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Cited by 116Head and Neck Cancer StudiesCancer Immunotherapy and BiomarkersEndometrial and Cervical Cancer Treatments

Safety and Efficacy of Pembrolizumab With Chemoradiotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma: A Phase IB Study

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Powell, Steven F., Gold, Kathryn A., Gitau, Mark M., Sumey, Christopher J., Lohr, Michele M., McGraw, Steven C., Nowak, Ryan K., Jensen, Ashley W. +10 more·2020·Journal of Clinical Oncology
DOI 10.1200/jco.19.03156PMC PMC7365766
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Abstract

PURPOSE: Pembrolizumab is a humanized monoclonal antibody that blocks interaction between programmed death receptor-1 (PD-1) and its ligands (PD-L1, PD-L2). Although pembrolizumab is approved for recurrent/metastatic head and neck squamous cell carcinoma (HNSCC), its role in the management of locally advanced (LA) disease is not defined. We report a phase IB study evaluating the safety and efficacy of adding pembrolizumab to cisplatin-based chemoradiotherapy in patients with LA HNSCC. PATIENTS AND METHODS: Eligible patients included those with oral cavity (excluding lip), oropharyngeal, hypopharyngeal, or laryngeal stage III to IVB HNSCC (according to American Joint Committee on Cancer, 7th edition, staging system) eligible for cisplatin-based, standard-dose (70 Gy) chemoradiotherapy. Pembrolizumab was administered concurrently with and after chemoradiotherapy with weekly cisplatin. Safety was the primary end point and was determined by incidence of chemoradiotherapy adverse events (AEs) and immune-related AEs (irAEs). Efficacy was defined as complete response (CR) rate on end-of-treatment (EOT) imaging or with pathologic confirmation at 100 days postradiotherapy completion. Key secondary end points included overall (OS) and progression-free survival (PFS). RESULTS: The study accrued 59 patients (human papillomavirus [HPV] positive, n = 34; HPV negative, n = 25) from November 2015 to October 2018. Five patients (8.8%) required discontinuation of pembrolizumab because of irAEs, all of which occurred during concurrent chemoradiotherapy; 98.3% of patients completed the full planned treatment dose (70 Gy) of radiotherapy without any delays ≥ 5 days; 88.1% of patients completed the goal cisplatin dose of ≥ 200 mg/m 2. EOT CR rates were 85.3% and 78.3% for those with HPV-positive and -negative HNSCC, respectively. CONCLUSION: Pembrolizumab in combination with weekly cisplatin-based chemoradiotherapy is safe and does not impair delivery of curative radiotherapy or chemotherapy in HNSCC. Early efficacy data support further investigation of this approach.

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  • α-PD-1/PD-L1 plus chemoradiotherapy was tolerable in advanced NSCLC, HNSCC, and SCLC patients, with promising clinical outcomes, in phase 1/2 studies.

    “Moreover, the results of some phase 1/2 studies (NCT02621398, NCT02434081, NCT02586207, NCT02383212, and NCT02402920) showed that α-PD-1/PD-L1 plus chemoradiotherapy was tolerable in advanced NSCLC, head and neck squamous cell carcinoma (HNSCC), and SCLC patients, with promising clinical outcomes [78–82].”

    From Combination strategies with PD-1/PD-L1 blockade: current advances and future directions (2022) · cites this paper as [79]

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Authors
Powell, S. F., Gold, K. A., Gitau, M. M., Sumey, C. J., Lohr, M. M., McGraw, S. C., Nowak, R. K., Jensen, A. W., Blanchard, M. J., Fischer, C. D., Bykowski, J., Ellison, C. A., Black, L. J., Thompson, P. A., Callejas-Valera, J. L., Lee, J. H., Cohen, E. E. W., & Spanos, W. C.
Affiliations
  • Sanford Health (US)
  • University of California San Diego (US)
  • Sanford Medical Center (US)
  • Sanford Research, Sanford Health, Sioux Falls, SD
  • ImmunityBio (United States) (US)
ORCID
Venue
Journal of Clinical Oncology
Publisher
American Society of Clinical Oncology (ASCO)
Published
2020-07-20
Volume
38
Issue
21
Pages
2427-2437
ISSN
  • 0732-183X (ISSN-L)
  • 1527-7755
DOI
10.1200/jco.19.03156
PMC
PMC7365766
OpenAlex
W3029965317
Cited by
116
References
33
Citations by year
2026: 4 · 2025: 10 · 2024: 17 · 2023: 19 · 2022: 29 · 2021: 30 · 2020: 7
FWCI
17.13
Type
journal article
Language
en
Open access
Locations
  • Journal of Clinical Oncology (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
  • eScholarship (California Digital Library) (submittedVersion)
Funders
  • National Cancer Institute (P30CA023100)
  • National Institute of General Medical Sciences (P20GM103548)
  • National Institute of Dental and Craniofacial Research (R01DE026125, R01DE029524)
Topics
  • Health Sciences › Medicine › Otorhinolaryngology › Head and Neck Cancer Studies
  • Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
  • Health Sciences › Medicine › Obstetrics and Gynecology › Endometrial and Cervical Cancer Treatments
Keywords
pembrolizumab, head and neck squamous cell carcinoma, locally advanced disease, chemoradiotherapy, cisplatin, immune checkpoint inhibitors, PD-1/PD-L1 blockade, immune-related adverse events, HPV status, complete response, treatment safety, oral cancer, oropharyngeal cancer, hypopharyngeal cancer, laryngeal cancer, concurrent immunotherapy
MeSH terms
Antineoplastic Agents, Immunological, Squamous Cell Carcinoma of Head and Neck, Adult, Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, Retrospective Studies, Chemoradiotherapy, Antibodies, Monoclonal, Humanized

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