans
  • Intestinal Obstruction / epidemiology
  • Leucovorin / therapeutic use
  • Male
  • Middle Aged
  • Neoplasm Recurrence, Local / pathology
  • Neoplasm Recurrence, Local / therapy*
  • Penile Erection / drug effects
  • Penile Erection / radiation effects
  • Preoperative Care
  • Quality of Life
  • Radiotherapy / adverse effects
  • Rectal Neoplasms / pathology
  • Rectal Neoplasms / therapy*
  • Sex Factors
  • Sexuality
  • Surgical Stomas / statistics & numerical data
  • Surveys and Questionnaires
  • Time Factors
  • Tumor Burden
  • Urinary Incontinence / epidemiology
  • Vagina / drug effects
  • Vagina / radiation effects

Substances

  • Antineoplastic Agents
  • Leucovorin
  • Fluorouracil