Phase II trial of anastrozole in women with asymptomatic mullerian cancer
Phase II trial of anastrozole in women with asymptomatic mullerian cancer
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DOI：
10.1016/j.ygyno.2003.08.021
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发表时间：
2003-12-01
影响因子：
4.7
通讯作者：
Seiden, MV
中科院分区：
文献类型：
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作者：
del Carmen, MG;Fuller, AF;Seiden, MV
Objective.为了评价选择性芳香化酶抑制剂阿那曲唑（Arimidex）的疗效和毒性，我们对53例无症状复发/持续性苗勒管癌患者进行了11期临床试验。卵巢癌、腹膜癌或输卵管癌患者有资格入组。合格患者的ECOG PS：！I和无立即全身化疗的临床指征。将患者分别分配至可测量（队列1）或可评价疾病（队列2）队列。患者每天口服阿那曲唑1 mg。每月随访包括中期病史、体格检查和CA-125，每3个月进行一次放射学评估。雌激素、孕激素和Her-2/neu受体状态也在存档的肿瘤样本中进行了评估。入组了53名中位年龄为63岁（范围：46-86岁）的女性。29名女性入组队列I，24名入组队列2。分别有43例、7例和3例卵巢癌、原发性腹膜癌和输卵管癌患者。所有53例患者均可评价治疗毒性和反应。至疾病进展的中位时间为85天（队列I为85天，队列2为82天）。在1例具有可测量疾病的患者中记录了部分缓解。42%的患者病情稳定（以治疗终止时间衡量）>90天，15%>180天，7%>270天，4%>360天。1例患者在15个月时仍使用阿那曲唑。毒性为中度（1级）且不常见，最常见的毒性为疲劳和潮热。无血栓形成并发症。雌激素受体阳性肿瘤患者的中位进展时间为72天，而雌激素受体阴性肿瘤患者为125天（P = 0.95，对数秩检验）。孕酮阳性肿瘤患者的中位进展时间为77天，孕酮阴性肿瘤患者为91天。总之，阿那曲唑是一种耐受性良好的口服药物，但在复发性/持续性苗勒氏管癌女性中具有极低的杀肿瘤活性。少数患者在使用该药物期间表现出长期稳定的疾病。(C)2003年爱思唯尔公司All rights reserved.
Objective. To evaluate the efficacy and toxicity of the selective aromatase inhibitor anastrozole (Arimidex), we conducted a phase 11 trial in 53 women with asymptomatic recurrent/persistent mullerian cancer.Methods. Patients with ovarian, peritoneal, or fallopian tube carcinoma were eligible for enrollment. Eligible patients had an ECOG PS :! I and no clinical indication for immediate systemic chemotherapy. Patients were assigned to measurable (cohort 1) or evaluable disease (cohort 2) cohorts, respectively. Patients were treated with anastrozole I mg po daily. Monthly follow-up included interim history, physical exam, and CA-125 with radiologic evaluation every 3 months. Estrogen, progesterone, and Her-2/neu receptor status was also evaluated in archived tumor samples.Results. Fifty-three women with a median age of 63 (range, 46-86) years were enrolled. Twenty-nine women enrolled in cohort I and 24 in cohort 2. Included were 43, 7, and 3 women with ovarian, primary peritoneal, and fallopian tube carcinoma, respectively. All 53 patients were evaluable for treatment toxicity and response. The median time to disease progression was 85 days (85 days for cohort I and 82 days for cohort 2). A partial response was documented in a single patient with measurable disease. Forty-two percent of patients had stable disease (measured as time to treatment termination) for >90 days, 15% for >180 days, 7% for >270 days, and 4% for >360 days. One patient remained on anastrozole at 15 months. Toxicity was modest (grade 1) and infrequent, with the most common toxicities being fatigue and hot flashes. There were no thrombotic complications. Median time to progression for patients with estrogen receptor-positive tumors was 72 days as compared to 125 days for those with tumors negative for the estrogen receptor (P = 0.95, log-rank test). The median time to progression in patients with progesterone-positive tumors was 77 days and 91 days for patients with progesterone-negative tumors.Conclusion. In summary, anastrozole is a well-tolerated oral agent but with minimal tumoricidal activity in women with recurrent/persistent mullerian cancers. A minority of patients demonstrated prolonged stable disease while on this agent. (C) 2003 Elsevier Inc. All rights reserved.