SABCS年度回顾早期乳腺癌.pptx

1、SABCS2015 早期乳腺癌年度回顾Early breast cancer-More or Less?,仅供医疗专业人士参考审批号/有效期至：,ER阳性乳腺癌-“更少”的治疗,至今我们知晓哪些？ 化疗对部分ER阳性的乳腺癌 并非是必须的（TAILORx，S1-08*）我们是否清楚哪些患者需要延长辅助治疗？是否所有患者都需要延长辅助治疗？（ASCO BCI）哪些患者需要“更多”的治疗？ （S2-02*: The impact of adjuvant denosumab on disease-free survival: Results from 3,425 postmenopausal pat

2、ients of the ABCSG-18 trial）,*High risk premenopausal luminal A breast cancer patients derive no benefit from adjuvant chemotherapy: Results from DBCG77B randomized trial*The impact of adjuvant denosumab on disease-free survival: Results from 3,425 postmenopausal patients of the ABCSG-18 trial,Trial

3、 Assigning Individualized Options for Treatment (TAILORx),入组标准：淋巴结阴性ER+, HER2-T1c-T2（high risk T1b）18-75岁无部分乳房照射（PBI）计划,统计学设计：RS11-25：非劣效90% vs 87% Idfs835个DFS事件RS2cm,许多ER阳性乳腺癌并不受益于化疗TAILORx研究定义的低危患者Luminal A型乳腺癌我们是否清楚哪些患者需要延长辅助治疗？BCI能够鉴别出哪些患者可以在5年终止治疗骨相关的治疗药物能够改善骨密度，并且改善预后,ER阳性乳腺癌的分子分型,HER2阳性乳腺癌,我们

4、是否可以对部分患者给予“更少”的治疗？ 小肿瘤（S6-06*）三阳性乳腺癌（S5-03*，ASCO）哪些患者需要“更多”的辅助抗HER2治疗？延长抗HER2治疗（S5-02*）,*The effect of trastuzumab-based therapy on overall survival in small, node-negative HER2-positive breast cancer: To treat or not to treat?* Final analysis of WSG-ADAPT HER2+/HR+ phase II trial: Efficacy, safety

5、, and predictive markers for 12-weeks of neoadjuvant TDM1 with or without endocrine therapy versus trastuzumab+endocrine therapy in HER2-positive hormone-receptor-positive early breast cancer* Neratinib after trastuzumab-based adjuvant therapy in early-stage HER2+ breast cancer: 3-year analysis from

6、 a phase 3 randomized, placebo-controlled, double-blind trial (ExteNET),一期HER2阳性乳腺癌的治疗,一期HER2阳性乳腺癌的治疗,一期HER2阳性乳腺癌：总生存期,一期HER2阳性乳腺癌：不同分型分析,APT研究：12周紫杉醇联合曲妥珠单抗,Rinawi CCR 2013,ADAPT HER2+/HR+：试验设计,预后,活检,疗效,活检,三周治疗,内分泌治疗,曲妥珠单抗,内分泌治疗,手术*,终点,*推荐术后标准化疗，完成共1年的曲妥珠单抗治疗,Presented By Nadia Harbeck at 2015 ASCO

7、 Annual Meeting,ADAPT HER2+/HR+：pCR（乳腺和淋巴结非浸润性癌）,ADAPT HER2+/HR+：早期反应的生物标记物,早期反应： 低肿瘤细胞密度（500 肿瘤细胞）或者三周内Ki67 下降30%,Carey et al Proc ASCO 2014,HER2阳性，HR阴性乳腺癌的固有亚型,ExteNET：最终研究设计,HER2+乳腺癌(局部)既往辅助曲妥珠单抗&化疗淋巴结阳性或新辅助治疗后残留浸润性疾病ER/PR阳性或阴性,1:1随机分组,来那替尼1年240mg/天,安慰剂1年,N=2840,2年随访的DFS,5年随访的DFS,5年以上生存,A,B,C,主要终

8、点：无浸润性疾病生存期(iDFS)iDFS：HR=0.67 (0.50-0.91); p=0.009激素受体阳性 (n=1631; 57.4%); HR=0.51; p=0.001中心确认的HER2阳性60% (n=1463; 51%); HR=0.51; p=0.002,Presented By Arlene Chan at 2015 ASCO Annual Meeting,3年iDFS分析（ITT=2840）,无疾病生存率(%),来那替尼 安慰剂,安慰剂,来那替尼,双侧检验 P=0.023HR(95%CI)=0.74(0.56-0.96),不同激素受体状态: 3年iDFS,HR阳性,HR阴

9、性,3年iDFS分析：激素受体状态&中心确认的HER2阳性,HER2阳性乳腺癌,我们是否可以对部分患者给予“更少”的治疗？ 小肿瘤-NCCN指南给予确认三阳性乳腺癌-显示这类患者需要一些新化疗方案哪些患者需要“更多”的辅助抗HER2治疗？激素受体阳性乳腺癌？,哪些患者需要“更多”的治疗？增加卡铂（S2-04*，S2-05*, S6-07*）新辅助化疗后-需要新的方案（S1-07#）是否有些患者需要“更少”的治疗？肿瘤浸润淋巴细胞（TILs）（S1-03&）雄激素受体表达,三阴性乳腺癌,*Early survival analysis of the randomized phase II tri

10、al investigating the addition of carboplatin to neoadjuvant therapy for triple-negative and HER2-positive early breast cancer (GeparSixto)* Event-free and overall survival following neoadjuvant weekly paclitaxel and dose-dense AC +/- carboplatin and/or bevacizumab in triple-negative breast cancer: O

11、utcomes from CALGB 40603 (Alliance)* Comparison of 12 weeks neoadjuvant nab-paclitaxel combined with carboplatinum vs. gemcitabine in triple-negative breast cancer: WSG-ADAPT TN randomized phase II trial# A phase III trial of adjuvant capecitabine in breast cancer patients with HER2-negative patholo

12、gic residual invasive disease after neoadjuvant chemotherapy (CREATE-X, JBCRG-04)& Pooled individual patient data analysis of stromal tumor infiltrating lymphocytes in primary triple negative breast cancer treated with anthracycline-based chemotherapy,不同亚型的针对性靶向治疗,卡铂提高TNBC的pCR率,Von Minckwitz et al.

13、Lancet Onco 2014,增加卡铂能够改善TNBC的DFS,研究活检冰冻和固定,C40603：方案-随机二期研究,临床分期为-期三阴性乳腺癌,22R,紫杉醇 80mg/m2，每周1次12周,贝伐单抗 10mg/kg 每周2次9周,主要终点：乳房pCR（*ASCO 2013),ddAC4,紫杉醇 80mg/m2，每周1次12周,卡铂 AUC 6 每周3次4周,紫杉醇 80mg/m2，每周1次12周,卡铂 AUC 6 每周3次4周,紫杉醇 80mg/m2，每周1次12周,贝伐单抗 10mg/kg 每周2次9周,ddAC4,ddAC4,ddAC4,手术XRT未计划行辅助全身治疗,Presen

14、ted By Mehra Golshan at 2015 ASCO Annual Meeting,OR=1.71 p=0.0029,CALGB40603：乳腺/腋窝pCR（ypT0/isN0）,OR=1.36 p=0.0570,CALGB40603：乳腺/腋窝pCR患者EFS,CALGB40603：是否增加卡铂的EFS,术后推荐标准化疗（4 EC）/ 12周后活检（non-pCR）,ADAPT HR-/HER2-：研究设计,ADAPT HR-/HER2-：病理完全缓解（pCR）,分子分型变化不影响卡铂治疗获益（交互检验 p=0.93）,卡铂：分子分型和pCR的相关性,乳腺pCR：,根据gBRC

15、A状态和卡铂治疗TNBC的pCR率,新辅助治疗后有残余病灶：CREATE -X研究设计,日韩进行的前瞻性、多中心、开放、随机III期研究,分层因素：ER，年龄，NAC，ypN，5FU等标准治疗：HR+：后续内分泌治疗HR-：没有后续系统治疗,CREATE X：DFS和OS,CREATE X：亚组分析,DDFS和OS分析结果,DDFS,OS,基质TILs 20%的淋巴结阴性TNBC患者：有较好的D-DFS,TNBC不同亚型与化疗反应的相关性（蒽环-紫杉药）,Masuda et al Clin Cancer Res 2013,基于AR和pCR的TNCB的5年DFS,DFS-month,哪些患者需要

16、“更多”的治疗？增加卡铂-仍悬而未决新辅助化疗后-需要新的方案是否有些患者需要“更少”的治疗？肿瘤浸润淋巴细胞（TILs）雄激素受体表达,三阴性乳腺癌,55,Author | 00 Month Year,Set area descriptor | Sub level 1,Confidentiality Notice,This file is private and may contain confidential and proprietary information. If you have received this file in error, please notify us and

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