Outcome of Adjuvant Therapy in Biliary Tract Cancers

Objective: 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.

Methods: 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.

Results: 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).

Conclusions: 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.