The evaluation of efficacy and safety of sunitinib on EGFR-TKI pretreated advanced non-small cell lung cancer patients in China

Background Sunitinib is an oral multitargeted tyrosine kinase inhibitor (TKI) exhibiting antiagiogenic and antitumor effects. Objective To evaluate the efficacy and potential toxicity of sunitinib therapy in advanced non-small cell lung cancer (NSCLC) patients in China. Methods From January 2009 to August 2011, 30 patients with stage IV NSCLC, who were pretreated with the epidermal growth factor receptor (EGFR)-TKIs and then received sunitinib, were retrospectively reviewed. Univariate and multivariate Cox proportional hazard regression analysis was performed to determine the potential prognostic risk factors influencing NSCLC survival. Results The median progression-free survival (PFS) and median overall survival (OS) of all 30 treated patients was 1.25 months [95% confidence interval (CI): 0.90-1.9 months] and 3.40 months (95% CI: 3.00-6.80 months), respectively. Cox regression analysis suggested that Eastern Cooperative Oncology Group (ECOG) performance status (PS) is predictive of both PFS (P = 0.001) and OS (P < 0.001). Common adverse events (AEs) included hand-foot syndrome (53.3%), mucositis (40.0%), rash (36.7%) and diarrhea (33.3%). Conclusion No sign of overall clinical benefits of sunitinib was detected in patients with pretreated EGFR-TKIs. Most patients suffered AEs from mild to moderate severity. ECOG PS is highly associated with PFS and OS rate. Further studies in NSCLC are required to determine whether sunitinib is beneficial nor not.