Abstract
Background: On the basis of preclinical data and phase I trials, a disease-orientated phase II trial was conducted with 4’-iodo-4’-deoxydoxorubicin (I-DOXO) in advanced and measurable non-small cell lung cancer (NSCLC). Patients and Methods: Twenty-three patients with advanced and measurable NSCLC were treated with 80 mg/m2 I-DOXO every 3 weeks. Results: Three partial remissions (13%, 95% confidence interval: 2.8-33.6%) lasting 3.5, 5, and 6.5 months, were observed. Nine patients (39%) demonstrated no change of short duration and 11 (48%) patients had progressive disease. Hematologic side effects were mild to moderate without any WHO grade 2 leuko- or thrombocyto-penia. No severe nonhematologic toxicities occurred. Conclusions: I-DOXO has only minimal efficacy in NSCLC.
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