Tumour shrinkage at 6?weeks predicts favorable clinical outcomes in a phase III study of gemcitabine and oxaliplatin with or without erlotinib for advanced biliary tract cancer

摘要

Background The aim of this study was to determine whether early tumor shrinkage (ETS) at 6?weeks after treatment correlates with progression-free survival (PFS) and overall survival (OS) in advanced biliary tract cancer (BTC) patients receiving gemcitabine plus oxaliplatin (GEMOX), with or without erlotinib. Methods This was a multicenter, open label, randomized, phase III trial of 103 BTC patients (ClinicalTrials.gov Identifier; NCT01149122, and Rigistration date; January, 7, 2010), comparing GEMOX with GEMOX plus erlotinib. Tumor 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 patients (52.4?%) received GEMOX and 49 patients (47.6?%) received GEMOX plus erlotinib. 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 Conclusions ETS might predict PFS and OS in BTC patients treated with GEMOX with or without erlotinib. Additionally, ETS may be an indication for adding erlotinib to chemotherapy for BTC patients wild-type KRAS . These findings need to be prospectively validated.