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New data indicate DOXIL is appropriate first-line therapy for Kaposi's sarcoma.


WASHINGTON--(HealthWire)--Jan. 24, 1997--

-- DOXIL(R) vs. ABV ABV Above
ABV Alcohol By Volume
ABV Abuja, Nigeria (airport code)
ABV Assault Breacher Vehicle
ABV Accredited Business Valuation specialist
ABV Auxiliary Building Ventilation
ABV Annual Buy Value
ABV Air Bleed Valve
, BV Efficacy and Safety Data To Be Presented

at Conference on Retroviruses and Opportunistic Infections Opportunistic infections

Infections that cause a disease only when the host's immune system is impaired. The classic opportunistic infection never leads to disease in the normal host.
 --

DOXIL(R) is indicated for first-line treatment for Kaposi's sarcoma (KS) and is suitable for long-term therapy, based on integrated efficacy and safety data from two studies to be presented tomorrow at the 4th Conference on Retroviruses and Opportunistic Infections.

DOXIl is a formulation of doxorubicin hydrochloride encapsulated in polyethylene glycol-coated liposomes Liposomes

Aqueous compartments enclosed by lipid bilayer membranes; liposomes are also known as lipid vesicles. Phospholipid molecules consist of an elongated nonpolar (hydrophobic) structure with a polar (hydrophilic) structure at one end.
.

Dr. Donald Northfelt of Pacific Oaks Medical Group, and the University of California, San Diego UCSD is consistently ranked among the top ten public universities for undergraduate education in the United States by U.S. News & World Report.[3] It is a Public Ivy. [1] For graduate studies, most of UCSD's Ph.D. , served as co-principal investigator in the two trials, which compared the activity of DOXIL to combinations of Adriamycin (doxorubicin doxorubicin /doxo·ru·bi·cin/ (dok?so-roo´bi-sin) an antineoplastic antibiotic, produced by Streptomyces peucetius, which binds to DNA and inhibits nucleic acid synthesis; used as the hydrochloride salt and as a liposome-encased )-bleomycin-vincristine (ABV) and to bleomycin-vincristine (BV). A total of 254 patients were treated with DOXIL, 125 with ABV and 120 with BV. Two dosing intervals were included in the protocol: two weeks in the DOXIL vs. ABV study and 3 weeks in the DOXIl vs. BV study.

"The data clearly indicate that single agent DOXIL is an important first-line, long-term treatment option," said Dr. Northfelt. "DOXIL has a superior tumor response rate relative to both ABV and BV, a superior safety profile to ABV and an equivalent safety profile to BV, but without the common dose-limiting toxicities associated with BV."

The trials yielded a response of 52% in the combined DOXIL group, 25% in the ABV group and 23% among BV patients. A greater number of DOXIL patients were able to complete the trials (68% for DOXIL vs. 34% for ABV and 55% for DOXIL vs. 31% for BV).

Fewer and less severe adverse events, including nausea/vomiting, alopecia alopecia (ăl'əpē`shēə): see baldness. , peripheral sensory neuropathy and neutropenia Neutropenia Definition

Neutropenia is an abnormally low level of neutrophils in the blood. Neutrophils are white blood cells (WBCs) produced in the bone marrow that ingest bacteria.
 (<1000 cells/mm3), were reported in the DOXIL arm relative to ABV, with the exception of mucositis, which was more frequent among DOXIL patients. Less than 1% of all patients reported skin toxicity.

As compared to BV, Dr. Northfelt reported a greater degree of neutropenia in DOXIL patients, but less peripheral neuropathy and nausea/vomiting. The rates of opportunistic infections were similar among DOXIL, ABV and BV patients.

CONTACT: Pacific Oaks Medical Group

Donald W. Northfelt, M.D., F.A.C.P.

619/864-1492

Fax: 619/864-1495
COPYRIGHT 1997 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1997, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Date:Jan 24, 1997
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