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).