NOVEL NEOADJUVANT IMMUNOTHERAPY REGIMEN SAFETY AND SURVIVAL IN HEAD AND NECK SQUAMOUS CELL CANCER

被引：44

作者：

Wolf, Gregory T. ^{[1
]}

Fee, Willard E., Jr. ^{[2
]}

Dolan, Robert W. ^{[3
]}

Moyer, Jeffrey S. ^{[1
]}

Kaplan, Michael J. ^{[2
]}

Spring, Paul M. ^{[4
]}

Suen, James ^{[4
]}

Kenady, Daniel E. ^{[5
]}

Newman, Jason G. ^{[6
]}

Carroll, William R. ^{[7
]}

Gillespie, M. Boyd ^{[8
]}

Freeman, Scott M. ^{[9
]}

Baltzer, Lorraine ^{[10
]}

Kirkley, Terry D. ^{[10
]}

Brandwein, Harvey J. ^{[11
]}

Hadden, John W. ^{[9
]}

机构：

[1] Univ Michigan, Dept Otolaryngol Head & Neck Surg, Ann Arbor, MI 48109 USA

[2] Stanford Univ, Med Ctr, Stanford Canc Ctr, Stanford, CA 94305 USA

[3] Lahey Clin Fdn, Med Ctr, Burlington, MA USA

[4] Univ Arkansas Med Sci, Dept Otolaryngol Head & Neck Surg, Little Rock, AR 72205 USA

[5] Univ Kentucky, Lexington, KY USA

[6] Univ Penn, Philadelphia, PA 19104 USA

[7] Univ Alabama Hosp & Clin, Dept Otolaryngol Head & Neck Surg, Birmingham, AL USA

[8] Med Univ S Carolina, Dept Otolaryngol Head & Neck Surg, Charleston, SC 29425 USA

[9] IRX Therapeut, Dept Med Affairs, New York, NY USA

[10] IRX Therapeut, Dept Clin Operat, New York, NY USA

[11] IRX Therapeut, Dept Sci Affairs, New York, NY USA

来源：

HEAD AND NECK-JOURNAL FOR THE SCIENCES AND SPECIALTIES OF THE HEAD AND NECK | 2011年 / 33卷 / 12期

关键词：

cytokine; head and neck squamous cell carcinoma; immune response; IRX-2; phase; 2; T-CELLS; CARCINOMA; INTERLEUKIN-2; STATISTICS; IMMUNITY; IRX-2;

D O I：

10.1002/hed.21660

中图分类号：

R76 [耳鼻咽喉科学];

学科分类号：

100213 ;

摘要：

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-naive 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. (C) 2011 Wiley Periodicals, Inc. Head Neck 33: 1666-1674, 2011

引用

页码：1666 / 1674

页数：9

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