| General information |
| Database: | DB00762 |
| Objective: | This prospective trial was conducted to evaluate the role of gefitinib in neversmokers with advanced or metastatic adenocarcinoma of the lung. |
| Authors: | Lee DH, et al |
| Title: | The role of gefitinib treatment for Korean neversmokers with advanced or metastatic adenocarcinoma of the lung: a prospective study. |
| Journal: | J Thorac Oncol. |
| Year: | 2006 |
| PMID: | 17409980 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | gefitinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | lung cancer |
| Cancer Subtype: | advanced lung adenocarcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a prospective study |
| Key Patients Feature: | The main inclusion criteria were stage IIIB/IV adenocarcinoma of the lung and status as a lifetime neversmoker |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients received a 250mg single oral daily dose of gefitinib until disease progression, unacceptable toxicity, or patient's refusal. Tumor response was assessed after every two 4week cycles according to the World Health Organization response criteria. Additional analyses were performed to identify predictors of response and survival. |
| Primary End Point: | response, toxicity, quality of life, and survival |
| Secondary End Point: | NA |
| Patients Number: | 72 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 55.6% (95% confidence interval [CI], 43.467.3%). |
| Disease Control Rate: | 66.7% (95% CI, 54.6-77.3%) |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 5.5 months (95% CI, 4.4-6.5 months) |
| Median OS A vs. C: | 19.7 months (95% CI, 18.521.0 months) with a 1year survival rate of 76.3%. |
| Adverse Event(agent arm): | NA |
| Conclusions: | Gefitinib showed very promising antitumor activity and survival outcome in Korean neversmokers with adenocarcinoma of the lung. It seems to be a good alternative to standard chemotherapy as a firstline therapy for this subgroup. |