Outcomes of Adjuvant Therapy after Cholecystectomy in Patients With Gallbladder Cancer From The National Cancer Database, 2004-2015

Abstract

There are limited prospective data evaluating the optimal adjuvant therapy in patients with resected gallbladder cancer. This National Cancer Data Base (NCDB) analysis was conducted to compare the overall survival (OS) of adjuvant therapy regimens after cholecystectomy in patients with gallbladder cancer. The NCDB was queried for patients with T0-4, N0-2 gallbladder cancer who underwent cholecystectomy and were classified according to their adjuvant treatment as chemotherapy (CT), radiotherapy (RT), chemoradiotherapy (CRT), or none (surgery only). Univariable and multivariable frailty survival models were used to quantify the effect of each therapy modality on overall survival. From 2004-2015, 7,258 patients met eligibility criteria. Of these, 4098 (56.5%) underwent surgery alone, 1368 (18.9%) received CT, 283 (3.9%) received RT, and 1509 (20.8%) received CRT. The median age of patients was 67.7, with median follow-up of 59 months. On multivariable analysis, after controlling for age, gender, race, Charlson-Deyo Comorbidity Score, geographic region, TNM stage and surgical margin status, CRT was associated with higher OS (Hazard ratio [HR] = 0.80, 95% Confidence interval [CI] = 0.73-0.87, p = <.001) than surgery alone, whereas CT (HR = 1.33, CI = 1.22-1.44, p = <.001) was associated with lower OS than surgery alone. In this NCDB analysis, CRT was associated with a higher OS, suggesting a role for CRT as optimal adjuvant therapy patients with resected gallbladder cancer. Given the inherent biases of population-based analyses, these results warrant further investigation in randomized clinical trials.