Sorafenib (Sor) In Advanced Non-Small Cell Lung Cancer (Nsclc): A Phase Ii Study Of Patient Progress After Several Lines Of Treatment.

e18070 Background: Sorafenib is a potent inhibitor of c-Raf, b-Raf VEGFR-1/2/3 and PDGFR-β. In NSCLC, proliferative signaling through the Ras/Raf/MEK/ERK pathway is often activated from K-ras mutations. Their efficacy as monotherapy to treat advanced NSCLC has been demonstrated in several trials. In them, SOR improved the rate of disease stabilization in patients who had previously been treated with chemotherapy. Our objective is to confirm the clinical and safety results in the daily clinical activity. Methods: Between October 2008 and December 2011, patients with metastatic NSCLC and measurable disease, ECOG 0-1 were treated after having received two or more prior chemotherapy regimens for metastatic disease. SOR was administered at a starting dose of 400 mg bid continuously in 28-day cycles.The primary end points were Overall Survival (OS) and Progression Free Survival (PFS). Survival medians were estimated by the Kaplan-Meier method and comparisons between subgroups were assessed by the log-rank test. Results: Fifteen Caucasian patients were enrolled, with a mean age at diagnosis of 61 (SD = 13.5) years and most of them were males (n = 10, 67%). The predominant histologic type was adenocarcinoma (n = 9, 60%). Twelve (80%) patients were in stage IV at diagnosis. The predominant metastatic sites were lung (n = 8, 53%), lymph nodes, (n = 5, 33%), pleura (n =3, 20%) and bone (n=3, 20%).Patients received a median of 3 (range: 2 to 4) treatment lines prior to the SOR regimen, with a median duration of 80.5 (range: 9 to 247) days.Median OS and median PFS were 98 and 84 days, respectively. No significant differences in survival were found according to gender, smoking, histologic type, stage, metastatic site, ECOG nor presence of biomarkers.The toxicity profile was mild. Adverse events CTC G3/4 were dyspnea (n = 4, 27%), skin toxicity (n = 1, 7%) and vomiting (n = 1, 7%). Conclusions: In this study, patients with metastatic NSCLC receiving SOR had a median PFS of 3 months. The safety profile is acceptable, reversible and manageable without unexpected adverse events to this therapy. While still waiting for the results of ongoing trials, we can say thatSOR is safe, so far, in patients who have been widely treated.