ICRF-187治疗获得性免疫缺陷相关卡波西肉瘤（艾滋病相关卡波西肉瘤，AIDS-KS）患者的II期试验。

Phase II trial of ICRF-187 in patients with acquired immune deficiency related Kaposi's sarcoma (AIDS-KS).

作者信息

Chachoua A, Green M, Wernz J, Muggia F

机构信息

New York University Medical Center, Rita & Stanley Kaplan Cancer Center, New York.

出版信息

Invest New Drugs. 1989 Nov;7(4):327-31. doi: 10.1007/BF00173762.

DOI:10.1007/BF00173762

PMID:2513285

Abstract

Thirteen patients with AIDS related Kaposi's Sarcoma were entered on a phase II trial of ICRF-187, 1000 mg/m2 IV daily for 3 days every 3 weeks. Eight patients had received prior chemotherapy for AIDS-KS. Six patients had prior opportunistic infection. There were no complete responses; one partial response lasting six months was seen. Toxicity was significant, and of the first 5 patients treated, 3 out of 5 had grade III or IV neutropenia. Because of this, subsequent patients received 800 mg/m2 IV days 1-3 if previously untreated or 600 mg/m2 if previously treated. Overall 4 of 13 patients had Grade IV neutropenia and 5 of 13 had Grade III neutropenia. One patient had Grade IV thrombocytopenia. ICRF-187 at a daily x 3 schedule has some efficacy in the treatment of AIDS related KS, future trials should evaluate lower doses or alternate schedules of administration.

摘要

13例艾滋病相关卡波西肉瘤患者进入了ICRF - 187的II期试验，剂量为1000mg/m²，静脉注射，每日1次，共3天，每3周重复。8例患者曾接受过针对艾滋病相关卡波西肉瘤的化疗。6例患者曾有机会性感染。无完全缓解病例；观察到1例部分缓解，持续6个月。毒性反应显著，在前5例接受治疗的患者中，5例中有3例出现III级或IV级中性粒细胞减少。因此，后续患者若此前未接受过治疗，则在第1 - 3天接受800mg/m²静脉注射；若此前接受过治疗，则剂量为600mg/m²。总体而言，13例患者中有4例出现IV级中性粒细胞减少，13例中有5例出现III级中性粒细胞减少。1例患者出现IV级血小板减少。按每日1次共3天的给药方案，ICRF - 187在治疗艾滋病相关卡波西肉瘤方面有一定疗效，未来试验应评估更低剂量或不同的给药方案。