| General information |
| Database: | DB01013 |
| Objective: | Gefitinib and erlotinib are potent EGFR TKIs, with antitumor activity. In this randomized, singlecenter, noncomparativephase II trial, the efficacy and safety of gefitinib and erlotinib was evaluated as the secondline therapy for advanced non small cell lung cancer (non small cell lung cancer). |
| Authors: | Kim ST, et al |
| Title: | Randomizedphase II study of gefitinib versus erlotinib in patients with advanced non small cell lung cancer who failed previous chemotherapy. |
| Journal: | Lung Cancer. |
| Year: | 2012 |
| PMID: | 21684626 |
| 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 |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | Randomizedphase II study |
| Key Patients Feature: | Patients with locally advanced, metastatic stage IIIB/IV non small cell lung cancer who failed firstline chemotherapy and had either EGFR mutation or at least two out of three clinical factors associated with higher incidence of EGFR mutations (female, adenocarcinoma histology, and neversmoker) were eligible. |
| Biomarker: | EGFR mutations |
| Biomark Analysis: | as in the conclusion |
| Control Group Info: | erlotinib |
| Treatment Info: | Patients were randomly assigned in a 1:1 ratio to gefitinib (250 mg orally once daily) or erlotinib (150 mg orally once daily) administered every 4 weeks |
| Primary End Point: | efficacy and safety |
| Secondary End Point: | NA |
| Patients Number: | 96 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 47.9% in the gefitinib arm and 39.6% in the erlotinib arm. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 4.9 months (95% CI, 1.38.5) in the gefitinib arm and 3.1 months (95% CI, 0.06.4) in the erlotinib arm. |
| Median OS A vs. C: | 4.9 vs. 3.1 months |
| Adverse Event(agent arm): | The most common grade 3/4 adverse event was skin rash. Although more patients in the erlotinib arm showed grade 3/4 skin rash, the number of patients requiring dose reduction of each arm was similar between two arms (4 in the gefitinib arm and 6 in the erlotinib). Any grades of skin rash were developed in 60-70% of patients in two groups. There were slightly more grade 2-3 skin rash (43.7% vs. 10.4%) in the erlotinib arm. Also, more patients of erlotinib group suffered from fatigue (16.7% vs. 0%). Two patients of gefitinib group and 1 patient of erlotinib group died due to pneumonia. however, there was no interstitial lung disease confirmed. |
| Conclusions: | Both gefitinib and erlotinib showed effective activity and tolerable toxicity profiles as secondline treatment for the selected population of non small cell lung cancer. they may consider conducting aphase III trial to directly compare the efficacy and toxicity bettheyen gefitinib and erlotinib in an enriched patient population. |