来曲唑后续强化治疗分析.ppt

NSABP B-42试验：5年AI或者5年他莫昔芬序贯AI治疗之后接受来曲唑 vs 安慰剂后续治疗 Mamounas et al. Clin Breast Cancer. 2006;7:416. ER+和/或PgR+的绝经后妇女完成5年AI或者他莫昔芬-AI治疗 组 1每天接受安慰剂治疗，5年 组2来曲唑2.5 mg/d，治疗5年 分层：淋巴结阳性 vs 淋巴结阴性；他莫昔芬治疗 vs 未治疗；BMD T-评分 -2.0 vs ≤ -2.0 计划入组患者数：3840 主要终点：DFS 开始：2006年8月 随机 MA17试验的临床意义 MA17试验证实他莫昔芬5年辅助治疗后，需要继续来曲唑后续强化辅助治疗5年 即使TAM治疗结束长期停药后，重新开始来曲唑治疗仍然获益 目前证据提示高危患者（淋巴结阳性或初诊时为绝经前妇女）的后续强化治疗获益更多 MA17提示来曲唑5年后续强化治疗是目前理想的内分泌治疗持续时间，更长久的治疗有待临床试验进一步回答 天津 * TAM用10年比5年DFS不但没有提高，反而下降，横坐标0指结束5年TAM后， 但是该实验缺陷：仅LN－病人 NSABP B-14: No Benefit of Extending Tamoxifen—Neither in efficacy nor in safety Patients who continued on tamoxifen had reduced DFS and OS benefits compared with those who switched to placebo. Through 7 years of follow-up therapy, DFS in the placebo arm (82%) was significantly higher than in the arm that continued on tamoxifen (78%) (P=0.03). OS after 7 years of follow-up was 94% for women who received 5 years of tamoxifen therapy followed by placebo vs 91% for women who received tamoxifen for more than 5 years (P=0.07). Prolonging adjuvant tamoxifen therapy beyond 5 years was also associated withan increase in SAEs (endometrial cancer, pulmonary embolism, and stroke). * MA.17: Trial Design MA.17 is a phase 3 randomized, double-blind, placebo-controlled trial of letrozole in postmenopausal women with primary breast cancer completing approximately 5 years (4.5 to 6 years) of early adjuvant tamoxifen. Patients were randomized to receive either placebo or letrozole 2.5 mg orally, dailyfor 5 years. Stratification factors included ER status (positive, unknown), lymph node status (positive, negative, unknown), and prior adjuvant chemotherapy (yes, no). The primary end point of this trial was DFS. Secondary end points included OS, safety, and QOL. Goss et al. N Engl J Med. 2003;349:1793. Goss et al. J Natl Cancer Inst. 2005;97:1262. * MA.17: Initial and Final Analyses Two interim analyses were scheduled for when 171 and 342 events were observed. The initial analysis, published in Oct