| General information |
| Database: | DB00750 |
| Objective: | Although standard schedule of gefitinib was the administration of 250 mg tablet every day, many patients need dose reduction because of toxicities. however, the efficacy of such lowdose gefitinib for patients with epidermal growth factor receptormutated non small cell lung cancer has rarely been evaluated. |
| Authors: | Satoh H, et al |
| Title: | Lowdose gefitinib treatment for patients with advanced non small cell lung cancer harboring sensitive epidermal growth factor receptor mutations. |
| Journal: | J Thorac Oncol. |
| Year: | 2011 |
| PMID: | 21681118 |
| 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: | A post hoc comparison of the efficacy in NEJ00II study |
| Key Patients Feature: | pts of NEJ002 study |
| Biomarker: | sensitive epidermal growth factor receptor mutations |
| Biomark Analysis: | The results suggest that lowdose gefitinib may be clinically not inferior to standarddose gefitinib for non small cell lung cancer with sensitive epidermal growth factor receptor mutations. |
| Control Group Info: | lowdose group versus standarddose group |
| Treatment Info: | A post hoc comparison of the efficacy (response rate and survival) in patients treated with gefitinib with or without any dose reduction in NEJ002 study was performed. |
| Primary End Point: | efficacy (response rate and survival) |
| Secondary End Point: | NA |
| Patients Number: | 114 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 83% in the lowdose group and 66% in the standarddose group, respectively. |
| Disease Control Rate: | 98% in the lowdose group and 82% in standarddose group, respectively. |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 11.8 versus 9.9 months; p = 0.144 |
| Median OS A vs. C: | median survival time, 32.7 versus 25.3 months; p = 0.049 |
| Adverse Event(agent arm): | NA |
| Conclusions: | The results suggest that lowdose gefitinib may be clinically not inferior to standarddose gefitinib for non small cell lung cancer with sensitive epidermal growth factor receptor mutations. Prospective study of lowdose gefitinib is warranted especially for frail patients who need less toxic treatment. |