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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},
}