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A RANDOMIZED PHASE III STUDY OF THALIDOMIDE VERSUS PLACEBO IN EXTENDED-DISEASE (ED) SMALL CELL LUNG CANCER (SCLC) PATIENTS AFTER RESPONSE TO CHEMOTHERAPY (CT)

CH Belfort Chest Department, Belfort, France

PURPOSE: This study aimed at determining whether or not thalidomide, an antiangiogenesis agent, prolongs survival of patients(pts) suffering from SCLC.

METHODS: Eligibility criteria consisted of previously untreated ED-SCLC, age <70, PS<2, weightloss<10%, and for women, post-menopausal status. Pts were registered in the study and received two courses of PCDE( etoposide 100mg/m2 on days 1-3, cisplatin 100mg/m2 on day 2, cyclophosphamide 400mg/m2 on days 1-3, epidoxorubicine 40mg/m2 on day 1) given 4 weeks apart. Afterwards pts who experienced a response were randomly assigned to receive 4 additional cycles of PCDE plus thalidomide(400mg/m2 daily)or placebo.The planned accrual was 200 pts in order to detect a 20% survival improvement.

RESULTS: Due to a low accrual rate the study was shortened with final analysis performed taking into account 119 registered pts. There were 4 toxic-deaths(3.3%). Tumor assessment performed after the first two CT cycles 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 43 in placebo group. The 5 remaining pts were not randomised due to poor recovery from previous CT. The planned six cycles of PCDE were delivered to an equal proportion of pts in both groups(75.5% versus 74.4%). Mean +/-SD exposure duration to thalidomide was 4.5 months+/-2.7 and to placebo 5.1+/-2.4(NS). Reasons for withdrawal differed between the two groups with toxicity as main reason for thalidomide(55.3% versus 35%) and disease progression as main reason for placebo(43% versus 62%: p=0.06). In cox model of overall survival within the 9 months following randomisation, pts allocated to the thalidomide group had the longest survival(HR of death for pts in the thalidomide group:0.48[95%CI:0.24-0.93]:p=0.03; median survival from randomisation: 11.7 versus 8.7 months for thalidomide and placebo groups respectively).

CONCLUSION: Thalidomide prolongs survival of pts with SCLC after response to CT.

CLINICAL IMPLICATIONS: This study is a clue in favour of angiogenesis process as therapeutic window in SCLC therapy.

DISCLOSURE: Jean Luc Breton, None.