title: Randomized multicenter phase II study of larotaxel (XRP9881) in combination with cisplatin or gemcitabine as first-line chemotherapy in nonirradiable stage IIIB or stage IV non-small cell lung cancer.
abstract: BACKGROUND
  This randomized phase II study investigated the efficacy and safety of a new taxane, larotaxel (XRP9881), in combination with either cisplatin or gemcitabine in the first-line treatment of patients with nonirradiable stage IIIB or stage IV non-small cell lung cancer to select the combination having the most promising antitumor activity.
  
  
  METHODS
  Patients received either larotaxel (50 mg/m) as a 1-hour infusion, followed by a 1-hour infusion of cisplatin (75 mg/m), every 3 weeks (arm A), or gemcitabine (800 mg/m) as a 30 minute infusion, on days 1 and 8, and larotaxel (60 mg/m) as a 1-hour infusion, on day 8 (following gemcitabine), every 3 weeks (arm B). The primary end point was the objective response rate (per-protocol population).
  
  
  RESULTS
  Thirty-two patients were randomized to arm A and 30 to arm B. The response rate was higher in arm A compared with arm B in both the per-protocol (26.7% versus 18.2%) and intention-to-treat (28.1% versus 13.3%) populations. In the intention-to-treat population, median progression-free survival for arm A versus arm B was 4.7 versus 3.3 months and median overall survival was 8.6 versus 7.3 months, respectively. Fifty percent of patients in arm A and 66.7% in arm B experienced at least one National Cancer Institute common toxicity criteria grade 3/4 adverse event and grade 3/4 neutropenia was observed in 46.9% and 41.4% of patients, respectively.
  
  
  CONCLUSIONS
  Both larotaxel combinations were effective and manageable, however all measured efficacy parameters (response rate, progression free survival, and survival) seemed to favor the combination with cisplatin.
authors.affiliation: Department of Pneumology and Thoracic Surgery, 3rd Faculty of Medicine, Charles University, Faculty Hospital Bulovka and Postgraduate Medical School, Praha, Czech Republic.
authors.forename: Petr
authors.initials: P
authors.lastname: Zatloukal
authors.forename: Radj
authors.initials: R
authors.lastname: Gervais
authors.forename: Johan
authors.initials: J
authors.lastname: Vansteenkiste
authors.forename: Léon
authors.initials: L
authors.lastname: Bosquee
authors.forename: Christiana
authors.initials: C
authors.lastname: Sessa
authors.forename: Etienne
authors.initials: E
authors.lastname: Brain
authors.forename: Eric
authors.initials: E
authors.lastname: Dansin
authors.forename: Thierry
authors.initials: T
authors.lastname: Urban
authors.forename: Nadine
authors.initials: N
authors.lastname: Dohollou
authors.forename: Michèle
authors.initials: M
authors.lastname: Besenval
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Quoix
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D000093542:Gemcitabine
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D002945:Cisplatin; C531079:larotaxel; D000093542:Gemcitabine