| General information |
| Database: | DB00748 |
| Objective: | Recent studies have demonstrated that firstline treatment with gefitinib, an epidermal growth factor receptor (EFGR)targeted tyrosine kinase inhibitor, is significantly superior to standard chemotherapy for advanced non small cell lung cancer (non small cell lung cancer) harboring EGFR sensitive mutations. Meanwhile, the efficacy of gefitinib therapy among elderly populations diagnosed with EGFRmutated non small cell lung cancer has not yet been elucidated. The purpose of this study was to investigate the efficacy and feasibility of gefitinib for chemotherapynaive patients aged 75 or older with non small cell lung cancer harboring EGFR mutations; generally, these patients have no indication for treatment with platinum doublets. |
| Authors: | Maemondo M, et al |
| Title: | Firstline gefitinib in patients aged 75 or older with advanced non small cell lung cancer harboring epidermal growth factor receptor mutations: NEJ 003 study. |
| Journal: | J Thorac Oncol. |
| Year: | 2012 |
| PMID: | 22895139 |
| 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 harboring epidermal growth factor receptor mutations |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a multicentricphase II study |
| Key Patients Feature: | Chemotherapynaive patients aged 75 years or older with performance status 0 to 1 and advanced non small cell lung cancer harboring EGFR mutations, as determined by the peptide nucleic acidlocked nucleic acid polymerase chain reaction clamp method, were enrolled. |
| Biomarker: | EGFR Mutation |
| Biomark Analysis: | This is the first study that verified safety and efficacy of firstline treatment with gefitinib in elderly patients having advanced non small cell lung cancer with EGFR mutation |
| Control Group Info: | single arm |
| Treatment Info: | The enrolled patients received 250 mg/day of gefitinib orally. |
| Primary End Point: | safety and efficacy |
| Secondary End Point: | NA |
| Patients Number: | 31 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 74% (95% confidence interval, 58%91%) |
| Disease Control Rate: | 90% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 12.3 months. |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | The common adverse events were rash, diarrhea, and liver dysfunction. |
| Conclusions: | This is the first study that verified safety and efficacy of firstline treatment with gefitinib in elderly patients having advanced non small cell lung cancer with EGFR mutation. Considering its strong antitumor activity and mild toxicity, firstline gefitinib may be preferable to standard chemotherapy for this population. |