Outcome of adjuvant therapy in biliary tract cancers.

There are high rates of recurrence after definitive surgery in biliary tract cancer patients. We reviewed the use and effectiveness of adjuvant therapy (AT; chemotherapy±radiotherapy) in a single institution series. Characteristics, treatment details, and follow-up data of all patients with biliary tract cancer who had definitive surgery from January 1987 to September 2011 were reviewed. The association between baseline variables and disease-free survival/overall survival (OS) were tested using Cox proportional hazard analysis in the univariable and multivariable settings. Analysis included 296 patients (58% male; median age, 63 y). Negative or microscopically positive resections were reported in 42% and 14%, respectively, with 44% not reported. Node positivity was reported in 35% patients. AT was given in 28% of patients with 59% receiving chemotherapy and 35% concurrent chemotherapy/radiotherapy. Disease recurred in 60% patients. AT was associated with significantly improved OS (hazard ratio, 0.41; P=0.02). Compared with R0 resection, patients with R1 resection derived significantly increased benefit from AT (P for difference 0.02). In the node positive population (n=103), AT was associated with significantly improved OS (hazard ratio, 0.60; 95% confidence interval, 0.38-0.95; P=0.03). Patients with R1 resection and node positive disease receiving AT after definitive surgery seem to derive OS advantage. Large prospective trials are needed to confirm these data.