| General information |
| Database: | DB00749 |
| Objective: | For non small cell lung cancer (non small cell lung cancer) patients with epidermal growth factor receptor (EGFR) mutations, firstline gefitinib produced a longer progression free survival interval than firstline carboplatin plus paclitaxel but did not show any survival advantage in the North East Japan 002 study. This report describes the quality of life (QoL) analysis of that study. |
| Authors: | Oizumi S, et al |
| Title: | Quality of life with gefitinib in patients with EGFRmutated non small cell lung cancer: quality of life analysis of North East Japan Study Group 002 Trial. |
| Journal: | Oncologist. |
| Year: | 2012 |
| PMID: | 22581822 |
| 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: | quality of life analysis of North East Japan Study Group 00II Trial. |
| Key Patients Feature: | Chemotherapyna ve patients with sensitive EGFRmutated, advanced non small cell lung cancer were randomized |
| Biomarker: | EGFRmutated |
| Biomark Analysis: | NA |
| Control Group Info: | gefitinib versus chemotherapy |
| Treatment Info: | Patient QoL was assessed weekly using the Care Notebook |
| Primary End Point: | the QoL analysis was time to deterioration from baseline on each of the physical, mental, and life wellbeing QoL scales. |
| Secondary End Point: | NA |
| Patients Number: | 148 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 73.7% versus 30.7%; p < .001 |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | Patients in the gefitinib arm had a significantly longer PFS time (median PFS time, 10.8 months versus 5.4 months; HR, 0.30; 95% CI, 0.22-0.41; p < .001) |
| Median OS A vs. C: | 27.7 months in the gefitinib arm and 26.6 months in the chemotherapy arm |
| Adverse Event(agent arm): | The most common adverse events of any grade were rash (71.1%) and aspartate aminotransferase or alkaline phosphatase elevation (55.3%) in the gefitinib arm and neutropenia (77.0%), anemia (64.6%), appetite loss (56.6%), and sensory neuropathy (54.9%) in the chemotherapy arm |
| Conclusions: | QoL was maintained much longer in patients treated with gefitinib than in patients treated with standard chemotherapy, indicating that gefitinib should be considered as the standard firstline therapy for advanced EGFRmutated non small cell lung cancer in spite of no survival advantage. |