Response to liposomal doxorubicin and clinical outcome of HIV-1-infected patients with Kaposi's sarcoma receiving highly active antiretroviral therapy.
OBJECTIVE
HIV-associated Kaposi's sarcoma (KS) may not resolve despite highly active antiretroviral therapy (HAART). Moreover, the therapeutic goal has shifted from palliative care to long-term durable complete remission. The objective of the study was to assess the impact of liposomal doxorubicin in the treatment of HIV-associated KS in the HAART era.


METHODS
In this prospective, noncomparative, multicenter study, patients with more than 10 cutaneous lesions or visceral disease were treated with 20 mg/m(2) of liposomal doxorubicin (Caelyx) every 3 weeks in addition to their antiretroviral therapy. In addition to tumor measurements and laboratory tests, human herpes virus 8 (HHV-8) polymerase chain reaction (PCR) in peripheral blood mononuclear cells (PBMC) was performed.


RESULTS
Out of 79 participants enrolled in the study, 47 (59%) had stage T(1), 41 (52%) I(1), and 32 (40%) S(1). Nine individuals were not evaluable for response, 32 (40%) had complete response, 30 (38%) partial response, 5 (6%) stable disease, and 3 (4%) progression. Regression analysis did not find any statistically significant factor predicting response. HHV-8 PCR was positive in 37/53 (70%) patients with available PBMC samples, and HHV-8 viremia cleared in 14/27 (52%) without correlation with clinical response. Eleven (14%) participants experienced a relapse of KS, while at the last update of data, 49 (62%) remained stable. The only risk factor for recurrence identified was the follow-up time (odds ratio [OR] 1.21, 95% CI 1.07-1.36; p =.002).


CONCLUSIONS
The response rate of AIDS-associated KS to liposomal doxorubicin administered with HAART was high, and most often the response was durable. HHV-8 viremia did not correlate well with clinical outcome.
Núñez
M
M
Hospital Carlos III, Madrid, Spain. m_nunez_g@hotmail.com
Saballs
P
P
Valencia
M E
ME
Santos
J
J
Ferrer
E
E
Santos
I
I
Berrocal
A
A
Galindo
M J
MJ
Podzamczer
D
D
Gonzlez-Lahoz
J
J
D017088:AIDS-Related Opportunistic Infections / Q000188:drug therapy*; D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D004279:DNA, Viral / Q000032:analysis; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D015497:HIV-1; D006402:Hematologic Diseases / Q000139:chemically induced; D019288:Herpesvirus 8, Human / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D007963:Leukocytes, Mononuclear / Q000821:virology; D008081:Liposomes; D008297:Male; D011446:Prospective Studies; D012514:Sarcoma, Kaposi / Q000188:drug therapy* / Q000821:virology; D016896:Treatment Outcome
D019380:Anti-HIV Agents; D000970:Antineoplastic Agents; D004279:DNA, Viral; D008081:Liposomes; D004317:Doxorubicin