title: Ifosfamide and vinorelbine as first-line chemotherapy for metastatic breast cancer.
abstract: OBJECTIVE
  To evaluate the efficacy and toxicity of the combination of ifosfamide (IFX) and vinorelbine (VNB) as first-line chemotherapy in metastatic breast cancer (MBC).
  
  
  METHODS
  Between August 1993 and August 1995, 45 patients with untreated MBC received a regimen that consisted of IFX 2 g/m2 by 1-hour intravenous (i.v.) infusion on days 1 to 3, mesna 400 mg/m2 by i.v. bolus at hours 0 and 4 and 800 mg/m2 orally at hour 8 on days 1 to 3, and VNB 35 mg/m2 by 20-minute i.v. infusion on days 1 and 15. Courses were repeated every 28 days. During the first course only, half-dose VNB (17.5 mg/m2) was administered on days 8 and 22. The median age was 53 years and 30 patients (67%) were postmenopausal. Dominant sites of disease were soft tissue in nine patients, bone in seven, and visceral in 29.
  
  
  RESULTS
  Objective responses (ORs) were recorded in 25 of 43 assessable patients (58%; 95% confidence interval, 43% to 73%). Complete remissions (CRs) occurred in six patients (14%) and partial remissions (PRs) in 19 (44%). No change (NC) was recorded in 10 patients (23%) and progressive disease (PD) in eight patients (19%). The median time to treatment failure was 12 months and the median survival duration 19 months. Myelosuppression was the limiting toxicity, mainly leukopenia in 32 patients (74%). In contrast, anemia and thrombocytopenia were mild. Other significant toxicities included peripheral neuropathy in nine patients (21%), constipation in 15 (35%), and myalgias in 11 (26%).
  
  
  CONCLUSIONS
  IFX/VNB is an active combination against MBC with moderate toxicity and deserves further evaluation.
authors.affiliation: Grupo Oncológico Cooperativo del Sur, Neuquén, República Argentina. 70501-1204@Compuserve.com
authors.forename: B A
authors.initials: BA
authors.lastname: Leone
authors.forename: C T
authors.initials: CT
authors.lastname: Vallejo
authors.forename: A O
authors.initials: AO
authors.lastname: Romero
authors.forename: J E
authors.initials: JE
authors.lastname: Perez
authors.forename: M A
authors.initials: MA
authors.lastname: Cuevas
authors.forename: J A
authors.initials: JA
authors.lastname: Lacava
authors.forename: C L
authors.initials: CL
authors.lastname: Sabatini
authors.forename: M E
authors.initials: ME
authors.lastname: Dominguez
authors.forename: R
authors.initials: R
authors.lastname: Rodriguez
authors.forename: M R
authors.initials: MR
authors.lastname: Barbieri
authors.forename: E H
authors.initials: EH
authors.lastname: Ortiz
authors.forename: M A
authors.initials: MA
authors.lastname: Salvadori
authors.forename: L A
authors.initials: LA
authors.lastname: Acuña
authors.forename: J M
authors.initials: JM
authors.lastname: Acuña
authors.forename: M J
authors.initials: MJ
authors.lastname: Langhi
authors.forename: S
authors.initials: S
authors.lastname: Amato
authors.forename: M R
authors.initials: MR
authors.lastname: Machiavelli
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy / Q000473:pathology*; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011446:Prospective Studies; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D000077235:Vinorelbine; D007069:Ifosfamide