| General information |
| Database: | DB00756 |
| Objective: | Thisphase III study (V1532) compared gefitinib (250 mg/d) with docetaxel (60 mg/m(2)) in patients (N = 489) with advanced/metastatic non small cell lung cancer (non small cell lung cancer) who had failed one or two chemotherapy regimens. |
| Authors: | Maruyama R, et al |
| Title: | Phase III study, V1532, of gefitinib versus docetaxel in previously treated Japanese patients with non small cell lung cancer. |
| Journal: | J Clin Oncol. |
| Year: | 2008 |
| PMID: | 18779611 |
| Trial Design |
| Clinical Trial Id: | NCT00252707 |
| Agent: | gefitinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | non small cell lung cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | Phase III study (VI5IIIII) |
| Key Patients Feature: | patients (N = 489) with advanced/metastatic non small cell lung cancer (non small cell lung cancer) who had failed one or two chemotherapy regimens. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | gefitinib versus docetaxel |
| Treatment Info: | An unadjusted Cox regression model was used for the primary analysis. |
| Primary End Point: | compare overall survival to demonstrate noninferiority for gefitinib relative to docetaxel. |
| Secondary End Point: | NA |
| Patients Number: | 489 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | gefitinib was statistically superior to docetaxel (22.5% v 12.8%; odds ratio, 2.14; 95% CI, 1.21 to 3.78; P = .009) |
| Disease Control Rate: | 34.0% v 33.2%; odds ratio, 1.08; 95% CI, 0.69 to 1.68; P = .735 |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | median PFS was 2.0 months with both treatments |
| Median OS A vs. C: | The median survival and the 1year survival rates were 11.5 months and 47.8%, respectively, for gefitinib and were 14.0 months and 53.7%, respectively, for docetaxel. |
| Adverse Event(agent arm): | The most common AEs with gefitinib were rash/acne (76.2%) and diarrhea (51.6%), and the most common AEs with docetaxel were neutropenia (79.5%) and alopecia (59.4%; Table 4). There was a higher incidence of grades 3 to 4 neutropenia with docetaxel (73.6%) compared with gefitinib (8.2%). Interstitial lung disease events occurred in 5.7% (n = 14) and 2.9% (n = 7) of patients who received gefitinib and docetaxel, respectively (Table 3). |
| Conclusions: | Noninferiority in overall survival bettheyen gefitinib and docetaxel was not demonstrated according to predefined criteria; hotheyver, there was no statistically significant difference in overall survival. Secondary end points showed similar or superior efficacy for gefitinib compared with docetaxel. Gefitinib remains an effective treatment option for previously treated Japanese patients with non small cell lung cancer. |