A Randomized Trial of Adjuvant BCG Immunotherapy in Head and Neck Cancer

Abstract

\s=b\ Fifty-two patients with locally advanced squamous cell cancer were entered into a randomized trial of BCG vaccine following definitive local therapy.Patients were stratified and randomized to receive BCG vaccine (25 patients) or no adjuvant immunotherapy (27 patients). The BCG vaccine therapy began two weeks following definitive therapy with 2 to 4 \m=x\106 Tice strain BCG organisms given intradermally (ID) in alternating sides of the neck every two weeks six times, then every four weeks nine times. In addition, all patients received methotrexate prior to definitive therapy. Median duration of follow-up at the time of analysis was 41 months. Groups were balanced by sex, disease site and stage, histologic grade, and prior therapy. Thirteen (52%) of the BCG vaccine-treated group remain disease free v seven (26%) of the controls. Similarly, 17 (68%) of the BCG vaccine-treated group survived v 11 (41%) of the controls. We conclude regional ID BCG vaccine increases disease-free and actuarial survival in this study population and adjuvant immunotherapy should be further explored in ear, nose, and throat cancer.

Adjuvant corynebacterium parvum immunotherapy for squamous cell epitheliomas of the oral cavity, pharynx, and larynx

“…The only other randomized trial of immunotherapy in patients with head and neck cancer was reported by Taylor et a1 [26]. They randomized patients to either observation or intradermal BCG following definitive therapy and demonstrated a slightly increased diseasefree and overall survival.…”

Gene Therapy for the Treatment of Oral Squamous Cell Carcinoma

“…Patients with squamous cell carcinoma of the head and neck demonstrate deficient function of several categories of immune cells, including natural killer cells, T-lymphocytes, and several cytokines (Gleich, 2000). Early attempts to enhance the immune response with bacillus Calmette-Guerin, either alone or in combination with methotrexate, demonstrated limited benefit (Papac et al, 1978;Taylor et al, 1983). Although oral cancer is not classically immunogenic, there is abundant evidence for immune recognition.…”

Gene Therapy for Head and Neck Cancer

“…Trials of BCG therapy frequently combined BCG with methotrexate and demonstrated minimal benefits. 122–125 More recent immune therapy studies used the cytokine interleukin (IL)‐2. IL‐2 is produced by activated T lymphocytes and stimulates the activity of both T and NK cells.…”