title: Phase II Study of Vinorelbine Plus Trastuzumab in HER2 Overexpressing Metastatic Breast Cancer Pretreated with Anthracyclines and Taxanes.
abstract: OBJECTIVE
  The role of first-line trastuzumab-based therapy has been firmly established in patients with human epidermal growth factor receptor-2 (HER2) positive metastatic breast cancer. In this trial, we evaluated the efficacy and safety of a vinorelbine and trastuzumab combination chemotherapy in patients who were pretreated with anthracyclines and taxanes.
  
  
  METHODS
  Thirty-three patients with HER2 overexpressing metastatic breast cancer, all of whom had previously been treated with anthracyclines and taxanes, were included in this study. The patients were treated with 25 mg/m(2) of vinorelbine (over a 15-minute infusion) on days 1 and 8 every 3 weeks. Additionally, trastuzumab was administered at an initial dose of 4 mg/kg over 90 minutes, and was subsequently administered at weekly doses of 2 mg/kg (over 30 minutes).
  
  
  RESULTS
  The median age of the patients was 53 years (range, 39-72 years). The overall response rate was 30.3% (10 patients; 95% confidence interval [CI], 23-57%). The median time to progression was 6.8 months (95% CI, 5.3-8.2 months). The median overall survival was 12.4 months (95% CI, 10.3-14.6 months). In the 194 cycles of treatment, the incidence rates of grade ≥3 neutropenia and anemia were 7.2% and 1.0%, respectively. Neutropenic fever was detected in three cycles (1.5%). The non-hematological toxicities were not severe: grade 1 or 2 nausea or vomiting was detected in 15.2%, and grade 2 neuropathy was noted in 6.1% of patients. None of the patients experienced any serious cardiac toxicity, and no treatment-related deaths occurred.
  
  
  CONCLUSIONS
  These results show that a combination chemotherapy consisting of vinorelbine and trastuzumab is useful in patients with HER2-overexpressing metastatic breast cancer who were pretreated with anthracyclines and taxanes, with a favorable toxicity profile.
authors.affiliation: Department of Internal Medicine, Dong-A University College of Medicine, Busan, Korea.
authors.forename: Yu Rim
authors.initials: YR
authors.lastname: Lee
authors.forename: Seok Jae
authors.initials: SJ
authors.lastname: Huh
authors.forename: Dong Hyun
authors.initials: DH
authors.lastname: Lee
authors.forename: Hyun Hwa
authors.initials: HH
authors.lastname: Yoon
authors.forename: Young-Mi
authors.initials: YM
authors.lastname: Seol
authors.forename: Young-Jin
authors.initials: YJ
authors.lastname: Choi
authors.forename: Kyung A
authors.initials: KA
authors.lastname: Kwon
authors.forename: Suee
authors.initials: S
authors.lastname: Lee
authors.forename: Sung Yong
authors.initials: SY
authors.lastname: Oh
authors.forename: Sung-Hyun
authors.initials: SH
authors.lastname: Kim
authors.forename: Hyo-Jin
authors.initials: HJ
authors.lastname: Kim
authors.forename: Hyuk-Chan
authors.initials: HC
authors.lastname: Kwon