Clinical Efficacy And Prognostic Analysis Of Apatinib In Advanced Metastatic Triple Negative Breast Cancer

BackgroundAccording to 2019 US cancer statistics,the three major tumors that threaten women are s till breast cancer,lung cancer,and colorectal cancer.Among them,breast cancer is a common mal ignant tumor in women,accounting for 30% of all new tumors in women,and there are about 1.7million new cases each year.TNBC breast cancer accounts for 15% of breast cancer incidence,b ut mortality accounts for 25% of all breast cancers.Despite significant improvements in breast can cer treatment over the past decade,metastatic TNBC remains incurable,with a median life expecta ncy of 1-2 years.It is defined as triple negative breast cancer(TNBC)due to the lack of estroge n receptor(ER),progesterone receptor(PR)and human epidermal growth factor receptor-2(HER-2).TNBC is a heterogeneous disease that is the most invasive subtype of breast cancer.There has been no specific treatment for a long time,and traditional chemotherapy is still the standard treat ment.At present,with the development of molecular biology,the molecular typing of TNBC has gr adually become clear.Targeted therapeutic drugs based on molecular typing are also undergoing P hase I-III clinical studies,in which clinical trials of angiogenesis inhibitors have achieved good cli nical efficacy.Apatinib is a targeted anti-angiogenesis drug developed in China.Its single drug ap plication can achieve better PFS and OS in the phase II clinical studies of metastatic TNBC,whic h may become one of the promising therapies.ObjectiveTo observe the clinical efficacy and prognostic factors of Apatinib in patients with metast atic TNBC who failed in multiline therapy.MethodsThe clinical data of 31 patients with metastatic TNBC who were treated with apatinib aft er multi-line treatment failure from January 2017 to September 2018 in the First Affiliated Hospita l of Henan University were retrospectively analyzed.To compare the effects of apatinib and apatin ib in combination with chemotherapy,on patients with ORR,DCR,PFS and survival risk factors.SPSS17.0 software was used to analyze the data,K-M univariate survival analysis was used to fin d the risk factors affecting PFS,and COX multivariate survival analysis was used to find independ ent prognostic factors.ResultsOf the 31 patients we collected,clinical data from 29 patients were evaluated.The PFS of the 29 patients was 1.9 to 7.3 months,and the overall median PFS was 3.7 months.The ORR was 13.79%(4/29)and the DCR was 51.72%(15/29).Kaplan-Meier method univariate analysis showed: apatinib combined with chemotherapy(17cases,58.62%),PFS was 2.0-7.1 months,median PFS was 3.4 months,and apatinib single drug(12 cases,41.38)%),PFS was 1.9-7.3 months,median PFS was 3.7 months,there was no signific ant difference between them(P=0.371).The Ki-67 index was ≤14%(8 cases,27.59%),the PFS was 2.2-7.3 months,the median PFS was 5.6 months,the Ki-67 index was >14%(21 cases,72.41%),and the PFS was 1.9-7.1 months,the median PFS was 3.3 months,and there was a statistic al difference between the two(P=0.011);Visceral metastasis(21 cases,72.41%),PFS was 1.9-7.1 months,median PFS was 3.1 months,no visceral metastasis(8 cases,27.59%),PFS was 3.4-7.3 months,and median PFS was 5.5 months.There was a statistical difference between them(P=0.028);Brain metastases(5 cases,17.24%),PFS was 1.9-3.3 months,median PFS was 2.1 months,no brain metastasis(24 cases,82.76%),PFS was 2.2-7.3 months,and median PFS was 5.0 months.There was a statistical difference between the two(P = 0.000).In summary,Ki-67 index,visceral metastasis,and brain metastasis are the main risk factors affecting the prognosis of patients with advanced metastatic TNBC.Other factors such as age,menopausal status,apatinib monotherapy an d combination chemotherapy,previous chemotherapy line,tumor diameter have no significant impa ct on the prognosis of TNBC patients(P=0.646;P=0.726;P=0.371;P=0.492;P=0.455).The results of COX regression model showed that Ki-67 index(P=0.020)and brain metastasis status(P=0.003)were independent prognostic factors for PFS in patients with advanced metastatic TNBC.Most of the treatment-emergent adverse events of grade 1-2 after apatinib chemotherapy were hypertension(7 cases,22.58%),hand-foot syndrome(6 cases,19.35%),oral mucositis(4 case s,12.9%),fatigue(7 cases,22.58%)and leukopenia(5 cases,25.8%).The main adverse reactions of grade 3 to 4 were hypertension(1 case,3.23%),hand-foot syndrome(1 case,3.23%)and leuko penia(2 cases,3.45%).Conclusion(1)Apatinib improves the patient’s disease control rate,improves PFS,and can be tolerated in patients with advanced metastatic TNBC,which deserves further investigation.(2)Ki-67 index and brain metastasis status influence the independent prognostic factors of Apatinib in advanced metastatic TNBC.