Prognostic Factors and Predictive Model in Patients With Advanced Biliary Tract Adenocarcinoma Receiving First-Line Palliative Chemotherapy

BACKGROUND: Advanced biliary tract adenocarcinoma (BTA) has been a rare but fatal cancer. If unresectable, palliative chemotherapy improved the quality and length of life, but to the authors' knowledge, prognostic factors in such patients have not been well established to date. In the current study, prognostic factors were investigated in patients with advanced BTA receiving first-line palliative chemotherapy. METHODS: Data from 213 patients with advanced BTA who were in prospective phase 2 or retrospective studies from September 2000 through October 2007 were used. RESULTS: With a median follow-up duration of 29.7 months, the median overall survival (OS) was 7.3 months (95% confidence interval [95% CI], 6.3 months-8.3 months). A Cox proportional hazards model indicated that metastatic disease (hazards ratio [HR], 1.521; P = .011), intrahepatic cholangiocellular carcinoma (HR, 1.368; P = .045), liver metastasis (HR, 1.845; P < .001), Eastern Cooperative Oncology Group performance status (HR, 1.707; P < .001), and alkaline phosphatase level (IU/L) (HR, 1.001; P < .001) were statistically significant independent predictors of poor prognosis. Patients were classified into 3 risk groups based on the prognostic index (PI), which was constructed using the regression coefficients of each variable. The median OS was 11.5 months (95% Cl, 9.6 months-13.5 months) for the low-risk group (PI <= 1.5; n = 67), 7.3 months (95% Cl, 5.7 months-8.9 months) for the intermediate-risk group (PI > 1.5 but <= 2.2; n = 75), and 3.6 months (95% Cl, 2.9 months-4.1 months) for the high-risk group (PI > 2.2; n = 70 [P < .001]). CONCLUSIONS: Five prognostic factors in patients with advanced ETA were identified. The predictive model based on PI appears to be promising and may be used for the management of individual patients and to guide the design of future clinical trials, although external validation is needed. Cancer 2009;115:4148-55. (C) 2009 American Cancer Society.