Huaqiang Zhou1,2,3,4, Jiaqing Liu4, Yaxiong Zhang1,2,3, Li Zhang5,6,7. 1. Department of Medical Oncology, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou, 510060, Guangdong, People's Republic of China. 2. State Key Laboratory of Oncology in South China, Guangzhou, People's Republic of China. 3. Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's Republic of China. 4. Zhongshan School of Medicine, Sun Yat-sen University, Guangzhou, People's Republic of China. 5. Department of Medical Oncology, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou, 510060, Guangdong, People's Republic of China. zhangli6@mail.sysu.edu.cn. 6. State Key Laboratory of Oncology in South China, Guangzhou, People's Republic of China. zhangli6@mail.sysu.edu.cn. 7. Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's Republic of China. zhangli6@mail.sysu.edu.cn.
Abstract
PURPOSE: PD-1/PD-L1 inhibitors have demonstrated unparalleled therapeutic efficacy in multiple tumor types. Additionally, metformin has been linked to favorable outcomes in tumors. Many researchers have reported immune-mediated adverse events induced by immune checkpoint inhibitors (ICI) single agent. However, little is documented on the adverse events of the combined use of ICI and metformin. METHODS: To address this question, we used the Food and Drug Administration Adverse Event Reporting System (FAERS) to display the landscape of adverse events associated with the combined use of ICI and metformin. We identified 38 adverse event cases about the combination treatment between January 1, 2015 and June 30, 2018. RESULTS: There are 36 cases in patients receiving nivolumab plus metformin (NM) therapy, and the other 2 cases were pembrolizumab plus metformin (PM). Among the 36 patients receiving NM therapy, the most common indication was for treatment of malignant lung cancer (20, 55.56%), Notably, 9 cases of inflammatory bowel disease (IBD) and diarrhea were reported. CONCLUSIONS: Our findings revealed that higher risk of IBD might occur in lung cancer patients during the combined therapy of nivolumab plus metformin. Further studies are needed to verify our findings.
PURPOSE: PD-1/PD-L1 inhibitors have demonstrated unparalleled therapeutic efficacy in multiple tumor types. Additionally, metformin has been linked to favorable outcomes in tumors. Many researchers have reported immune-mediated adverse events induced by immune checkpoint inhibitors (ICI) single agent. However, little is documented on the adverse events of the combined use of ICI and metformin. METHODS: To address this question, we used the Food and Drug Administration Adverse Event Reporting System (FAERS) to display the landscape of adverse events associated with the combined use of ICI and metformin. We identified 38 adverse event cases about the combination treatment between January 1, 2015 and June 30, 2018. RESULTS: There are 36 cases in patients receiving nivolumab plus metformin (NM) therapy, and the other 2 cases were pembrolizumab plus metformin (PM). Among the 36 patients receiving NM therapy, the most common indication was for treatment of malignant lung cancer (20, 55.56%), Notably, 9 cases of inflammatory bowel disease (IBD) and diarrhea were reported. CONCLUSIONS: Our findings revealed that higher risk of IBD might occur in lung cancerpatients during the combined therapy of nivolumab plus metformin. Further studies are needed to verify our findings.