Purpose: Topotecan has recently shown activity in small cell lung cancer (SCLC) patients. The aim of the present phase II study was to assess the antitumor activity and toxicity of the combination of topotecan plus etoposide in chemotherapynaive patients with advanced SCLC on an outpatient basis.
Patients and methods: From December 1998 to February 2001 24 previously untreated patients with histologically proven advanced (stage IIIB and IV) SCLC received topotecan 1.2 mg/m(2), days 1-5, followed by etoposide 100 mg/m(2), days 8-10, every 3 weeks, up to 6 cycles (less if progressive disease).
Results: Twenty-two patients were males and 2 females. Their median age was 54 years (range 37-67 years). World Health Organization (WHO) performance status (PS) was 0-1 in 12 patients and 2 in 12. AJCC stage IIIB was found in 6 patients and IV in 18.
Toxicity: 76 cycles (median 3.5 cycles) were given with no toxic deaths. Grade 4 toxicity was registered in 10 (13%) cycles for neutropenia, 4 (5%) cycles for anaemia, 1 (1.3%) cycle for thrombocytopenia and 1 (1.3%) cycle for diarrhea. Activity: among 23 evaluable patients, 8 had an objective response to chemotherapy (response rate - RR- 34.7%, 95% confidence interval -CI- 14-55%) with 4 (17.4%) complete remissions (CRs) and 4 (17.4%) partial remissions (PRs). Survival: with a median follow-up of 8 months (range 1.5-25 months), one-year actuarial survival was 48% (95% CI 28-69%) and median survival was 47.8 weeks.
Conclusion: Although the combination of topotecan and etoposide proved easy to administer on an outpatient basis with moderate and manageable toxicity, it showed only moderate activity as first-line chemotherapy in advanced SCLC.