title: Oral vinorelbine: feasibility and safety profile.
abstract: BACKGROUND
  Patient preference as well as concerns and difficulties with intravenous access and pharmaco-economic issues have driven the development of oral vinorelbine.
  
  
  METHODS
  Four phase II studies were conducted in chemotherapy-naive non-small-cell lung cancer (NSCLC) and as first-line chemotherapy of advanced breast cancer (ABC). As recommended in the phase I dose-finding study, the first step used a weekly dose of 80 mg/m2. This regimen was associated with an excessive rate of early deaths (10%) due to complicated neutropenia and led to discontinuation of the first two studies. In a second step, the dose of 60 mg/m2/week was given for the first three courses and subsequently increased to 80 mg/m2/week, in the absence of severe neutropenia.
  
  
  RESULTS
  One hundred and thirty eight patients (76 with NSCLC and 62 with ABC) received this regimen, of whom only five were unable to undergo dose escalation. The incidence of febrile neutropenia and neutropenic sepsis were low (2.9 and 3.6%, respectively). Although severe events were uncommon, nausea/vomiting and diarrhoea were frequent and primary prophylaxis with antiemetics should be recommended.
  
  
  CONCLUSIONS
  Overall, the safety profile of oral vinorelbine at 60 mg/m2/week for the first three courses with escalation to 80 mg/m2 is qualitatively comparable to that of i.v. vinorelbine at standard doses. Similarly to i.v. chemotherapy, close haematological monitoring is necessary.
authors.affiliation: Department of Pneumology, Centre Hospitalier Universitaire Minjoz, Besançon, France.
authors.forename: A
authors.initials: A
authors.lastname: Depierre
authors.forename: G
authors.initials: G
authors.lastname: Freyer
authors.forename: J
authors.initials: J
authors.lastname: Jassem
authors.forename: H
authors.initials: H
authors.lastname: Orfeuvre
authors.forename: R
authors.initials: R
authors.lastname: Ramlau
authors.forename: E
authors.initials: E
authors.lastname: Lemarie
authors.forename: P
authors.initials: P
authors.lastname: Koralewski
authors.forename: L
authors.initials: L
authors.lastname: Mauriac
authors.forename: J L
authors.initials: JL
authors.lastname: Breton
authors.forename: T
authors.initials: T
authors.lastname: Delozier
authors.forename: V
authors.initials: V
authors.lastname: Trillet-Lenoir
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D004341:Drug Evaluation; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced; D012449:Safety; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D000077235:Vinorelbine
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D014747:Vinblastine; D000077235:Vinorelbine