| General information |
| Database: | DB00767 |
| Objective: | The results of the Iressa in non small cell lung cancer for maintenance study (NCT00770588; CTONG 0804), which compared gefitinib and placebo as maintenance therapy in patients with advanced non small cell lung cancer without disease progression after firstline chemotherapy, were published previously. The objective of this report is to provide a mature analysis of overall survival (OS) for Iressa in non small cell lung cancer for maintenance study in intention to treat (ITT) population and in subgroups according to epidermal growth factor receptor (EGFR) mutation status. |
| Authors: | Zhao H, et al |
| Title: | Final overall survival results from a phase III, randomized, placebocontrolled, parallelgroup study of gefitinib versus placebo as maintenance therapy in patients with locally advanced or metastatic non small cell lung cancer (INFORM; CTONG 0804). |
| Journal: | J Thorac Oncol. |
| Year: | 2015 |
| PMID: | 25546556 |
| Trial Design |
| Clinical Trial Id: | NCT00770588; CTONG 0804 |
| 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: | Final overall survival results from a phase III, randomized, placebocontrolled, parallelgroup study |
| Key Patients Feature: | patients with locally advanced or metastatic non small cell lung cancer (INFORM; CTONG 0804) |
| Biomarker: | EGFR mutation status |
| Biomark Analysis: | EGFR mutation was the strongest predictive biomarker for OS benefit of gefitinib as maintenance treatment. |
| Control Group Info: | gefitinib versus placebo |
| Treatment Info: | patients were assessable for EGFR mutations. OS was analyzed by a Cox proportional hazards model adjusted for the same covariates in ITT population and subgroups according to EGFR mutation status. |
| Primary End Point: | Final overall survival results |
| Secondary End Point: | NA |
| Patients Number: | 296 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | OS was similar for gefitinib and placebo with no significant difference between the two arms (112 and 118 events, respectively; HR, 0.88; 95% CI, 0.68-1.14; p = 0.335; median OS for gefitinib, 18.97 months vs. 16.00 months for placebo) |
| Adverse Event(agent arm): | NA |
| Conclusions: | EGFR mutation was the strongest predictive biomarker for OS benefit of gefitinib as maintenance treatment. The analyses of OS showed that patients achieve a clear and significant survival benefit if they receive EGFR tyrosine kinase inhibitors as maintenance treatment in EGFR mutationpositive patients. |