PHASE-2 STUDY OF PROLONGED ADMINISTRATION OF ORAL ETOPOSIDE IN COMBINATION WITH WEEKLY CISPLATIN IN ADVANCED NONSMALL CELL LUNG-CANCER

We administered chemotherapy consisting of a 21-day course of oral eto poside (50 mg/m(2)/day) and a 3-weekly dose of cisplatin (30-33 mg/m(2 )/week) to 23 chemotherapy-naive patients with advanced non-small cell lung cancer (NSCLC). Six patients achieved a partial response (28.6%; 95% confidence interval, 11.3-52.2%), with a median response duration of 4 months and a median overall survival of 5 months. Besides alopec ia, myelosuppression was the most significant drug-related toxicity. O bserved side effects in 59 cycles of chemotherapy were granulocytopeni a (<1,000/mu l) in 23% of the treatment cycles, thrombocytopenia (<75, 000/mu l) in 25%, anemia (<10 g/dl) in 64%, and nausea-vomiting (grade s greater than or equal to 2) in 8%. Mild renal insufficiency (serum c reatinine, 1.5-2.1 mg/dl) occurred in six patients. Three toxic deaths were observed during or immediately after cycle 1, and were related t o granulocytopenia. We conclude that this regimen has modest activity in advanced NSCLC; but this therapeutic approach does not appear to pr oduce a major improvement in the treatment of this disease. Thus, in a dvanced NSCLC, continued evaluation of new chemotherapeutic agents sho uld remain the major emphasis of investigational therapy.