| General information |
| Database: | DB01002 |
| Objective: | Efficacy of gefitinib therapy strongly depends on epidermal growth factor receptor (EGFR) mutation status in patients with non small cell lung cancer (non small cell lung cancer). however, cumulative data from many clinical studies demonstrated that some patients with wildtype (WT) EGFR also responded to gefitinib with durable disease control rate (DCR). The aim of this trial was to evaluate the efficacy and toxicity of gefitinib in non small cell lung cancer patients with WT EGFR who failed previous chemotherapy. |
| Authors: | Choi MK, et al |
| Title: | a phase II trial of gefitinib monotherapy in pretreated patients with advanced non small cell lung cancer not harboring activating EGFR mutations: implications of sensitive EGFR mutation test. |
| Journal: | Cancer Chemother Pharmacol |
| Year: | 2015 |
| PMID: | 25903122 |
| 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 not harboring activating EGFR mutations |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a phase II trial |
| Key Patients Feature: | Patients with advanced or recurrent non small cell lung cancer whose tumors have WT EGFR were eligible |
| Biomarker: | sensitive EGFR mutation |
| Biomark Analysis: | Of 11 gefitinib responders, 6 patients were identified as having tumor with activating EGFR mutation by peptide nucleic acid (PNA)mediated PCR clamping method |
| Control Group Info: | single arm |
| Treatment Info: | Gefitinib (250 mg/day) was administered until disease progression or unacceptable toxicity occurred. |
| Primary End Point: | DCR at 8 weeks. |
| Secondary End Point: | NA |
| Patients Number: | 85 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 12.90% |
| Disease Control Rate: | 37.60% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 1.9 months |
| Median OS A vs. C: | 10.9 months |
| Adverse Event(agent arm): | The most common adverse events were skin rash/ache (41.2 %) and anorexia (16.5 %). Grade more than and equal to 3 events included skin rash in five patients (5.9 %) and mucositis in two patients (2.4 %). One patient developed ILD, but the patient recovered soon with steroid treatment. Treatmentrelated adverse events led to drug interruption or discontinuation in three patients (3.5 %). There were no treatmentrelated deaths in the study population. |
| Conclusions: | Small proportion of non small cell lung cancer patients with the WT EGFR benefits with gefitinib. Optimized diagnosis through more sensitive bioassay could have major consequences in terms of the selection of candidate for EGFR TKI in patients with WT EGFR by direct sequencing. |