title: Multicenter study of pegylated liposomal doxorubicin in patients with cutaneous T-cell lymphoma.
abstract: BACKGROUND
  In single center studies and case reports, it was shown that pegylated liposomal doxorubicin (PEG-DOXO) was effective as second-line therapy for patients with cutaneous T-cell lymphoma (CTCL). The objective of this study was to evaluate the efficacy and toxicity of single-agent PEG-DOXO as second-line chemotherapy in patients with CTCL.
  
  
  METHODS
  A retrospective, multicenter study was performed evaluating 34 patients (31 male patients and 3 female patients). Twenty-seven patients received PEG-DOXO 20 mg/m(2), 5 patients received PEG-DOXO 20-30 mg/m(2), and 2 patients received PEG-DOXO 40 mg/m(2). PEG-DOXO was administered intravenously every 2 weeks in 6 patients, every 2-3 weeks in 4 patients, and every 4 weeks in 23 patients. One patient received only a single course of PEG-DOXO. Outcomes were evaluated, and adverse effects were recorded.
  
  
  RESULTS
  Thirty-four patients received at least 1 cycle of PEG-DOXO. Disease was classified as mycosis fungoides in 28 patients, mycosis fungoides with follicular mucinosis in 2 patients, small or medium-sized pleomorphic CTCL in 2 patients, Sèzary syndrome in 1 patient, and CD30 positive CTCL in 1 patient. Fifteen patients achieved a complete response (CR), including patients who achieved a CR and patients who achieved a CR defined by clinical criteria only with no biopsy (CRu), and 15 patients achieved a partial response (PR), resulting in a response rate (CRs, CRus, and PRs) of 88.2%. Two patients dropped out: one patient after a single PEG-DOXO infusion because of Grade 3 capillary leakage syndrome and one patient after two cycles because of a suicide attempt that was not related to treatment or to CTCL. All other patients received at least four cycles of PEG-DOXO. Overall survival was 17.8 months +/- 10.5 months (n = 33 patients), event-free survival was 12.0 months +/- 9.5 months, and disease-free survival was 13.3 +/- 10.5 months (n = 16 patients). Adverse effects were seen in 14 of 34 patients (41.2%); they were temporary and generally mild. Only 6 patients had Grade 3 or 4 adverse effects.
  
  
  CONCLUSIONS
  This multicenter study provided evidence of high efficacy of PEG-DOXO monotherapy with a low rate of severe adverse effects compared with other chemotherapy protocols in patients with CTCL.
authors.affiliation: Department of Dermatology, Hospital Dresden-Friedrichstadt, Friedrichstrasse 41, 01067 Dresden, Germany. wollina-uw@khdf.de
authors.forename: Uwe
authors.initials: U
authors.lastname: Wollina
authors.forename: Reinhard
authors.initials: R
authors.lastname: Dummer
authors.forename: Norbert H
authors.initials: NH
authors.lastname: Brockmeyer
authors.forename: Helga
authors.initials: H
authors.lastname: Konrad
authors.forename: J-O
authors.initials: JO
authors.lastname: Busch
authors.forename: Martin
authors.initials: M
authors.lastname: Kaatz
authors.forename: Burkhard
authors.initials: B
authors.lastname: Knopf
authors.forename: Hans-Jürgen
authors.initials: HJ
authors.lastname: Koch
authors.forename: Axel
authors.initials: A
authors.lastname: Hauschild
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000494:pharmacology*; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D005260:Female; D006801:Humans; D008081:Liposomes; D016410:Lymphoma, T-Cell, Cutaneous / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D008081:Liposomes; D004317:Doxorubicin