课件：乳腺癌靶向治疗进展.pptx

乳腺癌靶向治疗年度进展刘健本资料仅代表个人观点，旨在促进学术信息的沟通和交流。处方请参考国家食品药品监督管理总局批准的药品说明书。仅供医疗卫生专业人士参考。P-HER-2016.02-004 Valid Until 2018.02早期乳腺癌靶向治疗进展HERA研究: Her2阳性早期乳腺癌曲妥珠单抗辅助治疗10年随访结果 - 最终分析Poster presentation at SABCS 2015 11 December 2015(Poster PD5-01)Jackisch C, Piccart MJ, Gelber RD, Procter M, Goldhirsch A, DeAzambuja E, Castro G Jr, Untch M, Smith I, Gianni L, Baselga J, Al-Sakaff N, Lauer S, McFadden E, Leyland-Jones B, Bell R, Dowsett M, Cameron DHERA: 研究设计Her2阳性浸润性早期乳腺癌(中心确认)手术+ (新)辅助化疗± 放疗1:1:1 随机分组*LVEF ≥55%(N = 5102) 2 年赫赛汀n = 1701 1 年赫赛汀n = 1703 观察组n = 1698eBC, early breast cancer; HR, hormone receptor; LVEF, left ventricular ejection fraction.* Stratification factors include HR status and endocrine therapy. Jackisch C, et al. SABCS 2015 (Poster PD5-01).HERA: 患者特征HR, hormone receptor; ITT, intent-to-treat.Jackisch C, et al. SABCS 2015 (Poster PD5-01).基线激素受体状态:50% HR-阳性50% HR-阴性随机时年龄≤49岁患者: 52%之前接受过蒽环类药物化疗的患者: 97%2005年中期分析结果阳性, 共有884例观察组患者 (占观察组患者52%) 选择交叉至赫赛汀治疗组这部分患者继续纳入观察组分析HERA: 中位随访11年后，与观察组相比，DFS显著提高观察组赫赛汀治疗1 年83.4%10076.4%赫赛汀治疗2 年9081.3%69.3%71.2%75.9%8068.5%70.7%7075.2%70.0%6064.7%62.5%DFS (%)50Pts*EventsHR (vs. obs.)95% CIp value2 year77(0.69–0.87) 0.00011 yea76(0.68–0.86) 0.0001Observation 1697608403020100012345678910Years from randomisationNumber at risk观察组169712011095946831赫赛汀治疗1 年1702131912131099996赫赛汀治疗2 年1700136112221087965CI, confidence interval; DFS, disease-free survival; HR, hazard ratio; ITT, intent-to-treat.* Three patients excluded from the ITT population due to lack of documentation of informed consent.Jackisch C, et al. SABCS 2015 (Poster PD5-01).HERA: 赫赛汀辅助治疗1年，DFS 随访超过4年后持续稳定获益Median follow-up(% follow-up timeafter selective crossover)DFS benefit(95% CI)No. of DFS events:1 year Herceptinvs. observation0.542005(0%)127 vs. 220p 0.00011 year MFU(0.43–0.67)0.642006(4.3%)218 vs. 321p 0.00012 years’ MFU(0.54–0.76)0.762008(33.8%)369 vs. 458p 0.00014 years’ MFU(0.66–0.87)0.762012(48.6%)471 vs. 570p 0.00018 years’ MFU(0.67–0.86)0.76201