Phase II trial of thalidomide with chemotherapy and as maintenance therapy for patients with poor prognosis small-cell lung cancer

Background: Despite the high response rates achieved following standard chemotherapy for small-cell lung cancer (SCLC), the majority of patients wilt subsequently die from disease progression. Materials and methods: We examined the efficacy and toxicity of thalidomide, an antiangiogenic agent, in combination with carboplatin and etoposide and as maintenance therapy in patients with untreated SCLC. Twenty-five chemotherapy-naive patients with extensive disease (ED) or limited disease (LD) SCLC were enrolled in a single-arm phase 11 study. Carboplatin and etoposide were given every 3 weeks for 6 cycles with concurrent thalidomide 100 mg orally daily. The treatment with thalidomide was continued as maintenance for up to 2 years. Results: Median progression free and overall survival were 8.3 months and 10.1 months, respectively. One-year survival was 40% and the 1-year progression-free survival was 36%. The overall response rate was 68% (95% CI 46-85%) with four complete remissions (20%) and 13 partial remissions (48%). We observed no increase in chemotherapy related toxicity. Thalidomide was well-tolerated and median time on thalidomide treatment was 7.6 months. Conclusion: Concurrent thalidomide with chemotherapy followed by maintenance thalidomide appears to be well tolerated. The results on tumour response rate and survival led us to initiate a randomised phase III trial in the United Kingdom. (C) 2007 Elsevier Ireland Ltd. All rights reserved.