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M94A3009.TXT
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1994-10-25
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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).