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
Dana-Farber Brigham Cancer Center, Boston, MA, USA.
The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Ann Surg Oncol. 2025 Apr;32(4):2756-2764. doi: 10.1245/s10434-024-16642-6. Epub 2025 Feb 1.
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.
KEYNOTE-716试验先前的结果表明，对于已切除的IIB期或IIC期黑色素瘤患者，辅助使用帕博利珠单抗对比安慰剂可显著改善无复发生存期（RFS）和无远处转移生存期（DMFS）。我们根据原发肿瘤部位进行了一项事后疗效分析。
KEYNOTE-716（NCT03553836）是一项随机、多中心、双盲的III期研究。年龄≥12岁、新诊断且已切除的IIB期或IIC期黑色素瘤（前哨淋巴结阴性）患者被随机分配（1:1）接受每3周一次的帕博利珠单抗200mg（儿科患者剂量为2mg/kg，最高200mg）或安慰剂治疗。这项事后分析根据头颈部、躯干或四肢的原发肿瘤部位评估RFS和DMFS。
总体而言，976例患者被分配接受帕博利珠单抗（n = 487）或安慰剂（n = 489）治疗。中位随访时间为39.4个月（范围26.0 - 51.4个月）。头颈部亚组RFS的风险比{HRs（95%置信区间[CI]）}为0.60（0.38 - 0.93），躯干亚组为0.57（0.38 - 0.84），四肢亚组为0.69（0.47 - 1.02）。头颈部亚组DMFS的HRs（95%CI）为0.65（0.37 - 1.14），躯干亚组为0.59（0.
