| General information |
| Database: | DB01014 |
| Objective: | In the placebocontrolledphase III SATURN study, maintenance erlotinib after firstline chemotherapy demonstrated significantly prolonged progression free survival (PFS) and overall survival (OS) in the overall study population of patients with advanced non small cell lung cancer (non small cell lung cancer). |
| Authors: | Coudert B, et al |
| Title: | Survival benefit with erlotinib maintenance therapy in patients with advanced non small cell lung cancer (non small cell lung cancer) according to response to firstline chemotherapy. |
| Journal: | Ann Oncol |
| Year: | 2012 |
| PMID: | 21610154 |
| Trial Design |
| Clinical Trial Id: | NCT00556712 |
| Agent: | erlotinib
|
| 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: | placebocontrolledphase III SATURN study |
| Key Patients Feature: | patients with advanced non small cell lung cancer (non small cell lung cancer) according to response to firstline chemotherapy |
| Biomarker: | EGFR mutation status |
| Biomark Analysis: | The erlotinibrelated OS benefit in the SD group remained significant across subgroups, irrespective of tumour histology and/or EGFR mutation status |
| Control Group Info: | erlotinib versus placebo |
| Treatment Info: | After four cycles of platinumbased doublet chemotherapy, patients without progressive disease (PD) were randomised to erlotinib (150 mg/day) or placebo until PD or unacceptable toxicity. |
| Primary End Point: | PFS, OS and toxicity |
| Secondary End Point: | NA |
| Patients Number: | 889 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 44% |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 12.1 versus 11.3 weeks (2.8 versus 2.6 months), respectively. |
| Median OS A vs. C: | 11.9 versus 9.6 months |
| Adverse Event(agent arm): | Mild or moderate rash and diarrhoea were the most frequently observed erlotinibrelated toxic effects |
| Conclusions: | Patients with advanced non small cell lung cancer and SD following firstline platinumbased doublet chemotherapy derive a significant OS benefit from maintenance erlotinib therapy |