Sorafenib in Advanced Non-Small-Cell Lung Cancer: A Retrospective Analysis of Patients in Progression After Two or More Lines of Therapy

Background Sorafenib (SOR) 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 for treating 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 daily clinical activity. Methods Between October 2008 and December 2011, 16 Caucasian patients with metastatic NSCLC and measurable disease were treated after having received two or more prior lines of therapy for metastatic disease.SOR was administered at a starting dose of 400 mg bid continuously in 28-day cycles.The primary end-point was Progression Free Survival (PFS). The secondary end-points were Overall Survival (OS) and Response Rate (RR). Results Median age was 59 years (40-86). 100% patients were PS (ECOG) 0/1 (5/11, 31/69%). Most were males (n = 10, 62%). The predominant histologic type was adenocarcinoma (n = 10, 62%). Thirteen (81%) patients were in stage IV at diagnosis. The predominant metastatic sites were lung (n = 9, 56%), lymph nodes, (n = 6, 38%), pleura (n =3, 19%) and bone (n = 3, 19%) Patients received a median of 3 (range: 2 to 4) treatment lines prior to the SOR regimen; Eleven (68.8%) patients received at least 3 treatment lines before SOR. The median duration of the SOR regimen was 114 days (9-247).Median PFS and median OS were 2.8 and 3.3 months, respectively. After administration of SOR, 2 patients (13%) had a partial response and 5 (33%) had stable disease. The toxicity profile was mild. Adverse events CTC G3/4 were dyspnea (n = 4, 25%), skin toxicity (n = 1, 6%) and vomiting (n = 1, 6%). In 1 case, treatment was interrupted by non-hematological toxicity. Conclusions Patients with advanced NSCLC receiving SOR after two or more lines of therapy got a 2.8 and 3.3 months median PFS and OS, respectively, with a 46% Disease Control Rate and with an acceptable safety profile. While still waiting for the results of ongoing trials, SOR is active and safe in this widely treated patient population. Disclosure All authors have declared no conflicts of interest.