title: A phase III randomised trial comparing sequential chemotherapy using cisplatin-based regimen and paclitaxel to cisplatin-based chemotherapy alone in advanced non-small-cell lung cancer.
abstract: BACKGROUND
  The purpose of this study is to determine whether in advanced non-small-cell lung cancer (NSCLC), the sequential administration of cisplatin-based chemotherapy and paclitaxel (Taxol) is superior to a cisplatin-based chemotherapy, followed by paclitaxel as salvage treatment.
  
  
  METHODS
  A total of 485 chemotherapy naive patients with advanced NSCLC were treated with three courses of GIP (gemcitibine + ifosfamide + cisplatin), consisting of cisplatin 50 mg/m(2) on day 1, ifosfamide 3 g/m(2) on day 1 and gemcitabine 1 g/m(2) on days 1 and 8. Patients with nonprogressive disease were then randomised to further similar courses of GIP or courses of paclitaxel (225 mg/m(2) over 3 h every 3 weeks).
  
  
  RESULTS
  Objective response or nonprogression after induction GIP occurred in 174 and 115 patients, respectively. After randomisation, there were 140 patients in the GIP arm and 141 in the paclitaxel arm. In terms of postrandomisation survival, there was no statistically significant difference (P = 0.17) between the two arms. Median times were 9.7 [95% confidence interval (CI) 7.8-11.6] and 11.9 (95% CI 9.4-14.3) months for paclitaxel and GIP, respectively. Multivariate analysis demonstrated that sex and haemoglobin were independent prognostic factors. After adjustment for these factors, the observed hazard ratio was 0.81 (95% CI 0.63-1.04) in favour of GIP (P = 0.10). Toxicity was tolerable; there was a significantly higher rate of grades III/IV thrombocytopenia with GIP and more alopecia with paclitaxel.
  
  
  CONCLUSIONS
  Sequential chemotherapy using cisplatin-based regimen followed by paclitaxel does not result in better outcome than cisplatin-based chemotherapy using taxane as salvage treatment.
authors.affiliation: Institut Jules Bordet, Department of Intensive Care and Thoracic Oncology, Brussels, Belgium. sculier@bordet.be
authors.forename: J P
authors.initials: JP
authors.lastname: Sculier
authors.forename: J J
authors.initials: JJ
authors.lastname: Lafitte
authors.forename: J
authors.initials: J
authors.lastname: Lecomte
authors.forename: C G
authors.initials: CG
authors.lastname: Alexopoulos
authors.forename: O
authors.initials: O
authors.lastname: Van Cutsem
authors.forename: V
authors.initials: V
authors.lastname: Giner
authors.forename: A
authors.initials: A
authors.lastname: Efremidis
authors.forename: M C
authors.initials: MC
authors.lastname: Berchier
authors.forename: T
authors.initials: T
authors.lastname: Collon
authors.forename: A P
authors.initials: AP
authors.lastname: Meert
authors.forename: A
authors.initials: A
authors.lastname: Scherpereel
authors.forename: V
authors.initials: V
authors.lastname: Ninane
authors.forename: M
authors.initials: M
authors.lastname: Paesmans
authors.forename: T
authors.initials: T
authors.lastname: Berghmans
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000627:therapeutic use*; D016019:Survival Analysis; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000970:Antineoplastic Agents; D003841:Deoxycytidine; D017239:Paclitaxel; D002945:Cisplatin; D007069:Ifosfamide; D000093542:Gemcitabine