| General information |
| Database: | DB00056 |
| Objective: | Erlotinib has been shown to improve progression free survival compared with chemotherapy when given as firstline treatment for Asian patients with non small cell lung cancer (non small cell lung cancer) with activating EGFR mutations. they aimed to assess the safety and efficacy of erlotinib compared with standard chemotherapy for firstline treatment of European patients with advanced EGFRmutation positive non small cell lung cancer. |
| Authors: | Rosell R, et al |
| Title: | Erlotinib versus standard chemotherapy as firstline treatment for European patients with advanced EGFR mutationpositive non small cell lung cancer (EURTAC): a multicentre, openlabel, randomisedphase 3 trial. |
| Journal: | Lancet Oncol. |
| Year: | 2012 |
| PMID: | 22285168 |
| Trial Design |
| Clinical Trial Id: | NCT00446225 |
| Agent: | erlotinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | (EGFR) mutationpositive advanced non small cell lung cancer (non small cell lung cancer) |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | Phase III EURTAC:openlabel, randomisedphase III trial |
| Key Patients Feature: | 42 hospitals in France, Italy, and Spain;adults (> 18 years) with non small cell lung cancer and EGFR mutations |
| Biomarker: | EGFR mutations (exon 19 deletion or L858R mutation in exon 21) |
| Biomark Analysis: | they strengthen the rationale for routine baseline tissuebased assessment of EGFR mutations in patients with non small cell lung cancer and for treatment of mutationpositive patients with EGFR tyrosinekinase inhibitors |
| Control Group Info: | Platinum doublet |
| Treatment Info: | they randomly allocated participants (1:1) according to a computergenerated allocation schedule to receive oral erlotinib 150 mg per day or 3 week cycles of standard intravenous chemotherapy of cisplatin 75 mg/m(2) on day 1 plus docetaxel (75 mg/m(2) on day 1) or gemcitabine (1250 mg/m(2) on days 1 and 8). Carboplatin (AUC 6 with docetaxel 75 mg/m(2) or AUC 5 with gemcitabine 1000 mg/m(2)) was allowed in patients unable to have cisplatin. |
| Primary End Point: | progression free survival (PFS) in the intentiontotreat population |
| Secondary End Point: | NA |
| Patients Number: | 173 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Two (3%) of 77 patients in theerlotinib group had a complete response. 47 (61%) of77 patients in the erlotinib group and 13 (18%) of 73 patientsin the standard chemotherapy group had partial response(odds ratio 7.5, 95% CI 3.6-15.6; p<0.0001) |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 9.7 vs 5.2;0.37, 95% CI 0.250.54; p < 0.0001 |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | rash, neutropenia, anaemia, increased aminotransferase concentrations |
| Conclusions: | Our findings strengthen the rationale for routine baseline tissuebased assessment of EGFR mutationsin patients with non small cell lung cancer and for treatment of mutationpositive patients with EGFR tyrosinekinase inhibitors. |