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...

Celý popis

Uložené v:
Podrobná bibliografia
Vydané v:Frontiers in immunology Ročník 16; s. 1530262
Hlavní autori: 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:English
Vydavateľské údaje: Switzerland Frontiers Media S.A 2025
Predmet:
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
On-line prístup:Získať plný text
Tagy: Pridať tag
Žiadne tagy, Buďte prvý, kto otaguje tento záznam!
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.
Bibliografia: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