Phase II trial of prednimustine (NSC-134087) in the treatment of small-cell anaplastic carcinoma of the lung.

In a phase II trial, the clinical activity of prednimustine, an ester of chlorambucil and prednisolone, was evaluated in 28 patients with small-cell anaplastic carcinoma of the lung. Prednimustine was given at dose levels ranging from 130 to 220 mg/m2/daily for 5 days every 3 weeks. Among 19 previously treated patients no responses were observed, while responses of 2, 2, and 3 months' duration were seen in three of nine previously untreated patients more than 70 years old. The toxicity took the form of mental disturbances in six patients, while the hematologic toxicity was mild. The therapeutic effectiveness of prednimustine in small-cell carcinoma of the lung is thus limited although some activity is observed in previously untreated patients.