| General information |
| Database: | DB00755 |
| Objective: | In non small cell lung cancer, an exon 19 deletion and an L858R point mutation in the epidermal growth factor receptor (EGFR) are predictors of a response to EGFRtyrosine kinase inhibitors. however, it is uncertain whether other uncommon EGFR mutations are associated with sensitivity to EGFRtyrosine kinase inhibitors. |
| Authors: | Watanabe S, et al |
| Title: | Effectiveness of gefitinib against non small cell lung cancer with the uncommon EGFR mutations G719X and L861Q. |
| Journal: | J Thorac Oncol. |
| Year: | 2014 |
| PMID: | 24419415 |
| 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 with the uncommon EGFR mutations G719X and L861Q |
| 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: | uncommon EGFR mutations G719X and L861Q |
| Biomark Analysis: | Overall survival (OS) was significantly shorter among patients with uncommon EGFR mutations (G719X or L861Q) compared with OS of those with common EGFR mutations (12 versus 28.4 months; p = 0.002). In the gefitinib group (n = 114), patients with uncommon EGFR mutations had a significantly shorter OS (11.9 versus 29.3 months; p < 0.001). By contrast, OS was similar between patients with uncommon mutations and those with common mutations in the carboplatinpaclitaxel group (n = 111; 22.8 versus 28 months; p = 0.358). |
| Control Group Info: | gefitinib versus gefitinib with carboplatinpaclitaxel |
| Treatment Info: | A posthoc analysis to assess prognostic factors was performed with the use of patients with EGFR mutations (exon 19 deletion, L858R, G719X, and L861Q) who were treated with gefitinib in the NEJ002 study, which compared gefitinib with carboplatinpaclitaxel as the firstline therapy. |
| Primary End Point: | Effectiveness of gefitinib |
| Secondary End Point: | NA |
| Patients Number: | 225 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | significantly lotheyr in patients with uncommon EGFR mutations compared with the objective response rate in those with common EGFR mutations when treated with gefitinib (20% versus 76%; p = 0.017). By contrast, similar objective response rates were observed for patients with uncommon EGFR mutations and those with common EGFR mutations in the carboplatinpaclitaxel group (20% versus 32%; p = 0.336). |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | In the gefitinib group, the median PFS was significantly shorter for patients with uncommon EGFR mutations compared with median PFS of those with common EGFR mutations (2.2 versus 11.4 months; p < 0.001). By contrast, the median PFS did not differ significantly between patients with uncommon EGFR mutations and those with common EGFR mutations in the carboplatinpaclitaxel group (5.9 versus 5.4 months; p = 0.847) |
| Median OS A vs. C: | OS was significantly shorter among patients with uncommon EGFR mutations (G719X or L861Q) compared with OS of those with common EGFR mutations (12 versus 28.4 months; p = 0.002). In the gefitinib group (n = 114), patients with uncommon EGFR mutations had a significantly shorter OS (11.9 versus 29.3 months; p < 0.001). By contrast, OS was similar between patients with uncommon mutations and those with common mutations in the carboplatinpaclitaxel group (n = 111; 22.8 versus 28 months; p = 0.358). |
| Adverse Event(agent arm): | NA |
| Conclusions: | The posthoc analyses clearly demonstrated shorter survival for gefitinibtreated patients with uncommon EGFR mutations compared with the survival of those with common mutations and suggest that the firstline chemotherapy may be relatively effective for non small cell lung cancer with uncommon EGFR mutations |