培训资料--乳腺癌临床研究进展.ppt

2008乳腺癌临床研究进展;;Big 1-98 ;BIG 1-98 Overall Design;BIG 1-98: Primary Core Analysis (PCA);BIG 1-98: Primary Core Analysis;;Primary Core Analysis: Key End Points at a Median Follow-up of 26 Months;Primary Core Analysis:Safety at Median Follow-up of 26 Months;BIG 1-98: PCA Updateat 61 Months Median Follow-Up;Selective Crossover in Tamoxifen-alone Arm;Both ITT and Censored Analysis are Likely to be Biased;Cumulative Incidence of DFS Events (ITT);Endpoints: ITT and Censored* Results;*ITT included 25.2% of women in TAM arm who crossed over to receive LET during years 3-5 ? Patients who were censored at the time of cross over from TAM to LET;BIG 1-98: Safety Results Overtime;Conclusions;BIG 1-98 Monotherapy Comparison: Arms A vs B (Median Follow-Up 51 Months) ;;Hazard Ratio;BIG 1-98 Monotherapy UpdateMedian Follow-up 76 months;单药对照分析结论（ 76 Months）;BIG 1-98 Sequential Therapy;BIG 1-98 Sequential Therapy Two Pairwise Comparisons ;Sequential Treatment ComparisonsMedian Follow-up 71 Months;BIG 1-98 UpdateConclusions ;NSABP B-30: Study Design;NSABP B-30: DFS According to Subgroups;BCIRG 005: Study Design;BCIRG 005 Primary Analysis: DFS ;BCIRG 005 Primary Analysis: Overall Survival;双磷酸盐抗肿瘤临床研究;DFS 无病生存率; OS = 总生存率. 1. Diel IJ, et al. N Engl J Med. 1998;339:357-363; 2. Diel IJ, et al. Proc Am Soc Clin Oncol. 2000;19:82a. Abstract 314; 3. Powles T, et al. Breast Cancer Res. 2006;8:R13; 4. Saarto T, et al. Acta Oncol. 2004;43:650-656.;口服帕米膦酸未能改善乳腺癌疾病终点;他莫昔芬 20 mg/day ;ABCSG-12: 无病生存率;首次DFS 事件数 (ITT 人群);ABCSG-12: 需要治疗的患者数 (NNT);小结; 来曲唑;Z-FAST－－腰椎和髋骨： 与基线比较１２和２４个月BMD的平均变化;ZO-FAST 36个月主要研究终点：早期治疗组BMD显著提高;Z-FAST / ZO-FAST 综合分析;;结 论;研究终点 主要终点: 无病生存率 其他终点: 至骨转移/远处转移的时间；SREs；总生存率;AZURE: 新辅助治疗患者的亚组分析;新辅助治疗 AZURE;AZURE新辅助化疗亚组：结论;现有双膦酸盐辅助治疗临床研究;HERA试验;HERA 研究设计;赫赛汀的研发历程;HERA 研究终点;100;100;HERA: 不同随访时间的无病生存和总生存 ;;;交叉接受赫赛汀治疗的时间 (n=885);观察组患者中52%选择赫赛汀治疗，打破了1年赫赛汀治疗组和观察组的随机分组，能导致意向性治疗分析数据（ITT）结果的偏差吗？;无病生存期 (ITT分析): 4-年中位随访时间;总生存 (ITT分析): 4年中位随访;HERA: 不同随访时间的无病生存和总生存 ;观察组中无病生存的患者1