Phase II Clinical Trial of Neoadjuvant and Adjuvant Pembrolizumab in Resectable Local–Regionally Advanced Head and Neck Squamous Cell Carcinoma

医学 彭布罗利珠单抗 内科学 肿瘤科 头颈部鳞状细胞癌 危险系数 放射治疗 阶段(地层学) 头颈部癌 外科 癌症 置信区间 免疫疗法 生物 古生物学
作者
Trisha M. Wise‐Draper,Shuchi Gulati,Sarah Palackdharry,Benjamin H. Hinrichs,Francis P. Worden,Matthew Old,Neal E. Dunlap,John M. Kaczmar,Yash Patil,Muhammed Kashif Riaz,Alice Tang,Jonathan Mark,Chad Zender,Ann M. Gillenwater,Diana Bell,Nicky Kurtzweil,Maria Mathews,Casey L. Allen,Michelle Mierzwa,Keith Casper,Roman Jandarov,Mario Medvedovic,John Lee,Nusrat Harun,Vinita Takiar,Maura L. Gillison
出处
期刊:Clinical Cancer Research [American Association for Cancer Research]
卷期号:28 (7): 1345-1352 被引量:41
标识
DOI:10.1158/1078-0432.ccr-21-3351
摘要

Abstract Purpose: Patients with resected, local–regionally advanced, head and neck squamous cell carcinoma (HNSCC) have a one-year disease-free survival (DFS) rate of 65%–69% despite adjuvant (chemo)radiotherapy. Neoadjuvant PD-1 immune-checkpoint blockade (ICB) has demonstrated clinical activity, but biomarkers of response and effect on survival remain unclear. Patients and Methods: Eligible patients had resectable squamous cell carcinoma of the oral cavity, larynx, hypopharynx, or oropharynx (p16-negative) and clinical stage T3-T4 and/or two or more nodal metastases or clinical extracapsular nodal extension (ENE). Patients received neoadjuvant pembrolizumab 200 mg 1–3 weeks prior to surgery, were stratified by absence (intermediate-risk) or presence (high-risk) of positive margins and/or ENE, and received adjuvant radiotherapy (60–66 Gy) and concurrent pembrolizumab (every 3 weeks × 6 doses). Patients with high-risk HNSCC also received weekly, concurrent cisplatin (40 mg/m2). Primary outcome was one-year DFS. Secondary endpoints were one-year overall survival (OS) and pathologic response (PR). Safety was evaluated with CTCAE v5.0. Results: From February 2016 to October 2020, 92 patients enrolled. The median age was 59 years (range, 27–80), 30% were female, 86% had stage T3–T4, and 69% had ≥N2. At a median follow-up of 28 months, one-year DFS was 97% (95% CI, 71%–90%) in the intermediate-risk group and 66% (95% CI, 55%–84%) in the high-risk group. Patients with a PR had significantly improved one-year DFS relative to patients without response (93% vs. 72%, hazard ratio 0.29; 95% CI, 11%–77%). No new safety signals were identified. Conclusions: Neoadjuvant and adjuvant pembrolizumab increased one-year DFS rate in intermediate-risk, but not high-risk, HNSCC relative to historical control. PR to neoadjuvant ICB is a promising surrogate for DFS.
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