The DOI matches its Crossref record; 19 of the 19 references it cites were found in a registry or an index.
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.
Overview
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
In the citing paper
“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]
Citations
Cites
New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1)
Eisenhauer, E. A., Therasse, P., Bogaerts, J., Schwartz, L. H., Sargent, D., Ford, R., Dancey, J., Arbuck, S., Gwyther, S., Mooney, M., et al. (2009) · European Journal of Cancer · doi:10.1016/j.ejca.2008.10.026 · Cited by 29,534
Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck
Ferris, R. L., Blumenschein, G., Fayette, J., Guigay, J., Colevas, A. D., Licitra, L., Harrington, K., Kasper, S., Vokes, E. E., Even, C., et al. (2016) · New England Journal of Medicine · doi:10.1056/nejmoa1602252 · Cited by 5,101
Tumor mutational load predicts survival after immunotherapy across multiple cancer types
Samstein, R. M., Lee, C.-H., Shoushtari, A. N., Hellmann, M. D., Shen, R., Janjigian, Y. Y., Barron, D. A., Zehir, A., Jordan, E. J., Omuro, A., et al. (2019) · Nature Genetics · doi:10.1038/s41588-018-0312-8 · Cited by 4,071
Self-citationBurtness, B., Harrington, K. J., Greil, R., Soulières, D., Tahara, M., de Castro, G., Psyrri, A., Basté, N., Neupane, P., Bratland, Å., et al. (2019) · The Lancet · doi:10.1016/s0140-6736(19)32591-7 · Cited by 3,336
Deng, L., Liang, H., Xu, M., Yang, X., Burnette, B., Arina, A., Li, X.-D., Mauceri, H., Beckett, M., Darga, T., et al. (2014) · Immunity · doi:10.1016/j.immuni.2014.10.019 · Cited by 2,182
Palma, D. A., Olson, R. A., Harrow, S., Gaede, S., Louie, A. V., Haasbeek, C. J. A., Mulroy, L. A., Lock, M. I., Rodrigues, G., Yaremko, B., et al. (2019) · The Lancet · doi:10.1016/s0140-6736(18)32487-5 · Cited by 1,879
Cohen, E. E. W., Soulières, D., Tourneau, C. L., Dinis, J., Licitra, L. F., Ahn, M., Soria, A., Machiels, J., Mach, N., Mehra, R., et al. (2018) · The Lancet · doi:10.1016/s0140-6736(18)31999-8 · Cited by 1,737
Using immunotherapy to boost the abscopal effect
Ngwa, W., Irabor, O. C., Schoenfeld, J. D., Hesser, J., Demaria, S., & Formenti, S. C. (2018) · Nature Reviews Cancer · doi:10.1038/nrc.2018.6 · Cited by 1,260
Theelen, W. S. M. E., Peulen, H. M. U., Lalezari, F., van der Noort, V., de Vries, J. F., Aerts, J. G. J. V., Dumoulin, D. W., Bahce, I., Niemeijer, A.-L. N., de Langen, A. J., et al. (2019) · JAMA Oncology · doi:10.1001/jamaoncol.2019.1478 · Cited by 1,020
Radiotherapy induces responses of lung cancer to CTLA-4 blockade
Formenti, S. C., Rudqvist, N.-P., Golden, E., Cooper, B., Wennerberg, E., Lhuillier, C., Vanpouille-Box, C., Friedman, K., Ferrari de Andrade, L., Wucherpfennig, K. W., et al. (2018) · Nature Medicine · doi:10.1038/s41591-018-0232-2 · Cited by 928
Flagged first, then by citations
Cited by
Sorted by citations
Items 401–402 of 402
Hurt, C. N., Park, S., Chambers, J., Brammer, C., Griffin, M., Harilal, V., Stone, R., Haris, P. A., Shakir, R., Karsera, L., et al. (2026) · International Journal of Cancer · doi:10.1002/ijc.70802
Spindler, N. J., Eefsen, R. L., Persson, G. F., Nielsen, D. L., & Juhl, C. B. (2026) · Clinical and Translational Radiation Oncology · doi:10.1016/j.ctro.2026.101328
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
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
