HIV and AIDS Malignancy Branch, Center for Cancer Research, NCI, NIH, Bethesda, Maryland.
Biostatistics and Data Management Section, Center for Cancer Research, NCI, NIH, Bethesda, Maryland.
Clin Cancer Res. 2022 Mar 1;28(5):840-850. doi: 10.1158/1078-0432.CCR-21-3364.
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.
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.
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.
Pomalidomide is a safe and active chemotherapy-sparing agent for the treatment of KS among individuals with or without HIV.
卡波氏肉瘤（KS）是由卡波氏肉瘤疱疹病毒（KSHV）引起的，也称为人类疱疹病毒 8 型（HHV-8）。KS 最常发生在 HIV 感染者中，通常采用化疗治疗，但这些药物具有急性和累积毒性。我们之前描述了沙利度胺口服免疫调节剂来那度胺治疗 KS 患者的初步试验结果。在此，我们报告了完整队列的结果和生存结局。
患有或不患有 HIV 的 KS 患者接受来那度胺 5mg 每日一次治疗，28 天周期内连用 21 天，同时每日服用阿司匹林 81mg 用于血栓预防。HIV 感染者接受抗逆转录病毒治疗。根据 AIDS 临床试验组 KS 标准的改良版本来评估肿瘤反应（包括接受第二疗程的患者）、不良事件、无进展生存期（PFS）和长期结局。
共纳入 28 名参与者。18 名（64%）为 HIV 阳性，21 名（75%）为晚期（T1）疾病。总缓解率为 71%：95%置信区间（CI）为 51%-87%。18 名 HIV 阳性患者中有 12 名（67%；95%CI，41%-87%）和 10 名 HIV 阴性患者中有 8 名（80%；95%CI，44%-97%）有反应。4 名接受第二疗程来那度胺的患者中有 2 名部分缓解。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 阳性患者出现其他 KSHV 相关疾病。
来那度胺是一种安全有效的化疗药物，可用于治疗 HIV 感染者和非 HIV 感染者的 KS。
