| General information |
| Database: | DB00747 |
| Objective: | NEJ002 study, comparing gefitinib with carboplatin (CBDCA) and paclitaxel (PTX; Taxol) as the firstline treatment for advanced non small cell lung cancer (non small cell lung cancer) harboring an epidermal growth factor receptor (EGFR) mutation, previously reported superiority of gefitinib over CBDCA/PTX on progression free survival (PFS). Subsequent analysis was carried out mainly regarding overall survival (OS). |
| Authors: | Inoue A, et al |
| Title: | Updated overall survival results from a randomizedphase III trial comparing gefitinib with carboplatinpaclitaxel for chemona ve non small cell lung cancer with sensitive EGFR gene mutations (NEJ002). |
| Journal: | Ann Oncol. |
| Year: | 2013 |
| PMID: | 22967997 |
| 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: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | gefitinib with carboplatinpaclitaxel |
| Study Type: | Updated overall survival results from a randomizedphase III trial |
| Key Patients Feature: | pts of NEJ002 study |
| Biomarker: | sensitive EGFR gene mutations |
| Biomark Analysis: | NA |
| Control Group Info: | gefitinib with carboplatin (CBDCA) versus paclitaxel |
| Treatment Info: | survival data were updated in December, 2010. Detailed information regarding subsequent chemotherapy after the protocol treatment was also assessed retrospectively and the impact of some key drugs on OS was evaluated. |
| Primary End Point: | Updated overall survival results |
| Secondary End Point: | NA |
| Patients Number: | 228 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | the gefitinib group and that of the CBDCA/PTX group were 10.8 months and 5.4 months, respectively (HR, 0.322; 95% CI 0.236-0.438; P < 0.001) |
| Median OS A vs. C: | 27.7 months for the gefitinib group, and was 26.6 months for the CBDCA/PTX group (HR, 0.887; P=0.483). |
| Adverse Event(agent arm): | No additional serious adverse event (NCICTC grade more than and equal to 3) was reported in either group after the previous report. Briefly, the most common adverse events reported were rash and diarrhea with gefitinib, and appetite loss, sensory neuropathy, and myelotoxicities with CBDCA/PTX. The combined incidence of serious adverse events combined was significantly higher in the CBDCA/PTX group than in the gefitinib group (71.7% versus 41.2%; P < 0.001). |
| Conclusions: | No significant difference in OS was observed bettheyen gefitinib and CBDCAPTX in the NEJ002 study, probably due to a high crossover use of gefitinib in the CBDCAPTX group. Considering the many benefits and the risk of missing an opportunity to use the most effective agent for EGFRmutated non small cell lung cancer, the firstline gefitinib is strongly recommended. |