| General information |
| Database: | DB00052 |
| Objective: | Non small cell lung cancer with sensitive mutations of the epidermal growth factor receptor (EGFR) is highly responsive to EGFR tyrosine kinase inhibitors such as gefitinib, but little is known about how its efficacy and safety profile compares with that of standard chemotherapy. |
| Authors: | Maemondo M, et al |
| Title: | Gefitinib or chemotherapy for non small cell lung cancer with mutated EGFR. |
| Journal: | N Engl J Med |
| Year: | 2010 |
| PMID: | 20573926 |
| Trial Design |
| Clinical Trial Id: | UMINCTR number, C000000376 |
| 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: | Phase III |
| Key Patients Feature: | EGFR mutant |
| Biomarker: | mutated EGFR; |
| Biomark Analysis: | Firstline gefitinib for patients with advanced non small cell lung cancer who were selected on the basis of EGFR mutations improved progression free survival, with acceptable toxicity, as compared with standard chemotherapy |
| Control Group Info: | Carboplatin, paclitaxel |
| Treatment Info: | Eligible patients were randomly assigned to receive either gefitinib (at a dose of 250 mg per day orally) or standard chemotherapy. The standard chemotherapy consisted of paclitaxel (at adose of 200 mg per square meter of bodysurface area, given intravenously over a 3hour period) and carboplatin (at a dose equivalent to an area underthe concentration-time curve [AUC] of 6, given intravenously over a 1hour period), both administered on the first day of every 3week cycle. |
| Primary End Point: | progression free survival |
| Secondary End Point: | overall survival, response rate, and toxic effects |
| Patients Number: | 230 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | The objective response rate was significantly higher in the gefitinib group than the chemotherapy group (73.7% vs. 30.7%, P<0.001) |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 10.8 vs. 5.4;0.3, 0.220.41; P<0.001 |
| Median OS A vs. C: | 30.5 vs 23.6;P=0.31 |
| Adverse Event(agent arm): | rash (71.1%) and elevated aminotransferase levels (55.3%) |
| Conclusions: | Firstline gefitinib for patients with advanced non small cell lung cancer who were selected on the basis of EGFR mutations improved progression free survival, with acceptable toxicity, as compared with standard chemotherapy. |