Five-year quality of life of endometrial cancer patients treated in the randomised Post Operative Radiation Therapy in Endometrial Cancer (PORTEC-2) trial and comparison with norm data

Nout, Remi A.; Putter, Hein; Jürgenliemk-Schulz, Ina M.; Jobsen, Jan J.; Lutgens, Ludy C.H.W.; van der Steen-Banasik, Elzbieta M.; Mens, Jan Willem M.; Slot, Annerie; Stenfert Kroese, Marika C.; Nijman, Hans W.; van de Poll-Franse, Lonneke V.; Creutzberg, Carien L.

doi:10.1016/j.ejca.2011.11.014

« BackEuropean Journal of Cancer

Article in Press

Five-year quality of life of endometrial cancer patients treated in the randomised Post Operative Radiation Therapy in Endometrial Cancer (PORTEC-2) trial and comparison with norm data☆

Presented at: Part of this research has been presented at the 29th Biennial European Society of Radiation Oncology (ESTRO) Conference, Barcelona, Spain, September 12–16, 2010.

Remi A. Nout
- Department of Clinical Oncology, Leiden University Medical Center, Leiden, The Netherlands
- Corresponding author: Address: Department of Clinical Oncology, Leiden University Medical Center, P.O. Box 9600, 2300 RC Leiden, The Netherlands. Tel.: +31 (0)71 5261990; fax: +31 (0)71 5266760.
- For the PORTEC Study Group.
Hein Putter
- Department of Medical Statistics, Leiden University Medical Center, Leiden, The Netherlands
- For the PORTEC Study Group.
Ina M. Jürgenliemk-Schulz
- Department of Radiation Oncology, University Medical Center Utrecht, The Netherlands
- For the PORTEC Study Group.
Jan J. Jobsen
- Department of Radiotherapy, Medisch Spectrum Twente, Enschede, The Netherlands
- For the PORTEC Study Group.
Ludy C.H.W. Lutgens
- MAASTtricht Radiation Oncology Clinic, The Netherlands
- For the PORTEC Study Group.
Elzbieta M. van der Steen-Banasik
- Arnhem Radiotherapy Institute, Arnhem, The Netherlands
- For the PORTEC Study Group.
Jan Willem M. Mens
- Department of Radiation Oncology, Erasmus MC–Daniel den Hoed Cancer Center, Rotterdam, The Netherlands
- For the PORTEC Study Group.
Annerie Slot
- Radiotherapy Institute Friesland, Leeuwarden, The Netherlands
- For the PORTEC Study Group.
Marika C. Stenfert Kroese
- Radiotherapy Institute Stedendriehoek en Omstreken, Deventer, The Netherlands
- For the PORTEC Study Group.
Hans W. Nijman
- Department of Gynecology, University Medical Center Groningen, The Netherlands
- For the PORTEC Study Group.
Lonneke V. van de Poll-Franse
- Comprehensive Cancer Centre South, Eindhoven and Center of Research on Psychology in Somatic Diseases (CoRPS), Tilburg University, The Netherlands
- For the PORTEC Study Group.
Carien L. Creutzberg
- Department of Clinical Oncology, Leiden University Medical Center, Leiden, The Netherlands
- For the PORTEC Study Group.

published online 19 December 2011.
Corrected Proof

Abstract

Background

The PORTEC-2 trial showed efficacy and reduced side-effects of vaginal brachytherapy (VBT) compared with external beam pelvic radiotherapy (EBRT) for patients with high-intermediate risk endometrial cancer. The current analysis was done to evaluate long-term health related quality of life (HRQL), and compare HRQL of patients to an age-matched norm population.

Methods

Patients were randomly allocated to EBRT (n=214) or VBT (n=213). HRQL was assessed using EORTC QLQ-C30 and subscales from PR25 and OV28 (bladder, bowel, sexual symptoms); and compared to norm data.

Findings

Median follow-up was 65 months; 348 (81%) patients were evaluable for HRQL (EBRT n=166, VBT n=182). At baseline, patient functioning was at lowest level, increasing during and after radiotherapy to reach a plateau after 12 months, within range of scores of the norm population. VBT patients reported better social functioning (p=0.005) and lower symptom scores for diarrhoea, faecal leakage, need to stay close to a toilet and limitation in daily activities due to bowel symptoms (p⩽0.001), compared to EBRT. There were no differences in sexual functioning or symptoms between the treatment groups; however, sexual functioning was lower and sexual symptoms more frequent in both treatment groups compared to the norm population.

Interpretation

Patients who received EBRT reported clinically relevant higher levels of bowel symptoms and related limitations in daily activities with lower social functioning, 5 years after treatment. VBT provides a better HRQL, which remained similar to that of an age-matched norm population, except for sexual symptoms which were more frequent in both treatment groups.

Keywords: Randomised trial, Quality of life, Radiotherapy, Brachytherapy, Endometrial carcinoma, Toxicity