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

Abstract

Pegylated liposomes are stable, long-circulating carriers useful 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 used in the treatment of Kaposi's sarcoma, no data are available for tumors, such as primary cutaneous T-cell lymphomas (CTCLs). Our purpose was to determine the efficacy and toxicity of pegylated liposomal doxorubicin in patients with relapsing or recalcitrant CTCL. The cumulative dose was limited to 320 mg. A prospective pilot study was performed. Six patients (1 woman and 5 men) aged 59 to 78 years with relapsing or recalcitrant CTCL of the mycosis fungoides type, stage (Ib/IIb), were treated with pegylated liposomal doxorubicin to induce a clinical response. The drug was administered at a dosage of 20 mg m(-2) once a month. Four patients received 8 doses, and 2 patients received 6 doses. The best response was a complete response in 4 patients and a partial 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 response rate, 83%). The responders showed a decrease of lymphocytic infiltrates and activated T lymphocytes in skin biopsy specimens. Side effects were seen temporarily, ranging from grade 0 to grade 3. The most frequent side effects were mild anemia and lymphopenia. There was no need of additional therapy because of side effects. These results indicate that patients with relapsing or recalcitrant CTCL can achieve a high response rate with pegylated liposomal doxorubicin and that a monthly dose is a well-tolerated regimen.