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100 1 _ |a Meixner, Eva
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245 _ _ |a Health-related quality of life and patient-reported symptoms after postoperative proton beam radiotherapy of cervical and endometrial cancer: 2-year results of the prospective phase II APROVE-trial.
260 _ _ |a London
|c 2023
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520 _ _ |a The 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.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 (CTCAE) and institutional patient-reported symptoms grading.Scores regarding global health status were markedly impaired at baseline (mean: 58.0 ± 20.1) compared to reference population data, but significantly (p = 0.036) improved and evened out to comparable norm values 2 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 CTCAE ≥ 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.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 2 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.The trial was registered at https://clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT03184350, 09th June 2017).
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650 _ 7 |a Quality of life
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650 _ 7 |a Radiochemotherapy
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650 _ 7 |a Radiotherapy
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650 _ 7 |a Toxicity
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650 _ 7 |a Uterine neoplasm
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700 1 _ |a Wark, Antje
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700 1 _ |a Forster, Tobias
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700 1 _ |a Weykamp, Fabian
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700 1 _ |a Lang, Kristin
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700 1 _ |a König, Laila
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700 1 _ |a Lindel, Katja
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700 1 _ |a Oelmann-Avendano, Jan Tobias
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700 1 _ |a Krisam, Johannes
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700 1 _ |a Schneeweiss, Andreas
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700 1 _ |a Ellerbrock, Malte
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700 1 _ |a Mielke, Thomas
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700 1 _ |a Hörner-Rieber, Juliane
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700 1 _ |a Arians, Nathalie
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773 _ _ |a 10.1186/s13014-023-02198-4
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