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@ARTICLE{Schadendorf:276328,
      author       = {D. Schadendorf$^*$ and H. Tawbi and E. J. Lipson and F.
                      Stephen Hodi and P. Rutkowski and H. Gogas and C. D. Lao and
                      J.-J. Grob and A. Moshyk and J. Lord-Bessen and M. Hamilton
                      and S. Guo and L. Shi and S. Keidel and G. V. Long},
      title        = {{H}ealth-related quality of life with nivolumab plus
                      relatlimab versus nivolumab monotherapy in patients with
                      previously untreated unresectable or metastatic melanoma:
                      {RELATIVITY}-047 trial},
      journal      = {European journal of cancer},
      volume       = {187},
      issn         = {0014-2964},
      address      = {Amsterdam [u.a.]},
      publisher    = {Elsevier},
      reportid     = {DKFZ-2023-01058},
      pages        = {164 - 173},
      year         = {2023},
      abstract     = {Background:In the phase II/III RELATIVITY-047 trial, a
                      novel fixed-dose combination (FDC) of nivolumab plus
                      relatlimab (NIVO + RELA; a programmed death-1 and a
                      lymphocyte-activation gene 3 inhibitor, respectively)
                      significantly improved progression-free survival (PFS)
                      versus NIVO in patients with previously untreated
                      unresectable or metastatic melanoma (median follow-up, 13.2
                      months) with stable health-related quality of life (HRQoL),
                      although grade three or four treatment-related adverse
                      events (TRAEs) were more frequent with the combination.
                      Updated HRQoL results (median follow-up, 19.3 months) are
                      presented.Methods:Patients were randomised to receive
                      intravenous NIVO + RELA (480 mg and 160 mg,
                      respectively) or NIVO (480 mg) every 4 weeks. HRQoL was
                      assessed using the Functional Assessment of Cancer
                      Treatment-Melanoma (FACT-M) and EQ-5D-3L questionnaires at
                      baseline, before dosing at each treatment cycle, and at
                      follow-up (posttreatment) visits.Results:Consistent with the
                      initial analysis, HRQoL remained stable with NIVO + RELA
                      on treatment and was similar to that with NIVO. Mean changes
                      from baseline did not exceed clinically meaningful
                      thresholds. HRQoL results were consistent across instruments
                      and scales/subscales. Despite an increased rate of grade
                      three or four TRAEs with NIVO + RELA versus NIVO, the
                      proportion of patients reporting that they were bothered
                      'quite a bit' or 'very much' by TRAEs was low and comparable
                      between treatments.Conclusion:Results from the
                      RELATIVITY-047 trial show that the PFS benefit with
                      NIVO + RELA FDC over NIVO was obtained with stable
                      patient-reported HRQoL, supporting NIVO + RELA as a
                      first-line treatment option for patients with advanced
                      melanoma.},
      cin          = {ED01},
      ddc          = {610},
      cid          = {I:(DE-He78)ED01-20160331},
      pnm          = {899 - ohne Topic (POF4-899)},
      pid          = {G:(DE-HGF)POF4-899},
      typ          = {PUB:(DE-HGF)16},
      doi          = {10.1016/j.ejca.2023.03.014},
      url          = {https://inrepo02.dkfz.de/record/276328},
}