The aim of this study was to examine the outcome, adverse events and clinical complications of long-term
chemotherapy with
pegylated liposomal doxorubicin (PegLiposomal DOX) for human immunodeficiency virus (HIV)-associated
Kaposi's sarcoma (KS) in the pre-
highly active antiretroviral therapy (
HAART) era. A phase II study over a 4-year period in a tertiary care university hospital was carried out. 52
acquired immunodeficiency syndrome (
AIDS)-patients with advanced KS received long-term
chemotherapy (71+/-51 weeks) with a mean of 22.8+/-18.2 cycles and a mean cumulative
liposomal doxorubicin dose of 456+/-364 mg/m(2) (120-1040 mg/m(2)). Tumour burden, duration and dosage of PegLiposomal DOX, adverse events,
opportunistic infections, immunological parameters and HIV load were measured. A complete (10%) or partial response (56%) was achieved while on
chemotherapy. 10 patients (19%) showed stable disease. Tumour progression was observed in 8 patients (15%). Importantly,
chemotherapy with PegLiposomal DOX was also successful after previous
cytostatic therapy with
bleomycin and
vincristine. The most common adverse events included leucopenia,
neutropenia, anaemia, and increased liver function tests. 34 patients (65%) developed new
opportunistic infections and 29 patients (56%) died during the study period. To conclude,
pegylated liposomal doxorubicin is a safe and effective
drug for long-term
chemotherapy of advanced (
AIDS) KS without adverse effects on CD4 cell counts and HIV viral load.