| General information |
| Database: | DB00862 |
| Objective: | 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 (non small cell lung cancer), not progressing following standard 1stline chemotherapy |
| Authors: | Gaafar RM, et al |
| Title: | A doubleblind, randomised, placebocontrolledphase III intergroup study of gefitinib in patients with advanced non small cell lung cancer, nonprogressing after first line platinumbased chemotherapy (EORTC 08021/ILCP 01/03). |
| Journal: | Eur J Cancer. |
| Year: | 2011 |
| PMID: | 21802939 |
| Trial Design |
| Clinical Trial Id: | NCT00091156 |
| Agent: | gefitinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced non small cell lung cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | A doubleblind, randomised, placebocontrolledphase III intergroup study |
| Key Patients Feature: | Patients with advanced non small cell lung cancer, notprogressing after four cycles of platinumbased chemotherapy |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | gefitinib versus placebo |
| Treatment Info: | pts were randomised to receive either gefitinib 250mg/d or matched placebo until progression or unacceptable toxicity. |
| Primary End Point: | overall survival (OS) |
| Secondary End Point: | progression free survival (PFS) and toxicity |
| Patients Number: | 173 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 12% in the gefitinib arm versus 1% in the placebo arm (p = 0.004) |
| Disease Control Rate: | 79% in gefitinib arm compared to 66% in the placebo arm (p = 0.07) |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | in the gefitinib and placebo arms: 4.1 and 2.9months, HR=0.61, [95% CI 0.45, 0.83]), p=0.0015 |
| Median OS A vs. C: | in the gefitinib and placebo arms: 10.9 and 9.4months, HR 0.83 [95% confidence interval (95% CI) 0.601.15]; p=0.2 |
| Adverse Event(agent arm): | Most frequent grade 3-4 nonhaematological toxicities included fatigue (4.7% versus 1.2%), rash (2.4% versus 0%) and changes in transaminases (9.4% versus 1.2%) in the gefitinib and placebo arms, respectively |
| Conclusions: | Despite its premature closure, this trial confirms previous evidence that consolidation gefitinib is safe and improves PFS. Hotheyver, no difference in OS was observed in this study (NCT00091156). |