Northfelt D W, Dezube B J, Thommes J A, Levine R, Von Roenn J H, Dosik G M, Rios A, Krown S E, DuMond C, Mamelok R D
SEQUUS Pharmaceuticals, Inc, Menlo Park, CA, USA.
J Clin Oncol. 1997 Feb;15(2):653-9. doi: 10.1200/JCO.1997.15.2.653.
To determine the efficacy and safety of pegylated-liposomal doxorubicin in patients with AIDS and Kaposi's sarcoma (AIDS-KS) who experienced failure of standard chemotherapy.
Fifty-three patients with advanced AIDS-KS who experienced disease progression or intolerable toxicities while receiving standard doxorubicin/bleomycin/vincristine (ABV) or bleomycin/vincristine (BV) chemotherapy were identified from a cohort of patients who were then treated with pegylated-liposomal doxorubicin. Patients received 20 mg/m2 pegylated-liposomal doxorubicin (Doxil; Sequus Pharmaceuticals, Inc, Menlo Park, CA) every 3 weeks.
Nineteen patients (36%) had a partial response (PR) and one patient had a clinical complete response (CCR). The median duration of response and time (from study entry) to treatment failure were 128 and 134 days, respectively. Of 28 patients who experienced disease progression while receiving combination regimens that contained standard doxorubicin, the PR rate was 32%, which suggests that the pegylated-liposomal encapsulation increases the therapeutic effect of doxorubicin. Patients obtained clinical benefits such as flattening of lesions (48%), improved lesion color (56%), relief of pain (45%), and loss of edema (83%). Forty-nine percent of patients had more than one clinical benefit. The most common adverse effect was leukopenia, which occurred in 40% of patients. Only 15% of patients had nausea and/or vomiting, none of which was severe; 9% experienced alopecia, also generally mild.
Pegylated-liposomal doxorubicin offers a new alternative for treatment of patients who have experienced failure of standard chemotherapy for AIDS-KS.
确定聚乙二醇化脂质体阿霉素对标准化疗无效的艾滋病相关卡波西肉瘤（AIDS-KS）患者的疗效和安全性。
从一组接受聚乙二醇化脂质体阿霉素治疗的患者中，确定了53例晚期AIDS-KS患者，这些患者在接受标准阿霉素/博来霉素/长春新碱（ABV）或博来霉素/长春新碱（BV）化疗时出现疾病进展或不可耐受的毒性。患者每3周接受20mg/m²聚乙二醇化脂质体阿霉素（多美素；Sequus制药公司，加利福尼亚州门洛帕克）治疗。
19例患者（36%）有部分缓解（PR），1例患者有临床完全缓解（CCR）。缓解的中位持续时间和（从研究入组开始）至治疗失败的时间分别为128天和134天。在28例接受含标准阿霉素联合方案治疗时出现疾病进展的患者中，PR率为32%，这表明聚乙二醇化脂质体包封增加了阿霉素的治疗效果。患者获得了临床益处，如病变变平（48%）、病变颜色改善（56%）、疼痛缓解（45%）和水肿消退（83%）。49%的患者有不止一项临床益处。最常见的不良反应是白细胞减少，40%的患者发生。只有15%的患者有恶心和/或呕吐，均不严重；9%的患者出现脱发，通常也较轻。
聚乙二醇化脂质体阿霉素为标准化疗失败的AIDS-KS患者提供了一种新的治疗选择。
