医学常见的乳腺癌靶向治疗进展.ppt

刘健 乳腺癌靶向治疗年度进展 P-HER-2016.02-004 Valid Until 2018.02 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。 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 D eBC, 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: 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) 1 年赫赛汀 n = 1703 2 年赫赛汀 n = 1701 观察组 n = 1698 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 HR, hormone receptor; ITT, intent-to-treat. Jackisch C, et al. SABCS 2015 (Poster PD5-01). HERA: 患者特征 Number at risk 观察组 1697 1201 1095 946 831 赫赛汀治疗1 年 1702 1319 1213 1099 996 赫赛汀治疗2 年 1700 1361 1222 1087 965 CI, 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: 中位随访11年后，与观察组相比，DFS显著提高 Pts* Events HR (vs. obs.) 95% CI p value 2 years 1700 518 0.77 (0.69–0.87) 0.0001 1 year 1702 505 0.76 (0.68–0.86) 0.0001 Observation 1697 608 81.3% 83.4% 75.2% 76.4% 70.0% 70.7% 64.7% 69.3% 68.5% 62.5% 75.9% 71.2% DFS (%) Years from randomisation CI, confidence interval; DFS, disease-free survival; HR, hazard ratio; MFU, median follow-up. 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 CI, confidence interval; HR, hazard ratio; ITT, intent-to-treat; OS, overall survival. * Three patients were excluded from the ITT population due to lack of documentati