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

Academic Article


  • 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-na├»ve 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.
  • Published In


  • Adult, Aged, Antineoplastic Agents, Carcinoma, Squamous Cell, Cyclophosphamide, Cytokines, Disease-Free Survival, Drug Administration Schedule, Female, Gluconates, Head and Neck Neoplasms, Humans, Immunotherapy, Indomethacin, Injections, Subcutaneous, Interferon-gamma, Interleukin-1beta, Interleukin-2, Male, Middle Aged, Neoadjuvant Therapy, Survival Rate, Tumor Necrosis Factor-alpha
  • Digital Object Identifier (doi)

    Author List

  • Wolf GT; Fee WE; Dolan RW; Moyer JS; Kaplan MJ; Spring PM; Suen J; Kenady DE; Newman JG; Carroll WR
  • Start Page

  • 1666
  • End Page

  • 1674
  • Volume

  • 33
  • Issue

  • 12