Treatment of inoperable non-small cell carcinoma of the lung with radiation therapy, with or without levamisole

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Abstract
In a randomized trial, 251 patients with inoperable non-small cell lung cancer received radiation therapy (RT) with or without levamisole (2.5 mg/kg twice weekly for 1 yr, or until progression). Radiation therapy was delivered to 6000-6500 rad for Stages I and II, and 4000-4500 rad by continuous or split course for Stage III disease. Responses were observed in 40% of patients receiving placebo, and in 29% of patients taking levamisole. Relapse occurred at local sites only in 53% of the placebo- and 75% of the levamisole-treated patients. The frequency of relapse in distant sites was lower (25%) in the levamisole group as compared with the placebo group (47%). No significant difference in survival was observed between the placebo and levamisole-treated groups (median survival, 48.2 and 45 wk, respectively). Responders to radiotherapy survived significantly longer than nonresponders (median survival, 73 vs. 33.3 wk, P = 0.001). Among responders, the median survival of patients treated with levamisole was shorter (63.9 wk) than that of patients receiving placebo (92.7 wk). Toxicity attributable to levamisole included severe granulocytopenia in 5 patients and severe nausea and vomiting in 9. Levamisole is without significant benefit in this setting.