PHASE-II STUDY OF TOPOTECAN IN PATIENTS WITH ADVANCED NON-SMALL-CELL LUNG-CANCER PREVIOUSLY UNTREATED WITH CHEMOTHERAPY

Purpose: This study was designed to assess the antitumor activity of t opotecan (TPT) in patients with advanced non-small-cell lung cancer (N SCLC) previously untreated with chemotherapy. Patients and Methods: Pa tients with stage IIIB or IV NSCLC with measurable disease in nonrodia ted fields were eligible. Other eligibility criteria were Zubrod perfo rmance status (PS) less than or equal to 2 and adequate renal and live r function. TPT was administered at a dose of 1.5 mg/m(2)/d for 5 days over 30 minutes every 21 days. Of 48 registered patients, 40 were ful ly assessable. Nineteen patients had adenocarcinoma (AD), 14 squamous carcinoma (SCC), and seven poorly differentiated carcinoma. Results: S ix patients (15%) achieved a partial remission (PR) (durations: 8, 14, 18, 28, 58, and 61 weeks) and four patients a minor response; 10 pati ents had starate was 36% (five of 14 patients) in patients with SCC ve rsus 4% (one of 26 patients) in those with other histologies (P =.014) . The overall median survival time was 38 weeks and 30% of patients we re alive at 1 year. Grade 3 to 4 granulocytopenia and thrombocytopenia occurred after 76% and 10% of courses administered, respectively. No grade 3 to 4 nonhematologic toxicities were observed. Grade 1 or 2 non hematologic toxicities consisted of nausea (46% and 5%), vomiting (31% and 7%), and fatigue (53% and 16%). Conclusion: TPT at the dose and s chedule used has moderate antitumor activity in NSCLC; its activity is mostly limited to patients with SCC. TPT is well tolerated, with myel osuppression of short duration being the most common and limiting toxi city. (C) 1996 by American Society al Clinical Oncology.