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@ARTICLE{Arians:186757,
      author       = {N. Arians and K. Lindel and J. Krisam and J. T.
                      Oelmann-Avendano and E. Meixner and L. König and J.
                      Hoerner-Rieber and A. Wark and T. Forster and F. Weykamp and
                      K. Lang and A. Schneeweiss and M. Ellerbrock and T. Mielke
                      and K. Herfarth$^*$ and J. Debus$^*$},
      title        = {{T}reatment tolerability and toxicity of postoperative
                      proton beam therapy for gynecological malignancies - results
                      of the prospective phase {II} {APROVE}-trial.},
      journal      = {International journal of radiation oncology, biology,
                      physics},
      volume       = {116},
      number       = {4},
      issn         = {0360-3016},
      address      = {Amsterdam [u.a.]},
      publisher    = {Elsevier Science},
      reportid     = {DKFZ-2023-00101},
      pages        = {825-836},
      year         = {2023},
      note         = {#LA:E050# / 2023 Jul 15;116(4):825-836},
      abstract     = {The APROVE study is a prospective one-arm phase-II-study
                      investigating the safety and treatment tolerability of
                      postoperative proton beam therapy in women with uterine
                      cervical or endometrial cancer. In this analysis, we report
                      the primary study endpoint of safety and treatment
                      tolerability as well as toxicity rates and progression-free
                      survival (PFS).25 patients were treated with postoperative
                      proton beam therapy with a total dose of 45-50.4 Gy (RBE) in
                      5-6 × 1.8 Gy (RBE) weekly using active raster-scanning
                      intensity-modulated proton beam therapy (IMPT). Sequential
                      or simultaneous Platinum-based chemotherapy was administered
                      if indicated. The primary endpoint was defined as the lack
                      of any acute ≥ grade 3 gastrointestinal (GI) or urogenital
                      (GU) toxicity according to the Common Terminology Criteria
                      for Adverse Events v 4.0 or premature treatment abortion.
                      Secondary endpoints were clinical symptoms and toxicity,
                      quality of life and PFS.All patients completed IMPT
                      according to the protocol, with a median treatment duration
                      of 43 days (range: 33-51 days). No patient developed GI or
                      GU toxicity ≥ grade 3, the treatment tolerability rate was
                      $100\%.$ Therefore, the null hypothesis H0: Tolerability
                      Rate ≤ $80\%$ could be rejected in favor of the
                      alternative hypothesis H1: Tolerability rate $>80\%$ using
                      an exact binomial test with a one-sided significance level
                      of α = $10\%$ (one-sided p-value p=0.0059). The median
                      follow-up time after the end of IMPT was 25.1 months (range:
                      20.2 - 50.3 months). 18 of 25 $(75\%)$ patients completed
                      the study follow-up of 24 months. 7 patients had progressive
                      disease. Kaplan-Meier-estimated mean PFS was 39.9 months
                      $(95\%-CI$ 33.37 months; 46.5 months).Postoperative IMPT is
                      a safe treatment option for cervical and endometrial cancer
                      patients with only low-grade acute and late toxicities.
                      Larger randomized trials are necessary to further assess the
                      potential of IMPT and improve patient selection.},
      cin          = {E050 / HD01},
      ddc          = {610},
      cid          = {I:(DE-He78)E050-20160331 / I:(DE-He78)HD01-20160331},
      pnm          = {315 - Bildgebung und Radioonkologie (POF4-315)},
      pid          = {G:(DE-HGF)POF4-315},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:36642110},
      doi          = {10.1016/j.ijrobp.2023.01.004},
      url          = {https://inrepo02.dkfz.de/record/186757},
}