A Phase II trial of topotecan and gemcitabine in patients with previously treated, advanced nonsmall cell lung carcinoma

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Abstract
BACKGROUND: Multiple trials have been performed to evaluate second‐line clinical chemotherapy in patients with advanced nonsmall cell lung carcinoma (NSCLC). However, no single agent or combination has demonstrated superior activity.METHODS: Patients with advanced NSCLC who had aready received one chemotherapeutic regimen were treated with topotecan (0.75 mg/m2 over 30 minutes, Days 1–5) and gemcitabine (400 mg/m2 over 30 minutes, Days 1 and 5) every 21 days.RESULTS: Of 35 patients who were treated, 4 (11%) achieved a partial responses and 8 (23%) hadstable disease for at least four courses of treatment. The response rate for patients with refractory disease (progressing during frontline chemotherapy) was 18% (3 of 17) with 18% having stable disease for at least four courses of treatment. The median survival of the entire group was 7 months (range, 1.5–44 months) and 20% (7 of 35) of patients were alive 1 year from the initiation of topotecan and gemcitabine treatment. Patients with refractory disease had a median survival of 4½ months, with 6‐month and 1‐year survival rates of 47% and 18%, respectively. During Course 1, five patients (14%) developed Grade IV neutropenia and three patients (9%) developed Grade IV thrombocytopenia. Nonhematologic toxicity was relatively mild, with one patient developing Grade III side effects (fatigue) and eight patients (23%) developing Grade II nonhematologic side effects.CONCLUSIONS: The combination of topotecan and gemcitabine demonstrated antitumor activity with a modest side effect profile in patients with advanced, previously treated NSCLC. Cancer 2002;95:1274–8. © 2002 American Cancer Society.DOI 10.1002/cncr.10806

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