title: An ELCWP phase III trial comparing ifosfamide and cisplatin regimens in advanced NSCLC.
abstract: OBJECTIVE
  While meta-analyses and clinical trials show improved survival in advanced NSCLC treated with platinum-containing chemotherapy, there are few data concerning front-line platinum-free ifosfamide-based regimens. We aimed to compare cisplatin-based chemotherapy to ifosfamide-gemcitabine (IG) with pre-defined second-line docetaxel.
  
  
  METHODS
  693 Untreated advanced inoperable NSCLC cases were randomised to either GIP (gemcitabine, ifosfamide, cisplatin), DP (docetaxel, cisplatin) or IG. Primary outcome was overall survival.
  
  
  RESULTS
  Median age of the patients was 58 years with a predominance of males (75%), adenocarcinoma (56%), Karnofsky PS 80-100 (77%) and stage-IV disease (81%). Median survival times were 8.7, 8.8 and 8.3 months for IG, GIP and DP (p=0.79). GIP presented with (p<0.05) greater neutropenia, thrombopenia, vomiting, while greater cardiotoxicity, diarrhea, peripheral neuropathy were observed for DP and encephalopathy for IG.
  
  
  CONCLUSIONS
  In advanced NSCLC, cisplatin-based CT is not superior to a platinum-free regimen (ifosfamide-gemcitabine) with a favourable toxicity profile.
authors: Institut Jules Bordet, Rue Héger-Bordet, 1, B-1000 Brussels, Belgium. thierry.berghmans@bordet.be.
authors: Thierry
authors: T
authors: Berghmans
authors: Jean-Jacques
authors: JJ
authors: Lafitte
authors: Arnaud
authors: A
authors: Scherpereel
authors: Marianne
authors: M
authors: Paesmans
authors: Jacques
authors: J
authors: Lecomte
authors: Vicente Giner
authors: VG
authors: Marco
authors: Anne-Pascale
authors: AP
authors: Meert
authors: Nathalie
authors: N
authors: Leclercq
authors: Jean-Paul
authors: JP
authors: Sculier
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage / Q000627:therapeutic use*; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis
chemical_list: D002945:Cisplatin; D007069:Ifosfamide
keywords: Non-small cell lung cancer; cisplatin; docetaxel; ifosfamide; phase III trial; survival