title: A double-blind, randomised, placebo-controlled phase III intergroup study of gefitinib in patients with advanced NSCLC, non-progressing after first line platinum-based chemotherapy (EORTC 08021/ILCP 01/03).
abstract: BACKGROUND
  EORTC study 08021/ILCP 01/03 evaluated the role of consolidation gefitinib, an oral tyrosine kinase inhibitor (TKI), administered in patients with advanced non-small cell lung cancer (NSCLC), not progressing following standard 1st-line chemotherapy.
  
  
  METHODS
  Patients with advanced NSCLC, not-progressing after four cycles of platinum-based chemotherapy, were randomised to receive either gefitinib 250mg/d or matched placebo until progression or unacceptable toxicity. The primary end-point was overall survival (OS). Secondary end-points were progression-free survival (PFS) and toxicity. The study was powered to detect a 28% increase in OS from a median of 11-14.1months (HR=0.78) and planned to randomise 598 patients to observe 514 deaths.
  
  
  RESULTS
  After inclusion of 173 patients, the trial was prematurely closed due to low accrual. Baseline characteristics for gefitinib (n=86) and placebo (n=87) arms were well balanced. After a median follow up of 41months, the difference in median OS in the gefitinib and placebo arms was not statistically significant (10.9 and 9.4months, HR 0.83 [95% confidence interval (95% CI) 0.60-1.15]; p=0.2). The difference in median PFS significantly favoured gefitinib (4.1 and 2.9months, HR=0.61, [95% CI 0.45, 0.83]), p=0.0015). Adverse events reported in more than 10% of patients were rash (47% with gefitinib versus 13% with placebo) and diarrhoea (34% with gefitinib versus13% with placebo).
  
  
  CONCLUSIONS
  Despite its premature closure, this trial confirms previous evidence that consolidation gefitinib is safe and improves PFS. However, no difference in OS was observed in this study (NCT00091156).
authors.affiliation: National Cancer Institute, Cairo University, Cairo, Egypt. rababgaafar@link.net
authors.forename: Rabab M
authors.initials: RM
authors.lastname: Gaafar
authors.forename: Veerle F
authors.initials: VF
authors.lastname: Surmont
authors.forename: Giorgio V
authors.initials: GV
authors.lastname: Scagliotti
authors.forename: Rob J
authors.initials: RJ
authors.lastname: Van Klaveren
authors.forename: Demetris
authors.initials: D
authors.lastname: Papamichael
authors.forename: John J
authors.initials: JJ
authors.lastname: Welch
authors.forename: Baktiar
authors.initials: B
authors.lastname: Hasan
authors.forename: Valter
authors.initials: V
authors.lastname: Torri
authors.forename: Jan P
authors.initials: JP
authors.lastname: van Meerbeeck
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000201:enzymology / Q000401:mortality / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D004311:Double-Blind Method; D057239:Early Termination of Clinical Trials; D066246:ErbB Receptors / Q000037:antagonists & inhibitors / Q000378:metabolism; D005060:Europe; D005260:Female; D000077156:Gefitinib; D006801:Humans; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000201:enzymology / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D047428:Protein Kinase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011799:Quinazolines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D047428:Protein Kinase Inhibitors; D011799:Quinazolines; D016190:Carboplatin; C512478:EGFR protein, human; D066246:ErbB Receptors; D002945:Cisplatin; D000077156:Gefitinib