Retrospective analysis of the difference of prognosis between unresectable and recurrent biliary tract cancer: Kansai Hepatobiliary Oncology Group (KHBO) 1001.

Abstract

e14518 Background: The difference of prognosis between patients (pts) with unresectable and recurrent biliary tract cancer (BTC) receiving chemotherapy has not been clarified although some studies reported prognostic factors of BTC. In this study, we aimed to compare the prognosis of unresectable BTC with that of recurrent BTC. We also evaluated other prognostic factors of BTC. Methods: This study retrospectively reviewed the data of 403 consecutive pts with pathologically proven unresectable or recurrent BTC who received palliative chemotherapy from 18 hospitals in Japan between April 2006 and March 2009. The 1-year survival rate and overall survival (OS) and patient characteristics were compared between unresectable and recurrent cases. Univariate and multivariate analyses were performed to identify prognostic factors. Results: 380 pts (94.3%) received chemotherapy using gemcitabine and/or S-1. The 1-year survival rate and OS were significantly better in 192 pts with recurrent BTC than 211 pts with unresectable BTC (1-year survival 57.3% vs. 43.1%, p=0.005; OS 398 days [95% confidence interval (CI) 365-430] vs. 323 days [95% CI 282-364], p=0.004). In baseline characteristics, the proportion of pts who had distant metastasis was significantly greater in recurrent BTC than unresectable BTC (77.1% vs. 66.8%, p<0.001). In contrast, lymph node involvement, biliary intervention and elevated tumor marker levels (CEA and CA19-9) were more common in pts with unresectable BTC (p<0.001). After the multivariate analysis, unresectable BTC group still demonstrated a significantly worse survival than recurrent BTC group (hazard ratio [HR] 1.44, 95% CI 1.15-1.80, p=0.002). Other statistically significant prognostic factors were ECOG PS (HR 1.49, 95% CI 1.18-1.87, p<0.001), metastatic disease (HR 1.53, 95% CI 1.20-1.97, p<0.001) and higher CEA (≥5 ng/ml) (HR 1.71, 95% CI 1.36-2.15, p<0.001). Conclusions: The status of unresectable/recurrent disease is identified as one of the prognostic factors for pts with BTC receiving chemotherapy and recommended to be used as a stratification factor in the clinical trials.