A randomized phase II study of pemetrexed-carboplatin and gemcitabine-vinorelbine in patients with anthracycline- and taxane-pretreated advanced breast cancer.

1051 Background:Pemetrexed (Pem) and platinum compounds have single-agent activity in advanced breast cancer (BC). Anthracyclines (Atc) and taxanes are used to treat BC patients (pts), with limited options available after their failure. Pem-carboplatin (Pem-Carb) combination was active and well tolerated in a phase II study in first-line BC pts. It is worth exploring Pem-Carb combination in pts pretreated with Atc and taxanes. Methods:In this collaborative study with GEICAM, women pts with advanced BC previously treated with Atc and taxanes, with ≥1 measurable lesion by RECIST, and had received ≥1 dose of study drug. Pts were stratified by line of treatment (1st, 2nd), visceral disease (yes/no), and ECOG PS (0−1 vs 2) and randomized 1:1 to Pem-Carb (Pem, 600 mg/m2, D1 iv q21; Carb, AUC 5, D1 iv q21, vitamin B12 and folic acid supplementation) or gemcitabine-vinorelbine (Gem, 1200 mg/m2 D1, D8 iv q21; Vin, 30 mg/m2 D1, D8 iv q 21). Tx was continued until progression. The primary endpoint was objective resp...