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异环磷酰胺/美司钠联合阿霉素治疗成人软组织肉瘤的II期研究。

A phase II study of ifosfamide/mesna with doxorubicin for adult soft tissue sarcoma.

作者信息

Cantwell B M, Carmichael J, Ghani S, Harris A L

机构信息

University Department of Clinical Oncology, Newcastle General Hospital, Newcastle upon Tyne, England.

出版信息

Cancer Chemother Pharmacol. 1988;21(1):49-52. doi: 10.1007/BF00262738.

DOI:10.1007/BF00262738
PMID:3124971
Abstract

In a phase II study, 16 adult patients with locally advanced or metastatic soft tissue sarcomas were treated with i.v. infusions of ifosfamide/mesna 5 g/m2 plus i.v. doxorubicin 40 mg/m2. Courses were given every 3 weeks up to a maximum of six courses in responding patients. Six patients (37.5%) had either complete (1 patient) or partial responses (5 patients). Confidence limits for this response rate were 15.2%-64.5% (95% confidence level). There was one toxic death in association with encephalopathy, renal and bone marrow failure. Unilateral pneumothoraces occurred in 2 patients with large pulmonary metastases. Recurrent severe ifosfamide/mesna encephalopathy occurred in 2 patients at risk for this complication; patients who develop severe ifosfamide/mesna encephalopathy should not be retreated with this drug. Ifosfamide/mesna with doxorubicin is an active combination to treat adult soft tissue sarcoma but, despite the feasibility of the combination, sequential monotherapy with these drugs might provide similar or better clinical benefit.

摘要

在一项II期研究中,16例局部晚期或转移性软组织肉瘤成年患者接受了静脉输注异环磷酰胺/美司钠5 g/m²加静脉输注多柔比星40 mg/m²的治疗。每3周进行一个疗程,对有反应的患者最多进行6个疗程。6例患者(37.5%)达到完全缓解(1例)或部分缓解(5例)。该缓解率的置信区间为15.2%-64.5%(95%置信水平)。有1例患者因脑病、肾衰竭和骨髓衰竭导致毒性死亡。2例有巨大肺转移的患者发生了单侧气胸。2例有该并发症风险的患者出现了复发性严重异环磷酰胺/美司钠脑病;发生严重异环磷酰胺/美司钠脑病的患者不应再用此药进行治疗。异环磷酰胺/美司钠联合多柔比星是治疗成人软组织肉瘤的一种有效联合方案,但尽管该联合方案可行,序贯使用这些药物进行单一治疗可能会带来相似或更好的临床获益。

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本文引用的文献

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Cancer Chemother Pharmacol. 1983;11(2):69-72. doi: 10.1007/BF00254247.
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Prevention of isophosphamide-induced urothelial toxicity with 2-mercaptoethane sulphonate sodium (mesnum) in patients with advanced carcinoma.2-巯基乙烷磺酸钠(美司钠)预防晚期癌症患者异环磷酰胺诱导的尿路上皮毒性
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