TY  - JOUR
AU  - Meixner, Eva
AU  - Wark, Antje
AU  - Forster, Tobias
AU  - Weykamp, Fabian
AU  - Lang, Kristin
AU  - König, Laila
AU  - Lindel, Katja
AU  - Oelmann-Avendano, Jan Tobias
AU  - Krisam, Johannes
AU  - Schneeweiss, Andreas
AU  - Ellerbrock, Malte
AU  - Mielke, Thomas
AU  - Hörner-Rieber, Juliane
AU  - Herfarth, Klaus
AU  - Debus, Jürgen
AU  - Arians, Nathalie
TI  - 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.
JO  - Radiation oncology
VL  - 18
IS  - 1
SN  - 1748-717X
CY  - London
PB  - BioMed Central
M1  - DKFZ-2023-00058
SP  - 5
PY  - 2023
AB  - 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).
KW  - Gynecological cancer (Other)
KW  - Quality of life (Other)
KW  - Radiochemotherapy (Other)
KW  - Radiotherapy (Other)
KW  - Toxicity (Other)
KW  - Uterine neoplasm (Other)
LB  - PUB:(DE-HGF)16
C6  - pmid:36624483
DO  - DOI:10.1186/s13014-023-02198-4
UR  - https://inrepo02.dkfz.de/record/186689
ER  -