Document 3009
 DOCN  M94A3009
 TI    Efficacy and safety of Stealth liposomal doxorubicin (DOX-SL) in
       AIDS-related Kaposi's sarcoma. The International Dox-SL Study Group.
 DT    9412
 AU    Goebel FD; Medizinische Poliklinik, Universitat Munchen, Germany.
 SO    Int Conf AIDS. 1994 Aug 7-12;10(1):174 (abstract no. PB0123). Unique
       Identifier : AIDSLINE ICA10/94369566
 AB    OBJECTIVE: The utility of current chemotherapeutic regimens in the
       treatment of AIDS-related Kaposi's sarcoma (AIDS-KS) is often
       compromised by both limited efficacy and substantial toxicity. Dox-SL, a
       long-circulating, liposomally encapsulated doxorubicin, has been
       demonstrated to specifically deliver high concentrations of doxorubicin
       to KS lesions. This phase II study was therefore performed to evaluate
       the efficacy and safety of Dox-SL in the treatment of moderate to severe
       AIDS-KS. METHODS: Patients were treated biweekly with Dox-SL, in almost
       all cases at 10 or 20mg/m2. Lesion response was assessed according to
       ACTG criteria prior to each cycle. RESULTS: Best response was determined
       for 196 patients and was achieved after a mean of 2.5 cycles (range:
       1-20). Thirteen patients (6.6%) had a complete response (CR) to Dox-SL,
       143 (73.0%) had a partial response (PR), 38 (19.4%) had stable disease
       while 2 (1.0%) had disease progression. The degree of response to Dox-SL
       did not appear to correlate with dose. Mean response duration (measured
       from the time of best response) was 95.6 days (range: 4-451) for PRs
       and/or CRs and 53.9 (range: 25-77) for CRs. Dox-SL was well-tolerated:
       only 6 patients discontinued therapy because of adverse events during
       the first 6 cycles. CONCLUSIONS: 1) Dox-SL has substantial activity in
       AIDS-KS; 2) Dox-SL is well-tolerated, and may lack much of the toxicity
       of free doxorubicin; 3) Further study of Dox-SL in AIDS-KS is justified.
 DE    Acquired Immunodeficiency Syndrome/BLOOD/*DRUG THERAPY/PATHOLOGY
       Dose-Response Relationship, Drug  Doxorubicin/*ADMINISTRATION &
       DOSAGE/ADVERSE EFFECTS/  PHARMACOKINETICS  Drug Administration Schedule
       Drug Carriers  Follow-Up Studies  Human  Liposomes  Neoplasm Staging
       Sarcoma, Kaposi's/BLOOD/*DRUG THERAPY/PATHOLOGY  Skin
       Neoplasms/BLOOD/*DRUG THERAPY/PATHOLOGY  CLINICAL TRIAL  CLINICAL TRIAL,
       PHASE II  MEETING ABSTRACT

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).