期刊
CLINICAL CANCER RESEARCH
卷 28, 期 7, 页码 1345-1352出版社
AMER ASSOC CANCER RESEARCH
DOI: 10.1158/1078-0432.CCR-21-3351
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资金
- Merck Sharp Dohme Corp.
- National Institutes of Health/Translational Science Award KL2 [TR001426]
- American Cancer Society [RSG-19-111-01-CCE]
- Wiltse family
- Office of the Assistant Secretary of Defense for Health Affairs, through the Peer Reviewed Cancer Research Program [W81XWH-17-1-0377]
- Center for Clinical and Translational Science [2UL1TR001425-05A1]
- Career Development Award from the United States Department of Veterans Affairs Biomedical Laboratory Research and Development Service [IK2 BX004360]
- National Center for Advancing Translational Sciences of the National Institutes of Health [2KL2TR001426-05A1]
- ASCO Conquer Cancer Foundation Career Development Award
The study investigates the clinical activity and survival impact of neoadjuvant pembrolizumab in patients with head and neck squamous cell carcinoma. The results show a significant improvement in one-year disease-free survival rate for intermediate-risk patients, while no significant improvement was observed for high-risk patients.
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 x 6 doses). Patients with high-risk HNSCC also received weekly, concurrent cisplatin (40 mg/m(2)). 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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