Continuous infusion etoposide in advanced AIDS-related kaposi sarcoma.

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

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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。
我们进行了一项初步的II期临床试验,以确定对艾滋病相关卡波西肉瘤患者连续输注72小时依托泊苷的毒性、反应和生存率。9例活检证实并可测量的艾滋病相关卡波西肉瘤患者接受依托泊苷连续输注治疗,剂量为100mg /m2 /天,每3周3天。采用NCI共同毒性标准、东部肿瘤合作组(ECOG)和艾滋病临床试验组(ACTG)反应标准评估所有患者的毒性、反应和生存。根据ACTG分期标准,所有入组的患者至少有两个不良的研究危险因素。共进行17个疗程的治疗。35%的周期与3级或更高级别的白细胞减少有关。感染并发症很常见,有一例中毒性死亡。根据ACTG标准观察到两个部分反应(22%)(95%置信区间,0%至51%)。在缺乏使用更严格的实体瘤反应标准和遇到的毒性的客观反应的情况下,我们认为不需要进一步评估晚期艾滋病和低风险卡波西肉瘤患者72小时连续输注依托泊苷的计划。
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