Pilot clinical trial of neoadjuvant toll-like receptor 7 agonist (Imiquimod) immunotherapy in early-stage oral squamous cell carcinoma

There is no neoadjuvant immunotherapy for early-stage oral cancer patients. We report a single-arm, open-label, pilot clinical trial assessing the efficacy and safety of topical toll-like receptor-7 (TLR-7) agonist, imiquimod, utilized in a neoadjuvant setting in early-stage oral squamous cell carci...

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Vydáno v:	Frontiers in immunology Ročník 16; s. 1530262
Hlavní autoři:	Yoon, Angela J., Carvajal, Richard D., Graboyes, Evan M., Kaczmar, John M., Albergotti, William G., Kejner, Alexandra E., Troob, Scott H., Philipone, Elizabeth, Anoma, Jean-Sebastien, Armeson, Kent E., Hill, Elizabeth G., Richardson, Mary S., Woods, Tina R., Chera, Bhishamjit S., Nourollah-Zadeh, Farzad, Lee, Byung J., Pandruvada, Subramanya, Kourtidis, Antonis, Kingsley, Christina, O’Quinn, Elizabeth C., Mills, Stephanie, Jordan, Victoria C., Spencer, Mike, Fails, Danielle, McKee, Trevor D., Zaidi, Mark, Brisendine, Alan, Horn, Shane, Mehrotra, Shikhar, Ogretmen, Besim, Newman, Jason G.
Médium:	Journal Article
Jazyk:	angličtina
Vydáno:	Switzerland Frontiers Media S.A 2025
Témata:	Adult Aged Female Humans imiquimod Imiquimod - administration & dosage Imiquimod - adverse effects Imiquimod - therapeutic use Immunology immunotherapy Immunotherapy - methods Male Middle Aged Mouth Neoplasms - drug therapy Mouth Neoplasms - immunology Mouth Neoplasms - pathology neoadjuvant clinical trial Neoadjuvant Therapy Neoplasm Staging oral cancer Pilot Projects toll-like 7 receptor agonist Toll-Like Receptor 7 - agonists Treatment Outcome neoadjuvant clinical trial toll-like 7 receptor agonist oral cancer imiquimod immunotherapy
ISSN:	1664-3224, 1664-3224
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Popis
Shrnutí:	There is no neoadjuvant immunotherapy for early-stage oral cancer patients. We report a single-arm, open-label, pilot clinical trial assessing the efficacy and safety of topical toll-like receptor-7 (TLR-7) agonist, imiquimod, utilized in a neoadjuvant setting in early-stage oral squamous cell carcinoma (OSCC). The primary endpoint is reduction in tumor cell counts assessed by quantitative multiplex immunofluorescence and the immune-related pathologic response. The secondary endpoint is safety. 60% of patients experienced a 50% reduction or greater in tumor cell count post-treatment (95% CI = 32% to 84%). Similarly, 60% of patients had immune-related major pathologic response (irMPR) with two complete pathologic responses, and 40% had partial response (PR) with the percent residual viable tumor ranging from 25% to 65%. An increase in functional helper and cytotoxic T-cells significantly contributed to a reduction in tumor (R=0.54 and 0.55, respectively). The treatment was well tolerated with the application site mucositis being the most common adverse event (grades 1-3), and no grade 4 life-threatening event. The median follow-up time was 17 months (95% CI = 16 months - not reached), and one-year recurrence-free survival was 93% of evaluable patients. Neoadjuvant imiquimod immunotherapy could be safe and promising regimen for early-stage oral cancer. ClinicalTrials.gov, Identifier NCT04883645.
Bibliografie:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 Reviewed by: Dainius Characiejus, Vilnius University, Lithuania Edited by: Souvick Roy, University of California, San Diego, United States Ramireddy Bommireddy, Emory University, United States
ISSN:	1664-3224 1664-3224
DOI:	10.3389/fimmu.2025.1530262