Untch M
Zentralbl Gynakol. 1998;120(6):284-92.
In an open, prospective, multicentre phase III clinical trial 73 patients with newly diagnosed, metastatic breast cancer were enrolled. Most of them were hormone-receptor-positive. All patients were pre- or perimenopausal and treated with monthly sc. injections of 3.75 mg leuprorelinacetate-depot as monotherapy until disease progression. 50/73 patients (68.5%) had low-risk metastatic disease. A marked reduction of gonadotropin levels resulted in a profound and sustained suppression of the oestradiol levels to castration range (30 pg/ml) during the entire treatment period. The overall response rate based on the best response during treatment was as follows: CR + PR in 25/73 (34.2%) [25.1-44.4%] and CR + PR + SD in 42/73 patients (58%) [47.2-67.4%] respectively. The median time to progression (TTP) was 6 months and the median overall survival (OS) 24.3 months. Both parameters differed significantly when responder (CR/PR) and non-responder (NC/PD) were compared: 18.6 +/- 2.4 [13.9-23.4] vs. 5.8 +/- 0.6 [4.7-7.0] months (TTP, p < 0.0001) and 41.5 +/- 3.0 [35.5-47.5] vs. 15.6 +/- 2.4 [11.3-20.5] months (OS, p = 0.0019). The median duration of response was 12 (range: 3-48) months. Premenopausal low-risk patients without previous adjuvant treatment after primary surgery showed the best response during the GnRHa treatment. The main side effects (hot flushes, increased sweating, headache etc.) were related to oestradiol suppression. Treatment was well tolerated leading in only one case to a premature withdrawal due to side effects. Leuprorelinacetate-depot is a safe and effective palliative drug for pre- and perimenopausal metastatic breast cancer patients. Like other GnRH-agonists which have been evaluated for this indication, leuprorelinacetate-depot can be used as first-line endocrine treatment in these patients.
在一项开放、前瞻性、多中心III期临床试验中，纳入了73例新诊断的转移性乳腺癌患者。其中大多数为激素受体阳性。所有患者均处于绝经前或围绝经期，接受每月一次皮下注射3.75mg亮丙瑞林微球作为单一疗法，直至疾病进展。73例患者中有50例（68.5%）患有低风险转移性疾病。在整个治疗期间，促性腺激素水平显著降低，导致雌二醇水平深度且持续抑制至去势范围（30pg/ml）。基于治疗期间最佳反应的总体缓解率如下：完全缓解（CR）+部分缓解（PR）为25/73（34.2%）[25.1 - 44.4%]，CR + PR +疾病稳定（SD）为42/73例患者（58%）[47.2 - 67.4%]。中位疾病进展时间（TTP）为6个月，中位总生存期（OS）为24.3个月。在比较缓解者（CR/PR）和未缓解者（疾病进展/疾病稳定）时，这两个参数均有显著差异：18.6±2.4[13.9 - 23.4]个月 vs. 5.8±0.6[4.7 - 7.0]个月（TTP，p<0.0001），以及（41.5±3.0[35.5 - 47.5]个月 vs. 15.6±2.4[11.3 - 20.5]个月（OS，p = 0.0019）。中位缓解持续时间为12（范围：3 - 48）个月。原发性手术后未接受过辅助治疗的绝经前低风险患者在GnRHa治疗期间表现出最佳反应。主要副作用（潮热、出汗增多、头痛等）与雌二醇抑制有关。治疗耐受性良好，仅1例因副作用导致提前停药。亮丙瑞林微球是一种用于绝经前和围绝经期转移性乳腺癌患者的安全有效的姑息性药物。与已针对该适应症进行评估的其他GnRH激动剂一样，亮丙瑞林微球可作为这些患者的一线内分泌治疗药物。
