✦ LIBER ✦

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

✍ Scribed by 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

Publisher: John Wiley and Sons
Year: 2011
Tongue: English
Weight: 1016 KB
Volume: 33
Category: Article
ISSN: 1043-3074
DOI: 10.1002/hed.21660

No coin nor oath required. For personal study only.

✦ Synopsis

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

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