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Randomized Phase II Trial of Nivolumab With Stereotactic Body Radiotherapy Versus Nivolumab Alone in Metastatic Head and Neck Squamous Cell Carcinoma
Open accessAbstract
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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“However, in the phase 2 study NCT02684253, SBRT combined with nivolumab was not superior to nivolumab in response rate, PFS, and OS in advanced HNSCC [85].”
From Combination strategies with PD-1/PD-L1 blockade: current advances and future directions (2022) · cites this paper as [85]
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Metadata
- 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)
- ORCID
- Venue
- Journal of Clinical Oncology
- Published
- 2021-01-01
- Volume
- 39
- Issue
- 1
- Pages
- 30-37
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- PMC
- PMC8462641
- OpenAlex
- W3080889076
- Cited by
- 402
- References
- 19
- Citations by year
- 2026: 35 · 2025: 61 · 2024: 61 · 2023: 81 · 2022: 79 · 2021: 69
- FWCI
- 47.70
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- 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 › Dermatology › 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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