| General information |
| Database: | DB00789 |
| Objective: | The purpose of this study was to evaluate the efficacy of gefitinib and the feasibility of screening for epidermal growth factor receptor (EGFR) mutations among select patients with advanced non small cell lung cancer (non small cell lung cancer). |
| Authors: | Tamura K, et al |
| Title: | Multicentre prospectivephase II trial of gefitinib for advanced non small cell lung cancer with epidermal growth factor receptor mutations: results of the theyst Japan Thoracic Oncology Group trial (WJTOG0403). |
| Journal: | Br J Cancer. |
| Year: | 2008 |
| PMID: | 18283321 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | gefitinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced non small cell lung cancer harboring epidermal growth factor receptor mutations |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | Multicentre prospectivephase II trial |
| Key Patients Feature: | Stage IIIB/IV non small cell lung cancer, chemotherapynaive patients or patients with recurrences after up to two prior chemotherapy regimens were eligible. |
| Biomarker: | Direct sequencing using DNA from tumour specimens was performed by a central laboratory to detect EGFR mutations. |
| Biomark Analysis: | the benefit to patients of selecting gefitinib treatment based on their EGFR mutation status has been demonstrated |
| Control Group Info: | single arm |
| Treatment Info: | Patients harbouring EGFR mutations received gefitinib |
| Primary End Point: | response; |
| Secondary End Point: | toxicity, overall survival (OS), progression free survival (PFS), 1year survival (1YS) and the disease control rate (DCR). |
| Patients Number: | 118 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 75% |
| Disease Control Rate: | 96% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 11.5 months (95% CI: 7.3 months to ) |
| Median OS A vs. C: | median OS has not yet been reached, and the 1YS was 79%. |
| Adverse Event(agent arm): | The most frequent adverse events were rash, dry skin, diarrhoea, stomatitis and elevated AST/ALT levels. |
| Conclusions: | gefitinib chemotherapy in patients with advanced non small cell lung cancer harbouring EGFR mutations was highly effective. This trial documents the feasibility of performing a multicentrephase II study using a central typing laboratory, demonstrating the benefit to patients of selecting gefitinib treatment based on their EGFR mutation status. |