title: A phase II study of single-agent oral vinorelbine in patients with pretreated advanced non-small-cell lung cancer.
abstract: OBJECTIVE
  Intravenous vinorelbine has demonstrated its efficacy and tolerability in advanced non-small-cell lung cancer (NSCLC). An oral formulation of vinorelbine has been developed, and a number of phase II studies have shown its activity in chemotherapy-naive NSCLC, even in elderly patients, but no study has been performed to test activity and toxicity of oral vinorelbine in pretreated patients. The aims of our study were to investigate the activity and toxicity of oral vinorelbine in patients with NSCLC as salvage treatment.
  
  
  METHODS
  Twenty pretreated patients with locally advanced (n = 6) and metastatic (n = 14) NSCLC entered the study. The schedule was oral vinorelbine 60 mg/m(2) once a week until progression or development of unacceptable toxicity. Median age was 70 years (range, 49-84 years).
  
  
  RESULTS
  Seventeen patients were evaluable for response and all for toxicity. A median of 9 cycles were administered (range, 2-21 cycles). No objective responses were reported, 5 patients experienced stable disease, and 12 patients had progressive disease. Median time to progression was 2 months (range, 1-6 months), and median survival was 4 months (range, 1-13 months). Treatment was well tolerated, with grade 4 neutropenia in 1 patient (heavily pretreated); grade 2 diarrhea in 2 patients; asthenia in 2 patients; and abdominal pain in 1 patient.
  
  
  CONCLUSIONS
  Oral vinorelbine 60 mg/m(2) once a week is a very safe schedule in heavily pretreated locally advanced and metastatic NSCLC; however, at this dose, the drug is inactive. Other phase II studies with oral vinorelbine 80 mg/m(2) weekly are warranted.
authors.affiliation: Oncology Unit, S. Salvatore Hospital, Pesaro, Italy. d.rossi63@libero.it
authors.forename: David
authors.initials: D
authors.lastname: Rossi
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Catalano
authors.forename: Paolo
authors.initials: P
authors.lastname: Alessandroni
authors.forename: Anna
authors.initials: A
authors.lastname: Fedeli
authors.forename: Stefano Luzi
authors.initials: SL
authors.lastname: Fedeli
authors.forename: Paolo
authors.initials: P
authors.lastname: Giordani
authors.forename: Anna Maria
authors.initials: AM
authors.lastname: Baldelli
authors.forename: Virginia
authors.initials: V
authors.lastname: Casadei
authors.forename: Monica
authors.initials: M
authors.lastname: Ceccolini
authors.forename: Marcello
authors.initials: M
authors.lastname: Ugolini
authors.forename: Donatella
authors.initials: D
authors.lastname: Dennetta
authors.forename: Giuseppina
authors.initials: G
authors.lastname: Catalano
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000556:secondary; D002282:Adenocarcinoma, Bronchiolo-Alveolar / Q000188:drug therapy / Q000556:secondary; D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use*; D002277:Carcinoma / Q000188:drug therapy / Q000556:secondary; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000556:secondary; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000556:secondary; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control; D015996:Survival Rate; D016896:Treatment Outcome; D014747:Vinblastine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000077235:Vinorelbine
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D014747:Vinblastine; D000077235:Vinorelbine