395 - Docetaxel (D), Gemcitabine (G) and Bevacizumab (BEV) as Salvage Chemotherapy (CT) for HER-2 Negative Metastatic Breast Cancer (MBC)

Abstract

ABSTRACT Introduction The combination of D and G is a valid salvage CT regimen for the treatment of mBC. When combined with CT, Bev has increased the response rate and progression-free survival (PFS) in both first and second line treatment of mBC. In this multicenter study, we evaluated the combination of D, G, and Bev, administered biweekly, as second or further line CT in patients (pts) with HER-2 negative mBC. Methods Women with HER-2 negative mBC, who had received at least one prior line of CT, were treated with D 50 mg/m2, G 1500 mg/m2 and Bev 10 mg/Kg, in cycles every two weeks. Bev was continued until disease progression. This was a study with Simon's optimal two step statistical design. Results Forty-eight pts have been enrolled. Median age was 61 years, performance status was 0-1 in 95.8% and 2 in 4.2% of pts, 83.3% had hormone receptor positive disease, and 47.9% had received one prior line of CT. All pts were evaluable for toxicity and 43 for response. Objective response rate was 44.2% (95% confidence interval [CI], 29.3-59%), median PFS was 6.8 months (95% CI, 4.5-9.1 months), and median overall survival 20.1 months (95% CI, 9.9-30.3 months). Grade 3-4 hematologic toxicity consisted of neutropenia (39.6%) and febrile neutropenia (4.2%). Most common grade 2-3 non-hematologic adverse events included nausea (10.4%), diarrhea (10.5%), neurotoxicity (12.5%), fatigue (31.3%), allergic reactions (6.3%), hemorrhage (4.2%), and hypertension (4.2%). No grade 4 non-hematologic toxicities or toxic deaths were recorded. Conclusion The combination of D, G and Bev has promising activity and a manageable toxicity profile as salvage CT for HER-2 negative mBC. Updated results will be presented at the congress. Disclosure All authors have declared no conflicts of interest.