title: A phase II study of weekly vinorelbine and trastuzumab in patients with HER2-positive metastatic breast cancer.
abstract: BACKGROUND
  Trastuzumab combined with cytotoxic agents presents encouraging results in metastatic breast cancer (MBC), but cardiac toxicity limits some combinations. The synergism shown with trastuzumab and the favorable tolerability profile of vinorelbine provided the rationale for investigating this combination.
  
  
  METHODS
  Patients with HER2-positive MBC who had received <2 lines of chemotherapy for metastatic disease were included. Vinorelbine (25 mg/m2 on day 2, then weekly on day 1) and trastuzumab (4 mg/kg on day 1, then 2 mg/kg weekly) were administered for a maximum of 6 cycles (1 cycle=3 weeks).
  
  
  RESULTS
  A total of 52 patients were enrolled. The median age was 50 years (range, 26-79 years). Ninety percent of the patients had received adjuvant chemotherapy, 42% received a first line of chemotherapy for MBC, and 69% had disease at visceral sites. The overall response rate was 58% (95% CI, 43%-71%). The median time to progression and overall survival were 7 months (95% CI, 5-9 months) and 26 months (95% CI, 20-32 months), respectively. Grade 4 neutropenia was present in 3 courses; neutropenic fever was not reported. The main grade 3 nonhematologic toxicities were asthenia, neuropathy, diarrhea, alopecia, and nausea/vomiting. No patients experienced serious cardiac toxicity.
  
  
  CONCLUSIONS
  These results confirm that weekly vinorelbine/trastuzumab is an active and safe regimen in patients with HER2-positive MBC with an unfavorable prognosis.
authors.affiliation: Servicio de Oncología Médica, Hospital Juan Ramón Jiménez, Huelva, Spain. juanbayo@yahoo.es
authors.forename: Juan Lucas
authors.initials: JL
authors.lastname: Bayo-Calero
authors.forename: José I
authors.initials: JI
authors.lastname: Mayordomo
authors.forename: Pedro
authors.initials: P
authors.lastname: Sánchez-Rovira
authors.forename: Ramón
authors.initials: R
authors.lastname: Pérez-Carrión
authors.forename: José J
authors.initials: JJ
authors.lastname: Illaramendi
authors.forename: José M
authors.initials: JM
authors.lastname: García-Bueno
authors.forename: Encarnación
authors.initials: E
authors.lastname: González-Flores
authors.forename: Carmen
authors.initials: C
authors.lastname: Crespo
authors.forename: Manuel
authors.initials: M
authors.lastname: Ramos-Vázquez
authors.forename: Andrés
authors.initials: A
authors.lastname: García-Palomo
authors.forename: Manuel
authors.initials: M
authors.lastname: Ruiz-Borrego
authors.forename: Juan
authors.initials: J
authors.lastname: de la Haba
authors.forename: Amalia
authors.initials: A
authors.lastname: Gómez-Bernal
authors.forename: Alfonso
authors.initials: A
authors.lastname: Yubero-Esteban
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D010349:Patient Compliance; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000032:analysis*; D000068878:Trastuzumab; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / 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