title: Paclitaxel plus bevacizumab or paclitaxel as first-line treatment for HER2-negative metastatic breast cancer in a multicenter national observational study.
abstract: Bevacizumab combined with paclitaxel as first-line chemotherapy for patients with HER2-negative metastatic breast cancer (MBC) has led to mixed results in randomized trials, with an improvement in progression-free survival (PFS) but no statistically significant overall survival (OS) benefit. Real-life data could help in assessing the value of this combination.
  
  
  
  This study aimed to describe the outcome following first-line paclitaxel with or without bevacizumab in the French Epidemiological Strategy and Medical Economics (ESME) database of MBC patients, established in 2014 by Unicancer. The primary and secondary end points were OS and PFS, respectively.
  
  
  
  From 2008 to 2013, 14 014 MBC patient files were identified, including 10 605 patients with a HER2-negative status. Of these, 3426 received paclitaxel and bevacizumab (2127) or paclitaxel (1299) as first-line chemotherapy. OS adjusted for major prognostic factors was significantly longer in the paclitaxel and bevacizumab group compared with paclitaxel [hazard ratio (HR) 0.672, 95% confidence interval (CI) 0.601-0.752; median survival time 27.7 versus 19.8 months]. Results were consistent in all supportive analyses (using a propensity score for adjustment and as a matching factor for nested case-control analyses) and sensitivity analyses. Similar results were observed for the adjusted PFS, favoring the combination (HR 0.739, 95% CI 0.672-0.813; 8.1 versus 6.4 months).
  
  
  
  In this large-scale, real-life setting, patients with HER2-negative MBC who received paclitaxel plus bevacizumab as first-line chemotherapy had a significantly better OS and PFS than those receiving paclitaxel. Despite robust methodology, real-life data are exposed to important potential biases, and therefore, results need to be treated with caution. Our data cannot therefore support extension of current use of bevacizumab in MBC.
authors.affiliation: Department of Cancer Medicine, Institut Gustave Roussy, Villejuif suzette.delaloge@gustaveroussy.fr.
authors.forename: S
authors.initials: S
authors.lastname: Delaloge
authors.affiliation: Department of Biostatistics, Centre Léon Bérard, Lyon.
authors.forename: D
authors.initials: D
authors.lastname: Pérol
authors.affiliation: Department of Research and Development, R&D Unicancer, Paris.
authors.forename: C
authors.initials: C
authors.lastname: Courtinard
authors.affiliation: Department of Medical Oncology, Institut Curie, Paris and Saint-Cloud.
authors.forename: E
authors.initials: E
authors.lastname: Brain
authors.affiliation: Department of Research and Development, R&D Unicancer, Paris.
authors.forename: B
authors.initials: B
authors.lastname: Asselain
authors.affiliation: Department of Biostatistics, Centre Léon Bérard, Lyon.
authors.forename: T
authors.initials: T
authors.lastname: Bachelot
authors.affiliation: Department of Medical Oncology, Institut Bergonié, Bordeaux.
authors.forename: M
authors.initials: M
authors.lastname: Debled
authors.affiliation: Department of Medical Oncology, Institut Curie, Paris and Saint-Cloud.
authors.forename: V
authors.initials: V
authors.lastname: Dieras
authors.affiliation: Department of Medical Oncology, Institut de Cancérologie de l'Ouest, Nantes and Angers.
authors.forename: M
authors.initials: M
authors.lastname: Campone
authors.affiliation: Department of Medical Oncology, Centre François Baclesse, Caen.
authors.forename: C
authors.initials: C
authors.lastname: Levy
authors.affiliation: Department of Medical Oncology, Institut du Cancer de Montpellier, Montpellier.
authors.forename: W
authors.initials: W
authors.lastname: Jacot
authors.affiliation: Department of Medical Oncology, Centre Georges François Leclerc, Dijon.
authors.forename: V
authors.initials: V
authors.lastname: Lorgis
authors.affiliation: Department of Medical Oncology, Centre Henri Becquerel, Rouen.
authors.forename: C
authors.initials: C
authors.lastname: Veyret
authors.affiliation: Department of Medical Oncology, Institut Claudius Regaud, IUCT-Oncopole, Toulouse.
authors.forename: F
authors.initials: F
authors.lastname: Dalenc
authors.affiliation: Department of Medical Oncology, Centre Antoine Lacassagne, Nice.
authors.forename: J M
authors.initials: JM
authors.lastname: Ferrero
authors.affiliation: Department of Medical Oncology, Institut de Cancérologie de Lorraine, Vandoeuvre-lès-Nancy.
authors.forename: L
authors.initials: L
authors.lastname: Uwer
authors.affiliation: Department of Medical Oncology, Centre Eugène Marquis, Rennes.
authors.forename: P
authors.initials: P
authors.lastname: Kerbrat
authors.affiliation: Department of Medical Oncology, Institut Paoli-Calmettes, Marseille.
authors.forename: A
authors.initials: A
authors.lastname: Goncalves
authors.affiliation: Department of Medical Oncology, Centre Jean Perrin, Clermont Ferrand.
authors.forename: M A
authors.initials: MA
authors.lastname: Mouret-Reynier
authors.affiliation: Department of Medical Oncology, Centre Paul Strauss, Strasbourg.
authors.forename: T
authors.initials: T
authors.lastname: Petit
authors.affiliation: Department of Medical Oncology, Institut de Cancérologie Jean-Godinot, Reims.
authors.forename: C
authors.initials: C
authors.lastname: Jouannaud
authors.affiliation: Department of Medical Oncology, Centre Oscar Lambret, Lille.
authors.forename: L
authors.initials: L
authors.lastname: Vanlemmens
authors.affiliation: Capionis, Paris, France.
authors.forename: G
authors.initials: G
authors.lastname: Chenuc
authors.affiliation: Department of Research and Development, R&D Unicancer, Paris.
authors.forename: T
authors.initials: T
authors.lastname: Guesmia
authors.affiliation: Department of Research and Development, R&D Unicancer, Paris.
authors.forename: M
authors.initials: M
authors.lastname: Robain
authors.affiliation: Department of Research and Development, R&D Unicancer, Paris.
authors.forename: C
authors.initials: C
authors.lastname: Cailliot
mesh_terms: D000368:Aged; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D000068258:Bevacizumab / Q000008:administration & dosage* / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D064420:Drug-Related Side Effects and Adverse Reactions / Q000473:pathology; D005260:Female; D006801:Humans; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000235:genetics; D016896:Treatment Outcome
chemical_list: D020533:Angiogenesis Inhibitors; D000068258:Bevacizumab; D017239:Paclitaxel; D018719:Erb-b2 Receptor Tyrosine Kinases; C508053:ERBB2 protein, human
keywords: bevacizumab; breast cancer; metastatic; paclitaxel; real-life