A prospective randomized phase III, double-blind, placebo-controlled study of thalidomide in extended-disease (ED) SCLC patients after response to chemotherapy (CT): An intergroup study FNCLCC Cleo04 - IFCT 00–01

7057 Background: This study aimed at determining whether or not thalidomide prolongs survival of patients (pts) suffering from SCLC. Methods: Eligibility consisted of previously untreated ED-SCLC, age <70 years, PS ≤2, weight loss <10% and, for women, post-menopausal status. Pts were registered in the study and received two courses of PCDE given 4 weeks apart with G-CSF primary prophylaxis recommended. Afterwards, pts who experienced a response were randomized to receive four additional cycles of PCDE plus thalidomide, (400 mg daily) or placebo. The planned accrual was 200 randomised pts in order to detect a 20% survival improvement. Results: The study was shortened with final analysis performed taking into account 119 registered pts (low accrual). There were 4 toxic-deaths (3.3%). Tumour assessment performed after the first two CT courses demonstrated 11 complete responders and 86 partial responders (81.4% overall response rate). Among these pts, 92 were randomly assigned, 49 in the thalidomide group and...