BACKGROUND: The aim of this study was to determine whether @entity5 shrinkage (ETS) at 6  weeks after treatment correlates with progression-free survival (PFS) and @entity1349 ( @entity1349 ) in advanced @entity1125 ( @entity1125 ) @entity1 receiving @entity136 plus @entity901 (GEMOX), with or without @entity3866 . METHODS: This was a multicenter, open label, randomized, phase III trial of 103 @entity1125 @entity1 (ClinicalTrials.gov Identifier; NCT01149122, and Rigistration date; January, 7, 2010), comparing GEMOX with GEMOX plus @entity3866 . @entity5 shrinkage was expressed as a relative decrease compared to baseline and was dichotomized according to a previously reported cutoff value of 10  %. RESULTS: Fifty-four @entity1 (52.4  %) received GEMOX and 49 @entity1 (47.6  %) received GEMOX plus @entity3866 . The latter achieved a better overall response rate (RR) (40.8  % vs. 18.6  %, p   =   0.02) and showed ETS more frequently (63.2  % vs. 40.7  %, p   =   0.03). ETS was significantly correlated with the overall RR (correlation coefficient, 0.53; p   <   0.01). The median PFS and @entity1349 did not differ according to @entity3866 administration. However, the median PFS (7.3 vs. 2.1  months, p   <   0.01) and @entity1349 (10.7 vs. 5.8  months, p   <   0.01) were significantly longer amongst @entity1 with ETS at 6  weeks after treatment, irrespective of @entity3866 administration. In @entity1 with wild-type @entity984 who were treated with GEMOX plus @entity3866 , ETS was a significant prognostic factor for PFS (p   <   0.01). CONCLUSIONS: ETS might predict PFS and @entity1349 in @entity1125 @entity1 treated with GEMOX with or without @entity3866 . Additionally, ETS may be an indication for adding @entity3866 to chemotherapy for @entity1125 @entity1 wild-type @entity984 . These findings need to be prospectively validated.

@entity5 shrinkage at 6  weeks predicts favorable clinical outcomes in a phase III study of XXXX and @entity901 with or without @entity3866 for advanced @entity1125 .

@entity1 :: ('9606', 'Species') :: ['patients'] @entity901 :: ('MESH:C030110', 'Chemical') :: ['oxaliplatin'] @entity5 :: ('MESH:D009369', 'Disease') :: ['Tumor', 'early tumor'] @entity984 :: ('3845', 'Gene') :: ['KRAS'] @entity3866 :: ('MESH:C400278', 'Chemical') :: ['erlotinib'] @entity136 :: ('MESH:C056507', 'Chemical') :: ['gemcitabine'] @entity1125 :: ('MESH:D001661', 'Disease') :: ['biliary tract cancer', 'BTC'] @entity1349 :: ('MESH:D011475', 'Disease') :: ['OS', 'overall survival']
@entity136 :: (MESH:C056507,Chemical) :: ['gemcitabine']
