| General information |
| Database: | DB00086 |
| Objective: | to evaluate clinical activity and safety of sorafenib in combination with erlotinib or gemcitabine in unselected untreated elderly patients with non small cell lung cancer (non small cell lung cancer). |
| Authors: | Gridelli C, et al |
| Title: | Sorafenib in combination with erlotinib or with gemcitabine in elderly patients with advanced non small cell lung cancer: a randomizedphase II study. |
| Journal: | Ann Oncol. |
| Year: | 2011 |
| PMID: | 21212155 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | sorafenib, erlotinib
|
| Target: | a smallmolecule multitargeted kinase inhibitor that blocks the activation of CRAF, BRAF, cKIT, FLT3, RET, vascular endothelial growth factor receptor 2 (VEGFR2), VEGFR3 and plateletderived growth factor receptor ¦Â
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced non small cell lung cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 1 |
| Therapeutic Combination Content: | gemcitabine+sorafenib versus erlotinib+sorafenib |
| Study Type: | A multicenter, randomizedphase II study |
| Key Patients Feature: | previously untreated elderly (more than and equal to 70 years) stage IIIB or IV non small cell lung cancer patients, with performance status of zero to two |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | gemcitabine+sorafenib versus erlotinib+sorafenib |
| Treatment Info: | patients were randomly assigned to one of the following combinations: gemcitabine, 1200 mg/m(2) days 1 and 8, every 21 days, for a maximum of six cycles, plus sorafenib, 800 mg/day, until disease progression or unacceptable toxicity (arm 1); or erlotinib, 150 mg/day, plus sorafenib, 800 mg/day, until disease progression or unacceptable toxicity (arm 2). |
| Primary End Point: | 1year survival rate |
| Secondary End Point: | NA |
| Patients Number: | 60 |
| Trial Results |
| DLT_MTD: | gemcitabine, 1200 mg/m(2) days 1 and 8, every 21 days, for a maximum of six cycles+sorafenib, until disease progression or unacceptable toxicity (arm 1); or erlotinib, 150 mg/day, plus sorafenib(arm 2). |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | 10 pts [32%, 95%(CI) 16% to 49%] in arm 1 and 13 pts (45%, 95% CI 27% to 63%) in arm 2 were alive at 1 year, OS 6.6 vs 12.6(arm 1 vs 2) |
| Adverse Event(agent arm): | Observed toxic effects were consistent with the expected drug profiles |
| Conclusions: | The combination of erlotinib and sorafenib was feasible in elderly patients with advanced non small cell lung cancer and was associated with a higher 1year survival rate than the other arm. According to the selection design, this combination warrants further investigation inphase III trials. |