Fulvestrant500mg And250mg In The Treatment Of Advanced Breast Cancer Clinical Research

Background: Breast cancer is a malignant tumor, a threat to women’s health inrecent years, with changes in lifestyle and environmental factors, the incidence rateshowed an increasing trend, has leapt to the first female malignancy. China’s incidencerate of1%to2%higher than the world average. Become a serious threat to the health ofwomen in our country malignant tumors. Endocrine therapy plays an increasinglyimportant role in the treatment of breast cancer, can be used as neoadjuvant therapy,adjuvant therapy and recurrence and metastasis after remedial treatment. Hormonereceptor-positive breast cancer patients receiving endocrine drug therapy, such astamoxifen, AIS, etc., but many patients due to side effects of drugs and drug affects theendocrine drugs continue to use, so a new mechanism of endocrine drugs came intobeing, fulvestrant, fulvestrant compared to before the introduction of endocrine therapydrugs with new mechanisms. It competitive binding to estrogen receptors, and has ahigh affinity, fulvestrant, however, as a pure estrogen receptor antagonist andestrogen-like effects, unlike tamoxifen some organizations, have side effects such asbone, endometrial and vascular. Fulvestrant250mg has been approved by the StateFood and Drug Administration (SFDA) for postmenopausal estrogen receptor-positivemetastatic breast cancer anti-estrogen therapy has achieved good results. Fulvestrant asa new mechanism of endocrine drugs, better tolerated than tamoxifen, previous theendocrine drug treatment progression or recurrence of breast cancer patients can stillbenefit. And fulvestrant in a dose-dependent reduction of expression of ER, theEuropean Medicines Agency (EMA) and the U.S. Food and Drug Administrationapproval in March2010and September respectively fulvestrant500mg dose. At present,China is no fluorine Davis group500mg treatment of postmenopausal estrogenreceptor-positive advanced breast cancer clinical reports.Objective：Observed fulvestrant500mg group compared fulvestrant250mg group to the prior endocrine drug therapy or recurrence in postmenopausal patients withadvanced breast cancer, the efficacy and safety.Method: Retrospective analysis2011.03.01-2012.12.31The First AffiliatedHospital of Dalian Medical University and the Hospital of Oncology Dalian UniversityAffiliated Zhongshan,35patients with breast cancer, data analysis, the cut-off date(April1,2013). All patients were estrogen receptor-positive, had previously receivedendocrine therapy after progression or recurrence and metastasis in advanced breastcancer, fulvestrant500mg group of15patients,250mg group of20patients. Fulvestrant500mg program: Fulvestrant500mg/intramuscular injection,1,15,29days each time,every28days thereafter; fulvestrant250mg scheme: Fulvestrant250mg/intramuscularinjection, once every28days. Treatment for at least2cycles until disease progressionor can not tolerate the toxicity. CT scan evaluated every two cycles, and assessment ofadverse reactions.Results:35patients were evaluable for efficacy: Fulvestrant500mg and250mggroup patients have no complete remission (CR) cases, in Fulvestrant500mg grouppartial remission (PR) is4cases, Stable (SD≥24W) is5cases，(SD <24w) is4cases,progress (PD) patients is2cases, the objective response rate ORR(CR+PR)26.7%clinical benefit rate CBR (CR+PR+SD≥24w)60.0%; partial remission (PR) patients,stable disease (SDobjective efficiency ORR (CR+PR)25%) in12cases, progress (PD)patients, clinical benefit rate CBR (CR+PR+SD≥24w)60%. Fulvestrant500mggroup of patients with a median PFS of greater than250mg group patients (hazard ratio[HR]=0.78,95%CI for the0.60to0.91, P=0.009). Fulvestrant500mg group ofpatients’ clinical benefit duration (DoCB) is15.8Months, the250mg group patients’clinical benefit duration (DoCB) is13.2Months, the difference was not statisticallysignificant. The main adverse reactions were injection-site reactions:500mg group ofpatients was60%(9/15), in which three or more reaction rate was13.3%(2/15);250mggroup of patients was50%(10/20), in which three or more reaction rate was10%(2/20).Conclusion: Fulvestrant500mg and250mg objective of the two groups havesimilar efficiency and clinical benefit rate; significantly prolonged medianprogression-free survival500mg group than in the250mg group; the clinical sustainedremission500mg group than in the250mg group may be extended. Three or moreinjection-site reactions and other adverse effects were similar between the two groupsshowed no significant difference.