Cooley Timothy, Henry David, Tonda Margaret, Sun Steven, O'Connell Martin, Rackoff Wayne
Lahey Clinic, Burlington, Massachusetts, USA.
Oncologist. 2007 Jan;12(1):114-23. doi: 10.1634/theoncologist.12-1-114.
Despite a decreased incidence of AIDS-related Kaposi's sarcoma (KS) due to the advent of highly active antiretroviral therapy, approximately 15% of AIDS patients still develop AIDS-related KS. This study evaluated the clinical benefit, tumor response, and safety of pegylated liposomal doxorubicin for the treatment of AIDS-related KS.
This was a double-blind, multicenter study that randomized patients with AIDS-related KS to six cycles of pegylated liposomal doxorubicin (20 mg/m2; n = 60) or liposomal daunorubicin (40 mg/m2; n = 19) every 2 weeks. Clinical benefit was assessed using patient questionnaires and monitoring of KS-associated symptoms. Tumor responses were assessed using imaging techniques, direct measurement of skin lesions, and photographs, when possible.
Clinical benefit was observed in 48/60 patients (80%) receiving pegylated liposomal doxorubicin and was maintained for a median of 62 days (range, 28-107 days). Clinical benefit was achieved by 12/19 patients (63.2%) receiving liposomal daunorubicin and was maintained for a median of 55 days (range, 28-84 +days). Clinical benefit correlated with tumor response. Tumor responses were achieved by 55.0% of patients receiving pegylated liposomal doxorubicin and 31.6% of patients receiving liposomal daunorubicin. Response rates were similar within each treatment group when only those patients without changes in antiretroviral therapy during treatment were considered. Adverse events associated with pegylated liposomal doxorubicin were neutropenia (30%), nausea (28.3%), and asthenia (16.7%).
Pegylated liposomal doxorubicin is safe and effective for the treatment of AIDS-related KS, with most patients experiencing clinical benefit, tumor response, or both.
尽管高效抗逆转录病毒疗法的出现使艾滋病相关卡波西肉瘤（KS）的发病率有所下降，但仍有大约15%的艾滋病患者会患上艾滋病相关KS。本研究评估了聚乙二醇化脂质体阿霉素治疗艾滋病相关KS的临床疗效、肿瘤反应及安全性。
这是一项双盲、多中心研究，将艾滋病相关KS患者随机分为两组，分别每2周接受6个周期的聚乙二醇化脂质体阿霉素（20mg/m²；n = 60）或柔红霉素脂质体（40mg/m²；n = 19）治疗。通过患者问卷及对KS相关症状的监测评估临床疗效。尽可能使用成像技术、直接测量皮肤病变及拍照来评估肿瘤反应。
接受聚乙二醇化脂质体阿霉素治疗的60例患者中有48例（80%）观察到临床疗效，疗效维持的中位时间为62天（范围28 - 107天）。接受柔红霉素脂质体治疗的19例患者中有12例（63.2%）获得临床疗效，疗效维持的中位时间为55天（范围28 - 84 +天）。临床疗效与肿瘤反应相关。接受聚乙二醇化脂质体阿霉素治疗的患者中有55.0%出现肿瘤反应，接受柔红霉素脂质体治疗的患者中有31.6%出现肿瘤反应。仅考虑治疗期间抗逆转录病毒疗法无变化的患者时，各治疗组的反应率相似。与聚乙二醇化脂质体阿霉素相关的不良事件有中性粒细胞减少（30%）、恶心（28.3%）及乏力（16.7%）。
聚乙二醇化脂质体阿霉素治疗艾滋病相关KS安全有效，大多数患者有临床疗效、肿瘤反应或两者兼具。
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