title: Comparative study analyzing survival and safety of bevacizumab/carboplatin/paclitaxel versus carboplatin/docetaxel in initial treatment of metastatic Her-2-negative breast cancer.
abstract: OBJECTIVE
  In view of the previous reports demonstrating the positive outcome of bevacizumab in metastatic breast cancer, we aimed at comparing the role of bevacizumab-based metronomic combination with taxane (paclitaxel) versus a different taxane (docetaxel)-based regimen in addition to carboplatin as initial treatment for metastatic Her-2-negative breast cancer.
  
  
  METHODS
  This is a randomized Phase III study comparing the progression-free survival (PFS) and safety in Her-2-negative female patients with initial diagnosis of metastatic breast cancer with World Health Organization performance status of 0-II. Forty-one patients were randomized from September 2008 to July 2009 to receive either; (1) bevacizumab 5 mg/kg day 1 and day 15, carboplatin area under the curve (AUC)-2 day 1, day 8, and day 15, and paclitaxel 60 mg/m(2) day 1, day 8, and day 15 (arm-I); or (2) carboplatin AUC-5 day 1, docetaxel 75 mg/m(2) day 1 (arm-II). The Kaplan-Meier method was used for estimating survival; log-rank test for comparing survival curves. The primary end point was PFS, and secondary end points were overall survival (OS) and safety.
  
  
  RESULTS
  PFS was 10 months in arm I versus 10.2 months in arm II (P = 0.9). The OS rate was similar in both arms: 37.6 months for arm I versus 37.4 months for arm II (P = 0.92). The toxicity revealed higher incidence of hypertension and proteinuria in arm I; however, with higher incidence of grade III-IV neutropenia and neutropenic fever in arm II. No treatment-related mortality was recorded.
  
  
  CONCLUSIONS
  Bevacizumab/carboplatin/paclitaxel and carboplatin/docetaxel show comparable PFS and OS with different toxicity profiles.
authors.affiliation: Department of Clinical Oncology, Cairo University, Cairo, Egypt.
authors.forename: Yasser Abdel
authors.initials: YA
authors.lastname: Kader
authors.affiliation: Department of Medical Oncology, Institute Gustave Rousssy, VuilleJuif, Paris, France.
authors.forename: Marc
authors.initials: M
authors.lastname: Spielmann
authors.affiliation: Department of Clinical Oncology, Cairo University, Cairo, Egypt.
authors.forename: Tamer
authors.initials: T
authors.lastname: El-Nahas
authors.affiliation: Department of Clinical Oncology, Cairo University, Cairo, Egypt.
authors.forename: Amr
authors.initials: A
authors.lastname: Sakr
authors.affiliation: Department of Clinical Oncology, Monufia University, Monufia, Egypt.
authors.forename: Hassan
authors.initials: H
authors.lastname: Metwally
keywords: Her-2 negative; bevacizumab; breast cancer; taxanes