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| 024 | 7 | _ | |a 10.1186/s13014-023-02198-4 |2 doi |
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| 082 | _ | _ | |a 610 |
| 100 | 1 | _ | |a Meixner, Eva |b 0 |
| 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 |b BioMed Central |
| 336 | 7 | _ | |a article |2 DRIVER |
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| 336 | 7 | _ | |a Journal Article |b journal |m journal |0 PUB:(DE-HGF)16 |s 1673361811_25367 |2 PUB:(DE-HGF) |
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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 Gynecological cancer |2 Other |
| 650 | _ | 7 | |a Quality of life |2 Other |
| 650 | _ | 7 | |a Radiochemotherapy |2 Other |
| 650 | _ | 7 | |a Radiotherapy |2 Other |
| 650 | _ | 7 | |a Toxicity |2 Other |
| 650 | _ | 7 | |a Uterine neoplasm |2 Other |
| 700 | 1 | _ | |a Wark, Antje |b 1 |
| 700 | 1 | _ | |a Forster, Tobias |b 2 |
| 700 | 1 | _ | |a Weykamp, Fabian |b 3 |
| 700 | 1 | _ | |a Lang, Kristin |b 4 |
| 700 | 1 | _ | |a König, Laila |b 5 |
| 700 | 1 | _ | |a Lindel, Katja |b 6 |
| 700 | 1 | _ | |a Oelmann-Avendano, Jan Tobias |b 7 |
| 700 | 1 | _ | |a Krisam, Johannes |b 8 |
| 700 | 1 | _ | |a Schneeweiss, Andreas |b 9 |
| 700 | 1 | _ | |a Ellerbrock, Malte |b 10 |
| 700 | 1 | _ | |a Mielke, Thomas |b 11 |
| 700 | 1 | _ | |a Hörner-Rieber, Juliane |0 P:(DE-He78)c59ff25b48c192ed3fd4ad3a4bc9b9c0 |b 12 |u dkfz |
| 700 | 1 | _ | |a Herfarth, Klaus |0 P:(DE-He78)ea5c703d5f5cf5f1c26a34b38a5056dc |b 13 |
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| 700 | 1 | _ | |a Arians, Nathalie |b 15 |
| 773 | _ | _ | |a 10.1186/s13014-023-02198-4 |g Vol. 18, no. 1, p. 5 |0 PERI:(DE-600)2224965-5 |n 1 |p 5 |t Radiation oncology |v 18 |y 2023 |x 1748-717X |
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