Cited by 402Head and Neck Cancer StudiesCancer Immunotherapy and BiomarkersNonmelanoma Skin Cancer Studies

Randomized Phase II Trial of Nivolumab With Stereotactic Body Radiotherapy Versus Nivolumab Alone in Metastatic Head and Neck Squamous Cell Carcinoma

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McBride, Sean, Sherman, Eric, Tsai, C. Jillian, Baxi, Shrujal, Aghalar, Jahan, Eng, Juliana, Zhi, Wanqing Iris, McFarland, Daniel +11 more·2021·Journal of Clinical Oncology

Abstract

PURPOSE: The objective response rate (ORR) for single-agent anti–programmed death receptor 1 (anti–PD-1) therapy is modest in patients with metastatic or recurrent head and neck squamous cell carcinoma (HNSCC). We aimed to test whether radiotherapy may act synergistically with anti–PD-1 therapy to improve response through the abscopal effect. PATIENTS AND METHODS: We conducted a single-center, randomized, phase II trial of nivolumab (anti–PD-1 therapy) versus nivolumab plus stereotactic body radiotherapy (SBRT) in patients with metastatic HNSCC. Patients had at least two metastatic lesions: one that could be safely irradiated and one measurable by RECIST version 1.1. Patients were randomly assigned (1:1), stratified by human papillomavirus status, to nivolumab (3 mg/kg intravenously every 2 weeks) or nivolumab (same dose) plus SBRT (9 Gy × 3) to 1 lesion. The primary end point was ORR in nonirradiated lesions, which was assessed by RECIST in patients with at least one available set of on-treatment images; safety was assessed in a per-protocol population. RESULTS: Between March 11, 2016, and June 22, 2018, 62 patients were randomly assigned to nivolumab (n = 30) or nivolumab plus SBRT (n = 32). There was no statistically significant ORR difference between arms (34.5% [95% CI, 19.9% to 52.7%] v 29.0% [95% CI, 16.1% to 46.6%]; P = .86). There was no significant difference in overall survival ( P = .75), progression-free survival ( P = .79), or response duration ( P = .26). Grade 3-5 toxicities were similar (13.3% v 9.7%; P = .70). CONCLUSION: We found no improvement in response and no evidence of an abscopal effect with the addition of SBRT to nivolumab in unselected patients with metastatic HNSCC.

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Crossref · 10.1200/jco.20.00290

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Authors
McBride, S., Sherman, E., Tsai, C. J., Baxi, S., Aghalar, J., Eng, J., Zhi, W. I., McFarland, D., Michel, L. S., Young, R., Lefkowitz, R., Spielsinger, D., Zhang, Z., Flynn, J., Dunn, L., Ho, A., Riaz, N., Pfister, D., & Lee, N.
Affiliations
Memorial Sloan Kettering Cancer Center (US)
Venue
Journal of Clinical Oncology
Published
2021-01-01
Volume
39
Issue
1
Pages
30-37
ISSN
  • 0732-183X (ISSN-L)
  • 1527-7755
OpenAlex
W3080889076
Cited by
402
References
19
Citations by year
2026: 35 · 2025: 61 · 2024: 61 · 2023: 81 · 2022: 79 · 2021: 69 · 2020: 8 · 2019: 7 · 2018: 1
FWCI
47.70
Type
journal article
Language
en
Open access
Locations
  • Journal of Clinical Oncology (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Funders
National Cancer Institute (P30CA008748)
Topics
  • Health Sciences › Medicine › Otorhinolaryngology › Head and Neck Cancer Studies
  • Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
  • Health Sciences › Medicine › Epidemiology › Nonmelanoma Skin Cancer Studies
Keywords
nivolumab, stereotactic body radiotherapy, metastatic head and neck squamous cell carcinoma, anti-PD-1 therapy, abscopal effect, objective response rate, HPV status, treatment toxicity
MeSH terms
Antineoplastic Agents, Immunological, Squamous Cell Carcinoma of Head and Neck, Nivolumab, Adult, Aged, Aged, 80 and over, Combined Modality Therapy, Female, Humans, Male, Middle Aged, Neoplasm Metastasis, Radiosurgery

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