Abstract 1640P
Background
The introduction of effective combination antiretroviral therapy (cART) has had a major influence on epidemiology of AIDS-associated cancer, nevertheless AIDS-KS remains the most common malignancy. In advanced stage or progressive forms chemotherapy (CT) in combination with cART is the treatment of choice. The aim of the study is to evaluate efficacy and tolerability of PLD as first line CT in AIDS-KS.
Methods
This is a single institution retrospective study conducted in L. Sacco Hospital (Milan, IT). We selected HIV+ patients (pts) with KS from 2009 to 2019. cART was continued during CT. AIDS-KS pts were staged according to AIDS Clinical Trials Group. CT was administered in poor risk and some cases of good prognosis/limited cutaneous disease. Treatment plan: PLD 20 mg/m2 IV every 2 wks for 6 to 12 cycles. Efficacy of CT was evaluated as response rate (RR) = complete response (CR) + partial response (PR) and disease progression (DP). CR was defined as total regression of complications, smoothing of all lesions, only pigmented inactive patches remaining. AEs were evaluated according to CTCAE v5.0.
Results
We enrolled 33 pts with AIDS-KS: median age 44ys (37, 49), male 90.9%, Caucasian 72.7%, cART-naïve (simultaneous diagnosis of HIV infection and KS) 84.4%, median lymphocyte CD4+ count 134cells/μL (43, 288), median HIV viral load 4.9 log10 copies/ml (4.5, 5.6). KS stage: Poor Risk in 32 (97%) pts. In 2 (6.1%) pts disease was limited to skin. A median of 6 cycles (range 6-12) of PLD were administered. Grade 3-4 toxicity: 8 (33.3%) pts; neutropenia 3 (12.5%), thrombocytopenia 2 (8.3%), hand-foot skin syndrome 2 (8.3%), infections 2 (8.3%), anemia 1 (4.2%). No cardiovascular events or severe sepsis. In 6 (25%) pts CT was delayed due to toxicity. 26 pts were evaluable for response. KS RR and CR: 24 (92.3%) and 20 (76.9%) pts respectively. After a median follow-up of 27 (12, 65) months, no disease related deaths. DP incidence rate: 0.78 (0, 2.31) per 1000 PY.
Conclusions
PLD associated with cART is an effective, feasible and well tolerated first-line CT in advanced AIDS-KS. We found a RR higher than other previous clinical studies (RR 58.7-84%), probably due to no prior systemic therapy and high percentage of cART-naïve pts.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
N.M. La Verde: Honoraria (self): eisai; Speaker Bureau/Expert testimony: roche; Speaker Bureau/Expert testimony: gentili; Speaker Bureau/Expert testimony: Pfizer; Speaker Bureau/Expert testimony: Gentili; Advisory/Consultancy: MSD; Advisory/Consultancy: Celgene; Advisory/Consultancy: novartis. All other authors have declared no conflicts of interest.