Treatment of HIV-1-associated Kaposi's sarcoma with pegylated liposomal doxorubicin and HAART simultaneously induces effective tumor remission and CD4+ T cell recovery.
BACKGROUND
The combination of highly active antiretroviral therapy (HAART) and liposomal doxorubicin is a promising approach for the treatment of progressive HIV-related Kaposi's sarcoma (KS). Here, we determined the safety, tolerability, and efficacy of liposomal doxorubicin and HAART as a combined treatment approach for advanced KS, and assessed the impact of liposomal doxorubicin on HAART-mediated immune reconstitution and viral suppression.


METHODS
In an uncontrolled observational trial, KS treatment responses were assessed in 54 HIV-1-infected patients with advanced KS according to ACTG criteria. Immunological and virological treatment responses were compared to 54 non-KS-affected HIV-1 patients who were individually matched to the study participants according to sex, age (+/- 5 years), CD4+ T cell count (+/- 25%), HIV RNA load (+/- 25%) and previous antiretroviral therapy exposure.


RESULTS
In 81.5% of the study patients, complete or partial responses were observed within a median of 8 weeks. Treatment-related side effects were predominantly confined to leukopenia (44.4% of patients) and mild-to-moderate liver enzyme elevation (22.3% of patients). Relative CD4+ T cell counts increased to a similar degree both in study patients and matched pairs (7% vs 6%, respectively), yet, absolute CD4+ T cell counts augmented considerably stronger in chemotherapy-naive matched pairs than in the study patients.


CONCLUSIONS
The simultaneous administration of HAART and liposomal doxorubicin is a safe and effective treatment approach for advanced KS and HAART-mediated recovery of relative CD4+ T cell counts does not seem to be impaired by concomitant treatment with liposomal doxorubicin.
Lichterfeld
M
M
Partners AIDS Research Center, Massachusetts General Hospital, Boston, MA 02129, USA. mlichterfeld@partners.org
Qurishi
N
N
Hoffmann
C
C
Hochdorfer
B
B
Brockmeyer
N H
NH
Arasteh
K
K
Mauss
S
S
Rockstroh
J K
JK
D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects; D015496:CD4-Positive T-Lymphocytes / Q000187:drug effects; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy*; D015497:HIV-1; D006801:Humans; D008081:Liposomes; D008297:Male; D012074:Remission Induction; D012514:Sarcoma, Kaposi / Q000188:drug therapy* / Q000209:etiology
D000903:Antibiotics, Antineoplastic; D008081:Liposomes; D004317:Doxorubicin