title: A randomised phase II trial of two sequential schedules of docetaxel and cisplatin followed by gemcitabine in patients with advanced non-small-cell lung cancer.
abstract: OBJECTIVE
  The aim of this study was to determine the activity and toxicity of two sequential chemotherapy regimens in the first-line treatment of advanced non-small-cell lung cancer (NSCLC).
  
  
  METHODS
  Eighty-eight chemonaive patients with stage IIIB/IV NSCLC were randomised to receive either three cycles of 75 mg/m(2) cisplatin plus 75 mg/m(2) docetaxel, both administered on day 1 every 21 days, followed by three cycles of 1,200 mg/m(2) gemcitabine on days 1 and 8 every 3 weeks (arm A), or three cycles of 25 mg/m(2) cisplatin plus 25 mg/m(2) docetaxel on days 1, 8 and 15 every 28 days, followed by three cycles of 1,200 mg/m(2) gemcitabine on days 1 and 8 every 3 weeks (arm B).
  
  
  RESULTS
  Of the evaluable patients, 61% in arm A (n = 41) and 36% (n = 44) in arm B completed treatment as per the protocol. The best tumour response rates were as follows (arm A and arm B): complete response: 2.4 and 2.3%; partial response: 39 and 20.4%; stable disease: 26.8 and 13.6%; and progressive disease: 31.8 and 45.4%. The median progression-free and overall survival were 3.9 and 12.3 months in arm A, respectively, 3.1 and 7.7 months in arm B. Grade 3-4 adverse events were more common in arm A. Grade 3-4 neutropenia was the main toxicity observed (56.1% in arm A and 11.4% in arm B).
  
  
  CONCLUSIONS
  Our data demonstrate the feasibility of a sequential approach of cisplatin plus docetaxel followed by single-agent gemcitabine. Weekly administration of platinum-docetaxel is associated with an improved safety profile but lower efficacy than the conventional three-weekly schedule (registration ID 2004-001044-72).
authors.affiliation: Istituto Nazionale per la Ricerca sul Cancro, S.S. Tumori Polmonari, Largo R. Benzi, 10, 16132 Genoa, Italy. francesco.grossi@istge.it
authors.forename: Francesco
authors.initials: F
authors.lastname: Grossi
authors.forename: Filippo
authors.initials: F
authors.lastname: de Marinis
authors.forename: Vittorio
authors.initials: V
authors.lastname: Gebbia
authors.forename: Ferdinando
authors.initials: F
authors.lastname: Riccardi
authors.forename: Orazio
authors.initials: O
authors.lastname: Caffo
authors.forename: Teresa
authors.initials: T
authors.lastname: Gamucci
authors.forename: Francesco
authors.initials: F
authors.lastname: Ferraù
authors.forename: Mario
authors.initials: M
authors.lastname: Nardi
authors.forename: Luca
authors.initials: L
authors.lastname: Moscetti
authors.forename: Luca
authors.initials: L
authors.lastname: Boni
authors.forename: Davide
authors.initials: D
authors.lastname: Dondi
authors.forename: Enzo
authors.initials: E
authors.lastname: Galligioni
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* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D007970:Leukopenia / Q000139:chemically induced; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D002945:Cisplatin; D000093542:Gemcitabine