医学
西妥昔单抗
彭布罗利珠单抗
内科学
不利影响
肿瘤科
头颈部癌
耐火材料(行星科学)
人口
无进展生存期
临床研究阶段
实体瘤疗效评价标准
进行性疾病
癌症
外科
化疗
免疫疗法
结直肠癌
物理
环境卫生
天体生物学
作者
Joshua Bauml,Tanguy Y. Seiwert,David G. Pfister,Francis P. Worden,Stephen V. Liu,Jill Gilbert,Nabil F. Saba,Jared Weiss,Lori J. Wirth,Ammar Sukari,Hyunseok Kang,Michael K. Gibson,Erminia Massarelli,Steven Powell,Amy Meister,Xinxin Shu,Jonathan D. Cheng,Robert I. Haddad
标识
DOI:10.1200/jco.2016.70.1524
摘要
Purpose There are no approved treatments for recurrent/metastatic head and neck squamous cell carcinoma refractory to platinum and cetuximab. In the single-arm, phase II KEYNOTE-055 study, we evaluated pembrolizumab, an anti-programmed death 1 receptor antibody, in this platinum- and cetuximab-pretreated population with poor prognosis. Methods Eligibility stipulated disease progression within 6 months of platinum and cetuximab treatment. Patients received pembrolizumab 200 mg every 3 weeks. Imaging was performed every 6 to 9 weeks. Primary end points: overall response rate (Response Evaluation Criteria in Solid Tumors v1.1, central review) and safety. Efficacy was assessed in all dosed patients and in subgroups on the basis of programmed death ligand 1 (PD-L1) expression and human papillomavirus (HPV) status. Results Among 171 patients treated, 75% received two or more prior lines of therapy for metastatic disease, 82% were PD-L1 positive, and 22% were HPV positive. At the time of analysis, 109 patients (64%) experienced a treatment-related adverse event; 26 patients (15%) experienced a grade ≥ 3 event. Seven patients (4%) discontinued treatment, and one died of treatment-related adverse events. Overall response rate was 16% (95% CI, 11% to 23%), with a median duration of response of 8 months (range, 2+ to 12+ months); 75% of responses were ongoing at the time of analysis. Response rates were similar in all HPV and PD-L1 subgroups. Median progression-free survival was 2.1 months, and median overall survival was 8 months. Conclusion Pembrolizumab exhibited clinically meaningful antitumor activity and an acceptable safety profile in recurrent/metastatic head and neck squamous cell carcinoma previously treated with platinum and cetuximab.
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