Novel neoadjuvant immunotherapy regimen safety and survival in head and neck squamous cell cancer
Gregory T Wolf, Willard E Fee Jr, Robert W Dolan, Jeffrey S Moyer, Michael J Kaplan, Paul M Spring, James Suen, Daniel E Kenady, Jason G Newman, William R Carroll, M Boyd Gillespie, Scott M Freeman, Lorraine Baltzer, Terry D Kirkley, Harvey J Brandwein, John W Hadden, Gregory T Wolf, Willard E Fee Jr, Robert W Dolan, Jeffrey S Moyer, Michael J Kaplan, Paul M Spring, James Suen, Daniel E Kenady, Jason G Newman, William R Carroll, M Boyd Gillespie, Scott M Freeman, Lorraine Baltzer, Terry D Kirkley, Harvey J Brandwein, John W Hadden
Abstract
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-naïve 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.
Copyright © 2011 Wiley Periodicals, Inc.
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Source: PubMed