阿那曲唑用于晚期复发性或持续性子宫内膜癌的II期试验：一项妇科肿瘤学组研究
A phase II trial of anastrozole in advanced recurrent or persistent endometrial carcinoma: a Gynecologic Oncology Group study.
作者信息
Rose P G, Brunetto V L, VanLe L, Bell J, Walker J L, Lee R B
机构信息
Department of Obstetrics and Gynecology, University Hospital of Cleveland, Ohio, 44106, USA.
出版信息
Gynecol Oncol. 2000 Aug;78(2):212-6. doi: 10.1006/gyno.2000.5865.
BACKGROUND
Some endometrial cancers are hormonally dependent. A principal source of circulating estrogen is conversion of adrenal androstenedione by aromatase. Anastrozole (Arimidex) is an oral nonsteroidal aromatase inhibitor which is active in recurrent breast cancer. This Phase II study was undertaken to evaluate anastrozole in recurrent endometrial carcinoma.
METHODS
Patients with advanced or recurrent endometrial cancer not curable with either surgery or radiation therapy and with measurable disease, a GOG (Zubrod) performance status of < or = 2, no more than one prior hormonal therapy regimen, and no prior chemotherapy were eligible. Anastrozole was administered at a dose of 1 mg/day orally for at least 28 days.
RESULTS
Twenty-three patients were entered on this trial. On central pathology review, 9 of them had grade 2 and 14 had grade 3 tumors. One to 24 courses (median: 1) of therapy were administered. Two partial responses were noted (9%; 90% confidence interval 3 to 23%). Two additional patients had short-term stable disease. With the exception of 1 case of venous thrombosis, the toxicity profile was mild. Median durations of progression-free survival and overall survival are 1 and 6 months, respectively.
CONCLUSIONS
Anastrozole has minimal activity in an unselected population of patients with recurrent endometrial cancer.
背景
一些子宫内膜癌具有激素依赖性。循环雌激素的主要来源是芳香化酶将肾上腺雄烯二酮转化而来。阿那曲唑（瑞宁得）是一种口服非甾体芳香化酶抑制剂，对复发性乳腺癌有效。本II期研究旨在评估阿那曲唑在复发性子宫内膜癌中的疗效。
方法
符合条件的患者为患有晚期或复发性子宫内膜癌，无法通过手术或放疗治愈且具有可测量病灶，GOG（Zubrod）体能状态≤2，既往接受不超过一种激素治疗方案且未接受过化疗。阿那曲唑以1毫克/天的剂量口服给药至少28天。
结果
23例患者进入该试验。经中心病理检查，其中9例为2级肿瘤，14例为3级肿瘤。给予1至24个疗程（中位数：1）的治疗。观察到2例部分缓解（9%；90%置信区间3%至23%）。另外2例患者病情短期稳定。除1例静脉血栓形成外，毒性反应较轻。无进展生存期和总生存期的中位数分别为1个月和6个月。
结论
在未经选择的复发性子宫内膜癌患者群体中，阿那曲唑的活性极小。
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