Uthayakumar S, Bower M, Money-Kyrle J, Muyshondt C, Youle M, Hannon F, Phillips R, Gazzard B G, Boag F
Department of HIV and Genitourinary Medicine, Chelsea and Westminster Hospital, London, UK.
AIDS. 1996 May;10(5):515-9. doi: 10.1097/00002030-199605000-00010.
To evaluate single-agent liposomal daunorubicin chemotherapy in the management of early HIV-related Kaposi's sarcoma (KS).
Randomized cross-over comparison of liposomal daunorubicin versus observation.
Study conducted at single site in tertiary referral HIV unit.
Twenty-nine HIV-seropositive men with < 20 cutaneous KS, no visceral involvement and CD4 cell counts < 400 x 10(6)/I were randomized. Adequate haematological, hepatic and renal function was required for entry. A left ventricular ejection fraction of > 45% was necessary for eligibility.
Patients were randomized to 12 weeks observation or 12 weeks of liposomal daunorubicin 40 mg/m2 every 2 weeks. After 12 weeks, or at disease progression, patients were crossed over to receive the alternative arm.
Disease evaluation was according to AIDS Clinical Trials Group criteria for response assessment and toxicity was recorded using the World Health Organization standardized grading.
Response rate to initial liposomal daunorubicin was six out of 15 (40%) and none experienced a spontaneous response during the observation arm. Six patients (40%) randomized to the initial chemotherapy arm progressed during chemotherapy, while 10(72%) in the observation arm progressed. Neutropenia was the main toxicity associated with liposomal daunorubicin and was documented following 20 out of 139(14%) treatment cycles.
Liposomal daunorubicin is a well tolerated and efficacious treatment for early KS; however, the duration of response is brief.
评估单药脂质体柔红霉素化疗用于早期HIV相关卡波西肉瘤（KS）治疗的效果。
脂质体柔红霉素与观察治疗的随机交叉对照研究。
在一家三级转诊HIV科室的单中心进行研究。
29名HIV血清学阳性男性，皮肤KS病灶少于20个，无内脏受累，CD4细胞计数<400×10⁶/I，被随机分组。入组要求具备足够的血液学、肝脏和肾脏功能。左心室射血分数>45%才有资格入选。
患者被随机分为接受12周观察或每2周接受12周脂质体柔红霉素40mg/m²治疗。12周后，或疾病进展时，患者交叉接受另一组治疗。
根据艾滋病临床试验组反应评估标准进行疾病评估，并使用世界卫生组织标准化分级记录毒性。
初始脂质体柔红霉素治疗的缓解率为15例中的6例（40%），观察治疗组中无人出现自发缓解。随机分配至初始化疗组的6例患者（40%）在化疗期间病情进展，而观察治疗组中有10例（72%）病情进展。中性粒细胞减少是与脂质体柔红霉素相关的主要毒性，139个治疗周期中有20个周期（14%）记录到该毒性。
脂质体柔红霉素是一种耐受性良好且有效的早期KS治疗方法；然而，缓解持续时间较短。
