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@ARTICLE{Heinrich:277743,
      author       = {K. Heinrich$^*$ and M. Karthaus and S. Fruehauf and U.
                      Graeven and L. Mueller and A. O. König and L. F. von
                      Weikersthal and K. Caca and A. Kretzschmar and E. Goekkurt
                      and S. Haas and A. H. S. Alig and A. Kurreck and A. Stahler
                      and S. Held and G. Sommerhäuser and V. Heinemann$^*$ and S.
                      Stintzing$^*$ and T. Trarbach and D. P. Modest$^*$},
      title        = {{I}mpact of sex on the efficacy and safety of panitumumab
                      plus fluorouracil and folinic acid versus fluorouracil and
                      folinic acid alone as maintenance therapy in {RAS} {WT}
                      metastatic colorectal cancer (m{CRC}). {S}ubgroup analysis
                      of the {P}ana{M}a-study ({AIO}-{KRK}-0212).},
      journal      = {ESMO open},
      volume       = {8},
      number       = {4},
      issn         = {2059-7029},
      address      = {London},
      publisher    = {BMJ},
      reportid     = {DKFZ-2023-01460},
      pages        = {101568},
      year         = {2023},
      abstract     = {Clinical trials in metastatic colorectal cancer (mCRC) are
                      usually conducted irrespective of sex. Sex-associated
                      differences relating to safety and efficacy in the treatment
                      of mCRC, however, are gaining interest.PanaMa investigated
                      the efficacy of panitumumab (Pmab) plus fluorouracil and
                      folinic acid (FU/FA) versus FU/FA alone after induction
                      therapy with six cycles of FU/FA and oxaliplatin plus Pmab
                      in patients with RAS wild-type mCRC. In this post hoc
                      analysis, the study population was stratified for sex.
                      Evaluated efficacy endpoints during maintenance treatment
                      were progression-free survival (PFS, primary endpoint of the
                      trial), overall survival (OS) and objective response rate
                      during maintenance therapy. Safety endpoints were rates of
                      any grade and grade 3/4 adverse events during maintenance
                      therapy.In total, 165 male and 83 female patients were
                      randomized and treated. Male and female patients showed
                      numerically better objective response rates with Pmab,
                      without reaching statistical significance. Male patients
                      derived a significant benefit from the addition of Pmab to
                      maintenance treatment with regard to PFS [hazard ratio (HR)
                      0.63; $95\%$ confidence interval (CI) 0.45-0.88; P = 0.006]
                      that was not observed in female patients (HR 0.85; $95\%$ CI
                      0.53-1.35; P = 0.491). The better PFS for male patients
                      treated with Pmab did not translate into improved OS (HR
                      0.85; $95\%$ CI 0.55-1.30; P = 0.452). Female patients
                      showed numerically improved OS when treated with Pmab. There
                      was no difference in the total of grade ≥3 adverse events
                      during maintenance regarding sex (P = 0.791). Female
                      patients, however, had a higher rate of any grade nausea,
                      diarrhea and stomatitis.In the PanaMa trial, the addition of
                      Pmab to maintenance treatment of RAS wild-type mCRC with
                      FU/FA improved the outcome in terms of the primary endpoint
                      (PFS) particularly in male patients. Female patients did not
                      show the same benefit while experiencing higher rates of
                      adverse events. Our results support the development of
                      sex-specific protocols.},
      keywords     = {EGFR-antibodies (Other) / colorectal cancer (Other) /
                      maintenance (Other) / sex (Other)},
      cin          = {MU01 / BE01},
      ddc          = {610},
      cid          = {I:(DE-He78)MU01-20160331 / I:(DE-He78)BE01-20160331},
      pnm          = {899 - ohne Topic (POF4-899)},
      pid          = {G:(DE-HGF)POF4-899},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:37441876},
      doi          = {10.1016/j.esmoop.2023.101568},
      url          = {https://inrepo02.dkfz.de/record/277743},
}