Journal of Clinical Oncology, Vol 15, 653-659, Copyright © 1997 by American Society of Clinical Oncology
Efficacy of pegylated-liposomal doxorubicin in the treatment of AIDS- related Kaposi's sarcoma after failure of standard chemotherapy
DW Northfelt, BJ Dezube, JA Thommes, R Levine, JH Von Roenn, GM Dosik, A Rios, SE Krown, C DuMond and RD Mamelok
SEQUUS Pharmaceuticals, Inc, Menlo Park, CA, USA. dnorthfelt@pol.net
PURPOSE: To determine the efficacy and safety of pegylated-liposomal
doxorubicin in patients with AIDS and Kaposi's sarcoma (AIDS-KS) who
experienced failure of standard chemotherapy. METHODS: Fifty-three patients
with advanced AIDS-KS who experienced disease progression or intolerable
toxicities while receiving standard doxorubicin/bleomycin/vincristine (ABV)
or bleomycin/vincristine (BV) chemotherapy were identified from a cohort of
patients who were then treated with pegylated-liposomal doxorubicin.
Patients received 20 mg/m2 pegylated-liposomal doxorubicin (Doxil; Sequus
Pharmaceuticals, Inc, Menlo Park, CA) every 3 weeks. RESULTS: Nineteen
patients (36%) had a partial response (PR) and one patient had a clinical
complete response (CCR). The median duration of response and time (from
study entry) to treatment failure were 128 and 134 days, respectively. Of
28 patients who experienced disease progression while receiving combination
regimens that contained standard doxorubicin, the PR rate was 32%, which
suggests that the pegylated-liposomal encapsulation increases the
therapeutic effect of doxorubicin. Patients obtained clinical benefits such
as flattening of lesions (48%), improved lesion color (56%), relief of pain
(45%), and loss of edema (83%). Forty-nine percent of patients had more
than one clinical benefit. The most common adverse effect was leukopenia,
which occurred in 40% of patients. Only 15% of patients had nausea and/or
vomiting, none of which was severe; 9% experienced alopecia, also generally
mild. CONCLUSION: Pegylated- liposomal doxorubicin offers a new alternative
for treatment of patients who have experienced failure of standard
chemotherapy for AIDS- KS.
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