A randomized trial of liposomal daunorubicin (DX) vs Adriamycin, bleomycin and vincristine (ABV) in 232 patients with advanced AIDS-related Kaposi's sarcoma (Meeting abstract).

Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.

A randomized trial of liposomal daunorubicin (DX) vs Adriamycin, bleomycin and vincristine (ABV) in 232 patients with advanced AIDS-related Kaposi's sarcoma (Meeting abstract).

Proc Annu Meet Am Assoc Cancer Res; 14:A830 1995. Unique Identifier : AIDSLINE ICDB/95613982
Gill PS; Wernz J; Scadden DT; Cohen P; vonRoenn J; Chew T; Kempin S; Silverberg I; Gonzales G; Rarick MU; et al; University of Southern California, Los Angeles, CA

Abstract: Kaposi's sarcoma (KS) is the most common tumor in patients with HIV-1 infection and can cause significant morbidity and mortality. Systemic chemotherapy is the most active treatment for advanced disease. We previously showed that DaunoXome has an improved pharmacokinetics profile with a prolonged area under the curve, preferential uptake in tumor tissue, a favorable toxicity profile, and anti-tumor activity (Gill et al, JCO, in press). We therefore conducted this multicenter phase III study in patients with advanced AIDS-KS (greater than 25 skin lesions, visceral disease, or symptomatic edema). DX (40 mg/m2) was compared with a modified ABV regimen (A (10 mg/m2), B (15 U) and V (1 mg)) to permit concurrent antiretroviral therapy. Patients were balanced equally between treatment arms based on prognostic criteria. Both regimens were given intravenously every 2 weeks until disease progression. An interim analysis was conducted on the first 115 patients. From an efficacy perspective, there was no difference in response rates between the two treatment arms. Although the time to first evidence of disease progression was slightly prolonged for DaunoXome, this was not significant. The DaunoXome arm was substantially better tolerated: alopecia (1/58 vs 15/56, p less than 0.0001), insomnia (1/58 vs 8/56, p = 0.03), neuropathy (5/58 vs 21/56 p less than 0.001). In addition, whereas DaunoXome patients consistently gained weight during treatment, patients on ABV lost weight (p less than 0.05). We conclude that DaunoXome is well tolerated, with a reduced toxicity profile when compared to ABV. A detailed analysis of efficacy and safety will be presented on the entire cohort of 232 patients, followed for at least three months.

Keywords: Acquired Immunodeficiency Syndrome/*COMPLICATIONS/DRUG THERAPY Antineoplastic Agents, Combined/*THERAPEUTIC USE Antiviral Agents/THERAPEUTIC USE Bleomycin/ADMINISTRATION & DOSAGE Comparative Study Daunorubicin/*ADMINISTRATION & DOSAGE/*THERAPEUTIC USE Doxorubicin/ADMINISTRATION & DOSAGE Drug Carriers Follow-Up Studies Human Liposomes Neoplasm Staging Sarcoma, Kaposi's/*DRUG THERAPY/*ETIOLOGY/PATHOLOGY Time Factors Vinblastine/ADMINISTRATION & DOSAGE ABSTRACT CLINICAL TRIAL RANDOMIZED CONTROLLED TRIAL
951230
M95C3207

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