Docetaxel Regimen as Second-Line Treatment for Pretreated Advanced NSCLC Patients - A Large-Scale, Multicenter, Uncontrolled, Registry Study in China

ABSTRACT Background Docetaxel has been approved as a second-line therapy for advanced non-small cell lung cancer (NSCLC) patients. The objective of this study is to provide real-world data of docetaxel regimen as second-line treatment in Chinese NSCLC patients through comparing the efficacy, toxicities and therapeutic schema. Methods 1220 advanced NSCLC patients who had received docetaxel regimen as second-line treatment from nationwide 47 clinical centers in China from April 2009 to October 2010 were analyzed. The primary end point was overall survival (OS). Progression-free survival (PFS), response, toxicities and therapeutic models of docetaxel were assessed as secondary end points. Survival analysis was evaluated by Kaplan-Meier method. Single factor analysis and the COX regression model were performed to analyze the relationship between the influential factors and the prognosis of disease. Results Docetaxel as second-line treatment for NSCLC associated with high response rate (RR) of 29.7%, median PFS of 8.2 months, median OS of 16.1 months. TNM staging (IV vs non-IV, P = 0.0270) and docetaxel regimen (docetaxel-based combinations vs docetaxel alone, P  Conclusions Docetaxel as a second-line treatment provides better PFS and OS for Chinese NSCLC patients. The hematologic toxicity is the main adverse effect for docetaxel regimen. Owing to the limitation of registry study, further studies are warranted to confirm these findings. Disclosure All authors have declared no conflicts of interest.