Stephanie M de Boer1, Remi A Nout2, Ina M Jürgenliemk-Schulz3, Jan J Jobsen4, Ludy C H W Lutgens5, Elzbieta M van der Steen-Banasik6, Jan Willem M Mens7, Annerie Slot8, Marika C Stenfert Kroese9, Simone Oerlemans10, Hein Putter11, Karen W Verhoeven-Adema12, Hans W Nijman13, Carien L Creutzberg2. 1. Department of Radiation Oncology, Leiden University Medical Center, Leiden, The Netherlands. Electronic address: s.m.de_boer.ONCO@lumc.nl. 2. Department of Radiation Oncology, Leiden University Medical Center, Leiden, The Netherlands. 3. Department of Radiation Oncology, University Medical Center Utrecht, Utrecht, The Netherlands. 4. Department of Radiotherapy, Medisch Spectrum Twente, Enschede, The Netherlands. 5. Department of Radiation Oncology (MAASTRO), University Medical Centre Maastricht, The Netherlands. 6. Arnhem Radiotherapy Institute (ARTI), Arnhem, The Netherlands. 7. Department of Radiation Oncology, Erasmus MC-Daniel den Hoed Cancer Center, Rotterdam, The Netherlands. 8. Radiotherapy Institute Friesland, Leeuwarden, The Netherlands. 9. Department of Radiation Oncology, Radiotherapy Group Deventer, Deventer, The Netherlands. 10. Research Department, Netherlands Comprehensive Cancer Organization, Eindhoven, The Netherlands; Center of Research on Psychology in Somatic Diseases, Tilburg University, Tilburg, The Netherlands. 11. Department of Medical Statistics, Leiden University Medical Center, Leiden, The Netherlands. 12. Comprehensive Cancer Center The Netherlands-West, Leiden, The Netherlands. 13. Department of Gynecologic Oncology, University Medical Center Groningen, Groningen, The Netherlands.
Abstract
PURPOSE: To evaluate the long-term health-related quality of life (HRQL) after external beam radiation therapy (EBRT) or vaginal brachytherapy (VBT) among PORTEC-2 trial patients, evaluate long-term bowel and bladder symptoms, and assess the impact of cancer on these endometrial cancer (EC) survivors. PATIENTS AND METHODS: In the PORTEC-2 trial, 427 patients with stageI high-intermediate-risk EC were randomly allocated to EBRT or VBT. The 7- and 10-year HRQL questionnaires consisted of EORTC QLQ-C30; subscales for bowel and bladder symptoms; the Impact of Cancer Questionnaire; and 14 questions on comorbidities, walking aids, and incontinence pads. Analysis was done using linear mixed models for subscales and (ordinal) logistic regression with random effects for single items. A two-sided P value <.01 was considered statistically significant. RESULTS: Longitudinal HRQL analysis showed persisting higher rates of bowel symptoms with EBRT, without significant differences in global health or any of the functioning scales. At 7 years, clinically relevant fecal leakage was reported by 10.6% in the EBRT group, versus 1.8% for VBT (P=.03), diarrhea by 8.4% versus 0.9% (P=.04), limitations due to bowel symptoms by 10.5% versus 1.8% (P=.001), and bowel urgency by 23.3% versus 6.6% (P<.001). Urinary urgency was reported by 39.3% of EBRT patients, 25.5% for VBT, P=.05. No difference in sexual activity was seen between treatment arms. Long-term impact of cancer scores was higher among the patients who had an EC recurrence or second cancer. CONCLUSIONS: More than 7 years after treatment, EBRT patients reported more bowel symptoms with impact on daily activities, and a trend for more urinary symptoms, without impact on overall quality of life or difference in cancer survivorship issues.
RCT Entities:
PURPOSE: To evaluate the long-term health-related quality of life (HRQL) after external beam radiation therapy (EBRT) or vaginal brachytherapy (VBT) among PORTEC-2 trial patients, evaluate long-term bowel and bladder symptoms, and assess the impact of cancer on these endometrial cancer (EC) survivors. PATIENTS AND METHODS: In the PORTEC-2 trial, 427 patients with stage I high-intermediate-risk EC were randomly allocated to EBRT or VBT. The 7- and 10-year HRQL questionnaires consisted of EORTC QLQ-C30; subscales for bowel and bladder symptoms; the Impact of Cancer Questionnaire; and 14 questions on comorbidities, walking aids, and incontinence pads. Analysis was done using linear mixed models for subscales and (ordinal) logistic regression with random effects for single items. A two-sided P value <.01 was considered statistically significant. RESULTS: Longitudinal HRQL analysis showed persisting higher rates of bowel symptoms with EBRT, without significant differences in global health or any of the functioning scales. At 7 years, clinically relevant fecal leakage was reported by 10.6% in the EBRT group, versus 1.8% for VBT (P=.03), diarrhea by 8.4% versus 0.9% (P=.04), limitations due to bowel symptoms by 10.5% versus 1.8% (P=.001), and bowel urgency by 23.3% versus 6.6% (P<.001). Urinary urgency was reported by 39.3% of EBRTpatients, 25.5% for VBT, P=.05. No difference in sexual activity was seen between treatment arms. Long-term impact of cancer scores was higher among the patients who had an EC recurrence or second cancer. CONCLUSIONS: More than 7 years after treatment, EBRTpatients reported more bowel symptoms with impact on daily activities, and a trend for more urinary symptoms, without impact on overall quality of life or difference in cancer survivorship issues.
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