| General information |
| Database: | DB00055 |
| Objective: | Activating mutations in EGFR are important markers of response to tyrosine kinase inhibitor (TKI) therapy in non small cell lung cancer (non small cell lung cancer). The OPTIMAL study compared efficacy and tolerability of the TKI erlotinib versus standard chemotherapy in the firstline treatment of patients with advanced EGFR mutationpositive non small cell lung cancer. |
| Authors: | Zhou C, et al |
| Title: | Erlotinib versus chemotherapy as firstline treatment for patients with advanced EGFR mutationpositive non small cell lung cancer (OPTIMAL, CTONG0802): a multicentre, openlabel, randomised, phase 3 study. |
| Journal: | Lancet Oncol. |
| Year: | 2011 |
| PMID: | 21783417 |
| Trial Design |
| Clinical Trial Id: | NCT00874419 |
| Agent: | erlotinib
|
| 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: | Phase III OPTIMAL, CTONG080II:openlabel, randomised |
| Key Patients Feature: | 22 centres in China |
| Biomarker: | EGFR mutationpositive |
| Biomark Analysis: | Compared with standard chemotherapy, erlotinib conferred a significant progression free survival benefit in patients with advanced EGFR mutationpositive non small cell lung cancer and was associated with more favourable tolerability. |
| Control Group Info: | gemcitabine, carboplatin |
| Treatment Info: | Eligible patients were randomly assigned to receiveeither oral erlotinib 150 mg once daily until disease progression or unacceptable toxic eff ects, or up to fourcycles of platinumbased doublet chemotherapy(intravenous gemcitabine 1000 mg/m2 on days 1 and 8and intravenous carboplatin [area under the curve=5] onday 1 of a 3week cycle, which is a standard regimen inChina). |
| Primary End Point: | progression free survival, analysed in patients with confirmed disease who received at least one dose of study treatment |
| Secondary End Point: | NA |
| Patients Number: | 154 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Two (2%) of 82 patients in the erlotinib group achieved acomplete response, compared with none of the 72 patientson chemotherapy. 66 (80%) of 82 patients on erlotinib hada partial response compared with 26 (36%) of 72 patientsallocated chemotherapy, giving an overall response rate of83% (68/82) for erlotinib and 36% (26/72) for chemotherapy(p<0.0001). |
| Disease Control Rate: | 96% (79/82) witherlotinib and 82% (59/72) with chemotherapy (p=0.0022) |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 13.1 vs 4.6;0.16, 95% CI 0.100.26; p<0.0001 |
| Median OS A vs. C: | still in followups |
| Adverse Event(agent arm): | increased alanine aminotransferase concentrations ans skin rash |
| Conclusions: | Compared with standard chemotherapy, erlotinib conferred a significant progression free survival benefit in patients with advanced EGFR mutationpositive non small cell lung cancer and was associated with more favourable tolerability. These findings suggest that erlotinib is important for firstline treatment of patients with advanced EGFR mutationpositive non small cell lung cancer. |