Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 22, No 14S (July 15 Supplement), 2004: 510
© 2004 American Society of Clinical Oncology

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Abstract

Global phase III study of gemcitabine plus paclitaxel (GT) vs. paclitaxel (T) as frontline therapy for metastatic breast cancer (MBC): First report of overall surviva

Loyola University Chicago Med Ctr, Maywood, IL; Inlaks and Budhrani Hospital, Pune, Maharashtra, India; Instituto Nacional De Cancerologia, Thalpan, Mexico; Addington Hospital, Durban, South Africa; Instituto Valenciano De Oncologia, Valencia, Spain; Klinika Chemioterapii, Lodz, Poland; Center of Oncology, Krakow, Poland; Baylor-Sammons Cancer Center, Dallas, TX; Clinicas Las Condes, Santiago, Chile

510

Background: GT had phase II safety and efficacy in MBC after anthracyclines, so it was compared to T in a phase III study of frontline therapy. Accrual goals were met in 4/02 and at initial planned interim analysis, GT significantly improved time to progression (TTP), progression-free survival (PFS), objective response rates (ORR) and quality of life, with an acceptable toxicity profile (PASCO 22:161, 2003). It was uncertain if this would translate into overall survival (OS) benefit, the primary endpoint of the trial. This report presents the first OS analysis. Methods: Patients (pts) with measurable MBC, prior (neo)adjuvant anthracyclines and KPS 70 were randomized to GT (G 1250 mg/m2 d1,8; T 175 mg/m2 d1) or T (175 mg/m2 d1) q21 days to progression. With median follow-up of 15.6 mos (all but 1 pt off study), the first OS analyses by Kaplan-Meier and Cox regression were conducted at approximately 75% (343) of the deaths needed (440) for the planned final OS report. (All p-values are 2-sided; confidence intervals, 95%.) Results: Characteristics of the 529 eligible pts (267 GT, 262 T) with visceral-dominant disease; toxicity; and the significant benefit from GT in ORR, TTP and PFS were previously reported (ref. above). 38% on GT stopped therapy due to progression vs 55% on T; therapy ended due to adverse events in 6.7%, GT vs 5.0%, T. The OS hazard ratio (HR) was 0.775 (.627, .959) in favor of GT, p=.018. Median OS for GT was 18.5 mos (16.5–21.2) vs T, 15.8 mos (14.4–17.4). One-year survival was 70.7% (65.1–76.3%) for GT and 60.9% (54.8–66.9%) for T (p=.019). The HR in favor of GT persisted in Cox regression after adjusting for baseline covariates: 0.740 (.598, .915), p=.006. Second-line therapy was nearly identical between arms, except for a 4-fold greater use of gemcitabine in the T arm. Conclusions: GT provides significant OS advantage over T when both are given on a q3 week cycle, a result to be confirmed in the final planned analysis in late 2004. The TTP benefit predicted OS improvement with longer follow-up. GT should be considered a frontline regimen in MBC.

Author Disclosure

Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Eli Lilly Eli Lilly Eli Lilly

Abstract presentation from the 2004 ASCO Annual Meeting