Purpose: The efficacy and safety of a combined regimen of topotecan and etoposide was tested in patients with relapsed or refractory small-cell lung cancer.
Patients and methods: From October 2003 to May 2005, 23 patients who have failed to the previous irinotecan and platinum chemotherapy received intravenous topotecan 1 mg/m2 (day 1-5) and etoposide 80 mg/m2 (day 1-3). Treatment was repeated every 21 days for a maximum of 6 cycles.
Results: Twelve patients were refractory to first-line chemotherapy. Seventeen patients (73.9%) were male and the median age was 63 years. ECOG performance status was 0-1 in 13 (56.5%) patients. The median cycles of chemotherapy was three. Twenty-one patients were assessable for response evaluation. The overall response rate was 17.4% (0 CR, 4 PR, 7 SD, 10 PD) under the intent-to-treat analysis. Two sensitive case patients and two refractory case patients achieved partial response. After a median follow-up of 20.8 months, median progression free survival was 4.7 months and median overall survival was 9.5 months. The estimated 1-year survival rate was 38.7%. All patients were assessable for toxicity and major toxicities were myelosuppression. Grade 3/4 neutropenia and thrombocytopenia occurred in 18 (78.3%) and 12 (52.2%) patients, respectively. Grade 3/4 febrile neutropenia occurred in two patients (8.7%) and infection in three patients (13.0%). There was one treatment-related death due to pneumonia.
Conclusion: This salvage regimen showed modest efficacy and manageable toxicities. Further study will be required in recurrent SCLC patients pretreated irinotecan and platinum.