2014乳腺癌内分泌治疗年度进展.ppt

小结 预防： IBIS-1 辅助： TEXTSOFT 、 POEMS 、ABCS8 新辅助：OPPORTUNE研究 晚期：FERGI、PALOMA-1、 FIRST、China CONFIRM 个体化内分泌预防与治疗 内分泌联合靶向 谢谢！ * The primary endpoint was frequency of breast cancer (including DCIS). Predefined subgroups were oestrogen receptor status of the cancer, use of hormonal replacement therapy, and age (50, 50 years) Secondary endpoints were other cancers, thromboembolic events, cardiovascular events, and cause-specific mortality. * Methods: 7154 pre- and postmenopausal women were randomised to receive daily 20mg tamoxifen (N=3579) or matching placebo (N=3575) for 5 years. The primary endpoint of this analysis was the occurrence of breast cancer (invasive and ductal carcinoma in situ (DCIS)). Secondary endpoints included overall mortality, other cancers, and breast cancer specific mortality. Cox proportional hazard models were used to assess occurrence of breast cancer and survival. All statistical tests were two-sided. Results: After a median of 16.2 years (IQR 14.4 to 17.7) of follow-up, a total of 589 breast cancers have been reported (tamoxifen: 246 (6.9%) vs. placebo: 343 (9.6%)). Tamoxifen reduced the incidence of all breast cancer overall by 29% (HR=0.71 (0.60-0.83), P0.0001) (Figure 1). Invasive ER-positive (ER+) breast cancers were reduced by 35% (HR=0.65 (0.53-0.80), P0.0001) (Figure 1), but no effect was seen for invasive ER-negative (ER-) breast cancers (HR=1.06 (0.71-1.58), P=0.8). A non-significant 30% reduction in DCIS was seen with tamoxifen (36 vs. 51, HR=0.70 (0.46-1.07); P=0.1). The overall risk reduction was similar in years 0-10 (HR=0.71) and years 10-20 (HR=0.70). Similar effects were seen in pre- and postmenopausal women (HR 0.71 vs. 0.71). All-cause mortality was non-significantly increased in women randomised to tamoxifen (173 vs. 158, OR=1.10 (0.88-1.38), P=0.4). The excess in deaths with tamoxifen is smaller than in the 96 month update. No differences in breast cancer mortality was seen (24 tamoxifen vs. 27 pl