Clinical efficacy for refractory or intolerant AIDS-related Kaposi’s Sarcoma1
In an open-label, single-arm, multicenter study in patients retrospectively identified as having disease progression on prior systemic combination chemotherapy or as being intolerant to such therapy (n=77), DOXIL® demonstrated clinical efficacy and tolerability. Of the 77 patients, 34 were evaluable for investigator assessment and 42 were evaluable for indicator lesion assessment. The responses are shown below.1
Two analyses of tumor response were used: one based on investigator assessment of changes in lesions based on modified ACTG criteria (partial response defined as no new lesions, sites of disease, or worsening edema; flattening of ≥50% of previously raised lesions or area of indicator lesions decreasing by ≥50%; and response lasting at least 21 days with no prior progression), and one based on changes in up to 5 prospectively identified representative indicator lesions (partial response defined as flattening of ≥50% of previously raised indicator lesions, or >50% decrease in the area of indicator lesions and lasting at least 21 days with no prior progression).1
DOXIL® was studied in an open-label, single-arm, multicenter study at a dose of 20 mg/m2 every 3 weeks, until disease progression or unacceptable toxicity.
Data are described for a cohort of 77 patients retrospectively identified as having disease progression on prior systemic combination chemotherapy (at least 2 cycles of a regimen containing at least 2 of 3 treatments: bleomycin, vincristine or vinblastine, or doxorubicin) or as being intolerant to such therapy. Of the 77 patients, 49 (64%) had received prior doxorubicin HCl.
The median time on study was 5.1 months (range, 1 day-15 months). The median cumulative dose of DOXIL® was 154 mg/m2 (range, 20-620 mg/m2).
Baseline patient characteristics1
Baseline characteristics were balanced, with the majority of patients classified as ACTG poor risk.
Response in patients with refractory or intolerant AIDS-related Kaposi's Sarcoma*1
*Patients with disease that progressed on prior combination chemotherapy or who were intolerant to such therapy.
†There were no complete responses in this population.
Durable responses were also demonstrated in separate retrospective efficacy analyses of 2 trials1
- The studies included subsets of patients who received single-agent DOXIL® and were on stable antiretroviral therapy for at least 60 days prior to enrollment and until a response was demonstrated1
- 40% of patients in the first trial (7 of 17) had a durable response longer than 11.6 months (median duration was not reached)
- 40% of patients in the second trial (4 of 11) also demonstrated a durable response
DOXIL® (doxorubicin HCl liposome injection) Prescribing Information. Janssen Products, LP, Horsham, PA.