title: Cisplatin-vinorelbine combination chemotherapy in locally advanced non-small cell lung cancer.
abstract: OBJECTIVE
  The North Milan Group presents the results of a phase II study on a cisplatin-vinorelbine combination schedule in the treatment of locally advanced non-small cell lung cancer to evaluate its activity and tolerability.
  
  
  METHODS
  Seventy-six consecutive patients entered the study. Patients' characteristics were the following: males/females 69/7; median age, 61.4 years (range, 40-73); ECOG performance status, 0-1; 17 stage IIIa and 59 stage IIIb. There were 49 squamous cell carcinomas, 20 adenocarcinomas, and 7 large cell carcinomas. All patients had not been previously treated and showed measureable disease. Treatment consisted of vinorelbine, 25 mg/m2 on days 1 and 8, plus cisplatin, 80 mg/m2 on day 1, administered intravenously every 21 days for three standard courses.
  
  
  RESULTS
  Seventy-four patients were evaluable for response. Objective responses were documented in 42/74 patients with an overall response rate (CR+PR) of 56.7%; 18/74 patients (24.3%) showed stable disease and the remaining 14/74 (18.9%) went into progression. Twelve patients (16.2%) were suitable for a subsequent surgery. The median duration of response was 13.3 months. Survival time ranged from 4 to 36 months; it was 14.6 months for PR patients, 8.6 months for NC and 5 months for PD. Mean survival time is presently 12.85 months (SE, 1.2 months). Toxicity evaluated on 222 cycles administered was acceptable, and it was necessary to use G-CSF or delay the treatment because of severe leukopenia in only a few cases.
  
  
  CONCLUSIONS
  The regimen is active and safe: the slight survival increase is likely due to the small amenability to surgery achieved (16.2%). However, our results are fully comparable to others obtained with vinorelbine in two/three drug combination chemotherapy regimens.
authors.affiliation: Oncology Department, San Paolo Hospital, Milano, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Frontini
authors.forename: P
authors.initials: P
authors.lastname: Candido
authors.forename: M T
authors.initials: MT
authors.lastname: Cattaneo
authors.forename: S
authors.initials: S
authors.lastname: Zonato
authors.forename: E
authors.initials: E
authors.lastname: Piatto
authors.forename: R
authors.initials: R
authors.lastname: Scapaticci
authors.forename: L
authors.initials: L
authors.lastname: Isa
authors.forename: A
authors.initials: A
authors.lastname: Raina
authors.forename: V
authors.initials: V
authors.lastname: Lanzetti
authors.forename: G
authors.initials: G
authors.lastname: Pavia
authors.forename: W
authors.initials: W
authors.lastname: Legnani
authors.forename: V
authors.initials: V
authors.lastname: Filipazzi
authors.forename: B
authors.initials: B
authors.lastname: Rho
authors.forename: E
authors.initials: E
authors.lastname: Piazza
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D015996:Survival Rate; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine