Updated report of a phase III study of induction therapy with gemcitabine + carboplatin (GC) followed by either delayed vs. immediate second-line therapy with docetaxel (D) in advanced non-small cell lung cancer (NSCLC)

Abstract

7032 Background: GC is an active regimen in patients with advanced NSCLC. For non-progressors after induction treatment, optimal timing of sequential therapy is unclear. Is it best to sequence immediately to an active non-cross resistant agent or delay the introduction of this agent until time of disease progression (PD)? This trial was designed to answer this question. Methods: Pts with Stage IIIB or IV NSCLC were enrolled. G 1000mg/m2 was administered on day 1,8 followed by C at AUC 5.0 on day 1. After 4 cycles, non-progressers were then randomized to immediate D (75mg/m2 administered on day 1 every 3 wks) or delayed D (pts were observed until first evidence of PD). Conclusions: This study confirms that it is possible to deliver docetaxel immediately following four cycles of GC without significantly increasing toxicity. The response rate of 42.1% and clinical benefit rate (CR+PR+SD) of 88.2% observed in the immediate D arm compares favorably with the rates of 6.1% and 60.6% of the delayed D arm. Additional toxicity and response information will be available at the time of the meeting. [Table: see text] [Table: see text]