Evaluation of paclitaxel in previously treated leiomyosarcoma of the uterus: a gynecologic oncology group study
Evaluation of paclitaxel in previously treated leiomyosarcoma of the uterus: a gynecologic oncology group study
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评估紫杉醇对曾接受过治疗的子宫肌层肉瘤的疗效：妇科肿瘤小组的一项研究
DOI：
10.1016/s0090-8258(02)00136-1
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发表时间：
2003-04-01
影响因子：
4.7
通讯作者：
Morgan, MA
中科院分区：
文献类型：
--
作者：
Gallup, DG;Blessing, JA;Morgan, MA
Objective.这项11期临床试验的目的是评估静脉注射紫杉醇治疗复发或晚期子宫平滑肌肉瘤的疗效。复发性或持续性子宫平滑肌肉瘤患者必须有既往未接受过紫杉醇治疗的可测量疾病，并且有足够的血液学检查，（WBC ≥ 3000/穆尔，血小板计数≥ 100，000/穆尔），肾（血清肌酐小于或等于2.0 mg%）和肝功能（胆红素小于或等于1.5 X机构正常值）。紫杉醇以175 mg/m2的剂量（既往放疗患者为135 m（g）/m2）静脉注射，每3周3次，每次3 μ l。53例患者入组本研究; 48例可评价毒性和反应。15例既往接受过放疗，39例既往接受过化疗。平均2个疗程（范围：1-12）。3例（6.3%）患者发生4级中性粒细胞减少。未报告4级血小板减少症，且无死亡可归因于治疗。4例（8.4%）患者完全或部分缓解，22.9%患者病情稳定。虽然毒性很小，但该方案在既往接受过治疗的晚期或复发性子宫平滑肌肉瘤患者中表现出适度的活性。(C)2003 Elsevier Science（美国）。All rights reserved.
Objective. The purpose of this phase 11 trial was to evaluate the efficacy of intravenous paclitaxel in patients with recurrent or advanced leiomyosarcoma of the uterus.Methods. To be eligible, patients with recurrent or persistent leiomyosarcoma of the uterus were to have measurable disease not previously treated with paclitaxel and adequate hematologic (WBC greater than or equal to 3000/mul, platelet count greater than or equal to 100,000/mul), renal (serum creatinine less than or equal to 2.0 mg%), and hepatic (bilirubin less than or equal to 1.5 X institutional normal) functions. Paclitaxel was given at a dose of 175 mg/m(2) (135 m(g)/m(2) for patients with prior radiotherapy) intravenously over 3 It every 3 weeks.Results. Fifty-three patients were entered on this study; 48 were evaluable for toxicity and response. Fifteen had prior irradiation and 39 had prior chemotherapy. A median of 2 (range: 1-12) courses was given. Grade 4 neutropenia occurred in 3 (6.3%) patients. No grade 4 thrombocytopenia was reported and no deaths were attributable to therapy. Four (8.4%) patients had a complete or partial response and 22.9% had stable disease.Conclusions. Although toxicity was minimal, this regimen demonstrated modest activity in patients with previously treated advanced or recurrent leiomyosarcoma of the uterus. (C) 2003 Elsevier Science (USA). All rights reserved.