2.5. Statistical Analysis
Descriptive methods were used for patient's demographic and clinic characteristics, treatment exposure, and safety analysis. For the analysis of overall survival, median values and 95% confidence interval (CI) were estimated. OS and PFS were determined by the Kaplan-Meier methodology, and 1- and 2-year survival rates were estimated. For the clinical response, a point estimate and a 95% CI were performed for the proportion of patients with complete response (CR) and objective response (CR+PR). Statistical analysis was performed with SPSS program (version 21.0).