| General information |
| Database: | DB00051 |
| Objective: | Previous, uncontrolled studies have suggested that firstline treatment with gefitinib would be efficacious in selected patients with non small cell lung cancer. |
| Authors: | Mok TS, et al |
| Title: | Gefitinib or carboplatinpaclitaxel in pulmonary adenocarcinoma. |
| Journal: | N Engl J Med |
| Year: | 2009 |
| PMID: | 19692680 |
| Trial Design |
| Clinical Trial Id: | NCT00322452 |
| Agent: | gefitinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | advanced solid tumors |
| Cancer Subtype: | advanced non small cell lung cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | Phase III The Iressa PanAsia Study (IPASS) |
| Key Patients Feature: | Adenocarcinoma, Asian, never or light smokers(NSLAs:neversmokers with lung adenocarcinoma) |
| Biomarker: | EFGR mutated |
| Biomark Analysis: | The presence in the tumor of a mutation of the EGFR gene is a strong predictor of a better outcome with gefitinib |
| Control Group Info: | Carboplatin, paclitaxel |
| Treatment Info: | they randomly assigned previously untreated patients in East Asia who had advanced pulmonary adenocarcinoma and who were nonsmokers or former light smokers to receive gefitinib (250 mg per day) (609 patients) or carboplatin (at a dose calculated to produce an area under the curve of 5 or 6 mg per milliliter per minute) plus paclitaxel (200 mg per square meter of bodysurface area) (608 patients). |
| Primary End Point: | progression free survival. |
| Secondary End Point: | NA |
| Patients Number: | 1217 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | The objective response rate in the overall population was significantly higher with gefitinib than with carboplatin-paclitaxel (43.0% vs. 32.2%; odds ratio, 1.59; 95% CI, 1.25 to 2.01; P<0.001) |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 9.8 vs 6.4;0.48, 0.650.85; P<0.001 |
| Median OS A vs. C: | OS (954 deaths).HR=0.90; 95% CI, 0.79 to 1.02; P = .109 |
| Adverse Event(agent arm): | rash or acne (in 66.2% of patients) and diarrhea (46.6%) in group A |
| Conclusions: | Gefitinib is superior to carboplatinpaclitaxel as an initial treatment for pulmonary adenocarcinoma among nonsmokers or former light smokers in East Asia. The presence in the tumor of a mutation of the EGFR gene is a strong predictor of a better outcome with gefitinib. |