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M94A3013.TXT
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1994-10-25
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Document 3013
DOCN M94A3013
TI Liposomal doxorubicin in AIDS-related Kaposi's sarcoma.
DT 9412
AU Caldeira L; Antunes F; Carvalho C; Duarte N; Doroana M; Forte M; Servico
de Doencas Infecciosas, Hospital de Santa Maria,; Lisbon.
SO Int Conf AIDS. 1994 Aug 7-12;10(1):173 (abstract no. PB0119). Unique
Identifier : AIDSLINE ICA10/94369562
AB The authors report their experience with a new formulation of liposomal
doxorubicin (DOX-SL) in the treatment of this disease. Seven HIV1+ male
homosexual pts of caucasian origin (ages 29-42) were treated i.v. with
20mg/m2/cycle of this investigational formulation. At the beginning of
therapy all pts had KS-associated edema and one had GI involvement.
Cycles were administered every 2 weeks for the first 6 and every 3 weeks
thereafter. Four of the pts had previously been treated with the
combination of bleomycin and vincristine for a median of 6 cycles (range
3-9), one of these pts had two additional cycles of daunorubicin and 2
had been treated with the combination of alpha-IFN and low dose AZT. All
of the pts had been switched to DOX-SL due to disease progression.
RESULTS: A total of 77 cycles were administered between July 92 and
December 93 with an median of 11 cycles per pt (range 2-25). Six of the
7 pts (85%) achieved a partial response, as assessed by the reduction or
disappearance of lesion-associated edema, reduction in the number of
lesions on examination and reduction of the surface covered by 5 target
lesions measured at every visit. Partial response was obtained within a
median of 3 cycles (range 1-4) and persisted in 5/6 pts who completed,
at least, 6 cycles. Three pts died, 2 before completing 6 cycles and 1
of these, who died after 2 cycles, was the only pt who did not show a
partial response (stable disease). None of the deaths were due to the
study drug or to KS-related complications. Repeated rectoscopy in the pt
with previously documented rectal disease showed no evidence of KS.
Grade II neutropenia was reported in 7/7 pts (appearance ranging from
cycle 1 to 14) and reached grade III in 2/7 pts. Other probably
drug-related Adverse Events (AEs) (grade II or greater) were nausea
(grade II in 5/7) and anemia (grade II in 2/7). One pt presented with
RBB block with no change in cardiac function as assessed by
echocardiography. In only, 2/77 cycles were reported local reactions due
to drug administration. DISCUSSION: Treatment of AIDS-related KS with 20
mg/m2 of DOX-SL every two to three weeks was associated with an overall
good response and safety in the long term even in patients previously
unresponsive to other chemotherapeutic regimens.
DE Acquired Immunodeficiency Syndrome/*DRUG THERAPY/MORTALITY Adult
Dose-Response Relationship, Drug Doxorubicin/*ADMINISTRATION &
DOSAGE/ADVERSE EFFECTS Drug Administration Schedule Drug Carriers
Follow-Up Studies Homosexuality Human Liposomes Male Neoplasms,
Multiple Primary/DRUG THERAPY/MORTALITY Sarcoma, Kaposi's/*DRUG
THERAPY/MORTALITY Skin Neoplasms/DRUG THERAPY/MORTALITY Survival Rate
MEETING ABSTRACT
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).