title: Pegylated doxorubicin for primary cutaneous T-cell lymphoma: a report on ten patients with follow-up.
abstract: OBJECTIVE
  Pegylated liposomal doxorubicin (PEG-DOXO) was found to be effective in primary cutaneous T-cell lymphomas (CTCL). The present observation reports on follow-up and relapse-free interval in patients with CTCL.
  
  
  METHODS
  Ten patients (one female, nine male) aged 50-78 years (mean 66.7 years) with relapsing or recalcitrant CTCL, stage I b (n = 3), II a (2), II b (3), IV a (1), and IV b (1) were treated with PEG-DOXO 20 mg m(-2) once a month with an upper limit of 400 mg or eight infusions to induce a clinical response. There was one drop out after a single infusion because of a capillary leak syndrome.
  
  
  RESULTS
  In nine patients with PEG-DOXO the best response was a complete response (CR) in five patients and a partial response (PR) in four patients. The final outcome was CR in six, PR in two, stable disease (SD) in one, and progressive disease (PD) in another patient. The overall response rate (CR + PR) was 80% (of ten patients). The follow-up was 2-22 months (mean 12.8+/-7.1 months). The overall survival was calculated as 19.8+/-7.4 months with eight out of ten patients still alive. Response duration was 15.2+/-3.9 months, disease-free survival 13.3+/-6.1 months, event-free survival 16.7+/-9.0 months, and progression-free survival 18.2+/-6.5 months. Four patients (stage I b and II b) achieved 12-19 months of disease-free survival. The follow-up after the first course with PEG- DOXO was 2-22 months (mean 12.8+/-7.1 months). The survival rate after 12 months of follow-up was 80% (n = 5). One patient free of relapse died after 12 months because of pulmonary embolism not related to disease or treatment. Another patient died 1 month after a second course of PEG-DOXO in an advanced tumor stage of CTCL. The most frequent side effects of treatment were anemia and lymphopenia without the need of supportive treatment or dose-reduction. Only one patient developed toxicity of grade 4 (anemia).
  
  
  CONCLUSIONS
  These results indicate that patients with relapsing or recalcitrant CTCL can achieve an 80% response rate with PEG-DOXO and long-term remissions.
authors.affiliation: Department of Dermatology and Allergology, Friedrich Schiller University of Jena, Germany. uwol@derma.uni-jena.de
authors.forename: U
authors.initials: U
authors.lastname: Wollina
authors.forename: T
authors.initials: T
authors.lastname: Graefe
authors.forename: M
authors.initials: M
authors.lastname: Kaatz
mesh_terms: D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage*; D004317:Doxorubicin / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007150:Immunohistochemistry; D008081:Liposomes; D016410:Lymphoma, T-Cell, Cutaneous / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols; D013501:Surface-Active Agents
chemical_list: D000903:Antibiotics, Antineoplastic; D008081:Liposomes; D013501:Surface-Active Agents; D011092:Polyethylene Glycols; D004317:Doxorubicin