Comparison study of liposomal doxorubicin (DOX) alone or with bleomycin and vincristine (DBV) for treatment of advanced AIDS-associated Kaposi's sarcoma (AIDS-KS): AIDS Clinical Trial Group (ACTG) protocol 286 (Meeting abstract).

Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.

Proc Annu Meet Am Soc Clin Oncol; 16:A191 1997. Unique Identifier : AIDSLINE MED/97621063
Mitsuyasu R; yon Roenn J; Krown S; Kaplan L; Testa M et al; UCLA, Los Angeles, CA

Abstract: Pegylated liposomal doxorubicin (DOX) is a safe and effective treatment for pts with advanced AIDS-KS. The addition of other chemotherapy drugs to DOX might increase KS tumor response, but might also lower tolerance of therapy. To test this, the ACTG performed a phase III study comparing DOX to DBV in advanced-stage AIDS-KS pts who had not received prior chemotherapy. Patients with multiple (25 or more) mucocutaneous lesions and/or visceral KS and/or symptomatic oral lesions, or those with CD4 less than or equal to 100 and 10 or more lesions, were randomized to receive DOX 20 mg/m2 +/- vincristine 1 mg and bleomycin 10 U/m2 IV every 2 wks. Toxicity was assessed every 2 wks and tumor response using ACTG criteria was assessed every 4 wks. From May, 1995 to July, 1996, 129 pts enrolled; 126 are evaluable (62 on DOX and 64 on DBV). The two groups had similar baseline characteristics. Median time to first grade 3 or higher toxicity was 10 wks for DOX and 7 wks for DBV (p=0.0095), and more pts discontinued treatment for toxicities from DBV (16) than DOX alone (4). The overall tumor responses were similar (5 CR + 43 PR [79%] on DOX and 5 CR + 46 PR [80%] on DBV), as were median times to tumor progression or death (29 wks on DOX and 32 wks on DBV). A scheduled interim analysis showed a trend toward better survival for DOX vs DBV (11 vs 18 deaths, p=0.079). Quality of life (QOL) scales decreased more rapidly during treatment with DBV than with DOX alone. All DBV pts were subsequently switched to DOX alone. We conclude that single agent therapy with DOX is effective initial treatment for advanced AIDS-KS and that the addition of BV to DOX may increase toxicity and decrease QOL without substantially improving clinical outcomes. (C) American Society of Clinical Oncology 1997

Keywords: *AIDS-Related Opportunistic Infections/DRUG THERAPY *Doxorubicin/THERAPEUTIC USE *Sarcoma, Kaposi/DRUG THERAPY
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