Quality of life results of the APROVE trial after proton beam therapy for gynecological cancer
MO-0054
Abstract
Quality of life results of the APROVE trial after proton beam therapy for gynecological cancer
Authors: Eva Meixner1, Antje Wark1, Tobias Forster1, Fabian Weykamp2, Kristin Lang1, Laila König1, Katja Lindel3, Jan Tobias Oelmann-Avendano4, Johannes Krisam5, Andreas Schneeweiss6, Malte Ellerbrock7, Thomas Mielke7, Juliane Hörner-Rieber1, Klaus Herfarth1, Jürgen Debus1, Nathalie Arians1
1Heidelberg University Hospital, Department of Radiation Oncology, Heidelberg, Germany; 2Heidelberg University Hospital, Department of Radiation Oncology, Heidelberg , Germany; 3Municipal Hospital Karlsruhe, Department of Radiation Oncology, Karlsruhe, Germany; 4Göttingen University Hospital, Department of Radiation Oncology, Göttingen, Germany; 5University of Heidelberg, Institute for Medical Biometry and Informatics, Heidelberg, Germany; 6Heidelberg University Hospital, Department of Gynecology and Obstetrics, Heidelberg, Germany; 7Heidelberg Ion Therapy Center (HIT), Heidelberg Ion Therapy Center (HIT), Heidelberg, Germany
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Purpose or Objective
Trial registration: The trial was registered at https://clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT03184350, 9th June 2017).
The prospective APROVE-trial investigated the tolerability of postoperative proton beam therapy in women with cervical or endometrial cancer. The present analysis evaluated the secondary endpoints of health-related quality of life (HRQOL) and patient-reported symptoms.
Material and Methods
25 patients were included in this prospective phase-II-trial and treated with postoperative radiotherapy using protons alone or in combination with chemotherapy. To attain general and gynecologic-specific HRQOL measures, the EORTC-QLQ-C30 questionnaires combined with -QLQ-CX24 for cervical and -QLQ-EN24 for endometrial cancer were assessed at baseline, at the end of RT and up to 2 years after radiotherapy. The results were compared to an age-matched norm reference population. Symptoms were assessed using Common Terminology Criteria for Adverse Events.
Results
Scores regarding global health status were markedly impaired at baseline (mean: 58.0±20.1) compared to reference data (Figure 1), but significantly (p=0.036) improved and evened out to comparable norm values two years after proton therapy (mean: 69.9±19.3). Treatment caused acute and long-term worsening of pain (p=0.048) and gastrointestinal symptoms (p=0.016) for women with endometrial cancer, but no higher-grade ≥3° toxicity was observed. Dosimetric evaluation of rectum, sigmoid, large and small bowel showed no correlation with the reported gastrointestinal symptoms. After 2 years, fatigue had significantly improved (p=0.030), whereas patients with cervical cancer experienced more often lymphedema (p=0.017). Scores for endometrial cancer pertaining to sexual activity (p=0.048) and body image (p=0.022) had improved post treatment; in the latter this effect persisted after 2 years (Figure 2).
Conclusion
Proton beam therapy in the adjuvant setting was well tolerated with only low-grade side effects concerning gastrointestinal symptoms, lymphedema and pain. Overall quality of life was impaired at baseline, but patients were able to recover to values comparable to norm population two years after proton therapy. Larger studies are needed to confirm whether the benefit of proton therapy translates into a clinical effect. Sexual dysfunction remains an important issue.