医学
彭布罗利珠单抗
耐受性
索拉非尼
内科学
不利影响
肝细胞癌
实体瘤疗效评价标准
临床终点
中止
无进展生存期
外科
肿瘤科
胃肠病学
临床研究阶段
毒性
临床试验
化疗
癌症
免疫疗法
作者
Masatoshi Kudo,Richard S. Finn,Julien Edeline,Stéphane Cattan,Satoshi Ogasawara,Daniel H. Palmer,Chris Verslype,Vittorina Zagonel,Laëtitia Fartoux,Arndt Vogel,Debashis Sarker,Gontran Verset,Stephen L. Chan,Jennifer J. Knox,Bruno Daniele,Thomas Yau,Ellen B. Gurary,Abby B. Siegel,Anran Wang,Ann‐Lii Cheng,Andrew X. Zhu
标识
DOI:10.1016/j.ejca.2022.02.009
摘要
Pembrolizumab, a PD-1 inhibitor, demonstrated anti-tumour activity and tolerability in patients treated with sorafenib and with advanced hepatocellular carcinoma in KEYNOTE-224. Longer-term efficacy and safety after ∼2.5 years of additional follow-up are reported.Adults with confirmed hepatocellular carcinoma who experienced progression after or intolerance to sorafenib treatment received pembrolizumab 200 mg every 3 weeks for ≤35 cycles or until confirmed progression, unacceptable toxicity, withdrawal of consent or investigator decision. The primary end-point was objective response rate assessed by blinded independent central review per Response Evaluation Criteria in Solid Tumours v1.1. The secondary end-points included duration of response, disease control rate, time to progression, progression-free survival, overall survival and adverse events.Efficacy and safety were assessed in 104 patients. The median time from first dose to data cutoff was 45.1 months (range, 41.3-49.3). Objective response rate was 18.3% (95% CI: 11.4-27.1), and median duration of response was 21.0 months (range, 3.1 to 39.5+). Disease control rate was 61.5%, and median time to progression was 4.8 months (95% CI: 3.9-7.0). Median progression-free survival was 4.9 months (95% CI: 3.5-6.7) and median overall survival was 13.2 months (95% CI: 9.7-15.3). Of 104 patients, 76 (73.1%) patients reported treatment-related adverse events; most were low grade in severity (grade 3-4, n = 26 [25.0%]; grade 5, n = 1 [1.0%]). Immune-mediated hepatitis occurred in 3 patients (all grade 3). No viral-induced hepatitis flares occurred.After ∼2.5 years of additional follow-up, pembrolizumab continued to provide durable anti-tumour activity and no new safety concerns were identified.NCT02702414.
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