Efficacy And Safety Of Apatinib Monotherapy Or Combination Therapy In Advanced Breast Cancer

Purpose:To retrospectively analyze the efficacy and safety of apatinib monotherapy or combination therapy in advanced breast cancer,and to find out the factors that affect the prognosis of patients.Methods:To collect the clinical data of 78 patients with advanced breast cancer who were treated with apatinib alone or in combination from January1,2014 to September 30,2019 in the Affiliated Cancer Hospital of Guangxi Medical University.The initial dose of apatinib was 500mg/d or 250mg/d,the combined treatment included combined chemotherapy,combined endocrine therapy and combined anti-human epidermal growth factor receptor 2 therapy.the combined drugs were treated at standard doses.The primary observation indicator was PFS,and the secondary observation indicators were ORR,DCR,OS and safety.To find independent factors affecting the prognosis of advanced breast cancer patients by single factor and multi-factor analysis.Results:1.Of 78 patients treated with apatinib alone or in combination,complete remission was achieved in 0 cases,partial remission in 14 cases,disease stabilization in 45 cases,disease progression in 19 cases,ORR was 17.9%,DCR was 75.6%,m PFS was 4.4 months and m OS was 10.1 months.2.Twenty-four patients with HR+ breast cancer who had previously failed treatment with non-steroidal AI were treated with apatinib combined with Exemestane for a m PFS of 6.3 months,with an ORR of 12.5% and a DCR of75.0%;The m PFS of 18 patients with three-negative breast cancer using apatinib combined with capecitabine was 4.0 months,ORR was 11.1% and DCR was77.8%.3.Factors affecting prognosis: univariate and multivariate Cox proportional hazards regression analysis indicated that proteinuria was a protective prognostic factor for advanced breast cancer PFS(HR=0.432,95%CI:0.202～0.925,P=0.031);while the combined brain metastasis was a prognostic risk factor for its PFS(HR=0.330,95%CI:0.167～0.654,P=0.001)and OS(HR=2.653,95%CI:1.159～6.076,P=0.021).4.The major hematological toxicity was leukopenia(35.9%),neutropenia(34.6%);major non-hematological toxicity included hypertension(55.1%)and elevated aminotransferase(48.8%);all of them were grade I ～ II.The most grade III adverse reactions were hypertension(30.8%),which could be alleviated after symptomatic treatment.A small dose of apatinib for 250 mg/d、combined with endocrine therapy adverse reactions mild.Conclusion:1.Apatinib monotherapy or combination therapy has a certain effect in advanced breast cancer;hormone receptor positive advanced breast cancer who have previously failed to use non-steroidal AI still have a better effect with apatinib combined with exemestane;second-line and above treatment of advanced third-negative breast cancer,apatinib combined with capecitabine may be an effective treatment,the subsequent need to expand the sample size for further verification;2.The combination of brain metastases and the presence of proteinuria associated with apatinib therapy are independent factors affecting the prognosis of patients;3.For patients with advanced breast cancer,low-dose apatinib 250 mg/d seems to be more tolerable,and the combined treatment is effective,the adverse reactions are mild,and further exploration is still needed.