PHASE-II STUDY OF 4'-IODO-4'-DEOXYDOXORUBICIN IN NONRESECTABLE NON-SMALL-CELL LUNG-CANCER

A total of 44 patients with previously untreated, non-resectable non-s mall-cell lung cancer (NSCLC) were treated with 4'-iodo-4'-deoxydoxoru bicin (IDX), which is an analogue of doxorubicin with less cardiotoxic ity. Patients received 80 mg/m2 i. v. every 3 weeks. Dose reductions w ere carried out for haematological toxicity. Response was assessed pri or to each treatment according to WHO criteria. Among the 43 evaluable patients, 1 (2%; 95% confidence limits, 0-8%) achieved a partial resp onse. Leucocytopenia of WHO grade 3 or 4 occurred in 64% of patients a nd corresponding thrombocytopenia grade 3 or 4 occurred in 30%. Of the 26 patients who were evaluated by measurements of the left ventricula r ejection fraction (LVEF), 4 had a decline in LVEF of more than 15%, and 2 patients developed congestive heart failure. Myocardial biopsies were not done. In conclusion, IDX is not active in NSCLC at the appli ed dose and on the schedule used. Moreover, it does not seem possible to increase the dose intensity further due to the observed toxicity.