Comparison of Three Treatments for Kaposi Sarcoma in Resource-Limited Settings

摘要

In a prospective randomized trial, paclitaxel plus ART had superior outcomes compared with two other widely used regimens for the treatment of AIDS-associated KS. Kaposi sarcoma (KS) remains a common complication of AIDS in resource-limited settings and is seen even among HIV-infected persons with relatively intact immunity. Various chemotherapy regimens plus antiretroviral therapy (ART) are used for treatment, without consensus on a preferred regimen. The AIDS Clinical Trials Group has now conducted a noninferiority study at 11 sites in Africa and South America, randomizing patients with advanced AIDS-related KS 1:1:1 to three different regimens (all combined with ART, which consisted of efavirenz, tenofovir [TDF], and emtricitabine [FTC]): intravenous (IV) bleomycin plus vincristine, oral etoposide, or IV paclitaxel (the control). The primary outcome was progression-free survival at week 48 (PFS; defined as absence of progression, death, entry to an additional treatment step, or loss to follow-up before week 48). Overall, 334 individuals (76%-81% male; median CD4 count range, 216-232 cells/mm3) were enrolled from October 2013 to March 2018. Per Data and Safety Monitoring Board recommendation, the etoposide arm closed in March 2016 because of inferiority to the control arm (48-week PFS difference, -30%; 50% with control vs. 20% with etoposide). In March 2018, the study was closed per DSMB recommendation for inferiority of bleomycin plus vincristine (PFS difference, -20%; 64% with control vs. 44% with bleomycin plus vincristine). Confidence intervals for both comparisons overlapped the predetermined noninferiority margin. Rates of the most common adverse events were similar for all three arms.