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1、乳癌内分泌治疗 新思路和临床实践,乳癌的治疗手段,Surgery 手术 Radiation therapy 放疗 Chemotherapy 化疗 Hormone therapy 内分泌治疗 Biotherapy 生物治疗 New therapies 新的治疗,乳癌内分泌治疗的发展,1970,1980,1990,2000,Tamoxifen,Tamoxifen,MA AG,新的芳香化酶抑制剂,Exemestane / MA,新的芳香化酶抑制剂,Tamoxifen pure A.E. ?,MA,III,I,II,III,Hormone Therapy Response Rate (%) in Di
2、fferent Receptor Status,Survival by Response Arimidex 1 mg,0,20,40,60,80,100,0,1,2,3,4,CR or PR,Stable,24 wks,Progression,Years from Randomisation,% Survival,MA AG,Prevention DCIS/ Neoadj,5 years,Metastatic Disease,1st,2nd,3rd,Adjuvant,TAM,TAM,TAM,TAM,OV ABL,三苯氧胺 （TAM) 最重要的乳癌内分泌治疗药物,Tamoxifen for 5
3、Years vs No Treatment,Percent,Years,ER+,85.2,76.1,68.2,73.7,62.7,54.9,11.5 (SE 0.9),13.4 (SE 1.1),13.4 (SE 1.4),68.2%,54.9%,0,20,40,60,80,100,0,5,10,15,vs,Recurrences,Breast Deaths,0,20,40,60,80,100,0,5,10,15,ER+,73.0%,64.0%,91.4,80.9,73.0,87.8,73.2,64.0,3.6 (SE 0.7),7.8 (SE 1.0),9.0 (SE 1.4),vs,Yea
4、rs,Percent,8,Tamoxifen Adjuvant Therapy for EBC 辅助内分泌治疗的决定因素是激素受体状况 ER阳性效果最好,9,Tamoxifen Adjuvant Therapy for EBC 合适的TAM服药时间为5年,10,Tamoxifen Adjuvant Therapy for EBC ER阳性无论年龄大小都可用TAM,11,Tamoxifen Adjuvant Therapy for EBC 降低对侧乳癌发生 增加子宫内膜癌的风险,Tamoxifen Adjuvant Therapy for EBC ER阳性TAM和化疗合用比单用TAM更有效 CA
5、F与TAM 序贯合用比同时效果更好,MA AG,Prevention DCIS/ Neoadj,5 years,Metastatic Disease,1st,2nd,3rd,Adjuvant,1,TAM,TAM,TAM,TAM,OV ABL,Tamoxifen Indications in Breast Cancer,三苯氧胺 乳癌内分泌治疗不可动摇的地位！？,Survival Data Anastrozole / MA,Median time to death(months),2 year survival rate (%),P 0.05,瑞宁得用药9个月没有明显的体重变化,瑞宁得 (Ari
6、midex) 比 MA更有效、更安全,瑞宁得 (Arimidex) 1 mg 在复发转移乳癌治疗中 缓解率 / 临床获益率相当 生存期更长 耐受性更好,Prevention DCIS/ Neoadj,5 years,Metastatic Disease,1st,2nd,3rd,AI,AI,Adjuvant,TAM,TAM,TAM,TAM,1,Arimidex in Breast Cancer,MA,Anastrozole is Superior to Tamoxifen in First Line Therapy（0030）,JCO 2000;18:3748,* Hazard ratio (t
7、am : Arimidex) 1.44, lower CL 1.16. Study powered for equivalence. Median follow-up of 18 months. 71% progressed,Trial 0030: Kaplan-Meier Curve of Probability of Time to Progression,AIs is Superior to Tamoxifen as First-line Therapy for Advanced Breast Cancer,芳香化酶抑制剂 取代三苯氧胺 成为标准的一线内分泌治疗,Prevention D
8、CIS/ Neoadj,5 years,Metastatic Disease,AI,1st,2nd,3rd,AI,AI,Adjuvant,TAM,TAM,TAM,TAM,1,Arimidex in Breast Cancer,MA,Rationale for Adjuvant Therapy With Aromatase Inhibitors (AIs),AIs Effective after tamoxifen Better than tamoxifen first line Well tolerated May overcome tamoxifen “resistance”,The Gol
9、d Standard,Tamoxifen,First-Line Letrozole is Anastrozole is = Exemestane is? Neoadjuvant Letrozole is Adjuvant ？ Anastrozole,Milestones Activated 1996 Planned accrual 9366 Accrual to date Closed 1999,Ongoing AI Adjuvant Trials: ATAC (Anastrozole),Trialists Group TA. Br J Cancer. 2001;85:317.,RANDOM
10、I ZE,Surgery,Tamoxifen 20 mg od,Anastrozole 1 mg od,Tamoxifen 20 mg od,Anastrozole 1 mg od,5 years,DFS/OS,KaplanMeier Curves of Disease-free Survival in ITT Population,Curves truncated at 42 months,KaplanMeier Curves of Disease-free Survival in Receptor-positive Population,Curves truncated at 42 mon
11、ths,Predefined adverse events* Hot flushes,A Arimidex T Tamoxifen C Combination,1060,T,C,1229,1243,A,% patients,A vs T C vs T A vs C,0.79 1.02 0.78,OR,0.0001 0.75 0.0001,p value,A vs T C vs T A vs C,0.52 0.94 0.56,0.0001 0.5 0.0001,OR,p value,A,T,C,A, Arimidex; C, combination; T, tamoxifen,138,253,2
12、38,% patients,Predefined adverse events Vaginal bleeding,The ATAC Early breast cancer trial in postmenopausal patients Endometrial sub-protocol results,Demographics,285 women from 31 centres in 10 countries Mean age 60 yrs ( 44 - 80 yrs ) Mean age at menopause 50 years 80% 4 years or more post menop
13、ause,Baseline Ultrasound,1,2,3,4,5,6,7,8,9,10,10,0,10,20,30,40,50,60,n,Endometrial thickness (mm),Median endometrial thickness,0,2,4,6,8,10,0,12,24,Endometrial thickness (mm),Arimidex Tamoxifen Combination,Time (months),A vs T C vs T A vs C,0.23 0.46 0.50,0.02 0.11 0.51,OR,p value,A,T,C,A, Arimidex;
14、 C, combination; T, tamoxifen,3,13,6,% patients,Predefined adverse events Endometrial cancer,ATAC Summary,Anastrozole is superior to tamoxifen in terms of: Disease-free survival in: Overall population (HR=0.83) Receptor-positive patients (HR=0.78) Incidence of contralateral breast cancer in: Overall population (OR=0.42),Conclusions,Anastrozole is the first and only AI to show superior efficacy and improved tolerability compared with tamoxifen in the treatment of EBC Overall risk-be
