Impact of adjuvant therapies on treatment outcomes for patients with resected gallbladder cancer and changes in treatment patterns in the United States over the past decade: An analysis from the National Cancer Data Base.

Abstract

391 Background: There are no randomized data to guide clinicians treating patients with gallbladder cancer (GBC). Several retrospective studies reported the survival benefits of adjuvant radiotherapy (RT) and chemoradiation (CRT). The aims of this study were to examine whether these publications have impacted the utilization of adjuvant therapies and whether their survival benefits were evident in contemporary cohort of patients. Methods: Using the National Cancer Data Base, we identified 5,029 patients diagnosed with T1-3N0-1 GBC and treated with surgical resection from 2005 to 2013. We described trends in receipt of adjuvant treatments for three time periods (2005-2007, 2008-2010, 2011-2013) and calculated 3-year overall survival (OS) probabilities for 2,989 patients treated in 2005-2010. Results: The percentage of patients who received no adjuvant treatment was unchanged from 2005 to 2013. Adjuvant RT decreased from 4.3% to 1.7% (p < 0.01), adjuvant chemotherapy increased from 8% to 14% (p < 0.01), and adjuvant CRT remained stable at 16% (p = 0.98). Even for locally advanced disease (T3N0 and T1-3N1) or in the setting of positive resection margins, over 50% of patients in US did not receive adjuvant treatments. Adjuvant treatments were associated with improved 3-year overall survival in patients with resected GBC, as listed in Table. Adjuvant CRT was associated with improved survival in all stages, except T1N0, and in patients with negative and positive margins. Conclusions: Over the past decade there was no increase in the utilization of adjuvant therapies in the US for patients with resected GBC. Adjuvant therapy is associated with significantly improved 3-yr OS. In the absence of randomized data, this analysis should form the basis for clinical recommendations and national guidelines should be amended to support adjuvant treatment.[Table: see text]