End points
death
ADVERSE EVENTS, DISEASE PROGRESSION, DISEASE, TOLERANCE
Progression-free survival (PFS) was defined as time from inclusion to first documentation of objective disease progression or death due to any cause or until the date of the last news (censored data). Evaluation of partial and complete response rate was performed by RECIST 1.1 in each arm. Duration of response was defined as the time from first met for complete or partial response (CR/PR) (whichever is first recorded) until the first date that recurrent or progressive disease which was objectively documented and calculated only in patients with a response to treatment (CR/PR). Clinical benefit is defined by the rate of complete response, the rate of partial response and the stability of lesions at 24 weeks according to criteria RECIST 1.1. Overall survival (OS) was defined as time from inclusion to death due to any cause. Tolerance of the treatment was based on adverse events occurrence according to criteria NCI CTCAEv4.03.