Annals of surgical oncology · 2025
Adjuvant Pembrolizumab in Stage II Melanoma: Outcomes by Primary Tumor Location in the Randomized, Double-Blind, Phase III KEYNOTE-716 Trial.
СтатьяКлиническое исследование III фазыРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Yoon Charles H, Ross Merrick I, Gastman Brian R, Luke Jason J, Ascierto Paolo A, Long Georgina V, Rutkowski Piotr, Khattak Muhammad, Del Vecchio Michele, de la Cruz Merino Luis, Mackiewicz Jacek, Chiarion-Sileni Vanna, Schadendorf Dirk, Carlino Matteo S, Zhao Yujie, Fukunaga-Kalabis Mizuho, Krepler Clemens, Eggermont Alexander M M, Gershenwald Jeffrey E, Sondak Vernon K
Аннотация
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSION: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSION: 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.
Предметные рубрики MeSH
HumansMelanomaDouble-Blind MethodAntibodies, Monoclonal, HumanizedFemaleMaleSurvival RateAgedMiddle AgedNeoplasm StagingChemotherapy, AdjuvantFollow-Up StudiesAdultSkin NeoplasmsPrognosisAntineoplastic Agents, ImmunologicalYoung AdultAdolescentChildNeoplasm Recurrence, LocalExtremitiesHead and Neck Neoplasms