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@ARTICLE{Yoon:298412,
      author       = {C. H. Yoon and M. I. Ross and B. R. Gastman and J. J. Luke
                      and P. A. Ascierto and G. V. Long and P. Rutkowski and M.
                      Khattak and M. Del Vecchio and L. de la Cruz Merino and J.
                      Mackiewicz and V. Chiarion-Sileni and D. Schadendorf$^*$ and
                      M. S. Carlino and Y. Zhao and M. Fukunaga-Kalabis and C.
                      Krepler and A. M. M. Eggermont and J. E. Gershenwald and V.
                      K. Sondak},
      title        = {{A}djuvant {P}embrolizumab in {S}tage {II} {M}elanoma:
                      {O}utcomes by {P}rimary {T}umor {L}ocation in the
                      {R}andomized, {D}ouble-{B}lind, {P}hase {III} {KEYNOTE}-716
                      {T}rial.},
      journal      = {Annals of surgical oncology},
      volume       = {32},
      number       = {4},
      issn         = {1068-9265},
      address      = {Berlin [u.a.]},
      publisher    = {Springer},
      reportid     = {DKFZ-2025-00268},
      pages        = {2756-2764},
      year         = {2025},
      note         = {2025 Apr;32(4):2756-2764},
      abstract     = {Previous results from the KEYNOTE-716 trial demonstrated
                      significantly improved recurrence-free survival (RFS) and
                      distant metastasis-free survival (DMFS) with adjuvant
                      pembrolizumab versus placebo in patients with resected stage
                      IIB or IIC melanoma. We present a post hoc analysis of
                      efficacy according to primary tumor location.KEYNOTE-716
                      (NCT03553836) is a randomized, multicenter, double-blind,
                      phase III study. Patients aged ≥ 12 years with newly
                      diagnosed, resected stage IIB or IIC melanoma (sentinel
                      node-negative) were randomly assigned (1:1) to pembrolizumab
                      200 mg every 3 weeks (2 mg/kg up to 200 mg for pediatric
                      patients) or placebo. This post hoc analysis evaluated RFS
                      and DMFS by primary tumor location of the head/neck, trunk,
                      or extremities.Overall, 976 patients were assigned to
                      pembrolizumab (n = 487) or placebo (n = 489). Median
                      follow-up was 39.4 months (range 26.0-51.4). The hazard
                      ratios {HRs $(95\%$ confidence interval [CI])} for RFS were
                      0.60 (0.38-0.93) for the head/neck subgroup, 0.57
                      (0.38-0.84) for the trunk subgroup, and 0.69 (0.47-1.02) for
                      the extremities subgroup. The HRs $(95\%$ CI) for DMFS were
                      0.65 (0.37-1.14) for the head/neck subgroup, 0.59
                      (0.38-0.92) for the trunk subgroup, and 0.53 (0.31-0.90) for
                      the extremities subgroup.RFS and DMFS consistently favored
                      adjuvant pembrolizumab over placebo in most subgroups
                      analyzed in this post hoc analysis from the KEYNOTE-716
                      trial. These results support the benefit of adjuvant
                      pembrolizumab on RFS and DMFS in patients with resected
                      high-risk stage II melanoma, irrespective of primary tumor
                      location.},
      keywords     = {Adjuvant (Other) / Adjuvant therapy (Other) / Immune
                      checkpoint inhibitors (Other) / Melanoma (Other) /
                      Pembrolizumab (Other) / Skin neoplasms (Other) / Surgery
                      (Other)},
      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},
      pubmed       = {pmid:39893343},
      doi          = {10.1245/s10434-024-16642-6},
      url          = {https://inrepo02.dkfz.de/record/298412},
}