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Novel neoadjuvant immunotherapy regimen safety and survival in head and neck squamous cell cancer
Author(s) -
Wolf Gregory T.,
Fee Willard E.,
Dolan Robert W.,
Moyer Jeffrey S.,
Kaplan Michael J.,
Spring Paul M.,
Suen James,
Kenady Daniel E.,
Newman Jason G.,
Carroll William R.,
Gillespie M. Boyd,
Freeman Scott M.,
Baltzer Lorraine,
Kirkley Terry D.,
Brandwein Harvey J.,
Hadden John W.
Publication year - 2011
Publication title -
head and neck
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.012
H-Index - 127
eISSN - 1097-0347
pISSN - 1043-3074
DOI - 10.1002/hed.21660
Subject(s) - medicine , regimen , immunotherapy , oncology , head and neck cancer , radiation therapy , immune system , cancer , immunology
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. © 2011 Wiley Periodicals, Inc. Head Neck, 2011