Abstract
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.
Publication types
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Clinical Trial, Phase II
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Multicenter Study
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Research Support, Non-U.S. Gov't
MeSH terms
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Adult
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Aged
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Aged, 80 and over
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Antineoplastic Agents / administration & dosage
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Antineoplastic Agents / adverse effects
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Antineoplastic Agents / therapeutic use*
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Combined Modality Therapy
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Disease-Free Survival
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Doxorubicin / administration & dosage
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Doxorubicin / adverse effects
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Doxorubicin / analogs & derivatives*
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Doxorubicin / therapeutic use
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Female
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Follow-Up Studies
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Humans
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Kaplan-Meier Estimate
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Liposomes / administration & dosage
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Lymphoma, T-Cell, Cutaneous / drug therapy*
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Male
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Middle Aged
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Mycosis Fungoides / drug therapy
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Polyethylene Glycols / administration & dosage
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Polyethylene Glycols / adverse effects
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Polyethylene Glycols / therapeutic use*
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Prospective Studies
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Remission Induction
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Salvage Therapy
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Sezary Syndrome / drug therapy
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Survival Analysis
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Survival Rate
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Treatment Outcome
Substances
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Antineoplastic Agents
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Liposomes
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liposomal doxorubicin
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Polyethylene Glycols
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Doxorubicin