Tolerability of Pegylated Liposomal Doxorubicin 20 mg/m² Every 2 Weeks in the Management of Kaposi’s Sarcoma and Hematologic Malignancies.

Pegylated liposomal doxorubicin (PLD, Doxil) was developed to decrease the risk of cumulative-dose cardiotoxicity associated with conventional doxorubicin. However, hand-foot syndrome (HFS) and stomatitis were associated with PLD in early clinical trials and were more common when patients with ovarian cancer received 50 mg/m² q4w (HFS, 37.4%; stomatitis, 37.4%) than when patients with AIDS-related Kaposi’s sarcoma (KS) received 20 mg/m² q3w (HFS, 3.4%; stomatitis, 6.8%). PLD is now commonly used with a dose intensity of 10 mg/m² per week (20 mg/m² q2w, 30 mg/m² q3w, or 40 mg/m² q4w). Recent reports with this reduced dose intensity have shown a marked decrease in the rate and grade of HFS and stomatitis. This retrospective chart review was performed to examine the tolerability and effectiveness of PLD 20 mg/m² q2w in patients with KS and hematologic malignancies. Patient charts from a community oncology clinic from January 2000 through December 2004 were reviewed. Data abstracted included patient demographics, PLD dosing, treatment response, and tolerability for all PLD recipients. Data were censored for patients with solid tumors or an initial PLD dose other than 20 mg/m² q2w. Of the 157 patients receiving PLD, 65 received 1206 cycles (range, 1–116; median, 17) of PLD at an initial dose of 20 mg/m² every 2 weeks as a component of care for KS (n=55), multiple myeloma (n=4), non-Hodgkin’s lymphoma (NHL, n=4), Hodgkin’s disease (n=1), or chronic lymphocytic leukemia (n=1). Most patients with KS also received highly active antiretroviral therapy (HAART). No signs (eg, decreased ejection fraction) or treatment-related symptoms (eg, shortness of breath) of cardiotoxicity were reported in any patient. Four patients (6.2%) had documented mild HFS; 3 patients with KS and 1 patient with a hematologic malignancy One case of HFS (1.5%) led to discontinuation of PLD. Three patients (4.6%) had documented symptoms of mucositis; all 3 patients had KS (5.5%). PLD was effective in most patients at this dose intensity; clinical response (complete or partial response) was seen in 55 patients (84.6%), stable disease in 1 patient (1.5%), and progression in 3 patients (4.6%, all with NHL), and response could not be determined in 5 patients (7.7%). The results of this retrospective review suggest that PLD at an initial dose of 20 mg/m² q2w is active and well tolerated, and that HFS and stomatitis occur in a low percentage of patients and rarely result in discontinuation. Moreover, the rates of HFS seen in patients with KS and hematologic malignancies seem similar. Prospective studies in larger populations are required to confirm the efficacy and safety of PLD 20 mg/m² q2w as a component of care for hematologic malignancies.