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[绝经后复发风险高的乳腺癌患者的辅助内分泌治疗。5. 丹麦乳腺癌协作组(DBCG)77C随机试验的结果]

[Adjuvant endocrine treatment of postmenopausal patients with breast cancer with high risk of recurrence. 5. Results from the DBCG (Danish Breast Cancer Cooperative Group) 77C randomized trial].

作者信息

Rose C, Andersen J A, Andersen K W, Axelsson C K, Blichert-Toft M, Dombernowsky P, Hansen M, Krag C, Mouridsen H T, Overgaard M

机构信息

Finseninstitutet, Rigshospitalet, København.

出版信息

Ugeskr Laeger. 1991 Aug 12;153(33):2283-7.

PMID:1781047
Abstract

The role of antiestrogen treatment of postmenopausal breast cancer patients with high risk of recurrent disease is evaluated in a nationwide, prospective trial conducted by the Danish Breast Cancer Cooperative Group (DBCG). After total mastectomy and postoperative radiotherapy (RT), 840 patients were randomized to treatment with tamoxifen (RT + TAM) for one year, and 824 were randomized to no further therapy (RT). The recurrenceree survival (RFS) after ten years of lifeable analysis is 31% in the RT + TAM treated group, and 28% in the RT group (p = 0.01). Survival is 38% and 34% in the two treatment groups, respectively (p = 0.04). The data were further analyzed with respect to prognostic factors such as age, number of positive nodes, tumour size, and degree of anaplasia. Survival is prolonged in nearly all subgroups of patients treated with RT + TAM. However, the prolongation is only significant in patients with four or more positive nodes, with tumours of less than 5 centimeters or with tumours of anaplasia grade II. Estrogen (ER) and progesterone receptor (PgR) concentrations were measured in tumours from 309 and 219 patients, respectively. Only patients with ER and PgR values above 100 fmol/mg cytosol protein seemed to have a prolongation of survival. In conclusion, a modest survival benefit is achieved with one year of adjuvant tamoxifen treatment. Nevertheless, this is the first example of a systemic treatment approach being able to change the fatal course of breast cancer in postmenopausal patients. By means of endocrine therapy, and in the context of a new randomized trial, the DBCG will try to improve the survival in these patients even further.

摘要

丹麦乳腺癌协作组(DBCG)开展了一项全国性前瞻性试验,评估抗雌激素治疗对复发风险高的绝经后乳腺癌患者的作用。在全乳切除术后进行术后放疗(RT)后,840例患者被随机分配接受他莫昔芬治疗(RT + TAM)一年,824例患者被随机分配不接受进一步治疗(RT)。经过十年可行分析后的无复发生存率(RFS),RT + TAM治疗组为31%,RT组为28%(p = 0.01)。两个治疗组的生存率分别为38%和34%(p = 0.04)。针对年龄、阳性淋巴结数量、肿瘤大小和间变程度等预后因素对数据进行了进一步分析。几乎所有接受RT + TAM治疗的患者亚组的生存期都有所延长。然而,仅在有四个或更多阳性淋巴结、肿瘤小于5厘米或间变二级肿瘤的患者中,生存期延长具有显著性。分别在309例和219例患者的肿瘤中测量了雌激素(ER)和孕激素受体(PgR)浓度。似乎只有ER和PgR值高于100 fmol/mg胞浆蛋白的患者生存期有所延长。总之,辅助他莫昔芬治疗一年可获得适度的生存获益。尽管如此,这是系统性治疗方法能够改变绝经后患者乳腺癌致命病程的首个实例。通过内分泌治疗,并在一项新的随机试验背景下,DBCG将试图进一步提高这些患者的生存率。

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