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 topotecan (TPT) in patients with advanced non-small-cell lung cancer (NSCLC) previously untreated with chemotherapy. Patients and Methods: Patients with stage IIIB or IV NSCLC with measurable disease in nonrodiated fields were eligible. Other eligibility criteria were Zubrod performance status (PS) less than or equal to 2 and adequate renal and liver 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 fully assessable. Nineteen patients had adenocarcinoma (AD), 14 squamous carcinoma (SCC), and seven poorly differentiated carcinoma. Results: Six patients (15%) achieved a partial remission (PR) (durations: 8, 14, 18, 28, 58, and 61 weeks) and four patients a minor response; 10 patients had starate was 36% (five of 14 patients) in patients with SCC versus 4% (one of 26 patients) in those with other histologies (P =.014). The overall median survival time was 38 weeks and 30% of patients were 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 nonhematologic toxicities consisted of nausea (46% and 5%), vomiting (31% and 7%), and fatigue (53% and 16%). Conclusion: TPT at the dose and schedule used has moderate antitumor activity in NSCLC; its activity is mostly limited to patients with SCC. TPT is well tolerated, with myelosuppression of short duration being the most common and limiting toxicity. (C) 1996 by American Society al Clinical Oncology.