| General information |
| Database: | DB00751 |
| Objective: | Salvage treatment for acquired resistance to gefitinib has yet to be developed. they conducted the first prospectivephase II study of gefitinib readministration in previous gefitinib responders |
| Authors: | Asahina H, et al |
| Title: | Phase II study of gefitinib readministration in patients with advanced non small cell lung cancer and previous response to gefitinib. |
| Journal: | Oncology |
| Year: | 2010 |
| PMID: | 21474967 |
| 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: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | the first prospectivephase II study |
| Key Patients Feature: | patients with advanced/metastatic non small cell lung cancer who had achieved objective response to initial gefitinib and subsequently received cytotoxic chemotherapy after disease progression with initial gefitinib. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Gefitinib (250 mg/day) was readministered to elligible patients |
| Primary End Point: | the objective response rate with gefitinib readministration. |
| Secondary End Point: | disease control rate, progression free survival (PFS), overall survival (OS), quality of life, and toxicity. |
| Patients Number: | 16 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | 44% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 2.5 months (95% CI, 1.6-3.2 months) |
| Median OS A vs. C: | 14.7 months (95% CI, 11.1-15.5 months) |
| Adverse Event(agent arm): | The most common adverse event was fatigue in 13 patients (81%), including 2 patients with grade 3. One patient experienced grade 4 central nervous system cerebrovascular ischemia and terminated gefitinib treatment on day 47. Overall, toxicity appeared to be similar to the previously published trials of gefitinib monotherapy. |
| Conclusions: | Gefitinib represents a useful therapeutic option for selected previous gefitinib responders. |