Quality of life after pelvic radiotherapy or vaginal brachytherapy for endometrial cancer: first results of the randomized PORTEC-2 trial.

PURPOSE Studies on quality of life (QOL) among women with endometrial cancer have shown that patients who undergo pelvic radiotherapy report lower role functioning and more diarrhea and fatigue. In the Post Operative Radiation Therapy in Endometrial Cancer (PORTEC) trial, patients with endometrial carcinoma were randomly assigned to receive external-beam radiotherapy (EBRT) or vaginal brachytherapy (VBT). QOL was evaluated by using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 and subscales from the prostate cancer module, PR-25, and the ovarian cancer module, OV-28. PATIENTS AND METHODS PORTEC-2 accrued 427 patients between 2002 and 2006, of whom 214 were randomly assigned to EBRT, and 213 were randomly assigned to VBT. Three-hundred forty-eight patients (81%) were evaluable for QOL. QOL outcomes were analyzed at a median follow-up of 2 years. Results At baseline after surgery, patient functioning was at the lowest level, and it increased during and after radiotherapy to reach a plateau after 12 months. Patients in the VBT group reported better social functioning (P < .002) and lower symptom scores for diarrhea, fecal leakage, the need to stay close to the toilet, and limitation in daily activities because of bowel symptoms (P < .001). At baseline, 15% of patients were sexually active; this increased significantly to 39% during the first year (P < .001). Sexual functioning and symptoms did not differ between the treatment groups. CONCLUSION Patients who received EBRT reported significantly higher levels of diarrhea and bowel symptoms. This resulted in a higher need to remain close to a toilet and, as a consequence, more limitation of daily activities because of bowel symptoms and decreased social functioning. Vaginal brachytherapy provides a better QOL, and should be the preferred treatment from a QOL perspective.

[1]  J. Coebergh,et al.  Impact of external beam adjuvant radiotherapy on health-related quality of life for long-term survivors of endometrial adenocarcinoma: a population-based study. , 2007, International journal of radiation oncology, biology, physics.

[2]  P. Koper,et al.  Surgery and postoperative radiotherapy versus surgery alone for patients with stage-1 endometrial carcinoma: multicentre randomised trial , 2000, The Lancet.

[3]  P. Koper,et al.  The morbidity of treatment for patients with Stage I endometrial cancer: results from a randomized trial. , 2001, International journal of radiation oncology, biology, physics.

[4]  M. Chadha,et al.  Patterns of failure in endometrial carcinoma stage IB grade 3 and IC patients treated with postoperative vaginal vault brachytherapy. , 1999, Gynecologic oncology.

[5]  D. Osoba,et al.  Interpreting the significance of changes in health-related quality-of-life scores. , 1998, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[6]  Wendy Levinson,et al.  A study of sexuality and health among older adults in the United States. , 2007, The New England journal of medicine.

[7]  Marianne Klee, David Machin Health-related Quality of Life of Patients with Endometrial Cancer Who are Disease-free Following External Irradiation , 2001, Acta oncologica.

[8]  K. Shin,et al.  Excellent long-term survival and absence of vaginal recurrences in 332 patients with low-risk stage I endometrial adenocarcinoma treated with hysterectomy and vaginal brachytherapy without formal staging lymph node sampling: report of a prospective trial. , 1997, International journal of radiation oncology, biology, physics.

[9]  M. Groenvold,et al.  Quality of life of Danish women: Population-based norms for the EORTC QLQ-C30 , 2004, Quality of Life Research.

[10]  D. Redelmeier,et al.  Interpreting clinically significant changes in patient‐reported outcomes , 2007, Cancer.

[11]  Y. Brandberg,et al.  Health-related Quality of Life Measured by the EORTC QLQ-C30: Reference Values From a Large Sample of the Swedish Population , 2000 .

[12]  H Putter,et al.  Tutorial in biostatistics: competing risks and multi‐state models , 2007, Statistics in medicine.

[13]  H. Putter,et al.  Vaginal brachytherapy versus external beam pelvic radiotherapy for high-intermediate risk endometrial cancer: Results of the randomized PORTEC-2 trial , 2008 .

[14]  C. Hess,et al.  Adjuvant vaginal high-dose-rate afterloading alone in endometrial carcinoma: patterns of relapse and side effects following low-dose therapy. , 1998, Gynecologic oncology.

[15]  F. Bray,et al.  Geographic and temporal variations in cancer of the corpus uteri: Incidence and mortality in pre‐ and postmenopausal women in Europe , 2005, International journal of cancer.

[16]  V. Abeler,et al.  Postoperative External Irradiation and Prognostic Parameters in Stage I Endometrial Carcinoma: CLINICAL AND HISTOPATHOLOGIC STUDY OF 540 PATIENTS , 1980, Obstetrics and gynecology.

[17]  D. Osoba,et al.  The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. , 1993, Journal of the National Cancer Institute.

[18]  J. Shepherd Revised FIGO staging for gynaecological cancer , 1989, British journal of obstetrics and gynaecology.

[19]  G. Samsioe,et al.  Quality of life in endometrial cancer survivors. , 1999, Maturitas.

[20]  P. Blake,et al.  Adjuvant external beam radiotherapy (EBRT) in the treatment of endometrial cancer: Results of the randomised MRC ASTEC and NCIC CTG EN.5 trial , 2007 .

[21]  D. Petereit,et al.  Post-operative high dose rate brachytherapy in patients with low to intermediate risk endometrial cancer. , 2000, Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology.

[22]  A. Bottomley,et al.  An international field study of the reliability and validity of a disease-specific questionnaire module (the QLQ-OV28) in assessing the quality of life of patients with ovarian cancer. , 2003, European journal of cancer.

[23]  M. Maiman,et al.  A phase III trial of surgery with or without adjunctive external pelvic radiation therapy in intermediate risk endometrial adenocarcinoma: a Gynecologic Oncology Group study , 2004 .

[24]  M. Hjermstad,et al.  Health-related quality of life and occurrence of intestinal side effects after pelvic radiotherapy--evaluation of long-term effects of diagnosis and treatment. , 2000, Acta oncologica.

[25]  P. Koper,et al.  Postoperative radiotherapy for Stage 1 endometrial carcinoma: long-term outcome of the randomized PORTEC trial with central pathology review. , 2005, International journal of radiation oncology, biology, physics.

[26]  B. Anderson,et al.  Quality of life and mental health in cervical and endometrial cancer survivors. , 2006, Gynecologic oncology.

[27]  T. Le,et al.  Quality-of-life analysis in the management of endometrial cancer. , 2005, American journal of obstetrics and gynecology.

[28]  Roger L. Brown,et al.  Sufficiently Important Difference: Expanding the Framework of Clinical Significance , 2005, Medical decision making : an international journal of the Society for Medical Decision Making.