Phase II study of mitoxantrone in patients with non-small cell lung cancer.

A phase II study of mitoxantrone was performed in 24 patients with non-small cell lung cancer (NSCLC). Mitoxantrone was administered by intravenous drip infusion of 12 mg/m2 every three weeks. There were no responders among the 21 evaluable patients including five patients without prior therapy. The major hematological toxic effect was leukocytopenia. Thrombocytopenia and decrease in hemoglobin were slight. A change in the electrocardiogram was observed in one patient and one patient experienced cardiogenic shock. Mitoxantrone is not acceptable for the treatment of NSCLC because of its low antitumor activity, and careful observation is needed for administration of this agent to patients with pre-existing risk factors, such as prior anthracycline exposure, mediastinal radiation or underlying cardiovascular disease.