Journal Article

Final results of a phase II study of nab-paclitaxel, bevacizumab, and gemcitabine as first-line therapy for patients with HER2-negative metastatic breast cancer

Castrellon, Aurelio, Seo, Pearl, Baez, Odalys, Reis, Isildinha, Richman, Stephen, Lopes, Gilberto, Ferrell, Annapoorna, Tukia, Keleni, Hurley, Erin, Higgins, Connie, Lobo, Christopher, Welsh, Catherine, Slingerland, Joyce, Glück, Stefan, Hurley, Judith, Silva, Orlando

2010

Overview

In order to examine the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-P) in combination with bevacizumab (B) and gemcitabine (G) for the first-line treatment of patients with HER2-negative metastatic breast cancer (MBC). In this single-center, open-label phase II trial, patients with HER2-negative MBC received gemcitabine 1500 mg/m², nab-paclitaxel 150 mg/m², and bevacizumab 10 mg/kg (each administered intravenously) on days 1 and 15 of a 28-day cycle. The primary end point was progression free survival (PFS); secondary end points were overall response rate (ORR), complete (CR) and partial (PR) response rates, clinical benefit (ORR + stable disease), overall survival (OS), and safety. Thirty patients were enrolled. One patient was ineligible and was not included in analysis. Median PFS was 10.4 months (95% CI: 5.6-15.2 months). ORR was 75.9%, comprising eight (27.6%) CRs and 14 (48.3%) PRs; five patients had stable disease (SD) and two patients (6.9%) had progressive disease (PD) as their best response. The clinical benefit rate was 93.1% (27/29) in the overall group and 84.6% in the triple-negative cohort (11/13). The 18-month survival rate was 77.2% (95% CI: 51.1-90.5%). Eight (27.6%) patients experienced grade 3 or 4 toxicity: grade 4 neutropenic fever (n = 1) and grade 3 infection (n = 6), leukopenia, thrombocytopenia, peripheral neuropathy, seizure, shortness of breath, hematuria, and cardiac tamponade (one each). First-line therapy with nab-P, B, and G demonstrated a median PFS of 10.4 months and a 75.9% ORR with acceptable toxicity; this novel combination warrants investigation in a randomized study.

• Publisher: Boston : Springer US,Springer US,Springer,Springer Nature B.V
• Subject: Adult / Aged / Albumins - administration & dosage / Antibodies, Monoclonal - administration & dosage / Antibodies, Monoclonal, Humanized / Antineoplastic Combined Chemotherapy Protocols - adverse effects / Antineoplastic Combined Chemotherapy Protocols - therapeutic use / Bevacizumab / Biological and medical sciences / Breast cancer / Breast Neoplasms - chemistry / Breast Neoplasms - drug therapy / Breast Neoplasms - mortality / Breast Neoplasms - secondary / Breast Neoplasms, Male - chemistry / Breast Neoplasms, Male - drug therapy / Breast Neoplasms, Male - mortality / Breast Neoplasms, Male - secondary / Cancer research / Cancer therapies / Care and treatment / Chemotherapy / Clinical Trial / Clinical trials / Deoxycytidine - administration & dosage / Deoxycytidine - analogs & derivatives / Disease-Free Survival / Drug Administration Schedule / Female / First-line therapy / Florida / Gemcitabine / Gynecology. Andrology. Obstetrics / Health aspects / HER2-negative metastatic breast cancer / Humans / Kaplan-Meier Estimate / Male / Mammary gland diseases / Medical sciences / Medicine / Medicine & Public Health / Metastasis / Middle Aged / Nab-paclitaxel / Oncology / Paclitaxel - administration & dosage / Product development / Proportional Hazards Models / Receptor, ErbB-2 - analysis / Risk Assessment / Risk Factors / Side effects / Time Factors / Toy industry / Treatment Outcome / Tumors