Methotrexate alone or with regional subcutaneous corynebacterium parvum in the treatment of recurrent and metastatic squamous cancer of the head and neck

Patients with advanced, incurable squamous cancer of the head and neck were randomly assigned to treatment with weekly methotrexate alone or methotrexate with Corynebacterium parvum given subcutaneously in weekly bilateral doses in sites around the neck. The addition of C. parvum did not alter the response rate, response duration, survival (either median or long-term) or severity of toxic effects compared to treatment with methotrexate alone. Response rates were higher for patients without distant metastases, ambulatory patients, and those younger than age 65 years. Median survival was improved for responders to chemotherapy and for those initially ambulatory. C. parvum given subcutaneously has no place in the treatment of far advanced cancer of the head and neck.