Single-agent Doxil, a formulation of pegylated liposomal doxorubicin(Drug information on doxorubicin) HCl, produces a higher response rate in patients with severe AIDS-related Kaposis sarcoma (KS) than does the combination of bleomycin(Drug information on bleomycin) and vincristine (BV), according to a study published in the February issue of the Journal of Clinical Oncology.
The phase III multicenter study compared single-agent liposomal doxorubicin to the BV combination. Primary end points for the study were tumor response and toxicity. Results from the study showed that patients who received liposomal doxorubicin treatment showed a superior response rate compared to patients given the BV regimen (58.7% vs 23.3%; P < .001). In addition, liposomal doxorubicin appeared to be better tolerated than BV but was more myelosuppressive. The multicenter study was conducted in 22 centers in several countries, including the United Kingdom, Germany, Switzerland, and the United States, between January 1993 and September 1995.
The trial results indicate that pegylated liposomal doxorubicin is an effective treatment for severe AIDS-related KS and shows a superior response rate when compared to the BV combination, said one of the studys co-authors, Dr. Simon Stewart of St. Marys Hospital, London, England.
The randomized study included a total of 241 patients with HIV-related KS. Of the total patient population, 121 patients received single-agent liposomal doxorubicin (20 mg/m²) and 120 patients received BV (bleomycin, 15 IU/m²; vincristine, 2 mg). Both regimens were administered every 3 weeks for six cycles.
Patients who were randomized to receive BV were more likely to terminate treatment early due to an adverse event than patients treated with liposomal doxorubicin (26.7% vs 10.7%), and fewer BV-treated patients were likely to complete the full six cycles of treatment (30.8% vs 55.4%). Treatment with BV was associated with a significantly higher incidence of peripheral neuropathy (P < .001), while liposomal doxorubicin was more commonly associated with neutropenia and delays in receiving treatment (P < .001).