title: Oral vinorelbine for the treatment of metastatic non-small cell lung cancer in elderly patients: a phase II trial of efficacy and toxicity.
abstract: OBJECTIVE
  Before now oral vinorelbine has not yet been tested in a cohort of elderly, advanced non-small cell lung cancer patients, even though the intravenous form of this drug provides a reasonable therapeutic option for this group. This trial was conducted to determine the tumor response rate and toxicity profile of oral vinorelbine in advanced non-small cell lung cancer patients > or = 65 years of age.
  
  
  METHODS
  Fifty-eight evaluable patients > or = 65 years of age with advanced non-small cell lung cancer were enrolled. Median age was 73 years (range: 65-87). The Eastern Cooperative Oncology Group (ECOG) performance score was 0, 1, or 2 in 29, 59, and 12% of patients, respectively. All patients had adequate organ function. Oral vinorelbine 60 mg/m2 per week was prescribed weekly as first-line therapy.
  
  
  RESULTS
  Two patients manifested a confirmed tumor response, yielding a response rate of 3.4% (95% confidence interval (CI): 0.4, 11.9%). There were no complete responses. Median progression-free survival was 3.5 months (95% CI: 2.2, 5.4 months), and median overall survival was 7.5 months (95% CI: 5.0, 12 months). There were five deaths, one of which might have been treatment-related, and there were 10 grade 4 events.
  
  
  CONCLUSIONS
  Oral vinorelbine, as prescribed in this trial, provides minimal activity in the treatment of advanced non-small cell lung cancer in patients > or = 65 years of age.
authors.affiliation: Mayo Clinic and Mayo Foundation, Rochester, MN 55905, USA.
authors.forename: Anne
authors.initials: A
authors.lastname: Kanard
authors.forename: Aminah
authors.initials: A
authors.lastname: Jatoi
authors.forename: Rene
authors.initials: R
authors.lastname: Castillo
authors.forename: Susan
authors.initials: S
authors.lastname: Geyer
authors.forename: Thomas K
authors.initials: TK
authors.lastname: Schulz
authors.forename: Tom R
authors.initials: TR
authors.lastname: Fitch
authors.forename: Kendrith M
authors.initials: KM
authors.lastname: Rowland
authors.forename: Suresh
authors.initials: S
authors.lastname: Nair
authors.forename: James E
authors.initials: JE
authors.lastname: Krook
authors.forename: John W
authors.initials: JW
authors.lastname: Kugler
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D008297:Male; D009367:Neoplasm Staging; D015996:Survival Rate; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D014747:Vinblastine; D000077235:Vinorelbine