| General information |
| Database: | DB00648 |
| Objective: | Gefitinib ("Iressa", ZD1839), an orally active epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (EGFR TKI), has shown antitumor activity in refractory patients with non small cell lung cancer (non small cell lung cancer) in clinical trials. they have retrospectively analyzed the efficacy and tolerability of gefitinib in patients with advanced non small cell lung cancer treated at Okayama University Hospital. |
| Authors: | Hotta K, et al |
| Title: | Effect of gefitinib ('Iressa', ZD1839) on brain metastases in patients with advanced non small cell lung cancer. |
| Journal: | Lung Cancer. |
| Year: | 2004 |
| PMID: | 15474674 |
| Trial Design |
| Clinical Trial Id: | retrospective analysis |
| Agent: | gefitinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | advanced cancer with brain metastasis |
| Cancer Subtype: | brain metastases from non small cell lung cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | retrospective analysis |
| Key Patients Feature: | NA |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | they reviewed the clinical records of 57 patients with advanced non small cell lung cancer who had received 250 mg/day gefitinib at our hospital between November 2000 and May 2003. Correlations between the sensitivity of brain metastases and extracranial disease following treatment with gefitinib were also investigated. |
| Primary End Point: | efficacy and tolerability |
| Secondary End Point: | NA |
| Patients Number: | 57 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Fourteen out of 57 patients had brain metastases; six experienced objective responses (one complete response, CR and five partial responses, PR) and eight had stable disease (SD) in the brain. Seven out of 14 patientswith brain metastases experienced objective responses in their extracranial tumorsand, interestingly, objective responses in the brain were observed in six (86%) of these patients |
| Disease Control Rate: | 0.73 |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | The majority of adverse events (AEs) were mild and reversible skin and gastrointestinal disorders, with grade 3 adverse events observed in six (11%) patients. |
| Conclusions: | This retrospective analysis has found that gefitinib is effective and well tolerated in patients with refractory non small cell lung cancer, confirming previous phase II trial data. Interestingly, gefitinib appeared to be effective for brain metastases as well as extracranial tumors. Further prospective trials are warranted to evaluate the efficacy of gefitinib in elderly patients and in patients with brain metastases. |