| General information |
| Database: | DB00753 |
| Objective: | This study was undertaken to investigate the efficacy and the feasibility of gefitinib for chemotherapyna ve patients with advanced non small cell lung cancer (non small cell lung cancer) harboring epidermal growth factor receptor (EGFR) mutations. |
| Authors: | Inoue A, et al |
| Title: | Prospectivephase II study of gefitinib for chemotherapynaive patients with advanced non small cell lung cancer with epidermal growth factor receptor gene mutations. |
| Journal: | J Clin Oncol. |
| Year: | 2006 |
| PMID: | 16785471 |
| 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: | Prospectivephase II study |
| Key Patients Feature: | The EGFR gene status in various tumor samples obtained from chemotherapyna ve advanced non small cell lung cancer patients |
| Biomarker: | epidermal growth factor receptor (EGFR) mutations |
| Biomark Analysis: | EGFR mutations were significantly frequent in females (P < .01) and never or light smokers (P < .001). Sixteen patients with EGFR mutations were enrolled onto the study. |
| Control Group Info: | single arm |
| Treatment Info: | Patients harboring EGFR mutations received gefitinib (250 mg/d) alone. |
| Primary End Point: | The response rate, progression free survival (PFS), and toxicity profile were assessed prospectively. |
| Secondary End Point: | NA |
| Patients Number: | 16 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 75% (95% CI, 54% to 96%) |
| Disease Control Rate: | 88% (95% CI, 71% to 100%) |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 9.7 months (95% CI, 7.4 to 9.9 months) |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | The most frequent AEs seen in this study were grade 1 to 2 skin rash, stomatitis, and diarrhea (Table 6). Two patients experienced grade 2 skin rash, and one of these patients also suffered from grade 2 nail changes. Although one patient suffered from grade 3 elevation of hepatic enzyme, he was able to restart gefitinib after 1 month. There was no treatmentrelated death in this study. |
| Conclusions: | Treatment with gefitinib alone for chemotherapyna?ve non small cell lung cancer patients with EGFR mutations could achieve a high efficacy with acceptable toxicity. To assess the proper timing of gefitinib in such patients, a subsequent randomized trial comparing gefitinib with standard chemotherapy is warranted. |