RANDOMIZED COMPARATIVE TRIAL OF PEGYLATED LIPOSOMAL DOXORUBICIN VERSUS BLEOMYCIN AND VINCRISTINE IN THE TREATMENT OF AIDS-RELATED KAPOSIS-SARCOMA

Purpose: Cytotoxic chemotherapy is frequently required for the more se vere manifestations of human immunodeficiency virus (HIV)-related Kapo si's sarcoma. Combinations of bleomycin and vincristine (BV) or BV wit h the addition of doxorubicin (ABV) are the most commonly used regimen s against which new treatments may be compared. We report a multicente r phase III study that compared pegylated liposomal doxorubicin (PLD) to the BV combination. Patients and Methods: We conducted a randomized study that compared PLD 20 mg/m(2) with a combination of bleomycin 15 IU/m(2) and vincristine 2 mg in 241 patients with HIV-related Kaposi' s sarcoma. Both regimens were administered by intravenous infusion eve ry 3 weeks for six cycles. Results: A total of 121 patients received P LD and 120 patients the BV combination. The response to PLD was superi or to BV: 58.7% versus 23.3% (P < .001). Patients who were randomized to receive BV, however, were more likely to terminate treatment early because of an adverse even, (26.7% v 10.7%), and fewer completed the f ull six cycles of treatment (30.8% v 55.4%). Treatment with BV was ass ociated with a significantly higher incidence of peripheral neuropathy (P < .001), whereas PLD treatment was more commonly associated with n eutropenia and delays in receiving treatment (P less than or equal to .001). Conclusion: Pegylated liposomal doxorubicin is an effective tre atment for HIV-related Kaposi's sarcoma with a higher response rate th an the BV combination. It is well tolerated but more myelosuppressive. (C) 1998 by American Society of Clinical Oncology.