Pomalidomide is active and well tolerated in patients with symptomatic Kaposi sarcoma regardless of human immunodeficiency virus (HIV) status, according to a study published in the Journal of Clinical Oncology.
Kaposi sarcoma is a multicentric tumor caused by Kaposi sarcoma-associated herpes virus. Among patients with Kaposi sarcoma associated with HIV, the foundation of treatment is antiretroviral therapy, but for those without HIV, the optimal treatment strategy is less defined. Researchers evaluated the activity and tolerability of the oral immunomodulatory agent, pomalidomide, in this patient population.
For the single-center, phase 1/2 study (ClinicalTrials.gov Identifier: NCT01495598), investigators enrolled 22 patients with Kaposi sarcoma, of which 68% were HIV-positive, 77% had advanced disease, and 86% had received at least 1 prior therapy excluding antiretroviral therapy. All participants received pomalidomide once daily for 21 days of each 4-week cycle in addition to daily thromboprophylactic aspirin.
Results showed that 73% (95% CI, 50-89) of patients responded to therapy, including 9 of 15 HIV-positive patients (60%; 95% CI, 32-84) and all 7 HIV-negative patients (100%; 95% CI, 59-100). Four patients achieved a complete response. Median time to response was 4 weeks.
No dose-limiting toxicities occurred during therapy. The most common adverse events were neutropenia, constipation, anemia, fatigue, and rash, with 10 patients experiencing grade 3 to 4 neutropenia.
Pomalidomide treatment was not associated with impairment in health-related quality of life occurred during treatment.
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Further trials evaluating the efficacy of pomalidomide monotherapy and in combination with cytotoxic chemotherapy among patients with Kaposi sarcoma are warranted.
- Polizzotto MN, Uldrick TS, Wyvill KM, et al. Pomalidomide for symptomatic Kaposi’s sarcoma in people with and without HIV infection: A phase I/II study. J Clin Oncol. 2016 Oct 3. doi: 10.1200/JCO.2016.69.3812 [Epub ahead of print]