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Clinical Benefit Sustained in AIDS-Related Kaposi’s Sarcoma Patients Treated With Pegylated Liposomal Doxorubicin

Clinical Benefit Sustained in AIDS-Related Kaposi’s Sarcoma Patients Treated With Pegylated Liposomal Doxorubicin

MOUNTAIN VIEW, California—Pegylated liposomal doxorubicin (Doxil,
Caelyx) offered a sustained clinical benefit to 37% of patients with
AIDS-related Kaposi’s sarcoma vs 16% of patients treated with liposomal
daunorubicin (DaunoXome) in a randomized trial comparing the two drugs (ASCO
abstract 1640).

"In the setting of Kaposi’s sarcoma, clinicians have wondered
whether tumor response is correlated with clinically significant
improvement," said study investigator Francis Martin, PhD, of Alza
Pharmaceuticals in Mountain View, California. "Although the Food and
Drug Administration has approved Doxil in Kaposi’s sarcoma on the basis of
tumor regression, they also want to know the association between tumor
response and benefit to the patients."

In this phase IV, double-blind, multicenter study, 80 patients with
AIDS-related Kaposi’s sarcoma were randomized 3:1 to one of two active
treatments, either pegylated liposomal doxorubicin at 20 mg/m², or liposomal
daunorubicin at 40 mg/m², every 2 weeks for up to six cycles. Baseline
characteristics were well balanced, and most patients had newly diagnosed
Kaposi’s sarcoma.

Clinical Benefit Shown

Clinical benefit was defined as improvement in at least one of five
symptom categories associated with Kaposi’s sarcoma: edema, pulmonary
involvement, gastrointestinal involvement, disfiguring lesions, and pain.
The final analysis used a more conservative definition of sustained clinical
benefit, defined as a sustained improvement lasting at least 28 days in at
least one symptom category without worsening of the other symptoms.

Each patient made a biweekly assessment of the five symptom categories
using an 11-item questionnaire. An independent blinded reviewer evaluated
photographs for disfiguring lesions and edema.

"On the basis of a patient-reported outcomes questionnaire, this
study did show that Doxil was associated with improvement in pain,
disfiguring lesions, gastrointestinal disease, pulmonary disease, and
lymphedema," said study investigator Margaret Tonda, PharmD, of Alza
Pharmaceuticals. "Often pain relief is linked to improvement in
lymphedema, as obstructed lymphatic drainage by Kaposi’s lesions can cause
pain in the feet." In addition to presenting the study results, Dr.
Martin and Dr. Tonda offered ONI their perspectives on the trial.

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