Early @entity5 shrinkage and depth of response predict long-term outcome in metastatic XXXX @entity1 treated with first-line chemotherapy plus bevacizumab: results from phase III TRIBE trial by the Gruppo Oncologico del Nord Ovest.

@entity1 @entity5 @entity470 @entity1493 @entity14 @entity1349
BACKGROUND: Early @entity5 shrinkage (ETS) and depth of response (DoR) predict @entity1349 ( @entity1349 ) in first-line trials of chemotherapy    anti- @entity470 monoclonal antibodies in metastatic @entity14 (mCRC). These associations and the predictive accuracy of response measurements for survival parameters were investigated in the phase III TRIBE trial of FOLFOXIRI plus bevacizumab ( @entity1493 ) versus FOLFIRI plus @entity1493 . @entity1 AND METHODS: A landmark approach was adopted to define the assessable population. The distribution of RECIST response rate, ETS and DoR was compared in the two arms. Associations between response measurements and progression-free survival (PFS), @entity1349 ( @entity1349 ) and @entity1349 were tested by univariate and multivariate Cox models. Prediction performance of each factor was estimated by C-index. RESULTS: A significantly higher percentage of @entity1 in the FOLFOXIRI plus @entity1493 arm achieved ETS >= 20%, when compared with the control arm (62.7% versus 51.9%, P = 0.025). Also the DoR was significantly higher in the triplet plus @entity1493 arm (43.4% versus 37.8%, P = 0.003). Both ETS and DoR were associated with PFS, @entity1349 and @entity1349 at the univariate analyses and in the multivariate models stratified for other prognostic variables. Both ETS and DoR were able to predict survival as accurately as RECIST response. CONCLUSION: FOLFOXIRI plus @entity1493 improves ETS and DoR when compared with FOLFIRI plus @entity1493 . Achieving rapid and deep @entity5 shrinkage consistently delays @entity5 progression and prolongs survival in @entity1 treated with first-line chemotherapy plus @entity1493 . ETS is a promising and valuable end point for clinical trials' design deserving further investigation.
