Safety of Endostar in combination with chemotherapy in patients with cancer

Abstract

Background: A number of studies indicated the benefits and safety of Endostar in combination with chemotherapy in cancer, but the exact real-life safety of Endostar is poorly known. This study aimed to assess the safety of Endostar in combination with chemotherapy in patients with cancer in a real-life setting in China. Methods: This was a retrospective study of patients treated with Endostarin combination with chemotherapy in the Chinese PLA General Hospital (Beijing, China) from 1 st January 2006to 31 st December 2017. All data were obtained from the Hospital Information System(HIS). Laboratory abnormalities were evaluated according to Common Terminology Criteria for Adverse Events(CTCAE) 4.0.Bleeding events and wound healing complications after surgery associated with Endostar were evaluated based on case records. Results: A total of 825 patients were included. There were no patients used Endostar alone in real-life settings. Overall, anemia occurred in 74.5% of the assessed patients, thrombocytopenia occurred in 29.0%, abnormal white blood cell count occurred in 54.5%, abnormal liver function occurred in 13.8%, and increased creatinine occurred in 1.2%. No definite bleeding events and wound healing complications after surgery associated with Endostar were found based on case records. Most laboratory AEs were of grade 1-2. Lung cancer, osteosarcoma and doxorubicin-based chemotherapy was associated with an increased risk of grade≥3 abnormal white blood cell count ( P <0.05). The total dose of Endostar was not associated with severe AEs(grade≥3)of thrombocytopenia and abnormal white blood cell count. Conclusion: The occurrence of AEs during treatment with Endostar in combination with chemotherapy differed across different tumor types and chemotherapy regimens. No new unexpected AEs relating to Endostar were observed from this study. The total dose of Endostar was not associated with increased risk of severe AEs (grade≥3)of thrombocytopenia and abnormal white blood cell count when used in combination with chemotherapy in the real-life setting.