Analysis of the Adverse Reactions and Risk Factors of Apatinib in the Treatment of Breast Cancer in Real World
MA Ying-lin1, LE Kai-di1, YAN Jia-qing1, TIAN Chun-hua2, WANG Tao2, LIU Min1*, LI Guo-hui1*
1. Department of Pharmacy, National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China; 2. Center for Drug Reevaluation, National Medical Products Administration, Beijing 100022, China
Abstract：OBJECTIVE To evaluate the safety of using apatinib in breast cancer patients in real world, analyze the risk factors of adverse drug reactions, and provide reference for the use of apatinib in breast cancer patients. METHODS Retrospective analysis of 193 cases of breast cancer patients treated with apatinib in our hospital from March 2016 to March 2020 was conducted. The basic case data and adverse reactions were collected. The correlation between clinical characteristics and adverse drug reactions was analyzed by logistic regression. RESULTS Among 193 patients, 132 patients (68.39%) had adverse reactions, most of which were grade 1 or grade 2. The most common adverse reactions were hypertension (27.46%) and hand foot syndrome (21.76%). Multivariate logistic regression analysis showed that patients with initial dose of 425 mg/500 mg had an increased risk of ADR compared with patients with 250 mg (OR=4.719, 95%CI: 2.315-9.621), and patients with combination chemotherapy had an increased risk of ADR compared with patients treated with single drug (OR=4.569, 95% CI: 2.082-10.030). Compared with patients without history of hypertension, patients with previous hypertension history had higher risk of hypertension adverse reactions (OR=2.528, 95% CI: 1.084-5.891). Patients with initial dose of 425 mg/500 mg had higher risk of adverse reactions of hypertension than patients with 250 mg (OR=3.622, 95% CI: 1.762-7.448). Patients with combined chemotherapy had a higher incidence of adverse reactions of hypertension than patients treated with single drug (OR=3.386, 95% CI: 1.106-10.369). CONCLUSION The adverse reactions of apatinib in the treatment of breast cancer are tolerable, the initial dose and combined chemotherapy are the risk factors of ADR; the history of hypertension, initial dosage and combined chemotherapy are the risk factors of adverse reactions of hypertension.
马颖林, 乐凯迪, 闫加庆, 田春华, 王涛, 刘敏, 李国辉. 真实世界阿帕替尼治疗乳腺癌的不良反应及危险因素分析[J]. 中国药学杂志, 2022, 57(4): 310-314.
MA Ying-lin, LE Kai-di, YAN Jia-qing, TIAN Chun-hua, WANG Tao, LIU Min, LI Guo-hui. Analysis of the Adverse Reactions and Risk Factors of Apatinib in the Treatment of Breast Cancer in Real World. Chinese Pharmaceutical Journal, 2022, 57(4): 310-314.
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2022, Vol. 57 
