title: A prospective multicenter phase II study of oral and i.v. vinorelbine plus trastuzumab as first-line therapy in HER2-overexpressing metastatic breast cancer.
abstract: BACKGROUND
  To evaluate the efficacy and safety of oral and i.v. vinorelbine plus trastuzumab as first-line regimen in a patient-convenient application for human epidermal growth factor receptor 2 (HER2)-overexpressing patients with metastatic breast cancer.
  
  
  METHODS
  Forty-two women were enrolled in a multicenter study. The patients received i.v. vinorelbine at a dose of 25 mg/m(2) on day 1 followed by oral vinorelbine at a dose of 60 mg/m(2) on days 8 and 15 in a 3-week cycle. Standard dose trastuzumab was given at 3-week intervals.
  
  
  RESULTS
  Complete response was observed in 7 patients (18.9%) and partial response in 19 patients (51.4%), for an overall response rate of 70.3% [95% confidence interval (CI) 53.0-84.1]. The disease control rate reached 91.9% (95% CI 78.1-98.3). The median time to progression was 9.3 months, while median overall survival reached 35.6 months. Hematological and non-hematological toxic effects were acceptable with grade 3-4 leukopenia of 14% and neutropenia of 38%; cardiac toxicity did not reach the level of clinical relevance.
  
  
  CONCLUSIONS
  The combination of i.v. and oral vinorelbine plus trastuzumab demonstrates high activity and good tolerability in first-line treatment of HER2-overexpressing metastatic breast cancer. In addition, it offers convenience for the patients with only one i.v. treatment every 3 weeks.
authors: Medical Department III, University of Munich, Munich. Electronic address: Volker.Heinemann@med.uni-muenchen.de.
authors: V
authors: V
authors: Heinemann
authors: Medical Department III, University of Munich, Munich.
authors: D
authors: D
authors: Di Gioia
authors: Oncological Practice, Landshut.
authors: U
authors: U
authors: Vehling-Kaiser
authors: Oncological Practice, Hof.
authors: H-D
authors: HD
authors: Harich
authors: Oncological Practice, Augsburg.
authors: B
authors: B
authors: Heinrich
authors: Department of Medicine (Cancer Research), West German Cancer Center, University Hospital Essen, Essen.
authors: A
authors: A
authors: Welt
authors: Oncological Practice, Troisdorf.
authors: C
authors: C
authors: Ziske
authors: Department of Gynecology, Diakonissenkrankenhaus Karlsruhe, Karlsruhe.
authors: G
authors: G
authors: Deutsch
authors: Oncological Practice, Rosenheim.
authors: R
authors: R
authors: Pihusch
authors: Department of Gynecology, University of Mainz, Mainz.
authors: H
authors: H
authors: Kölbl
authors: Oncological Practice, Hamburg, Germany.
authors: S
authors: S
authors: Hegewisch-Becker
authors: Medical Department III, University of Munich, Munich.
authors: M
authors: M
authors: Michl
authors: Medical Department III, University of Munich, Munich.
authors: H J
authors: HJ
authors: Stemmler
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology*; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011446:Prospective Studies; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism*; D000068878:Trastuzumab; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab; D014747:Vinblastine; D000077235:Vinorelbine; C508053:ERBB2 protein, human