Response to liposomal doxorubicin and clinical outcome of HIV-1-infected patients with Kaposi's sarcoma receiving highly active antiretroviral therapy.

Abstract

PURPOSE:

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.

METHOD:

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).

CONCLUSION:

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.

• Authors: M Núñez, P Saballs, M E Valencia, J Santos, E Ferrer, I Santos, A Berrocal, M J Galindo, D Podzamczer, J Gonzlez-Lahoz, Caelyx/KS Spanish Study Group
• Journal: HIV clinical trials (HIV Clin Trials) 2001 Sep-Oct Vol. 2 Issue 5 Pg. 429-37 ISSN: 1528-4336 [Print] England
• PMID: 11673818 (Publication Type: Clinical Trial, Clinical Trial, Phase IV, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-HIV Agents
• Antineoplastic Agents
• DNA, Viral
• Liposomes
• Doxorubicin

Topics

• AIDS-Related Opportunistic Infections (drug therapy)
• Adult
• Anti-HIV Agents (therapeutic use)
• Antineoplastic Agents (administration & dosage, therapeutic use)
• Antiretroviral Therapy, Highly Active
• DNA, Viral (analysis)
• Doxorubicin (administration & dosage, adverse effects, therapeutic use)
• Drug Therapy, Combination
• Female
• Gastrointestinal Diseases (chemically induced)
• HIV-1
• Hematologic Diseases (chemically induced)
• Herpesvirus 8, Human (genetics, isolation & purification)
• Humans
• Leukocytes, Mononuclear (virology)
• Liposomes
• Male
• Prospective Studies
• Sarcoma, Kaposi (drug therapy, virology)
• Treatment Outcome