Nordenskjöld Bo, Rosell Johan, Rutqvist Lars-Erik, Malmström Per-Olof, Bergh Jonas, Bengtsson Nils-Olof, Hatschek Thomas, Wallgren Arne, Carstensen John
Department of Oncology, Linköping University Hospital, Linköping, Sweden.
J Natl Cancer Inst. 2005 Nov 2;97(21):1609-10. doi: 10.1093/jnci/dji342.
From January 1, 1983, through December 31, 1992, a total of 4610 patients entered a randomized trial that compared mortality among patients receiving 2 years of adjuvant tamoxifen therapy with that in patients receiving 5 years of adjuvant tamoxifen therapy, 4175 of whom were recurrence free after 2 years of tamoxifen therapy. Among the 2046 patients randomly assigned to the 5-year group all-cause mortality, breast cancer-specific mortality, and the incidence of contralateral breast cancer were reduced, compared with those among 2129 patients randomized in the 2-year group, but the incidence of endometrial cancer was increased. In addition, mortality from coronary heart disease was statistically significantly reduced in the 5-year group, compared with that in the 2-year group (hazard ratio = 0.67, 95% confidence interval = 0.47 to 0.94; P = .022 [two-sided Wald test]). Ten years after surgery, 2.1% of the patients in the 5-year group and 3.5% of those in the 2-year group had died from coronary heart disease. No statistically significant increases in mortality from other heart diseases, cerebrovascular diseases, or other vascular diseases were observed.
从1983年1月1日至1992年12月31日,共有4610名患者进入一项随机试验,该试验比较了接受2年辅助性他莫昔芬治疗的患者与接受5年辅助性他莫昔芬治疗的患者的死亡率,其中4175名患者在接受2年他莫昔芬治疗后无复发。在随机分配到5年组的2046名患者中,与随机分配到2年组的2129名患者相比,全因死亡率、乳腺癌特异性死亡率和对侧乳腺癌的发病率均有所降低,但子宫内膜癌的发病率有所增加。此外,与2年组相比,5年组冠心病死亡率在统计学上显著降低(风险比=0.67,95%置信区间=0.47至0.94;P=0.022[双侧Wald检验])。手术后十年,5年组中有2.1%的患者和2年组中有3.5%的患者死于冠心病。未观察到其他心脏病、脑血管疾病或其他血管疾病的死亡率有统计学意义的增加。