PURPOSE Kaposi sarcoma (KS) is caused by Kaposi sarcoma herpesvirus (KSHV), also known as human herpesvirus 8 (HHV-8). KS, which develops most frequently among people with HIV, is generally treated with chemotherapy, but these drugs have acute and cumulative toxicities. We previously described initial results of a trial of pomalidomide, an oral immunomodulatory derivative of thalidomide, in patients with KS. Here, we present results on the full cohort and survival outcomes. PATIENTS AND METHODS Participants with KS with or without HIV were treated with pomalidomide 5 mg once daily for 21 days per 28-day cycle with aspirin 81 mg daily for thromboprophylaxis. Participants with HIV received antiretroviral therapy. Response was defined by modified version of the AIDS Clinical Trial Group KS criteria. We evaluated tumor responses (including participants who had a second course), adverse events, progression-free survival (PFS), and long-term outcomes. RESULTS Twenty-eight participants were enrolled. Eighteen (64%) were HIV positive and 21 (75%) had advanced (T1) disease. The overall response rate was 71%: 95% confidence interval (CI) 51%-87%. Twelve of 18 HIV-positive (67%; 95% CI, 41-87%) and 8 of 10 HIV-negative participants (80%; 95% CI, 44%-97%) had a response. Two of 4 participants who received a second course of pomalidomide had a partial response. The median PFS was 10.2 months (95% CI: 7.6-15.7 months). Grade 3 neutropenia was noted among 50% of participants. In the follow-up period, 3 participants with HIV had other KSHV-associated diseases. CONCLUSIONS Pomalidomide is a safe and active chemotherapy-sparing agent for the treatment of KS among individuals with or without HIV.

中文翻译：

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泊马度胺治疗感染或未感染 HIV 的个体卡波西肉瘤的安全性、活性和长期结果。


目的 卡波西肉瘤 (KS) 由卡波西肉瘤疱疹病毒 (KSHV) 引起，也称为人类疱疹病毒 8 (HHV-8)。 KS 在 HIV 感染者中最常见，通常采用化疗治疗，但这些药物具有急性和累积毒性。我们之前描述了泊马度胺（沙利度胺的一种口服免疫调节衍生物）在 KS 患者中试验的初步结果。在这里，我们展示了整个队列的结果和生存结果。患者和方法 伴有或不伴有 HIV 的 KS 参与者接受泊马度胺 5 mg 每日一次治疗，每 28 天周期 21 天，并每日服用阿司匹林 81 mg 以预防血栓。感染艾滋病毒的参与者接受了抗逆转录病毒治疗。疗效是根据 AIDS 临床试验组 KS 标准的修改版定义的。我们评估了肿瘤反应（包括接受第二个疗程的参与者）、不良事件、无进展生存期（PFS）和长期结果。结果 注册了 28 名参与者。 18 人 (64%) 为 HIV 阳性，21 人 (75%) 为晚期 (T1) 疾病。总体缓解率为 71%：95% 置信区间 (CI) 51%-87%。 18 名 HIV 阳性参与者中的 12 名（67%；95% CI，41-87%）和 10 名 HIV 阴性参与者中的 8 名（80%；95% CI，44%-97%）有反应。接受第二个泊马度胺疗程的 4 名参与者中有两人出现部分缓解。中位 PFS 为 10.2 个月（95% CI：7.6-15.7 个月）。 50% 的参与者出现 3 级中性粒细胞减少症。在随访期间，3 名 HIV 感染者患有其他 KSHV 相关疾病。结论 泊马度胺是一种安全有效的化疗节省药物，可用于治疗感染或未感染 HIV 患者的 KS。