U Wollina1, T Graefe, K Karte. 1. Department of Dermatology, Friedrich-Schiller-University, Germany.
Abstract
BACKGROUND: 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). OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.
BACKGROUND: 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). OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.