Study outcomes
toxicity, death
PROGRESSION, SECONDARY, DISEASE PROGRESSION, TUMOR PROGRESSION
The primary end point was 3-month Progression-free Rate (PFR) and the secondary end points included OS, Progression Free Survival (PFS), Response Rates (RR), toxicity profile and QoL analysis. 3-month PFR was defined as the proportion of patients who were free of disease progression at the end of 12 weeks. OS was defined as the time from randomization to occurrence of death due to any cause/or to the date of censoring at the last time the subject was known to be alive. PFS was the time between treatment initiation and tumor progression or death from any cause. The patient reported outcome (PRO) in terms of QoL was assessed at baseline and week 12.