Phase II study of idarubicin in extensive-disease non-small-cell lung cancer.

Fourteen patients with extensive-disease non-small-cell lung cancer (E-NSCLC) were treated with oral 4-demethoxydaunorubicin (idarubicin, 4DMDR) at a dosage of 10 mg/m2/day x 5 days every 3 weeks. The median cumulative dose was 110 mg/m2 (range: 50-1,100). Two patients had stable disease for 12 and 56 weeks, respectively, one patient had failed to respond to a doxorubicin hydrochloride (Adriamycin)-containing regimen, and one had had no prior therapy. Twelve of the 14 patients had prior radiotherapy, chemotherapy, or both. Median survival for this heavily treated group was 16 weeks. Myelosuppression was minimal. Nausea and vomiting occurred in 44% of all courses. No cardiac toxicity and no decrease in cardiac ejection fraction was observed. We conclude that 4DMDR is ineffective in heavily treated E-NSCLC patients. However, the drug's activity in untreated patients is unknown. Further study of 4DMDR is indicated in patients who have had no prior chemotherapy or radiotherapy, with routine administration of antiemetic drugs along with pharmacokinetic studies.