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持续输注依托泊苷治疗晚期艾滋病相关卡波西肉瘤。

Continuous infusion etoposide in advanced AIDS-related kaposi sarcoma.

作者信息

Remick S C, Reddy M, Ekman K, Vyzula R, Hilstro J, Horton J

机构信息

Albany Medical College, NY 12208-3479, USA.

出版信息

J Infus Chemother. 1996 Spring;6(2):92-6.

PMID:8809657
Abstract

We conducted a preliminary phase II clinical trial to determine the toxicity, response, and survival rate of 72-hour continuous infusion etoposide administered to patients with AIDS-related Kaposi sarcoma. Nine patients with biopsy proven and measurable disease AIDS-related Kaposi sarcoma were treated with a continuous infusion of etoposide at a dose of 100 mg/m2 per day for 3 days every 3 weeks. All patients were evaluated for toxicity, response, and survival employing the NCI Common Toxicity Criteria, and both the Eastern Cooperative Oncology Group (ECOG) and AIDS Clinical Trials Group (ACTG) response criteria. All patients enrolled had at least two on-study poor risk factors by ACTG staging criteria. A total of 17 cycles of therapy were administered. Thirty-five percent of cycles were associated with grade 3 or greater leukopenia. Infectious complications were common, and there was one toxic death. Two partial responses (22%) by ACTG criteria were observed (95% confidence interval, 0% to 51%). In the absence of objective responses using more strict solid tumor response criteria and toxicity encountered we believe further evaluation of a 72-hour continuous infusion schedule of etoposide in patients with advanced AIDS and poor risk Kaposi's sarcoma is not warranted.

摘要

我们开展了一项II期初步临床试验,以确定对艾滋病相关卡波西肉瘤患者进行72小时持续输注依托泊苷的毒性、反应及生存率。9例经活检证实且病灶可测量的艾滋病相关卡波西肉瘤患者,每3周接受一次依托泊苷持续输注,剂量为每日100 mg/m²,共3天。采用美国国立癌症研究所通用毒性标准以及东部肿瘤协作组(ECOG)和艾滋病临床试验组(ACTG)的反应标准,对所有患者进行毒性、反应及生存情况评估。根据ACTG分期标准,所有入组患者至少有两个研究中的不良风险因素。共进行了17个疗程的治疗。35%的疗程出现3级或更高级别的白细胞减少。感染并发症很常见,有1例因毒性死亡。观察到2例根据ACTG标准判定的部分缓解(22%)(95%置信区间,0%至51%)。鉴于使用更严格的实体瘤反应标准未出现客观反应且存在毒性,我们认为对于晚期艾滋病及高风险卡波西肉瘤患者,无需进一步评估依托泊苷72小时持续输注方案。

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