title: Phase II trial of oral vinorelbine for the treatment of metastatic breast cancer in patients > or = 65 years of age: an NCCTG study.
abstract: BACKGROUND
  A one-stage phase II trial was conducted to assess the tumor response rate and toxicity profile of single agent oral vinorelbine as first or second-line chemotherapy for women at least 65 years of age with metastatic breast cancer.
  
  
  METHODS
  Twenty-five patients with metastatic breast cancer aged > or = 65 years of age were enrolled to receive oral vinorelbine on a weekly basis. The oral vinorelbine was given at 60 mg/m2 weekly for the first four doses and was increased to 70 mg/m2 for the subsequent administrations if there was no grade 4 neutropenia or no more than one episode of grade 3 neutropenia. Therapy was continued until progression or intolerable toxicity.
  
  
  RESULTS
  Twenty-five patients were included and evaluable for analysis. One patient (4%) achieved a partial response (PR) that lasted for more than 13 months. Two additional patients remained stable for at least 6 months for a clinical benefit rate (PR + stable disease) of 12%. The 1-year survival rate was estimated to be 48% (95% CI 30% to 74.5%). Median time to progression was estimated to be 4.7 months (95% CI 2.0-5.5 months) and the 9-month disease progression-free rate was estimated to be 8% (95% CI 30.9% to 74.5%). The treatment was fairly well tolerated with grade 3 neutropenia in 12.5%, fatigue in 12.5% of the patients, and grade 2 neuromotor and neurosensory toxicities in 12.5% and 8.3%, respectively.
  
  
  CONCLUSIONS
  Oral vinorelbine as a single agent at these dose and schedule in this population of women > or = 65 years is well tolerated but has a low level of objective efficacy for the treatment of metastatic breast cancer.
authors.affiliation: Mayo Clinic, Jacksonville, FL 32224, USA.
authors.forename: M
authors.initials: M
authors.lastname: Baweja
authors.forename: V J
authors.initials: VJ
authors.lastname: Suman
authors.forename: T R
authors.initials: TR
authors.lastname: Fitch
authors.forename: J A
authors.initials: JA
authors.lastname: Mailliard
authors.forename: A
authors.initials: A
authors.lastname: Bernath
authors.forename: K M
authors.initials: KM
authors.lastname: Rowland
authors.forename: S R
authors.initials: SR
authors.lastname: Alberts
authors.forename: J S
authors.initials: JS
authors.lastname: Kaur
authors.forename: E A
authors.initials: EA
authors.lastname: Perez
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D005260:Female; D006801:Humans; D009362:Neoplasm Metastasis; D009503:Neutropenia / Q000139:chemically induced; D016019:Survival Analysis; D015996:Survival Rate; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000077235:Vinorelbine
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D014747:Vinblastine; D000077235:Vinorelbine