乳腺癌内分泌治疗的新思路和临床实践课件.ppt
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1、关于乳腺癌内分泌治疗的新思路和临床实践现在学习的是第1页,共87页乳癌的治疗手段乳癌的治疗手段 Surgery 手术 Radiation therapy 放疗 Chemotherapy 化疗 Hormone therapy 内分泌治疗 Biotherapy 生物治疗 New therapies 新的治疗现在学习的是第2页,共87页1970198019902000TamoxifenTamoxifenMAAGExemestane /MATamoxifenpure A.E. ?MA现在学习的是第3页,共87页Hormone Therapy Response Rate (%) in Different
2、 Receptor Status现在学习的是第4页,共87页Survival by Response Arimidex 1 mg% Survival 现在学习的是第5页,共87页MAAG Prevention DCIS/Neoadj 5 yearsMetastaticDisease 1st2nd3rdAdjuvant TAM TAMTAMTAMOVABL三苯氧胺三苯氧胺 (TAM) 最重要的乳癌内分泌治疗药物最重要的乳癌内分泌治疗药物现在学习的是第6页,共87页Tamoxifen for 5 Years vs No TreatmentPercentYearsER+68.2%54.9%02040
3、6080100051015vsRecurrencesBreast Deaths020406080100051015ER+73.0%64.0%vsYearsPercent现在学习的是第7页,共87页8Tamoxifen Adjuvant Therapy for EBC辅助内分泌治疗的辅助内分泌治疗的决定因素决定因素是激素受体状况是激素受体状况ERER阳性阳性效果最好效果最好 现在学习的是第8页,共87页9Tamoxifen Adjuvant Therapy for EBC合适的合适的TAMTAM服药时间服药时间为为5 5年年现在学习的是第9页,共87页10Tamoxifen Adjuvant T
4、herapy for EBC ERER阳性阳性无论年龄大小都可用无论年龄大小都可用TAMTAM现在学习的是第10页,共87页11Tamoxifen Adjuvant Therapy for EBC降低对侧乳癌发生降低对侧乳癌发生增加子宫内膜癌的风险增加子宫内膜癌的风险现在学习的是第11页,共87页Tamoxifen Adjuvant Therapy for EBC ERER阳性阳性TAMTAM和化疗合用和化疗合用比单用比单用TAMTAM更有效更有效CAFCAF与与TAMTAM 序贯合用序贯合用比比同时效果同时效果更好更好 现在学习的是第12页,共87页MAAG Prevention DCIS/
5、Neoadj 5 yearsMetastaticDisease 1st2nd3rdAdjuvant1 TAM TAMTAMTAMOVABLTamoxifenIndications in Breast Cancer三苯氧胺三苯氧胺 乳癌内分泌治疗不可动摇的地位!?乳癌内分泌治疗不可动摇的地位!?现在学习的是第13页,共87页Survival DataAnastrozole / MAMedian time to death(months)2 year survival rate (%)P Anastrozole is = Exemestane is? Neoadjuvant Letrozole i
6、s Adjuvant ? Anastrozole 现在学习的是第23页,共87页MilestonesActivated1996Planned accrual9366Accrual to dateClosed 1999 Ongoing AI Adjuvant Trials: ATAC (Anastrozole)Br J CancerRANDOM IZESurgeryTamoxifen 20 mg odAnastrozole 1 mg odTamoxifen 20 mg odAnastrozole 1 mg od5 yearsDFS/OS现在学习的是第24页,共87页Curves truncate
7、d at 42 monthsHR95.2% CIp-valueAN vs TAM0.830.710.960.0129Comb vs TAM1.020.881.180.7718TamoxifenAnastrozoleCombinationTime to event (months)Proportion event free (%)Time to event (months)Proportion event free (%)08085909510006121824303642现在学习的是第25页,共87页KaplanMeier Curves of Disease-free Survivalin R
8、eceptor-positive PopulationCurves truncated at 42 monthsHR95.2% CIp-valueAN vs TAM0.780.650.930.0054Comb vs TAM1.020.871.210.7786Time to event (months)Proportion event free (%)TamoxifenAnastrozoleCombination08085909510006121824303642现在学习的是第26页,共87页Predefined adverse events*Hot flushesA Arimidex T Ta
9、moxifen C Combination 1060TC12291243A% patientsA vs TC vs TA vs C0.791.020.78 OR0.00010.750.0001p value现在学习的是第27页,共87页A vs TC vs TA vs C0.520.940.560.00010.5100102030405060nEndometrial thickness (mm)现在学习的是第31页,共87页Median endometrial thickness024681001224Endometrial thickness (mm)ArimidexTamoxifenCom
10、binationTime (months)现在学习的是第32页,共87页A vs TC vs TA vs C0.230.460.500.020.110.51 ORp valueATCA, Arimidex; C, combination; T, tamoxifen3136% patientsPredefined adverse eventsEndometrial cancer现在学习的是第33页,共87页ATAC Summary Anastrozole is superior to tamoxifen in terms of: Disease-free survival in:Overall
11、population (HR=0.83)Receptor-positive patients (HR=0.78) Incidence of contralateral breast cancer in: Overall population (OR=0.42)现在学习的是第34页,共87页Conclusions Anastrozole is the first and only AI to show superior efficacy and improved tolerability compared with tamoxifen in the treatment of EBC Overal
12、l risk-benefit assessment supports anastrozole becoming the future adjuvant treatment of choice in postmenopausal women Anastrozole also shows promise for the chemoprevention of breast cancer现在学习的是第35页,共87页Analysis of the Incidence of New (Contralateral) Breast Primaries Time to first contralateral
13、new primary (months) 0612182430364209899100Proportion without CL BCa (%)AnastrozoleTamoxifenCombinationOR95% CIp-valueAN vs TAM0.420.220.790.0068Comb vs TAM0.840.511.40 0.5132现在学习的是第36页,共87页Arimidex (Anastrozole) in Breast cancer prevention: Design of IBIS II and data from ATAC现在学习的是第37页,共87页Why use
14、 an Aromatase Inhibitor? At least as effective as tamoxifen in ABC ATAC trial provides early warning on side effects ATAC trial provides efficacy data in early breast cancer at all endpoints; striking reduction in contralateral breast cancer events Very low side-effect profile 现在学习的是第38页,共87页ATAC: i
15、ncidence of new (contralateral) breast primaries in ITT population9 invasive05101520253035Tamoxifen(n=3116)Arimidex(n=3125)Combination(n=3125)5 DCIS3 DCIS23invasive5 DCIS30 invasiveNo. casesArimidex vs tamoxifen OR 0.42; 95% CI 0.22, 0.79; p=0.007Combination vs tamoxifen OR 0.84; 95% CI 0.51, 1.40;
16、p=0.51现在学习的是第39页,共87页Women-years of follow-up per arm 3100 x 2.8 = 8600 Rate of contralateral tumours in womennot treated with tamoxifen (women-years)Expected contralateral tumoursObserved on tamoxifen46% reductionObserved on Arimidex77% REDUCTIONATAC: projected contralateral tumour reduction rate f
17、or Arimidex7/1000613314现在学习的是第40页,共87页IBIS I Tamoxifen in preventionBreast cancer incidence is reduced by 32%101 ( placebo ) vs 69 ( TAM ) OR 0.68 p=0.01现在学习的是第41页,共87页IBIS II: Prevention High-risk postmenopausal women, aged 40-70 years 2-arm trial for high-risk patients 5-year treatment, placebo co
18、ntrolledN = 6000 high-risk patientsRandomizationArimidex1 mgPlacebo现在学习的是第42页,共87页IBIS II: DCISWomen, aged 40-70 years, who have had DCIS diagnosed within the previous 6 months2-arm trial (no placebo arm) 5-year treatment, 2 tablets/day RandomizationArimidex1 mgTamoxifen20 mg现在学习的是第43页,共87页NSABP NSA
19、BP centres: USA and Canada Double-blind randomized study Postmenopausal (n=3000)Start date: Q4 2002Randomize1:15 years anastrozole1 mg od 5 years tamoxifen20 mg od现在学习的是第44页,共87页 Prevention DCIS/ Neoadj5 yearsMetastaticDisease AI 1st2nd3rdAIAI AdjuvantTAM TAMTAMTAM1Arimidex in Breast CancerAI绝经后绝经后绝
20、经前绝经前 ?AIAI现在学习的是第45页,共87页绝经前乳癌内分泌治疗绝经前乳癌内分泌治疗 卵巢去势 绝经前 抗芳香化酶 瑞宁得(阿那曲唑)瑞宁得(阿那曲唑)氟隆氟隆 依西美坦依西美坦绝经后现在学习的是第46页,共87页卵巢切除加口服依西美坦卵巢切除加口服依西美坦治疗绝经前乳腺癌骨转移长期缓解治疗绝经前乳腺癌骨转移长期缓解 霍秀兰,女,41岁,住院号50982 2001.2 多发骨转移,左锁上淋巴结转移, 穿刺活检ER(+) PR(+) Her-2(+) 2001.4.6因患者未停经,予以双侧卵巢切除术,1月后骨痛症状改善,骨质修复; 2001.5.11口服依西美坦,2001.6.6 骨痛进
21、一步减轻,疗效评价:PR 现在学习的是第47页,共87页Zoladex 诺雷得诺雷得 用于绝经前乳腺癌患者的治疗用于绝经前乳腺癌患者的治疗现在学习的是第48页,共87页Zoladex与卵巢切除术与卵巢切除术治疗复发转移乳癌效果比较治疗复发转移乳癌效果比较Zoladex(n=67)卵巢切除(n=69)有效率(CR+PR)31%27%中位缓解期6 个月4 个月中位生存期37 个月33 个月现在学习的是第49页,共87页Zoladex 3.6mg 用于绝经前进展期乳腺癌II期临床试验资料来源于 29 个 II期临床试验 (n=228 )CR+PR = 36.4%中位缓解间期 = 22 周耐受性好,未
22、出现因不良反应退出抑制雌激素的药理作用是常见的面部潮红 ( 75.9%) 性欲减退 ( 47.4% )现在学习的是第50页,共87页Klijn JGM, et al. J Clin Oncol 2001; 19: 34353.变量变量LHRH类似物类似物LHRH 类似物类似物 + Tamoxifen相对相对危险度危险度p 值值OR (CR+PR)30%39%0.670.03PFS (中位中位)5.4月月8.7 月月0.70 Zoladex Arimidex TAM Zoladex + Arimidex 诺雷得 + 瑞宁得绝经前乳癌内分泌治疗绝经前乳癌内分泌治疗 现在学习的是第53页,共87页
23、诺雷德诺雷德 + 瑞宁得治疗绝经前患者瑞宁得治疗绝经前患者田田XX,女,女,39岁,住院号岁,住院号53056 2001.10 多发骨转移、肝转移多发骨转移、肝转移ER (+) PR (+) Her-2 (+)2001.11.2002.1 Herceptin治疗治疗 PD 2002.01. 2002.3. TA化疗化疗2周期周期 SD 2 mo 2002. 3.28 诺雷德诺雷德 + 瑞宁得瑞宁得 PR 症状明显改善,生活自理,症状明显改善,生活自理,KPS 90分分 B超示肝脏病灶明显缩小超示肝脏病灶明显缩小 X光片示骨病灶好转光片示骨病灶好转 至至2002年年11月疾病依然处于缓解期月疾病
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