Treatment of relapsing or recalcitrant cutaneous T-cell lymphoma with pegylated liposomal doxorubicin

Background: Pegylated liposomes are stable, long-circulating carriers usefu l for delivering doxorubicin to tumor sites with a lower toxicity than the free drug. Free doxorubicin is used in several treatment protocols for non- Hodgkin's lymphoma. Although pegylated liposomal doxorubicin is currently u sed in the treatment of Kaposi's sarcoma, no data are available for tumors, such as primary cutaneous T-cell lymphomas (CTCLs). Objective: Our purpose was to determine the efficacy and toxicity of pegyla ted liposomal doxorubicin in patients with relapsing or recalcitrant CTCL. The cumulative dose was limited to 320 mg. Methods: A prospective pilot study was performed. Six patients (1 woman and 5 men) aged 53 to 78 years with relapsing or recalcitrant CTCL of the myco sis fungoides type, stage (Ib/IIb), were treated with pegylated liposomal d oxorubicin to induce a clinical response. The drug was administered at a do sage of 20 mg m(-2) once a month. Four patients received 8 doses, and 2 pat ients received 6 doses. Results: The best response was a complete response in 4 patients and a part ial response in 2 patients. The final outcome was a complete response in 4, a partial response in 1, and progressive disease in 1 patient (overall res ponse rate, 83%). The responders showed a decrease of lymphocytic infiltrat es and activated T lymphocytes in skin biopsy specimens. Side effects were seen temporarily, ranging from grade 0 to grade 3. The mast frequent side e ffects were mild anemia and lymphopenia. There was no need of additional th erapy because of side effects. Conclusion: These results indicate that patients with relapsing or recalcit rant CTCL can achieve a high response rate with pegylated liposomal doxorub icin and that a monthly dose is a well-tolerated regimen.