A randomized comparative trial of Doxil versus bleomycin and vincristine (BV) in the treatment of AIDS-related Kaposi's sarcoma (Meeting abstract).

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

A randomized comparative trial of Doxil versus bleomycin and vincristine (BV) in the treatment of AIDS-related Kaposi's sarcoma (Meeting abstract).

Proc Annu Meet Am Soc Clin Oncol; 16:A190 1997. Unique Identifier : AIDSLINE MED/97621062
Stewart JS; Jablonowsky H; Goebel FD; L'age M; Spittle M; Opravi M; Doxil Trial Group; St. Mary's Hospital, London, UK

Abstract: Introduction: Kaposi's Sarcoma remains prevalent in patients with AIDS and systemic cytotoxic chemotherapy is frequently necessary for those patients with the more severe manifestations of this disease. Combinations of bleomycin and vincristine (BV), with or without addition of doxorubicin, (ABV) remain the most commonly used regimens against which new treatments may be compared. Doxil, a novel liposomal formulation of doxorubicin, has been demonstrated to be effective in the treatment of AIDS-related Kaposi's Sarcoma. We report the results of a multicenter Phase III study comparing Doxil to the BV combination. Methods: We conducted a randomized study comparing Doxil (20 mg/m2) versus BV bleomycin 15 mg/m2-vincristine 2 mg) in 241 patients with severe HIV related Kaposi's Sarcoma. Both regimens were administered by intravenous infusion every three weeks for six cycles. The primary endpoints of the study were turnout response and toxicity. Results: A total of 121 patients received single agent Doxil, and 120 received the BV combination. The response to single agent Doxil therapy was significantly superior to BV: 58.7% versus 23.3% (p less than 0.001). Patients randomized to receive BV were more likely to terminate treatment early due to an adverse event when compared with those treated with single agent Doxil (26.7% versus 10.7%), and fewer of the BV patients completed the full six cycles of treatment (30.8% versus 55.4%). Treatment with BV was associated with a significantly higher incidence of peripheral neuropathy (p les than 0.05) whilst Doxil treatment was more commonly associated with neutropenia (p less than 0.001). Conclusion: Treatment with single agent Doxil produced a superior response rate (58.7%) compared to that seen with the BV regimen (23.3%), with similar tolerance. (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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