title: Phase II study of vinorelbine in patients with pretreated advanced ovarian cancer: activity in platinum-resistant disease.
abstract: OBJECTIVE
  The aim of the study was to evaluate the activity of vinorelbine (VNLB) in a population of advanced ovarian cancer patients, with particular attention to defining its role in platinum-resistant disease.
  
  
  METHODS
  Thirty-three patients were recruited and treated with VNLB 25 mg/m2 intravenously (IV) weekly. the median age was 53 years, performance status 0 to 2, and number of previous chemotherapy regimens two (range, one to five). Twenty-four patients were platinum-resistant; the remaining nine either were platinum-sensitive (four cases) or had undetermined sensitivity (five cases).
  
  
  RESULTS
  The mean delivered dose-intensity of VNLB was 67% of the planned level, because 60% of the cycles were delayed due to neutropenia or anemia. Four partial responses (PRs) and one complete response (CR) were observed, for an overall response rate of 15% (95% exact confidence interval, 5.1% to 31.9%). All the responses occurred in the subgroup of 24 platinum-resistant cases, in whom the response rate was 21% (95% exact confidence interval, 7.1% to 42.1%). Seven patients became stabilized on VNLB, and 27% of the cases showed a reduction in serum cancer antigen 125 (CA 125) levels. G3/G4 side effects consisted of neutropenia, anemia, and worsening of preexisting peripheral neuropathy. No treatment-related deaths occurred.
  
  
  CONCLUSIONS
  VNLB led to a 21% response rate in the population of heavily pretreated and platinum-resistant ovarian cancer patients. Further studies of VNLB alone or in combination with taxanes are warranted in patients with less pretreatment.
authors.affiliation: Division of Medical Oncology B, Istituto Nazionale per lo Studio e la Cura dei Tumori, Milano, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Bajetta
authors.forename: A
authors.initials: A
authors.lastname: Di Leo
authors.forename: L
authors.initials: L
authors.lastname: Biganzoli
authors.forename: L
authors.initials: L
authors.lastname: Mariani
authors.forename: F
authors.initials: F
authors.lastname: Cappuzzo
authors.forename: M
authors.initials: M
authors.lastname: Di Bartolomeo
authors.forename: N
authors.initials: N
authors.lastname: Zilembo
authors.forename: S
authors.initials: S
authors.lastname: Artale
authors.forename: E
authors.initials: E
authors.lastname: Magnani
authors.forename: L
authors.initials: L
authors.lastname: Celio
authors.forename: R
authors.initials: R
authors.lastname: Buzzoni
authors.forename: C
authors.initials: C
authors.lastname: Carnaghi
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D018394:CA-125 Antigen / Q000032:analysis; D004351:Drug Resistance; D005260:Female; D006801:Humans; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000175:diagnosis / Q000188:drug therapy*; D017671:Platinum Compounds / Q000627:therapeutic use*; D014747:Vinblastine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000077235:Vinorelbine
chemical_list: D000970:Antineoplastic Agents; D018394:CA-125 Antigen; D017671:Platinum Compounds; D014747:Vinblastine; D000077235:Vinorelbine