Perspective: Information, Inspiration and Advocacy for People Living with HIV/AIDS

- S - 0lforTratng K

Paclitaxel for Treating KS
Paclitaxel (Taxol@) received FDA approval as a second-line
therapy for treating Kaposi's Sarcoma (KS). The bulk of the
information supplied to the FDA referred to the use of paclitaxel
in people who had previously treated KS with conventional
therapy and had progressed in disease despite treatment, or who
could not tolerate side effects associated with other therapies.

Paclitaxel is approved for use in combination with a growth factor called G-CSF,
which stimulates neutrophil growth, important cells for fighting bacterial infections.
The approval was based on two pivotal
studies, including a total of 85 people with
advanced HIV-related KS. One study evaluated a dose of 135 mg/m2 administered
every three weeks while the other evaluated
100 mg/m2 administered every 2 weeks. In
both studies volunteers were permitted to
remain on antiretroviral therapy throughout the KS treatment. Of the 85 study participants, 59 had previously been on KS
treatment and had either failed or were intolerant to therapy. Among this group, 2
people experienced a complete KS response
to paclitaxel therapy. A complete response
was defined as four or more weeks without
detectable KS lesions, other than discoloration of the skin in the area where the lesion
had been. Notably, 35 volunteers, or 59%
of the total, achieved a partial response,
which was defined as the absence of new
lesions or symptoms of KS and a 50% or
greater decrease in either the total number

of lesions, number of elevated lesions, or
the size of indicator lesions for at least one
month. Those with higher Karnofsky scores,
CD4+ counts and KS restricted to the skin
had the best likelihood of favorable responses to therapy. Of the 37 participants
who benefited from paclitaxel, the median
time to response was about 2 months; the
duration of response was a little over 9
months, with some sustaining responses for
upwards of 2 years.
Paclitaxel is known to suppress neutrophils.
Documented side effects in the combined
studies included fever, hair loss, weakness,
nausea, diarrhea, joint pain (arthralgia) or
muscle pain (myalgia), peripheral neuropathy, mucositis, neutropenia, alterations in
SGOT levels, kidney toxicity, anemia and
thrombocytopenia.
KS is the most common AIDS-related cancer. While it affects men (20-25%) at much
higher rates than women (1-3%), women
can get KS as well. Early stage KS is often
treated 'locally', meaning that lesions are

* treated directly with cryotherapy (freezing),
surgical removal, laser therapy or chemotherapy injected directly into the lesions. It
is important to remember that treating individual KS lesions might be appropriate
for someone with disfiguring lesions, however, this is merely a band-aid approach as
these treatments do not actually kill the cells
at the root of the lesion. For KS that has
* progressed, a number of different chemotherapy approaches are used. Clinical trials
have recently shown that treatment with
chemotherapy which is encapsulated in fat
(called liposomes) is more effective and
seemingly less toxic than traditional combination chemotherapy regimens. Two such
* therapies are approved. The first is liposomal daunorubicin (DaunoXome@), which
is approved as a first-line therapy for KS.
The other is liposomal doxorubicin (Doxil~),
which is currently approved as a secondline KS therapy but is pending review as a
first-line approach. These approaches are
becoming more widely used as new data
support their use over more traditional
'cocktails', such as ABV, VV, and BV; regi-. mens which include alternating or combin-. ing the chemotherapies vincristine, vinblas* tine, bleomycin and doxorubicin (Adria* mycin). For more information on KS treat* ment, call the Project Inform Hotline at 800-. 822-7422. Recently there have been reports
of people with HIV-related KS who have. initiated therapy with potent protease in* hibitor containing regimens and realized
spontaneous remissions of KS. Studies are. ongoing to examine this further. U

Resource Notes:
National Trials Hotline. The AIDS Clinical Trials Information Service provides information on federally
sponsored studies (and many others) open to enrollment nationally. Call 1-800-TRIALS-A (1-800-874 -2572). 800-AIDS-012 TTY/TTD serves the deaf and hearing impaired. The service also provides free
copies of the AmFAR Treatment Directory, which also lists studies conducted by private industry.
National AIDS Hotline. This Hotline operates 24 hours a day and provides referrals to local services
throughout the U.S. and information about a wide variety of non-treatment related topics. Call 1-800-342 -AIDS (2437). Spanish-speaking operators are available 8 AM to 2 AM EST at 1-800-344-SIDA (7432).
For the deaf and hearing impaired, call 10 AM to 10 PM EST at 1-800-AIDS-TTY (243-7889).
STEP Perspective is a newsletter produced by the Seattle Treatment Education Project. Call 800-869-STEP
for information on their publications.
WORLD is a newsletter for, by and about women facing HIV disease. WORLD strives to break the isolation
of HIV+ women by providing a forum for communication and information of interest to women. For more
information call 1-510-658-6930.

AIDS Treatment News
Treatment Issues (Gay Men's Health Crisis, New York)
Test Positive Aware (Chicago)
BETA (San Francisco AIDS Foundation)

1-800-873-2812
1-212-337-1950
1-312-472-6397
1-415-863-2437

PI PERSPECTIVE I

NUMBER 23 NOVEMBER 1997

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