title: Vinorelbine-based chemotherapy in hormone-refractory prostate cancer.
abstract: BACKGROUND
  No consensus exists regarding further therapy for the management of hormone-refractory prostate cancer. In this phase II study, the combination of Vinorelbine with 5-Fluorouracil and folinic acid (FLN regimen) was evaluated in patients with progressive or resistant disease after hormone therapy.
  
  
  METHODS
  Thirty-four patients were treated with Vinorelbine at a dose of 20 mg/m2 intravenously (i.v.) on days 1 and 3, folinic acid (FA), 100 mg/m2 i.v. and 5-Fluorouracil (5-FU), 350 mg/m2 i.v. as a short infusion on days 1 to 3. The therapy was given in an out-patient setting, every 3 weeks.
  
  
  RESULTS
  All of the 34 eligible patients were evaluable for toxicity and 30 for activity. A total of 127 cycles was administered (91% at full dose). Among thelS5 patients with measurable disease, four had a partial response (26.6%; C.I. 95%, 28.3% to 65.7%) and four achieved stable disease. In 14 patients (47%) a clinical benefit was documented. Six out of 15 patients with bone-only involvement had stable disease (40%). The median duration of stabilization and partial response was 16 weeks (range 4-24 weeks). The most common toxicity was hematological: Grade 4 (NCI-CTC scale) in five patients at re-cycle. Other toxicities were of low incidence and easy to manage.
  
  
  CONCLUSIONS
  The encouraging results obtained with the FLN regimen in terms of clinical benefit and its predictable and manageable toxicity support the palliative role of this chemotherapeutic strategy in hormone-refractory prostate patients.
authors.affiliation: Department of Medicine, European Institute of Oncology, 20141 Milan, Italy.
authors.forename: M G
authors.initials: MG
authors.lastname: Zampino
authors.forename: E
authors.initials: E
authors.lastname: Verri
authors.forename: M
authors.initials: M
authors.lastname: Locatelli
authors.forename: G
authors.initials: G
authors.lastname: Curigliano
authors.forename: G
authors.initials: G
authors.lastname: Ascione
authors.forename: A
authors.initials: A
authors.lastname: Sbanotto
authors.forename: A
authors.initials: A
authors.lastname: Rocca
authors.forename: F
authors.initials: F
authors.lastname: Verweij
authors.forename: V
authors.initials: V
authors.lastname: Matei
authors.forename: E
authors.initials: E
authors.lastname: Scardino
authors.forename: O
authors.initials: O
authors.lastname: Decobelli
authors.forename: A
authors.initials: A
authors.lastname: Goldhirsch
authors.forename: F
authors.initials: F
authors.lastname: Nolè
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy*; D000368:Aged; D018931:Antineoplastic Agents, Hormonal / Q000494:pharmacology; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D011471:Prostatic Neoplasms / Q000188:drug therapy*; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D018931:Antineoplastic Agents, Hormonal; D014747:Vinblastine; D002955:Leucovorin; D000077235:Vinorelbine; D005472:Fluorouracil