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@ARTICLE{Meixner:186689,
      author       = {E. Meixner and A. Wark and T. Forster and F. Weykamp and K.
                      Lang and L. König and K. Lindel and J. T. Oelmann-Avendano
                      and J. Krisam and A. Schneeweiss and M. Ellerbrock and T.
                      Mielke and J. Hörner-Rieber$^*$ and K. Herfarth$^*$ and J.
                      Debus$^*$ and N. Arians},
      title        = {{H}ealth-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.},
      journal      = {Radiation oncology},
      volume       = {18},
      number       = {1},
      issn         = {1748-717X},
      address      = {London},
      publisher    = {BioMed Central},
      reportid     = {DKFZ-2023-00058},
      pages        = {5},
      year         = {2023},
      abstract     = {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).},
      keywords     = {Gynecological cancer (Other) / Quality of life (Other) /
                      Radiochemotherapy (Other) / Radiotherapy (Other) / Toxicity
                      (Other) / Uterine neoplasm (Other)},
      cin          = {E050},
      ddc          = {610},
      cid          = {I:(DE-He78)E050-20160331},
      pnm          = {315 - Bildgebung und Radioonkologie (POF4-315)},
      pid          = {G:(DE-HGF)POF4-315},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:36624483},
      doi          = {10.1186/s13014-023-02198-4},
      url          = {https://inrepo02.dkfz.de/record/186689},
}