MOUNTAIN VIEW, CaliforniaPegylated liposomal doxorubicin(Drug information on 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(Drug information on 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.