Journal
HEAD AND NECK-JOURNAL FOR THE SCIENCES AND SPECIALTIES OF THE HEAD AND NECK
Volume 33, Issue 12, Pages 1666-1674Publisher
WILEY-BLACKWELL
DOI: 10.1002/hed.21660
Keywords
cytokine; head and neck squamous cell carcinoma; immune response; IRX-2; phase 2
Categories
Funding
- IRX Therapeutics
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Background. Cellular immune suppression is observed in head and neck squamous cell cancer (HNSCC) and contributes to poor prognosis. Restoration of immune homeostasis may require primary cell-derived cytokines at physiologic doses. An immunotherapy regimen containing a biologic, with multiple-active cytokine components, and administered with cytoxan, zinc, and indomethacin was developed to modulate cellular immunity. Methods. Study methods were designed to determine the safety and efficacy of a 21-day neoadjuvant immunotherapy regimen in a phase 2 trial that enrolled 27 therapy-naive patients with stage II to IVa HNSCC. Methods included safety, clinical and radiologic tumor response, disease-free survival (DFS), overall survival (OS), and tumor lymphocytic infiltrate (LI) data collection. Results. Acute toxicity was minimal. Patients completed neoadjuvant treatment without surgical delay. By independent radiographic review, 83% had stable disease during treatment. OS was 92%, 73%, and 69% at 12, 24, and 36 months, respectively. Histologic analysis suggested correlation between survival and tumor LI. Conclusion. Immunotherapy regimen was tolerated. Survival results are encouraging. (C) 2011 Wiley Periodicals, Inc. Head Neck 33: 1666-1674, 2011
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