Beyond T Staging in the Treat All Era: Capturing the Severity and Heterogeneity of Kaposi’s Sarcoma in East Africa

Abstract

Background: In the treat-all era of HIV, Kaposi’s sarcoma (KS) remains one of the most incident cancers in sub- Saharan Africa. The majority of patients with KS are diagnosed at advanced disease stage in this setting. Staging systems for KS, specifically the AIDS Clinical Trials Group (ACTG) system, were developed in the pre-ART era, were not meant to guide treatment, and may not fully capture the clinical heterogeneity of advanced disease. There is no international consensus on which KS patients need chemotherapy in addition to antiretroviral therapy (ART). Understanding KS severity of disease in the current era would help to inform prognosis and clarify treatment guidelines. Methods: We performed rapid case ascertainment (RCA) on people living with HIV ≥18 years old newly diagnosed with biopsy-proven KS from 2016 to 2019 at three clinic sites in Kenya and Uganda. As close as possible to time of diagnosis, we performed a structured interview, physical examination, and collection of laboratory specimens. We reported KS severity using ACTG and WHO staging criteria, as well as detailed measurements not captured in current staging systems. Results: We enrolled 264 adults newly diagnosed with KS. RCA was performed within 1 month of KS diagnosis for 62% of patients and within 6 months for 73% of patients. Patients were 61% Kenyan, 69% male, and with a median age of 35. Median CD4 count was 239 (IQR 87 to 408), with 72% of patients initiating ART greater than 60 days prior to diagnosis. The majority of patients had advanced stage of disease, with 82% qualifying as ACTG T1 and 64% as WHO Severe/Symptomatic KS. There was marked heterogeneity within advanced KS, with 25% of patients having two ACTG qualifiers and 3% of patients had three or more ACTG qualifiers. Conclusion: The majority of patients with KS in this study had advanced stage disease at time of diagnosis, highlighting the need to improve early diagnosis of KS. Within this group of advanced stage patients was large clinical heterogeneity, leading to questions about whether all patients with advanced KS require the same treatment strategy.