title: Carboplatin, vindesine, 5-fluorouracil-leucovorin and 13-cis retinoic acid in the treatment of advanced non-small cell lung cancer. A phase II study.
abstract: OBJECTIVE
  Carboplatin, vindesine and 5-fluorouracil/leucovorin are drugs active in the treatment of non-small cell lung cancer (NSCLC) and they can be administered in an outpatient setting. Retinoids, which are widely used agents in chemoprevention, have been reported to exert (in vitro models) growth inhibitory effects of synergistic type with chemotherapy, and differentiating effects on NSCLC cells.
  
  
  METHODS
  28 patients with advanced NSCLC with measurable disease were entered into the trial. Eligibility criteria included performance status < or = 3 and adequate renal and liver function. Patients with brain metastases were not excluded. Treatment was as follows: Carboplatin (CBCDA) 300 mg/m2 day 1, Vindesine (VDS) 3 mg/m2 days 1 and 5, leucovorin (L) 100 mg/m2, 5-fluorouracil (5-FU) 370 mg/m2 for 5 days and 13-cis retinoic acid (R) 1 mg/kg, administered between chemotherapy courses. After 6 courses of chemotherapy responders were maintained with R, until progression.
  
  
  RESULTS
  120 courses of chemotherapy have been delivered (median 4 courses per patient, range 1 to 6). All patients were evaluable for response and toxicity. Objective responses: 2 complete responses (CR) (7%), 9 partial responses (PR) (32%), 9 stable disease (SD) (32%), 8 progressive disease (PD) (29%). (Response rate 39%, 95% CI: 22% to 60%). Median time to progression was 7.7 months (range 3.4-22) and median survival was 9.7 months (range 0.5-27) with 40% of patients alive after one year. Toxicity WHO: hematological grade 3-4 in 46% of patients, grade 2 diarrhea in 21% of patients, ileus in 14% of patients, Neurologic grade 2 in 11% of patients.
  
  
  CONCLUSIONS
  The addition of RA to CBDCA, VDS, FU, L, R represents an effective treatment in NSCLC, with manageable toxicity.
authors.affiliation: Divisione di Oncologia, Ospedale Civile di Avezzano, Italy. franre@ermes.it
authors.forename: F
authors.initials: F
authors.lastname: Recchia
authors.forename: S
authors.initials: S
authors.lastname: De Filippis
authors.forename: P L
authors.initials: PL
authors.lastname: Pompili
authors.forename: M
authors.initials: M
authors.lastname: Rosselli
authors.forename: G
authors.initials: G
authors.lastname: Saggio
authors.forename: A
authors.initials: A
authors.lastname: Ciorra
authors.forename: M
authors.initials: M
authors.lastname: Piccinini
authors.forename: S
authors.initials: S
authors.lastname: Rea
mesh_terms: D000818:Animals; D000970:Antineoplastic Agents / Q000627:therapeutic use* / Q000633:toxicity; D016190:Carboplatin / Q000627:therapeutic use* / Q000633:toxicity; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use* / Q000633:toxicity; D006801:Humans; D015474:Isotretinoin / Q000627:therapeutic use* / Q000633:toxicity; D002955:Leucovorin / Q000627:therapeutic use / Q000633:toxicity; D008175:Lung Neoplasms; D008297:Male; D008875:Middle Aged; D018675:Toxicity Tests; D014751:Vindesine / Q000627:therapeutic use* / Q000633:toxicity; D014944:World Health Organization
chemical_list: D000970:Antineoplastic Agents; D016190:Carboplatin; D015474:Isotretinoin; D002955:Leucovorin; D014751:Vindesine; D005472:Fluorouracil