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570 Introduction: Capecitabine (Xeloda [X]) shows synergy with taxanes and adding X to docetaxel (T) extends overall survival (OS), response rate (RR) and progression free-survival (PFS) beyond T alone. Sequential single-agent therapy could confer convenience benefits and may be more appropriate than combination chemotherapy for some pts. Methods: Pts with anthracycline-pretreated MBC received 3-weekly cycles of 1 of the following regimens: X→taxane (X 1250mg/m2 bid d1–14, followed after progression (PD) by T 100mg/m2 or paclitaxel [P] 175mg/m2 day 1; X+P (X 825mg/m2 bid days 1–14 + P 175mg/m2 day 1) or X+T (X 825mg/m2 bid days 1–14 + T 75mg/m2 day 1). Results: Of the 368 pts enrolled, 91 are either still on therapy or not evaluable. The table shows baseline characteristics, efficacy and safety in evaluable pts. Median follow up is 15.5 months. Median doses for X in each arm (1st cycle vs. 8th cycle, mg/m2 bid): 1218 vs. 1054; 948 vs. 900; 846 vs. 751. Median doses for P and T (1st cycle vs. 8th cycle, mg/m2): 173 vs. 169 and 75 vs. 72, respectively. In the X→taxane arm, 58 pts (64%) received sequential taxane; the remainder did not receive a taxane, either because they were still on X, had CR or had rapid PD. Conclusions: RR is higher with XP and XT, but PFS and OS are similar at a median follow-up of 15.5 months. All regimens were well tolerated with minimal grade 4 AEs. Because there is no clear superiority of sequential vs. combined therapy, pt characteristics are likely to be used to decide which regimen is the most appropriate. [Table: see text] [Table: see text]

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575 Background: VG has shown to be efficacious and safe in MBC in pts previously treated with AT. This study compared treatment (TT) V with the combination of VG. Primary objective was progression free survival (PFS). Methods: pts previously treated with AT, aged ≥18, ECOG ≤ 2, were randomized to V: 30 mg/m2 day (d) 1, d8, or VG 30/1200 mg/m2 d1, d8, both every 21 days until disease progression. Stratification criteria were previous lines of TT for MBC (0 vs.1 vs.2) and visceral disease (yes vs. no). 126 pts per arm were needed to demonstrate a prolongation in PFS of 2 months (m) (from 3 to 5; HR = 1.67; α and β errors 0.05 and 10). Results: 252 pts (127 V and 125 VG) were recruited between 2001 and 2005. Arms were well balanced: median age was 57 years; median number of metastatic sites 2; visceral disease was present in 75% of pts; 17%, 53% and 29% of pts received study TT as first, second and third line respectively. Median number of cycles were 4 (1–21) in V and 6 (1–26) in VG. Median PFS was 6.3 m (95% CI, 5.3–7.3) for VG and 4.1 m (95% CI, 3.3–4.9) for V (p=0.0011). Objective response rate was 37% (CI 95% 29–46) for VG and 25% (CI 95%: 17–33) for V (p= 0.035). CTC grade 3–4 hematologic toxicity was significantly higher with VG vs. V (65% vs. 43% neutropenia, 33% vs. 17% leucopenia, and 11% vs. 2% thrombocytopenia); febrile neutropenia was present in 10.5% of pts on VG and 6% of pts in V (p=ns). Non-hematological toxicity was low and manageable in both arms. Conclusions: VG demonstrated significant efficacy advantages over V in pts with MBC previously treated with AT, with manageable toxicity. This favorable risk-benefit profile supports the use of this combination in this patient population. [Table: see text]