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Pegylated liposomal doxorubicin in the treatment of primary cutaneous T-cell lymphomas

From the Clinic of Hematology, Polytechnic University of the Marche Medical School, Ospedali Riuniti, Ancona, Italy (SP, SR, PL, AT, ARS, MO, SM, AS); Institute of Pathology, Department of Neurosciences, Polytechnic University of the Marche Medical School, Ospedali Riuniti, Ancona, Italy (GG); Department of Dermatological Sciences, University of Florence Medical School, Florence, Italy (NP); Department of Hematology, University of Florence Medical School, Florence, Italy (RA); Clinic of Dermatology, Polytechnic University of the Marche Medical School, Ospedali Riuniti, Ancona, Italy (GB) Division of Dermatology, I.N.R.C.A., Ancona, Italy (AG, GM, GR); Division of Dermatology, Jesi, Italy (GF); Division of Dermatology, Macerata, Italy (AB, MS); Dermatology, Grottammare, Italy (NN)

Correspondence: Stefano Pulini, MD, Clinic of Hematology, Polytechnic University of the Marche, Medical School, Ospedali Riuniti Umberto I, G.M. Lancisi-G. Salesi, via Conca 71, 60020 Ancona, Italy. E-mail: stpulini{at}bigfoot.com

Pegylated liposomal doxorubicin (Peg-Doxo) is a promising drug for advanced/recalcitrant primary cutaneous T-cell lymphomas (CTCLs). This prospective phase II trial enrolled 19 patients. We observed overall and complete response rates of 84.2% and 42.1% (with no significant differences between stage I–IIA and IIB–IV patients), and 11% grade III/IV toxicity. After a maximum 46 month-follow-up, median overall (OS), event-free (EFS) and progression-free (PFS) survival were 34, 18 and 19 months. OS, EFS and PFS rates at 46 months were 44%, 30% and 37% respectively. Peg-Doxo seems to be an active and safe principle that should be used in plurirelapsed, early stage-MF and in combination with other chemotherapeutic agents in advanced and aggressive CTCLs.

Key words: pegylated liposomal doxorubicin, primary cutaneous T-cell lymphomas, mycosis fungoides, Sézary syndrome.