Single-Agent Docetacel (D) Versus Docetaxel Alternating With Single-Agent Gemcitabine (G) As Treatments Of Patients (Pts) With Advanced Breast Cancer (Abc): Final Analysis Of A Randomized Trial

1035 Background: Alternating use of single agents has not been compared with single-agent taxane as treatment of ABC. Methods: The key eligibility criteria for this open-label, prospective, randomized, multicenter, phase II trial were female gender, age <70, WHO performance status <2, and no prior chemotherapy for ABC. Pts were allocated to receive either D (80 or 100 mg/m2, d. 1 of a 3-wk cycle; D-D-D-D… Group A) or D alternating with G (1,000 mg/m2, d. 1 and 8 of a 3-wk cycle; D-G-D-G… Group B). G was scheduled to be given after treatment failure in Group A, in Group B second-line therapy was not defined. Trastuzumab was allowed for HER2+ disease. The primary endpoint was time to treatment failure (TTTF). Pts were stratified for performance status, prior taxane exposure and center at randomization. The planned sample size was 240 pts, α 0.05, 1-β 0.80, 2- sided log-rank test. Results: 240 pts were entered between Mar 2002 and Sep 2006, of whom 237 were assigned to treatment (Group A, 115; Group B, 122). The groups were balanced with main prognostic factors (ER+, A 71%, B 74%; HER2+, A 24%, B 19%). In May 2007 166 pts (70%) had failed treatment (A, 74%; B, 66%). The median TTTF was 5.6 months in Group A and 6.2 months in Group B (hazard ratio 0.85, 95% CI 0.63–1.16; P=0.31); a median of 8 cycles were given in both groups before failure. There was no statistical difference in time to progression (HR 1.05, P=0.72), survival (HR 1.11, P=0.60), response rate (76% in both groups) or response duration between the groups. When adverse events were evaluated per cycle using generalized estimating equations for repeated measurements, both hematologic (P=0.014) and nonhematologic (P=0.007) grade 3 or 4 events were less frequent in Group B than in Group A. Conclusions: D alternating with G is an effective and generally well tolerated treatment for ABC. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Eli Lilly sanofi-aventis sanofi-aventis Eli Lilly, sanofi-aventis