脂质体阿霉素治疗复发性或晚期子宫平滑肌肉瘤的Ⅱ期临床试验研究:一项GOG研究

作     者：Sutton G. Blessing J. Hanjani P. Kramer P. 李巍 

作者机构：Gynecologic Oncology St. Vincent Hospitals Hlth. Serv. Oncology Center 8301 Harcourt Road Indianapolis IN 46260 United States 

出 版 物：《世界核心医学期刊文摘（妇产科学分册）》 (Core Journal in Obstetrics/Gynecology)

年 卷 期：2005年第1卷第7期

页      面：35-36页

学科分类：1002[医学-临床医学] 100214[医学-肿瘤学] 10[医学] 

主　　题：子宫平滑肌肉瘤 GOG Ⅱ期临床试验 皮肤恶性肿瘤 组织病理学 病理诊断 妇科肿瘤学 毒性反应 化疗史 耐受试验 

摘      要：Objective. This is a phase II group- wide study of liposomal doxorubicin chemotherapy in patients with advanced or recurrent uterine leiomyosarcomas. The aim was to evaluate clinical response and toxicity. Methods. Patients with histologically confirmed persistent or recurrent leiomyosarcomas of the uterus with documented disease progression after appropriate local therapy were invited to participate in this study. Bidimensionally measurable disease, GOG performance status of 0, 1, or 2 (Karnofsky 80- 100) was required; all patients must have failed local therapeutic measures and be considered incurable. Other eligibility criteria included adequate hepatic, renal, and hematologic function. Patients were ineligible if they had received previous chemotherapy or had other noncutaneous malignancies. Patients received liposomal doxorubicin 50 mg/m2 IV over 1 h. Courses were repeated every 4 weeks until disease progression or adverse side effects supervened. Results. Thirty- five patients were entered into this study between May 2000 and June 2001. Three patients were determined ineligible because of wrong pathological cell type or inadequate pathology information and one was inevaluable for lack of data. Median age was 52 years (range 36- 78 years). GOG performance status was 2 in 1 instance, 1 in 15 cases, and 0 in 15 others. Eleven patients (35.5% ) had received radiotherapy. A median of 2.0 courses was given (range 1- 8). Five patients (16.1% )- experienced grade 3 or 4 neutropenia, and seven (22.6% ) had grade 3 or 4 anemia. Two patients developed grade 3 and one patient developed grade 4 cardiovascular adverse events, not necessarily drug related. There were seven cases of grade 3 or 4 gastrointestinal toxicity and two patients developed grade 3 dermatologic toxicity. One complete (3.2% ) and four partial (12.9% ) responses were reported. Ten patients (32.3% ) had stable disease, 15 (48.4% ) had increasing disease, and response could not be assessed in 1 (3.2% ). Co