| General information |
| Database: | DB00754 |
| Objective: | Secondgeneration epidermal growth factor receptor tyrosine kinase inhibitor (EGFRTKI) afatinib as firstline treatment has been demonstrated to improve overall survival (OS) in patients with non small cell lung cancer (non small cell lung cancer) harboring an exon 19 deletion (del19) of EGFR compared to platinumdoublet chemotherapy. however, it is unclear whether firstgeneration EGFRTKIs improve OS in patients with del19 in the firstline treatment |
| Authors: | Watanabe S, et al |
| Title: | Comparison of Gefitinib Versus Chemotherapy in Patients with non small cell lung cancer with Exon 19 Deletion. |
| Journal: | Anticancer Res. |
| Year: | 2015 |
| PMID: | 26637922 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | gefitinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | non small cell lung cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a posthoc analysis of NEJ00II study |
| Key Patients Feature: | pts of NEJ002 study |
| Biomarker: | Exon 19 Deletion |
| Biomark Analysis: | No OS differences were observed between patients receiving gefitinib and carboplatinpaclitaxel irrespective of del19 (29.3 months vs. 29.7 months, p=0.53) or L858R (28.4 months vs. 25.1 months, p=0.45). |
| Control Group Info: | gefitinib and carboplatinpaclitaxel |
| Treatment Info: | they performed a posthoc analysis of patients with del19 or L858R mutation of EGFR who received gefitinib in the NEJ002 study, which compared gefitinib to carboplatinpaclitaxel. |
| Primary End Point: | OS |
| Secondary End Point: | NA |
| Patients Number: | 115 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | No OS differences were observed between patients receiving gefitinib and carboplatinpaclitaxel irrespective of del19 (29.3 months vs. 29.7 months, p=0.53) or L858R (28.4 months vs. 25.1 months, p=0.45). |
| Adverse Event(agent arm): | NA |
| Conclusions: | In contrast to afatinib, it is suggested that firstline gefitinib does not improve OS in patients with del19 of EGFR compared with platinumdoublet chemotherapy. |