Survival update for the phase III study of pemetrexed vs docetaxel in non-small cell lung cancer (NSCLC)

Abstract

7133 Background: Results from a large, randomized, phase III study of pemetrexed vs docetaxel as second-line treatment for advanced NSCLC indicated that pemetrexed, a novel multitargeted antifolate, has a median survival time (8.3 months) similar to that of docetaxel (7.9 months) with a more favorable safety profile [JCO 2004;22:1589–97]. This updated analysis reflects data available 23 months after the original analysis, which was performed Jan 2003 (after 519 deaths). Methods: Pts (n = 571) were randomized from March 2001 to Feb 2002 to receive either pemetrexed (500 mg/m2 IV infusion), supplemented with vitamin B12 injections and folic acid, or docetaxel (75 mg/m2 IV infusion) on day 1 of a 21-day cycle. An unadjusted survival analysis was performed and a Cox multiple regression analysis (n = 532) was done to adjust for factors (other than treatment intervention) that affected survival including ECOG performance status (PS), disease stage, and time since last chemotherapy. Percent retention was performed using the Rothmann method. Results: The updated survival analysis (performed after 519 deaths) indicated similar median survival times for pemetrexed (8.3 months; 95% CI: 7.0–9.4) and docetaxel (8.0 months; 95% CI: 6.6–9.3), and comparable hazard ratios (HR) (original 0.99 [95% CI: .82–1.20] vs updated 0.97 [95% CI: .81–1.15]). Percent of docetaxel benefit over best supportive care retained by pemetrexed was similar in both analyses: original 102% (95% CI: 52%-157%) vs updated 106% (95% CI: 68%-163%). Cox multiple regression analysis again showed that the two drugs were similar in survival after adjusting for factors significantly associated with increased survival. Conclusions: These updated survival analyses consistently demonstrate that second-line pemetrexed has similar survival to docetaxel in pts with NSCLC. Given the continued finding of comparable therapeutic efficacy, pemetrexed may be considered a standard second line therapy. [Table: see text] [Table: see text]