| General information |
| Database: | DB00744 |
| Objective: | Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors are particularly effective in non small cell lung cancer (non small cell lung cancer) patients harboring active EGFR mutations. however, some studies have reported survival benefits in non small cell lung cancer patients with wildtype EGFR upon erlotinib treatment. This trial was conducted to evaluate the efficacy of erlotinib monotherapy and investigate the predictive values of several biomarkers. |
| Authors: | Matsumoto Y, et al |
| Title: | a phase II study of erlotinib monotherapy in pretreated non small cell lung cancer without EGFR gene mutation who have never/light smoking history: reevaluation of EGFR gene status (NEJ006/TCOG0903). |
| Journal: | Lung Cancer. |
| Year: | 2014 |
| PMID: | 25249428 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | erlotinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | 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 phase II study |
| Key Patients Feature: | Patients with previously treated non small cell lung cancer but without EGFR gene mutations that had never or light smoked were eligible for this study |
| Biomarker: | EGFR gene status;Expression of hepatocyte growth factor (HGF), Met, and thymidylate synthase (TS) |
| Biomark Analysis: | Reexamination of EGFR gene status using different detecting method or different sample should be considered to grasp a chance of erlotinib treatment after first line treatment. In confirmed EGFR wild non small cell lung cancer, negative HGF staining could be a biomarker for longer PFS by erlotonib treatment. |
| Control Group Info: | single arm |
| Treatment Info: | Erlotinib was administered until disease progression or unacceptable toxicities occurred. EGFR gene status was reevaluated using the fragment method to detect exon 19 deletions and the CycleavePCR method to detect point mutations. Expression of hepatocyte growth factor (HGF), Met, and thymidylate synthase (TS) were evaluated using immunohistochemistry. |
| Primary End Point: | reevaluation of EGFR gene status |
| Secondary End Point: | NA |
| Patients Number: | 57 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 15.20% |
| Disease Control Rate: | 41.30% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 1.5 months (95% CI: 0.4-2.7 months) |
| Median OS A vs. C: | 8.0 months (95% CI: 2.4-13.6 months) |
| Adverse Event(agent arm): | The most common adverse events were skin rash (80.4%) and diarrhea (45.7%). Grade 3 or 4 adverse events were anorexia (four patients), skin rash (two patients), ILD (two patients), anemia (two patients), fatigue (one patient), rectal ulcer (one patient), cerebral infarction (one patient), neutropenia (one patient), and elevation of AST/ALT (one patient). No treatmentrelated deaths were observed |
| Conclusions: | Reexamination of EGFR gene status using different detecting method or different sample should be considered to grasp a chance of erlotinib treatment after first line treatment. In confirmed EGFR wild non small cell lung cancer, negative HGF staining could be a biomarker for longer PFS by erlotonib treatment. |