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Randomized comparative trial of DOXIL vs. Bleomycin and Vincristine in the treatment of AIDS-Related KS.


Int Conf AIDS. 1996 Jul 7-12;11(Program Supplement):27 (abstract no.

241 patients with HIV related Kaposi's Sarcoma (KS) were randomized to receive six 3-weekly cycles of either BV-Bleomycin, 15 mg/m(2) and Vincristine 2 mgs (120 patients)or DOXIL-20 mg/m(2) (121 patients). Both groups were well matched for prognostic factors: according to ACTG criteria, "Poor Risks KS" was seen in 57 (55.9%) of BV and 66 (56.9%) of DOXIL patients, Poor Immune Status" in 88 (86.3%) of BV and 103 (88.8%) of DOXIL patients and "Systemic Symptoms" in 42 (41.2%) of BV and 48 41.4%) of DOXIL patients. 57 (55.9%) of BV and 57 (49.1%) of DOXIL patients had a mean CD4=50 x 10(6)/L one hundred and two of the BV patients and 116 of the DOXIL were assessable for response and toxicity. KS response was assessed according to ACTG criteria and treatment intention. Patients who received DOXIL had a higher response rate than those receiving the BV combination - 7 (5.8%) CR and 63 (52.1%) PR versus 1 (0.8%) CR and 27 22.5%) PR (P-value less than 0.001). The mean time to response was shorter in the DOXIL arm - 48.8 versus 61.4 days (p is less than or equal to 0.009). Although DOXIL was better tolerated than BV with 15.7% versus 23.3% nausea/vomiting, 3.3% versus 8.3% alopecia and 8.3% versus 25.8% neuropathy it was more myelosuppressive; 76.0% versus 56.6% of patients had a neutrophil count less than 1.5 x 10(9)/l during treatment. Conclusions: DOXIL is recommended as first-line chemotherapy for HIV-related KS.

*AIDS-Related Opportunistic Infections/DRUG THERAPY *Antineoplastic Agents, Combined/THERAPEUTIC USE *Sarcoma, Kaposi's/DRUG THERAPY


Information in this article was accurate in September 30, 1997. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.