title: Efficacy and safety of pegylated liposomal doxorubicin in primary cutaneous B-cell lymphomas and comparison with the commonly used therapies.
abstract: OBJECTIVE
  The therapy of advanced, relapsed or refractory primary cutaneous lymphomas is often unsatisfactory. Recent data indicate a favourable pharmacokynetic, pharmacodynamic and toxicity profile of pegylated liposomal doxorubicin (Peg-Doxo) in primary cutaneous T-cell lymphomas, while in primary cutaneous B-cell lymphomas (PCBCLs), the drug efficacy has never been assessed so far.
  
  
  METHODS
  We performed a prospective phase II pilot clinical trial of Peg-Doxo monotherapy (20 mg/m(2)) in PCBCLs. One patient had a marginal zone B-cell lymphoma and four were affected by diffuse large B-cell lymphoma-leg type, all with widespread nodular lesions.
  
  
  RESULTS
  All the patients achieved a complete response (CR = 100%) in a short period of time (median 3 months), even when pretreated with radio-chemotherapy. Two experienced a relapse. At follow-up, one patient died for progressive disease; four are in CR after 5, 52, 63 and 69 months. As concerning the toxicity profile, the treatment was well-tolerated, no one decreased or delayed the dose. The haematological toxicity was mild with only one case of grade III neutropenia; a patient showed a grade I neurotoxicity. Dermatological toxicity, in particular the palmar-plantar erythrodysesthesia, did not occurred, probably because of both the low dosages of Peg-Doxo monotherapy and the oral prophylaxis with pyridoxine.
  
  
  CONCLUSIONS
  In spite of the small number of patients, it emerges that monochemotherapy with Peg-Doxo has a significantly high clinical activity and a good safety profile in PCBCLs, even in aggressive forms, compared with other therapeutic regimens, which are completely reviewed. It suggests the need of further investigations in this field.
authors.affiliation: Clinical Hematology, Department of Hematology, Spirito Santo Civic Hospital, Pescara, Italy. stpulini@gmail.com
authors.forename: Stefano
authors.initials: S
authors.lastname: Pulini
authors.forename: Serena
authors.initials: S
authors.lastname: Rupoli
authors.forename: Gaia
authors.initials: G
authors.lastname: Goteri
authors.forename: Nicola
authors.initials: N
authors.lastname: Pimpinelli
authors.forename: Renato
authors.initials: R
authors.lastname: Alterini
authors.forename: Alberta
authors.initials: A
authors.lastname: Bettacchi
authors.forename: Simonetta
authors.initials: S
authors.lastname: Mulattieri
authors.forename: Paola
authors.initials: P
authors.lastname: Picardi
authors.forename: Angela
authors.initials: A
authors.lastname: Tassetti
authors.forename: Anna Rita
authors.initials: AR
authors.lastname: Scortechini
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Fioritoni
authors.forename: Pietro
authors.initials: P
authors.lastname: Leoni
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004317:Doxorubicin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D016393:Lymphoma, B-Cell / Q000188:drug therapy* / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011092:Polyethylene Glycols / Q000009:adverse effects* / Q000627:therapeutic use*; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000473:pathology*
chemical_list: D000970:Antineoplastic Agents; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin