title: A phase I study of UFT-oral vinorelbine in metastatic breast cancer.
abstract: BACKGROUND
  Despite current treatment options, metastatic breast cancer (MBC) remains essentially incurable, requiring research on new drugs or combinations to improve survival and quality of life.
  
  
  METHODS
  This phase I study was designed to define the maximum-tolerated dose (MTD), dose-limiting toxicity (DLT) and recommended dose of all-oral tegafur-uracil (UFT)/folinic acid combined with vinorelbine as chemotherapy for MBC. Starting doses were 40 mg/m(2)/week of oral vinorelbine administered continuously and 250 mg/m(2)/day of UFT plus 90 mg/day of folinic acid from day 1 to day 28, followed by a 1-week rest period.
  
  
  RESULTS
  Ten patients were included. Eight were evaluable for toxicity and antitumor response. The second dose level was shown to be the MTD. At this dose, 2 out of 5 patients receiving oral vinorelbine at 40 mg/m(2)/week and UFT at 300 mg/m(2)/day developed DLT consisting of grade 3 asthenia and grade 3 nausea despite standard prophylaxis. Other toxicities were grade 1 diarrhea and anemia. There were no treatment-related deaths.
  
  
  CONCLUSIONS
  The recommended dose for this combination seems to be the first dose level. A stable response was observed for 6 patients (average 33 weeks). This combination appears to be well-tolerated and offers an alternative to intravenous chemotherapy.
authors.affiliation: Department of Medical Oncology, Centre Antoine Lacassagne, Nice, France.
authors.forename: J M
authors.initials: JM
authors.lastname: Ferrero
authors.forename: R
authors.initials: R
authors.lastname: Largillier
authors.forename: C
authors.initials: C
authors.lastname: Michel
authors.forename: V
authors.initials: V
authors.lastname: Amiot
authors.forename: G
authors.initials: G
authors.lastname: Milano
authors.forename: C
authors.initials: C
authors.lastname: Hébert
authors.forename: V
authors.initials: V
authors.lastname: Mari
authors.forename: A
authors.initials: A
authors.lastname: Courdi
authors.forename: A
authors.initials: A
authors.lastname: Figl
authors.forename: P
authors.initials: P
authors.lastname: Follana
authors.forename: J
authors.initials: J
authors.lastname: Barrière
authors.forename: E
authors.initials: E
authors.lastname: Chamorey
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009362:Neoplasm Metastasis; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects; D014498:Uracil / Q000008:administration & dosage / Q000009:adverse effects; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D005641:Tegafur; D014498:Uracil; D014747:Vinblastine; D002955:Leucovorin; D000077235:Vinorelbine