Document 1000
 DOCN  M9541000
 TI    Liposomal doxorubicin (Doxil): an effective new treatment for Kaposi's
       sarcoma in AIDS.
 DT    9504
 AU    James ND; Coker RJ; Tomlinson D; Harris JR; Gompels M; Pinching AJ;
       Stewart JS; Ludwig Institute for Cancer Research, St Mary's Hospital
       Medical; School, London, UK.
 SO    Clin Oncol (R Coll Radiol). 1994;6(5):294-6. Unique Identifier :
       AIDSLINE MED/95127530
 AB    The objective of this study was to assess the efficacy and toxicity of a
       novel Stealth liposomal encapsulated formulation of doxorubicin (Doxil).
       A Phase I/II dose escalation study was carried out in a specialist HIV
       oncology unit in a teaching hospital (predominantly in an outpatient
       department). Fifteen patients with HIV related, biopsy confirmed,
       cutaneous Kaposi's sarcoma, with or without visceral involvement of
       sufficient severity to require systemic chemotherapy, were treated. Most
       patients had poor prognosis disease as assessed by the Tumour/Immune
       status/Systemic symptoms (TIS) system and Karnofsky indices; six
       patients had previously received combination chemotherapy. Primary
       treatment consisted of a dose of Doxil 10 mg/m2, repeated after 2 weeks.
       If the Kaposi's sarcoma (KS) responded and the treatment was tolerated,
       the patient began maintenance therapy at the same dose every 2 weeks. If
       there was no clinical response, the dose was increased to 20 mg/m2 for
       the further two cycles, before proceeding to maintenance therapy.
       Treatment continued until other intercurrent disease, lack of further
       response, patient preference, or toxicity precluded further treatment.
       Tumour response was assessed 2 weeks after completion of at least two
       cycles of chemotherapy. Toxicity was assessed for each cycle. Doxil was
       well tolerated, and toxicity was manageable, the principal toxicity
       being haematological. A partial response rate of 11/15 (73%) was
       achieved, with disease stabilization in the remaining patients. We
       conclude that Doxil is an effective palliative treatment for epidemic KS
       in a patient group with a poor predicted outcome.(ABSTRACT TRUNCATED AT
       250 WORDS)
 DE    Acquired Immunodeficiency Syndrome/*COMPLICATIONS  Adult
       Doxorubicin/*ADMINISTRATION & DOSAGE/ADVERSE EFFECTS  Drug Carriers
       Human  Liposomes  Male  Middle Age  Palliative Treatment  Sarcoma,
       Kaposi's/*DRUG THERAPY/ETIOLOGY  Skin Neoplasms/*DRUG THERAPY/ETIOLOGY
       CLINICAL TRIAL  CLINICAL TRIAL, PHASE I  CLINICAL TRIAL, PHASE II
       JOURNAL ARTICLE

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