Dataset Information

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.

ABSTRACT:

Introduction

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.

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 (CTCAE) and institutional patient-reported symptoms grading.

Results

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.

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 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.

Trial registration

The trial was registered at https://clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT03184350, 09th June 2017).

SUBMITTER: Meixner E

PROVIDER: S-EPMC9827629 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature

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Publications

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.

Meixner Eva E Wark Antje A Forster Tobias T Weykamp Fabian F Lang Kristin K König Laila L Lindel Katja K Oelmann-Avendano Jan Tobias JT Krisam Johannes J Schneeweiss Andreas A Ellerbrock Malte M Mielke Thomas T Hörner-Rieber Juliane J Herfarth Klaus K Debus Jürgen J Arians Nathalie N

Radiation oncology (London, England) 20230109 1

<h4>Introduction</h4>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.<h4>Methods</h4>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 H ...[more]

PMID: 36624483

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Project description:BackgroundThe prognosis for patients with cervical or endometrial cancer has improved over the last decades. Thus, reducing therapy-related toxicity and impact on quality of life have become more and more important. With the development of new radiotherapy techniques like IMRT (Intensity-modulated radiotherapy) the incidence of acute and chronic toxicities has already been reduced. Nevertheless, rates of complications requiring medical treatment range from 0.7-8% according to literature. 7.7% of patients develop severe complications after 5 years with an increasing risk for complications of 0.3%/year. Particularly, the volume of the small and large bowel receiving low doses (15 Gy) has been shown to be a predictive factor for the development of higher bowel toxicity. With the introduction of proton therapy into clinical practice, there are new opportunities for optimization of organ at risk-sparing thus possibly reducing toxicity.Methods/designThe APROVE study is a prospective single-center one-arm phase-II-study. Patients with cervical or endometrial cancer after surgical resection who have an indication for postoperative pelvic radiotherapy will be treated with proton therapy instead of the commonly used photon radiation. A total of 25 patients will be included in this trial. Patients will receive a dose of 45-50.4 GyE in 1.8 GyE fractions 5-6 times per week using active raster-scanning pencil beam proton radiation. Platinum-based chemotherapy can be administered if indicated. For treatment planning, rectum, sigma, large and small bowel, bladder and femoral heads are defined as organs at risk. The CTV is defined according to the RTOG consensus guidelines.DiscussionThe primary endpoint of the study is the evaluation of safety and treatment tolerability of pelvic radiation using protons defined as the lack of any CTC AE Grade 3 or 4 toxicity. Secondary endpoints are clinical symptoms and toxicity, quality of life and progression-free survival. The aim is to explore the potential of proton therapy as a new method for adjuvant pelvic radiotherapy to decrease the dose to the bowel, rectum and bladder thus reducing acute and chronic toxicity and improving quality of life.Trial registrationRegistered at https://clinicaltrials.gov , ClinicalTrials.gov Identifier: NCT03184350 , registered 09 June 2017, enrolment of the first participant 19 June 2017.

Project description:BackgroundSince intensity-modulated radiation therapy (IMRT) has become popular for the treatment of gynecologic cancers, the contouring process has become more critical. This study evaluated the feasibility of atlas-based auto-segmentation (ABAS) for contouring in patients with endometrial and cervical cancers.MethodsA total of 75 sets of planning CT images from 75 patients were collected. Contours for the pelvic nodal clinical target volume (CTV), femur, and bladder were carefully generated by two skilled radiation oncologists. Of 75 patients, 60 were randomly registered in three different atlas libraries for ABAS in groups of 20, 40, or 60. ABAS was conducted in 15 patients, followed by manual correction (ABASc). The time required to generate all contours was recorded, and the accuracy of segmentation was assessed using Dice's coefficient (DC) and the Hausdorff distance (HD) and compared to those of manually delineated contours.ResultsFor ABAS-CTV, the best results were achieved with groups of 60 patients (DC, 0.79; HD, 19.7 mm) and the worst results with groups of 20 patients (DC, 0.75; p = 0.012; HD, 21.3 mm; p = 0.002). ABASc-CTV performed better than ABAS-CTV in terms of both HD and DC (ABASc [n = 60]; DC, 0.84; HD, 15.6 mm; all p < 0.017). ABAS required an average of 45.1 s, whereas ABASc required 191.1 s; both methods required less time than the manual methods (p < 0.001). Both ABAS-Femur and simultaneous ABAS-Bilateral-femurs showed satisfactory performance, regardless of the atlas library used (DC > 0.9 and HD ≤10.0 mm), with significant time reduction compared to that needed for manual delineation (p < 0.001). However, ABAS-Bladder did not prove to be feasible, with inferior results regardless of library size (DC < 0.6 and HD > 40 mm). Furthermore, ABASc-Bladder required a longer processing time than manual contouring to achieve the same accuracy.ConclusionsABAS could help physicians to delineate the CTV and organs-at-risk (e.g., femurs) in IMRT planning considering its consistency, efficacy, and accuracy.

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Dataset Information

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.

Introduction

Methods

Results

Conclusion

Trial registration

Publications

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.

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