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Head Neck. 2011 Dec;33(12):1666-74. doi: 10.1002/hed.21660. Epub 2011 Jan 31.

Novel neoadjuvant immunotherapy regimen safety and survival in head and neck squamous cell cancer.

Author information

1
Department of Otolaryngology-Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan, USA. gregwolf@umich.edu

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.

PMID:
21284052
PMCID:
PMC4062188
DOI:
10.1002/hed.21660
[Indexed for MEDLINE]
Free PMC Article
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