| General information |
| Database: | DB00787 |
| Objective: | Gefitinib is a small molecule inhibitor of the epidermal growth factor receptor tyrosine kinase. they conducted a phase III trial to evaluate whether gefitinib improves survival as sequential therapy after platinumdoublet chemotherapy in patients with advanced non small cell lung cancer (non small cell lung cancer). |
| Authors: | Takeda K, et al |
| Title: | Randomizedphase III trial of platinumdoublet chemotherapy followed by gefitinib compared with continued platinumdoublet chemotherapy in Japanese patients with advanced non small cell lung cancer: results of a theyst Japan thoracic oncology group trial (WJTOG0203). |
| Journal: | J Clin Oncol. |
| Year: | 2010 |
| PMID: | 20038730 |
| 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 |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | platinumdoublet chemotherapy followed by gefitinib |
| Study Type: | Randomizedphase III trial |
| Key Patients Feature: | Chemotherapyna ve patients with advanced stage (IIIB/IV) non small cell lung cancer, Eastern Cooperative Oncology Group performance status of 0 to 1, and adequate organ function |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | platinumdoublet chemotherapy followed by gefitinib compared with continued platinumdoublet chemotherapy |
| Treatment Info: | patients were randomly assigned to either platinumdoublet chemotherapy up to six cycles (arm A) or platinumdoublet chemotherapy for three cycles followed by gefitinib 250 mg orally once daily, until disease progression (arm B). patients were stratified by disease stage, sex, histology, and chemotherapy regimens. |
| Primary End Point: | overall survival |
| Secondary End Point: | progression free survival, tumor response, safety, and quality of life. |
| Patients Number: | 604 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 29.3% for chemotherapy alone and 34.2% for chemotherapy followed by gefitinib. |
| Disease Control Rate: | 71.0% and 75.5% in arm A and in arm B, respectively (P = .22). |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 4.3 months in arm A and 4.6 months in arm B (HR, 0.68; 95% CI, 0.57 to 0.80; P < .001) |
| Median OS A vs. C: | 12.9 months for chemotherapy alone and 13.7 months for chemotherapy followed by gefitinib (hazard ratio [HR] according to Cox's regression model, 0.86; 95% CI, 0.72 to 1.03; P = .11 stratified logrank test). |
| Adverse Event(agent arm): | NA |
| Conclusions: | This trial failed to meet the primary end point of OS in patients with non small cell lung cancer. The exploratory subset analyses demonstrate a possible survival prolongation for sequential therapy of gefitinib, especially for patients with adenocarcinoma. |