A RANDOMIZED CLINICAL-TRIAL EVALUATING TAMOXIFEN IN THE TREATMENT OF PATIENTS WITH NODE-NEGATIVE BREAST-CANCER WHO HAVE ESTROGEN-RECEPTOR POSITIVE TUMORS
A RANDOMIZED CLINICAL-TRIAL EVALUATING TAMOXIFEN IN THE TREATMENT OF PATIENTS WITH NODE-NEGATIVE BREAST-CANCER WHO HAVE ESTROGEN-RECEPTOR POSITIVE TUMORS
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DOI：
10.1056/nejm198902233200802
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发表时间：
1989-02-23
影响因子：
158.5
通讯作者：
KETNER, M
中科院分区：
文献类型：
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作者：
FISHER, B;COSTANTINO, J;KETNER, M
我们对2644例乳腺癌患者进行了一项随机、双盲、安慰剂对照的术后他莫昔芬治疗试验（10 mg，每日两次），这些患者的腋窝淋巴结组织学阴性，雌激素受体阳性（≥ 10 mg）。10 fmol）肿瘤。在四年的随访中没有观察到生存优势（安慰剂组为92%，他莫昔芬组为93%; P = 0.3）。与接受安慰剂的妇女相比，接受他莫昔芬治疗的妇女的无病生存期显著延长（83%对77%; P < 0.00001）。在两个患者中都观察到这种优势。49岁（P = 0.0005）及以上者50（P = 0.0008），尤其是前者，其中治疗失败率降低了44%。多变量分析表明，所有亚组的患者均受益。他莫昔芬显著降低了局部和远处治疗失败率、对侧乳房肿瘤发生率以及乳房肿瘤切除术和乳房放疗后肿瘤复发率。临床可感知的毒性反应发生率较低。所获得的改善幅度并不排除未来试验的需要，在这些试验中，给予他莫昔芬的患者可以作为对照组，以评估潜在的更好的治疗方法。他莫昔芬治疗是合理的患者谁符合本研究的资格标准，谁拒绝参加这些试验。 由于肿瘤太小而无法进行雌激素受体和孕酮受体浓度常规分析的患者不符合本研究的条件，因此没有信息表明此类患者应接受他莫昔芬治疗。
We conducted a randomized, double-blind, placebo-controlled trial of postoperative therapy with tamoxifen (10 mg twice a day) in 2644 patients with breast cancer, histologically negative axillary nodes, and estrogen-receptor-positive (.gtoreq. 10 fmol) tumors. No survival advantage was observed during four years of follow-up (92 percent for placebo vs. 93 percent for tamoxifen; P = 0.3). There was a significant prolongation of disease-free survival among women treated with tamoxifen, as compared with those receiving placebo (83 percent vs. 77 percent; P < 0.00001). This advantage was observed in both the patients .ltoreq. 49 years old (P = 0.0005) and those .gtoreq. 50 (P = 0.0008), particularly in the former, among whom the rate of treatment failure was reduced by 44 percent. Multivariate analysis indicated that all subgroups of patients benefited. Tamoxifen significantly reduced the rate of treatment failure at local and distant sites, tumors in the opposite breast, and the incidence of tumor recurrence after lumpectomy and breast irradiation. The benefit was attained with a low incidence of clinically appreciable toxic effects. The magnitude to the improvement obtained does not preclude the need for future trials in which patients given tamoxifen could serve as the control group in an evaluation of potentially better therapies. Tamoxifen treatment is justified in patients who meet the eligibility criteria of the present study and who refuse to participate in those trials. Since patients with tumors too small for conventional analysis of estrogen-receptor and progesterone-receptor concentrations were not eligible for this study, no information is available to indicate that such patients should receive tamoxifen.