proportion of patients with a best overall response of complete response or partial response
proportion of patients with the time from the date of first documented response until the date of documented progression or death in the absence of disease progression
proportion of patients with the time from randomization until the date of objective disease progression or death
the percentage of patients who have a best overall response of CR or PR or SD
the time from the date of randomization until death due to any cause
PROs will be assessed using the EORTC QLQ-C30,changes in score compared to baseline will be evaluated.
PROs will be assessed using the EORTC QLQ-LC13, changes in score compared to baseline will be evaluated.
To be assessed using the PRO CTCAE ,changes in symptoms compared to baseline will be evaluated.