A randomized phase III trial comparing bexarotene/carboplatin/paclitaxel versus carboplatin/paclitaxel in chemotherapy-naive patients with advanced or metastatic non-small cell lung cancer (NSCLC)

摘要: LBA7001 Background: Targretin (bexarotene) is a rexinoid that selectively activates RXR receptors which modulate functions associated with differentiation, inhibition of cell growth, apoptosis and metastasis. Data from four Phase I II studies suggest combining bexarotene chemotherapy in patients first-line NSCLC may prolong survival. This randomized, prospective III trial was performed to determine the survival benefit adding carboplatin/paclitaxel advanced NSCLC. Methods: 612 chemo-naive Stage IIIb disease pleural effusion or IV disease, who were performance status ECOG 0–1, had normalized triglyceride levels at study entry enrolled. size will allow detection 30% improvement treatment arm. Patients stratified by stage gender prior randomization capsules (400 mg/m2/day) carboplatin/p...