Efficacy and safety of adjuvant therapy after curative surgery for ampullary carcinoma: A systematic review and meta-analysis.

Abstract Background Ampullary carcinoma patients require radical resection for optimal survival; however, the outcomes are often unsatisfactory. The utility of adjuvant therapy among such patients is unclear, probably owing to its potential side effects. Therefore, this study investigated the benefits and safety of adjuvant therapy in resected ampullary carcinoma. Methods Cochrane, Embase, Medline, and PubMed databases were systematically searched for eligible studies, and those comparing adjuvant therapy and surgical treatment alone were included. Hazard ratios for survival outcomes and the number of adverse events for safety endpoints were extracted and subjected to pooled analyses through a random-effects model. Results In total, 27 studies involving 3,538 patients were included. Adjuvant therapy was significantly associated with decreased mortality risk (hazard ratio, 0.58; 95% confidence interval 0.40–0.84), especially for chemoradiotherapy (hazard ratio, 0.42; 95% confidence interval 0.28–0.62). Furthermore, adjuvant therapy was significantly associated with increased overall survival among high-risk patients (hazard ratio, 0.63; 95% confidence interval 0.48–0.82) or those with the pancreaticobiliary subtype (hazard ratio, 0.53; 95% confidence interval 0.32–0.85). By contrast, adjuvant therapy was not associated with improved overall survival among low-risk patients (hazard ratio, 0.93; 95% confidence interval 0.52–1.68) or those with the intestinal subtype (hazard ratio, 1.06; 95% confidence interval 0.57–1.95). Regarding the safety of adjuvant therapy, no intervention-related mortality occurred, and severe adverse events were within the acceptable range (risk difference, 0.04; 95% confidence interval 0.01–0.08). Conclusion The present results suggest that adjuvant therapy is safe and extends survival in high-risk patients or those with the pancreaticobiliary subtype of ampullary carcinoma.