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Clinical Trial
. 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

Gregory T Wolf  1 , 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
Affiliations
Clinical Trial

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

Gregory T Wolf et al. Head Neck. 2011 Dec.

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.

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Figures

FIGURE 1
FIGURE 1
Central diagnostic radiology assessment of target lesions using modified Response Evaluation Criteria in Solid Tumors (RECIST) at 3 weeks (percent change from baseline). One patient was adjudged by the central reviewer to be a complete response. CT/MRI of this site showed a −17.2% change (bar with diagonal stripes), which was in concurrence with the pathology report.
FIGURE 2
FIGURE 2
Fluorodeoxyglucose-positron emission tomography (FDG-PET) CT scan at baseline and before surgery at the completion of immunotherapy regimen (IRX-2) therapy.
FIGURE 3
FIGURE 3
Disease-free survival from date of surgery.
FIGURE 4
FIGURE 4
Overall survival from date of surgery.
FIGURE 5
FIGURE 5
Overall survival – high lymphocytic infiltrate (LI) versus low LI. Immunotherapy regimen (IRX-2).
See this image and copyright information in PMC

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