Treatment of advanced AIDS-associated Kaposi sarcoma in resource-limited settings: a three-arm, open-label, randomised, non-inferiority trial

 The Lancet, April 2020.

Dr. Susan E. Krown and colleagues published “Treatment of advanced AIDS-associated Kaposi sarcoma in resource-limited settings: a three-arm, open-label, randomized, non-inferiority trial” from the A5263 trial in The Lancet on April 11, 2020. Optimal treatment regimens for AIDS-associated Kaposi sarcoma (KS) have not been systematically evaluated in low and middle-income countries (LMIC), where the disease is most common. A5263 aimed to study optimal treatment strategies for advanced-stage disease in these settings. Participants with HIV and advanced-stage AIDS-associated KS were recruited from 11 ACTG sites in Brazil, Kenya, Malawi, South Africa, Uganda, and Zimbabwe. Eligible participants were randomly assigned (1:1:1) to receive either intravenous bleomycin and vincristine or oral etoposide (the investigational arms), or intravenous paclitaxel (the control arm), together with standard EFV-based ART.

Three hundred thirty-four participants were enrolled between October 1, 2013 and March 8, 2018, when the study was closed early due to inferiority of the bleomycin and vincristine plus ART arm. The etoposide plus ART arm had previously closed due to inferiority in March 2016. Week 48 progression-free survival rates were higher in the paclitaxel plus ART arm than in both investigational arms. Rates of adverse effects were equal across arms. Non-inferiority of either investigational intervention for advanced KS in LMICs was not demonstrated. Paclitaxel plus ART should continue to be used in treating advanced AIDS-associated KS in resource-limited settings.

Krown S., Moser C., Campbell T., MacPhail A., Matining R., Godfrey C., Caruso S., Hosseinipour M., Samaneka W., Nyirenda M., Busakhala N., Okuku F., Kosgei J., Hoagland B., Mwelase N., Oliver V., Burger H., Mngqibisa R., Nokta M., Borok-Williams M. Treatment of Advanced AIDS-associated Kaposi Sarcoma in Resource-Limited Settings: A Three-Arm, Open-Label, Randomised, Non-Inferiority Trial in Five sub-Saharan African Countries and Brazil (ACTG A5263/AMC066). Lancet Vol. 395. Iss 10231. 2020 Apr 11;. doi: 10.1016/S0140-6736(19)33222-2. Epub 2020 Mar. PubMedID: 32145827