Background:  HAART combined with specific chemotherapy has improved response rates and has decreased relapses in patients with Kaposi´s sarcoma (KS). However, the role of HAART alone in advanced KS is controversial. While in some patients HAART introduction lead to a complete KS response, other subjects developed KS progression. The objectives of our study were to compare the efficacy of HAART alone vs HAART plus pegylated liposomal doxorubicin (PLD) in KS, and to assess the tolerance of PLD.

Methods:  This is a prospective, randomized, multicenter study. Naīve or HAART-failing HIV patients with KS, were randomized to initiate only a new HAART regimen (froup A) or to initiate a new HAART regimen + PLD (group B). Patients should have more than 10 cutaneous lesions or moderate mucose or visceral involvement. Life threatening KS was excluded.  Response rates at 48 weeks were compared between groups. Those patients on group A with KS progression were considered as not responders and could be rescued with PLD. Results are given as median (IQ range) and percentages. Statistical analysis were performed using SPSS program (version 10.0).

Results:  The study included 28 patients (15 in group A, 13 in group B). No statistically baseline differences were observed between groups. CD4 cell counts were 97 (27 to 225) cells/mm³; log HIV-RNA 4.6 (4.2 to 5.6); naīve 80%; T1:25%; I1:64%; S1 28%. More than 10 cutaneous lesions 82%. Baseline human herpes virus 8 (HHV8) PCR was positive in 19/21 (90%) patients. At 48 weeks response rates were 20% and 76% for group A and B, respectively, on ITT (missing = failure) and 23% and 91%, respectively, on OT. During a median follow up time of 6 months HHV8 viremia cleared in 5/15 patients (33%). This conversion was not related to response. In the multivariate logistic regression analysis, the only factor related to response was PLD use. Of 15 patients in group A, 10 had to be rescued with PLD:  8 due to KS progression (6 during the first 3 months) and 2 because no response was observed after 9 months of HAART. Median number of PLD cycles necessary for achieving response was 11 (7 to 14). Although 33% of patients had some PLD related adverse events, only 3 subjects had to modify doses.

Conclusions:  In HIV-infected patients with moderate-advanced KS, HAART alone may not be enough for KS response. However, the combination of HAART plus PLD provides good response rates (76%) and it is well tolerated.

Keywords: Kaposi Sarcoma; Liposomal Doxorubicin