Journal of Clinical Oncology, Vol 16, 683-691, Copyright © 1998 by American Society of Clinical Oncology
Randomized comparative trial of pegylated liposomal doxorubicin versus bleomycin and vincristine in the treatment of AIDS-related Kaposi's sarcoma. International Pegylated Liposomal Doxorubicin Study Group
S Stewart, H Jablonowski, FD Goebel, K Arasteh, M Spittle, A Rios, D Aboulafia, J Galleshaw and BJ Dezube
Department of Oncology, St Mary's Hospital, London, UK. simon@dukeau.demon.co.uk
PURPOSE: Cytotoxic chemotherapy is frequently required for the more severe
manifestations of human immunodeficiency virus (HIV)-related Kaposi's
sarcoma. Combinations of bleomycin and vincristine (BV) or BV with the
addition of doxorubicin (ABV) are the most commonly used regimens against
which new treatments may be compared. We report a multicenter 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/m2 with a combination of bleomycin 15 IU/m2 and
vincristine 2 mg in 241 patients with HIV-related Kaposi's sarcoma. Both
regimens were administered by intravenous infusion every 3 weeks for six
cycles. RESULTS: A total of 121 patients received PLD and 120 patients the
BV combination. The response to PLD was superior 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 event (26.7%
v 10.7%), and fewer completed the full six cycles of treatment (30.8% v
55.4%). Treatment with BV was associated with a significantly higher
incidence of peripheral neuropathy (P < .001), whereas PLD treatment was
more commonly associated with neutropenia and delays in receiving treatment
(P < or = .001). CONCLUSION: Pegylated liposomal doxorubicin is an
effective treatment for HIV-related Kaposi's sarcoma with a higher response
rate than the BV combination. It is well tolerated but more
myelosuppressive.
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