https://orcid.org/0000-0003-1548-9753
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Abstract
Effective treatments for advanced/recurrent head and neck squamous-cell carcinoma are limited. For cases not curable by conventional local therapies, the immune checkpoint inhibitor pembrolizumab shows modest response rates. Quad-shot, a hypofractionated palliative radiotherapy regimen (14.8 Gy in four twice-daily fractions), can provide symptomatic relief, contributes to local control and may potentiate the effects of immune checkpoint inhibitors. In this study, 15 patients with advanced/recurrent head and neck squamous-cell carcinoma will be treated with pembrolizumab combined with up to three administrations of quad-shot before cycles four, eight and 13. Outcomes include disease response, survival and treatment toxicity. Correlative multiomics analysis of blood and saliva will identify molecular biomarkers of response to immune checkpoint inhibitor and the immune-related impact of quad-shot.Clinical trial registration: This study (WFBCCC 60320) is registered on NCT04454489 (ClinicalTrials.gov)
Plain language summary
Advanced and recurrent head and neck cancers are difficult to treat. Most patients receive systemic therapies, such as chemotherapy or immunotherapy, with modest rates of cancer control. We aim to test the effectiveness of an immunotherapy drug called pembrolizumab in combination with a type of low-dose radiation therapy called quad-shot. Patients will receive pembrolizumab every 3 weeks and will be treated with one to three low-dose radiation therapy courses targeted at their cancer in the head and neck approximately every 12 weeks. We plan to measure how well the cancer responds to treatment, how long this response lasts, how long patients survive and treatment side effects.
Tweetable abstract
In a pilot study, 15 advanced/recurrent head and neck squamous-cell carcinoma patients will be treated with pembrolizumab plus quad-shot hypofractionated palliative radiotherapy. Response, survival and toxicity will be measured.
Author contributions
Conception, design, drafting, revision, approval, agreement: RT Hughes, TW Lycan, BA Frizzell, PM Bunch and M Porosnicu. Design, drafting, revision, approval, agreement: RR Gebeyehu and JM Kalada. Design, revision, approval, agreement: RD Kinney. Conception, design, revision, approval, agreement: RB D’Agostino, P Triozzi, W Zhang and CM Furdui.
Disclosure
The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute.
Financial & competing interests disclosure
This clinical study is supported and funded by the National Cancer Institute’s Cancer Center Support Grant (award No. P30CA012197). The authors wish to acknowledge the support of the Wake Forest Baptist Comprehensive Cancer Center Bioinformatics Shared Resource and the Clinical Protocol and Data Management Shared Resource, supported by the National Cancer Institute’s Cancer Center Support Grant (award No. P30CA012197). This work was also supported by an Association of University Radiologists GE Radiology Research Academic Fellowship awarded to PM Bunch. M Porosnicu received clinical research support from Boehringer Ingelheim, AstraZeneca, Eli Lilly, Astellas Pharma and Sanofi-Aventis. M Porosnicu is also a consultant for Boehringer Ingelheim. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
No writing assistance was utilized in the production of this manuscript.
Ethical conduct of research
The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.