Clinical Effect Of Fulvestrant In Metastatic Breast Cancer

Purpose : Along with the changes of living environment and the way of life,morbidity of breast cancer in wowen is increasing gradually,and more and more younger patients.Breast cancer has becomed the first malignant tumor of a threat to women’s health.So the specific treatments become more and more important.In addition to surgery,chemotherapy,radiotherapy and biological immune therapy,endocrine therapy,as effective,lower toxic,less adverse reactions and good tolerance to patients,is indispensable in comprehensive treatments for hormone receptor(hormone receptor,HR)positive breast cancer.It has become the research focus of clinical workers and researchers at present.In the process of endocrine therapy,however,some patients will occur a primary or secondary drug resistance,the initial treatment is invalid or endocrine therapy after a period of time is invalid,or patients can’t tolerate the rare and serious adverse reactions of endocrine drugs,so can’t continue to use the same or similar drugs.At this point,it urgently needs a new kind of endocrine drugs,can satisfy the requirements of the subsequent endocrine therapy,and benefit patients.Fulvestrant is a new endocrine drug,unlike tamoxifen(TAM)or aromatase inhibitors(AIs).It is a new type of estrogen receptor(estrogen receptor,ER)antagonist,can competitively antagonise estrogen receptor and lower estrogen receptor expression level.It completely blocks ER,without estrogen-like effects and less adverse reactions at the same time,has been approved in hormone receptor-positive recurrent or metastatic breast cancers.Our study retrospectively analyzed datas of 30 patients with hormone receptor-positive metastatic breast cancer received fulvestrant 500 mg,observed the clinical efficacy,adverse reactions and the influencing factors of fulvestrant,and hoped to provide the references for endocrine therapy in hormone receptor-positive advanced breast cancers.Methods: Analyzed the clinical datas of 30 breast cancer patients in the First Affiliated Hospital of Bengbu Medical University between Jan.2015 and Dec.2016.All patients were hormone receptor-positive metastatic breast cancer,had disease progression after previously received endocrine therapies.We analyzed progression free survival(PFS),clinical benefit rate(CBR),including complete remission(CR),partial remission(PR),and stable disease(SD),objective response rate(ORR),including CR and PR,the related influencing factors,and the treatment-related adverse reactions of fulvestrant.All patients received fulvestrant 500 mg in deep hip intramuscular injection on day 1,14,28,repeating every 28 days(28 days for a cycle).Treatments for at least 2 cycles.If patients had disease progression,can’t tolerate the toxicity,refused to continue medication or lost to follow-up,treatments stopped.To check tumor markers(CEA and CA153)and imageological examinations(CT,MRI)every 2 cycles.We evaluated the clinical effects and adverse reactions every two cycles.Results: After the median follow-up of 8.4 months(3.0-18.8 months),All patients were evaluated the recent curative effects,CR 0 case,PR 2 cases(6.7%),SD 14 cases(46.7%),PD 14 cases(46.7%),ORR(CR + PR)6.7%,CBR(CR + PR+ SD)53.3%.The median PFS was 4.8 months(2.2-6.4 months).Subgroup analysis showed that ER and PR status,HER2 expression condition,whether internal metastasis and the lines of fulvestrant as endocrine therapy after disease progression on the influences to PFS had no statistical significance(P > 0.05).Equal to or more than 2 metastatic sites and had received chemotherapies after disease progression on the influences to PFS had statistical significance(P < 0.05),both are the risk factors for PFS.Hazard risk is 3.11 times of equal to or more than 2 metastatic sites comparing to one metastasis site(95%CI:1.44-14.18),the hazard risk is 3.08 times of received chemotherapies comparing to not received chemotherapies whose disease progressed after prior endocrine therapies(95%CI:1.26-12.32).Adverse reactions mainly concluded weak 2cases(6.7%),nausea 2 cases(6.7%),hot flashes 3 cases(10%),pain at the injection site 3 cases(10%),joint pain 2 cases(6.7%),diarrhea 1 case(3.3%),transaminase lifts 1 case(3.3%).All adverse reactions were grade 1 to 2,without 3 and above grade,and can be improved after symptomatic and supportive treatments,no patients stopped or delayed treatments because of adverse reactions.At the end of the last observation time,no patients died.Conclusions: 1.As for patients with disease progression after endocrine therapies in hormone receptor-positive metastatic breast cancer,fulvestrant can still benefit them.2.The clinical common adverse reactions of fulvestrant are not serious so that fulvestrant is well tolerable.