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异环磷酰胺与美司钠用于铂类化疗后复发或晚期卵巢混合性中胚叶肿瘤患者的II期试验:一项妇科肿瘤学组研究

A phase II trial of ifosfamide and mesna in patients with advanced or recurrent mixed mesodermal tumors of the ovary previously treated with platinum-based chemotherapy: a Gynecologic Oncology Group study.

作者信息

Sutton G P, Blessing J A, Homesley H D, Malfetano J H

机构信息

Section of Gynecologic Oncology, Indiana University Medical School, Indianapolis 46202.

出版信息

Gynecol Oncol. 1994 Apr;53(1):24-6. doi: 10.1006/gyno.1994.1081.

DOI:10.1006/gyno.1994.1081
PMID:8175017
Abstract

A phase II trial of ifosfamide and mesna in women with mixed mesodermal tumors of the ovary who had previously received platinum-containing chemotherapy was conducted by the Gynecologic Oncology Group (GOG). The starting dose of ifosfamide was 1.2 g/m2 daily iv for 5 days. Mesna was given intravenously with and at 4 and 8 hr following the administration of ifosfamide. Each dose of mesna was 20% of the total daily dose of ifosfamide. Thirty-two patients were placed on the study; 31 were evaluable for toxicity and 28 for response. Twenty-seven patients (87.1%) had previously undergone surgery and three (9.3%) had received radiotherapy before this trial. GOG grade 3 or 4 granulocytopenia occurred in 11 (35.5%) patients, and one (3.2%) developed grade 4 thrombocytopenia. Two patients (6.4%) had grade 3 neurotoxicity. A complete response was observed in one patient (3.6%) and partial responses in four patients (14.3%) for a total response rate of 17.9% (95% confidence interval = 6.1-36.9%). In conclusion, ifosfamide has activity in previously mixed mesodermal tumors of the ovary.

摘要

妇科肿瘤学组(GOG)开展了一项关于异环磷酰胺和美司钠的II期试验,受试对象为先前接受过含铂化疗的卵巢混合性中胚层肿瘤女性患者。异环磷酰胺的起始剂量为每日1.2 g/m²,静脉注射,共5天。美司钠在异环磷酰胺给药时、给药后4小时和8小时静脉注射。美司钠的每次剂量为异环磷酰胺每日总剂量的20%。32例患者参与了该研究;31例可评估毒性,28例可评估疗效。27例患者(87.1%)此前接受过手术,3例(9.3%)在本次试验前接受过放疗。11例患者(35.5%)出现了GOG 3级或4级粒细胞减少,1例(3.2%)出现了4级血小板减少。2例患者(6.4%)出现了3级神经毒性。1例患者(3.6%)出现完全缓解,4例患者(14.3%)出现部分缓解,总缓解率为17.9%(95%置信区间=6.1 - 36.9%)。总之,异环磷酰胺对先前的卵巢混合性中胚层肿瘤具有活性。

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