Randomized phase II study of docetaxel versus doxorubicin in first- and second-line chemotherapy for locally advanced or metastatic soft tissue sarcomas in adults: A study of the European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group
Randomized phase II study of docetaxel versus doxorubicin in first- and second-line chemotherapy for locally advanced or metastatic soft tissue sarcomas in adults: A study of the European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group
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DOI：
10.1200/jco.2000.18.10.2081
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发表时间：
2000-05-01
影响因子：
45.3
通讯作者：
Judson, IR
中科院分区：
文献类型：
--
作者：
Verweij, J;Lee, SM;Judson, IR
目的：比较多西紫杉醇与阿霉素一线治疗晚期和/或转移性软组织肉瘤的抗肿瘤反应和进展时间（TTP）。患者和方法：将软组织肉瘤病变可测量且骨髓、肝脏和肾脏功能正常的患者纳入研究。他们被随机分配到每3周静脉输注100 mg/m(2)的多西紫杉醇组或每3周静脉注射75 mg/m(2)的阿霉素组。最多安排了七个疗程的治疗。该研究设计为随机III期研究，采用log-rank模型评估TTP。如果在多西他赛治疗组的前25名可评估患者中观察到的应答少于5个，则有提前结束试验的条款。结果：86例患者被纳入研究；85例可评估毒性，83例可评估反应。严重粒细胞减少率在两组间无显著差异。恶心（P = 0.001），呕吐（P = 0.001）
Purpose: To assess antitumor response and time to progression (TTP) with docetaxel compared with doxorubicin in first-line treatment of advanced and/or metastatic soft tissue sarcoma.Patients and Methods: patients with measurable soft tissue sarcoma lesions and adequate bone marrow, liver, and renal function were entered onto the study. They were randomized to either docetaxel 100 mg/m(2) given as a 1-hour intravenous infusion every 3 weeks or doxorubicin 75 mg/m(2) given as a bolus injection every 3 weeks. A maximum of seven cycles of treatment were scheduled. The study was designed as a randomized phase III study evaluating TTP by log-rank model. There was a clause for premature closure of the trial if fewer than five responses were observed among the first 25 assessable patients in the docetaxel treatment arm.Results: Eighty-six patients were entered onto the study; 85 were assessable for toxicity and 83 for response. The rate of severe granulocytopenia was not significantly different between the two arms. Nausea (P =.001), vomiting (P