Safety of Endostar in combination with chemotherapy in patients with cancer.
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BACKGROUND: Several studies have indicated the benefits and safety of Endostar in combination with chemotherapy, 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 a real-life setting in China. MATERIALS AND METHODS: This was a retrospective study of patients treated with Endostar combined with chemotherapy from January 1, 2006, to December 31, 2017. Data were obtained from the Hospital Information System (HIS). Laboratory abnormalities were evaluated according to Common Terminology Criteria for Adverse Events, Version 4.0. Bleeding events and wound complications after surgery associated with Endostar were evaluated. RESULTS: Finally, 825 patients were included. No patients used Endostar alone. Anemia occurred in 74.5% of the patients, thrombocytopenia in 29.0%, abnormal white blood cell counts in 54.5%, abnormal liver function in 13.8%, and increased creatinine in 1.2%. No definite bleeding events and wound complications associated with Endostar were found. Most laboratory adverse effects (AEs) were found in Grades 1 and 2. Lung cancer, osteosarcoma, and doxorubicin-based chemotherapy were associated with an increased risk of Grade ≥3 abnormal white blood cell counts. The total dose of Endostar was not associated with severe (Grade ≥3) thrombocytopenia and abnormal white blood cell counts. CONCLUSION: The occurrence of AEs during Endostar and chemotherapy treatment differed across different tumor types and chemotherapy regimens. No new unexpected Endostar-related AEs were observed. The total dose of Endostar was not associated with an increased risk of severe (Grade ≥3) thrombocytopenia and abnormal white blood cell counts when used in combination with chemotherapy in the real-life setting.