Statistics
DISEASE PROGRESSION
We used Kaplan-Meier analysis to summarize the time-to-event variables, progression-free survival (PFS), and overall survival (OS). PFS was the time from treatment initiation to the first disease progression. Patients lost to follow-up were censored. No formal statistical calculation of sample size was made as the study followed a standard ‘3 + 3’ dose escalation design for 5 doses. A sample size of 3 evaluable patients per cohort was deemed a clinically reasonable sample. Approximately 18 evaluable patients were estimated.