Abstract
e14614 Background: There are no well-conducted randomized studies regarding the role of adjuvant chemotherapy for patients with radically resected biliary tract cancers and there is no standard accepted adjuvant treatment for these patients, even if the majority of them suffers from recurrent disease. Methods: We retrospectively reviewed the outcome of patients who underwent radical surgical resection for biliary tract cancer from 2005 to 2009 and who received adjuvant treatment or were followed up at our institution. The aim of our analysis was to evaluate the correlation between prognostic factors and disease-free survival (DFS) using Chi-square test and Cox regression analysis, and to explore the role of adjuvant treatment in these patients. The indication for adjuvant chemotherapy was based upon discussion of its role with every single patient. Results: Eighty-one evaluable patients, 44 (54%) women and 37 (46%) men, all ECOG performance status 0-1, were identified; median age was 67 years (range 30-81). The site of biliary cancer was intrahepatic in 19 patients, perihilar in 12, distal tree in 20, gallbladder in 11, ampullary carcinoma in 19 cases. Fifty-three patients (65%) had T3 or T4 tumors and 34 (42%) had positive nodes; 29 tumors (37%) were of grade 3-4; perineural or vascular invasion was present in 34 (42%) and 15 (19%) cases. Thirty-two (39%) patients received adjuvant chemotherapy with gemcitabine or fluoropyrimidines. On univariate analysis tumor extension, node status, grading, vascular invasion and adjuvant chemotherapy significantly correlated with DFS. In particular, patients with N1 tumour had a median DFS of 12.4 months versus 25.2 months of N0 patients. Patients who received adjuvant chemotherapy after surgery had a median DFS of 29.0 months compared to 17.5 months of patients treated with surgery alone (p=0.04). Multivariate analysis confirmed the negative prognostic role of lymph node involvement (p=0.04) and the positive impact of adjuvant chemotherapy (p=0.001). Conclusions: Adjuvant chemotherapy seems effective in prolonging DFS in radically resected biliary tract cancer patients. A phase III randomized trial should prospectively evaluate the role of adjuvant therapy.
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