title: First-line Bevacizumab-containing Therapy for HER2-negative Metastatic Breast Cancer: Final Results from a Prospective German Study.
abstract: OBJECTIVE
  The German ML21165 study evaluated bevacizumab-containing therapy for metastatic breast cancer (mBC) in routine oncology practice.
  
  
  METHODS
  Patients received bevacizumab with chemotherapy until disease progression, unacceptable toxicity or consent withdrawal. Pre-specified end-points were safety and efficacy [response rate, progression-free survival (PFS) and overall survival (OS)].
  
  
  RESULTS
  Between May 2007 and September 2009, 865 patients received first-line bevacizumab plus paclitaxel for mBC, of whom 16% were aged ≥70 years and 9% had ECOG performance status of 2 or more. At data cut-off (median of 15.9 months' follow-up), the median PFS was 9.6 months [95% confidence interval (CI)=9.0-10.4 months] and the median OS was 21.6 months (95% CI=19.4-23.5 months). The most common non-haematological adverse drug reactions of grade 3 or more were pain (9%), hypertension (5%), sensory neuropathy (3%) and proteinuria (3%). Prolonged bevacizumab was well-tolerated.
  
  
  CONCLUSIONS
  The efficacy and safety of first-line bevacizumab-paclitaxel in routine oncology practice is consistent with results from randomized trials.
authors.affiliation: National Center for Tumor Diseases, University Hospital, Heidelberg, Germany andreas.schneeweiss@med.uni-heidelberg.de.
authors.forename: Andreas
authors.initials: A
authors.lastname: Schneeweiss
authors.affiliation: Outpatient Department of Gynecologic Oncology Chemnitz & University of Applied Sciences Zwickau, Chemnitz, Germany.
authors.forename: Frank
authors.initials: F
authors.lastname: Förster
authors.affiliation: Center for Hematology and Medical Oncology at Bethanien Hospital, Frankfurt/Main, Germany.
authors.forename: Hans
authors.initials: H
authors.lastname: Tesch
authors.affiliation: Department of Gynecology and Obstetrics, University of Duisburg-Essen, Essen, Germany.
authors.forename: Bahriye
authors.initials: B
authors.lastname: Aktas
authors.affiliation: West German Study Group, Mönchengladbach, Germany.
authors.forename: Oleg
authors.initials: O
authors.lastname: Gluz
authors.affiliation: Department for Gynecooncology Mannheim, Mannheim, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Geberth
authors.affiliation: Praxis Hertz-Eichenrode/N. Kolloch, Remscheid, Germany.
authors.forename: Martin M
authors.initials: MM
authors.lastname: Hertz-Eichenrode
authors.affiliation: Praxis Winfried Schönegg, Berlin, Germany.
authors.forename: Winfried
authors.initials: W
authors.lastname: Schönegg
authors.affiliation: St Elisabeth Hospital, Breast Centre Köln-Hohenlind, Köln, Germany.
authors.forename: Claudia
authors.initials: C
authors.lastname: Schumacher
authors.affiliation: WiSP Research Institute, Langenfeld, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Kutscheidt
authors.affiliation: Roche Pharma AG, Grenzach, Germany.
authors.forename: Claudia
authors.initials: C
authors.lastname: Kiewitz
authors.affiliation: Roche Pharma AG, Grenzach, Germany.
authors.forename: Sandra
authors.initials: S
authors.lastname: Klawitter
authors.affiliation: Department of Obstetrics and Gynecology, University Hospital Mainz, Mainz, Germany.
authors.forename: Marcus
authors.initials: M
authors.lastname: Schmidt
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; 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* / Q000235:genetics / Q000401:mortality; D005260:Female; D005858:Germany; D006801:Humans; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000235:genetics*; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000068258:Bevacizumab; D017239:Paclitaxel; D018719:Erb-b2 Receptor Tyrosine Kinases; C508053:ERBB2 protein, human
keywords: Anti-angiogenic; bevacizumab; first-line; metastatic breast cancer; vascular endothelial growth factor