Limited squamous cell carcinoma of the lung: a Southwest Oncology Group randomized study of radiation with or without doxorubicin chemotherapy and with or without levamisole immunotherapy.

In 1976, the Southwest Oncology Group activated a four-arm randomized study of limited squamous cell carcinoma of the lung. The purpose of this study was to determine if doxorubicin and/or levamisole added to radiation therapy improved the local control rate and survival in patients with limited squamous cell carcinoma of the lung. Of the 107 eligible patients, 15 (14%) had complete responses and 20 (19%) had partial responses. When compared by chemotherapy, immunotherapy, and performance status, no statistically significant difference was found in response rates or in survival. Although not statistically significant, the survival and response rates of patients in the combined levamisole arms were shorter than those of patients in the combined arms not containing levamisole. Patients receiving radiation therapy alone had the best survival. The irradiated field was the site of failure in 68 (88%) of the 77 patients in whom the site of failure was specified. Fifty (65%) of the patients failed in the radiation therapy field only. Chemotherapy and/or immunotherapy as employed in this protocol were of no benefit.