Methotrexate compared with placebo in lung cancer

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Abstract
Two hundred thirty‐nine patients with microscopically proven, inoperable bronchogenic carcinoma were allocated at random to receive twice weekly I.M. injections of either methotrexate at “high dose” of 0.6 mg/kg/dose or methotrexate at “low dose” of 0.2 mg/kg or visually indistinguishable placebo in the same volume of 0.1 ml/kg for four months. Twelve patients were invalidated for procedural reasons. Objective response (50% tumor regression) was dose‐related with 21% of 48 patients with measurable disease on high dose, 11% of 37 patients on low dose, and 6% of 32 patients on placebo. Corresponding response rates for epidermoid carcinoma were 35% of 23 patients, 9% of 11 patients, and 0 of 13 patients. Responders in the two treatment groups had a three to four fold increase of median survival (p < .05). Non‐responders on high and low dose methotrexate lived as long as patients on placebo. Leukopenic patients in all three treatment groups lived substantially longer than patients without leukopenia < 4,500/mm3, irrespective of presence or absence of objective response. All three regimens were well tolerated. None of the patients had life‐threatening toxicity. It is concluded that methotrexate at “high dose” is a potentially useful drug for temporary palliation of epidermoid carcinoma of the lung. Cancer 40:4–8, 1977.