NIAID Now | March 06, 2020
The cancer drug paclitaxel and a suppressive regimen of antiretroviral therapy (ART) is an effective treatment for AIDS-related Kaposi’s sarcoma, according to researchers who conducted a clinical trial comparing three chemotherapy regimens in combination with ART in people with advanced AIDS-Kaposi’s sarcoma in Africa and South America. The full findings, published online today in The Lancet, affirmed conclusions from interim data released when the trial ended early in March 2018.
The randomized Phase 3 trial, known as ACTG A5263 and AMC-066, was funded by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Cancer Institute (NCI) and conducted by the AIDS Clinical Trial Group (ACTG) with the AIDS Malignancy Consortium.
Kaposi's sarcoma (KS) is a cancer that causes abnormal tissue to grow in the skin, the lining of the mouth and throat, lymph nodes, and the lungs and other internal organs. Since the development of ART, the number of KS cases has fallen dramatically in North America and Europe. However, KS remains common in other parts of the world, in part because ART availability and accessibility may be less comprehensive. This prevalence makes the study of KS critical to improving AIDS survival rates and informing the knowledge base for HIV and cancer research.
In this trial, investigators enrolled 334 men and women with AIDS-KS in six countries in South America and Africa beginning in October 2013. Participants were originally randomized to intravenously administered paclitaxel plus ART, intravenously delivered bleomycin and vincristine with ART or orally administered etoposide with ART. The etoposide arm was discontinued in 2016 when investigators found that the drug did not perform as well as paclitaxel.
When the trial ended in 2018, researchers found that after 48 weeks of treatment participants randomized to receive paclitaxel had higher rates of survival without tumor progression after 48 weeks of treatment than participants randomized to receive bleomycin and vincristine. Researchers now report that the rate of survival without tumor progression was 64% for participants who received paclitaxel compared with only 44% for participants who received bleomycin and vincristine. The data suggest that paclitaxel plus ART should be favored over the more commonly used bleomycin and vincristine regimen or etoposide alone as the first line of treatment for AIDS-KS in resource-limited settings.
S Krown et al. Treatment of Advanced AIDS-Associated Kaposi Sarcoma in Resource-Limited Settings: a Three-arm, Open-Label, Randomised, Non-Inferiority Trial. The Lancet DOI: 10.1016/S0140-6736(19)33222-2 (2020).