张莉莉--后续强化辅助内分泌治疗-MCC试题.ppt

* NSABP B-14: Trial Design—5 Years of Adjuvant Tamoxifen Therapy Followed by Rerandomization to Extended Adjuvant Tamoxifen vs Placebo National Surgical Adjuvant Breast and Bowel Project (NSABP) trial B-14 initially evaluated 5 years of adjuvant tamoxifen vs placebo in women with ER-positive and node-negative breast cancer, and a second randomization extended tamoxifen for another 5 years vs switching to placebo, to evaluate longer-term efficacy and safety of adjuvant tamoxifen for node-negative breast cancer following 5 years of tamoxifen.1,2 For the first randomization, follow-up of patients was for 10 years following completion of treatment (15 years from diagnosis).3 Initial results from NSABP trial B-14 demonstrated that patients with ER-positive and node-negative breast cancer received a significant survival benefit from 5 years of tamoxifen therapy.1 For the second randomization, women had to be disease-free after completion of 5 years of tamoxifen. Those women (n=1172) received either an additional 5 years of tamoxifen (n=593) or placebo (n=579). Follow-up of those patients was for 7 years from initiation of the second treatment.4 1. Fisher et al. N Engl J Med. 1989;320:479. 2. Fisher et al. J Natl Cancer Inst. 1996;88:1529. 3. Fisher et al. Lancet. 2004;364:858. 4. Fisher et al. J Natl Cancer Inst. 2001;93:684. * NSABP B-14: No Benefit of Extending Tamoxifen—Neither in Efficacy nor in Safety Patients who continued on tamoxifen had reduced disease-free survival (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 serio