| General information |
| Database: | DB00054 |
| Objective: | Gefitinib has shown high response rate and improved progression free survival (PFS) in neversmokers with lung adenocarcinoma (NSLAs). they compared efficacy of gefitinib with gemcitabine and cisplatin (GP) chemotherapy in this group of patients as firstline therapy. |
| Authors: | Han JY, et al |
| Title: | FirstSIGNAL: firstline singleagent iressa versus gemcitabine and cisplatin trial in neversmokers with adenocarcinoma of the lung. |
| Journal: | J Clin Oncol. |
| Year: | 2012 |
| PMID: | 22370314 |
| Trial Design |
| Clinical Trial Id: | Clinical Trials repository link available on JCO.org. |
| Agent: | gefitinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | lung cancer |
| Cancer Subtype: | advanced lung adenocarcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | Phase III FirstSIGNAL: firstline singleagent iressa |
| Key Patients Feature: | Korean neversmokers with stage IIIB or IV lung adenocarcinoma |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | gemcitabine, cisplatin |
| Treatment Info: | pts were randomly assigned to receive either gefitinib (250 mg daily) or GP chemotherapy (gemcitabine 1, 250 mg/m(2) on days 1 and 8; cisplatin 80 mg/m(2) on day 1 every 3 weeks, for up to nine courses). |
| Primary End Point: | better overall survival (OS) for gefitinib compared with GP in chemotherapynaive NSLAs. |
| Secondary End Point: | NA |
| Patients Number: | 313 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | ORR: 55.4% vs. 46%(gefitinib vs. GP)(95%CI:0.929 to 2.278, p=0.101) |
| Disease Control Rate: | 66.7% vs. 64% (gefitinib vs. GP) |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 16.7% vs.2.8%(1year PFS rates) |
| Median OS A vs. C: | 22.3 v 22.9; HR=0.932; 95% CI, 0.716 to 1.213; P = .604 |
| Adverse Event(agent arm): | skin toxicities and liver dysfunction |
| Conclusions: | Gefitinib failed to demonstrate superior OS compared with GP as firstline therapy for NSLAs |