title: Prospective international multicenter phase II trial of intravenous pegylated liposomal doxorubicin monochemotherapy in patients with stage IIB, IVA, or IVB advanced mycosis fungoides: final results from EORTC 21012.
abstract: OBJECTIVE
  Mycosis fungoides (MF) is the most common primary cutaneous T-cell lymphoma. There is a need for multicenter trials involving defined patient populations using rigorous assessment criteria. We have investigated pegylated liposomal doxorubicin (PLD) in a clearly defined patient population with advanced MF.
  
  
  METHODS
  Eligible patients had stage IIB, IVA, or IVB MF, refractory or recurrent after at least two previous systemic therapies. Patients were registered to receive a maximum of six cycles of PLD 20 mg/m2 on days 1 and 15, every 28 days (one cycle). The primary end point was response rate (RR).
  
  
  RESULTS
  Nine centers recruited 49 eligible patients. The median number of chemotherapy cycles received was five. There were no grade 3 to 4 hematologic toxicities. Grade 3 or 4 nonhematologic/nonbiochemical toxicities included cardiac symptom (2%), allergy/hypersensitivity (2%), constitutional symptom (4%), hand and foot reaction (2%), other dermatologic toxicity (6%), other GI toxicity (4%), infection (4%), pulmonary embolism (2%), and cardiac ischemia (2%). Of 49 patients, 20 (40.8%) were responders (complete clinical response [CCR] or partial response [PR] as overall response): three (6.1%) experienced CCRs, and 17 (34.7%) experienced PRs. A 50% or greater reduction of cutaneous manifestations was observed in 26 (60.5%) of 43 assessable patients. Two early deaths were reported, resulting from related cardiovascular toxicity and disease progression. The lower limit of the one-sided 90% CI for RR was 31.2%. Median time to progression and median duration of response were 7.4 and 6 months, respectively.
  
  
  CONCLUSIONS
  PLD has an acceptable safety profile in patients with advanced MF. The efficacy of PLD seems promising.
authors.affiliation: Department of Dermatology, University Hospital of Zurich, Gloriastrasse 31, 8091 Zurich, Switzerland. reinhard.dummer@usz.ch
authors.forename: Reinhard
authors.initials: R
authors.lastname: Dummer
authors.forename: Pietro
authors.initials: P
authors.lastname: Quaglino
authors.forename: Jürgen C
authors.initials: JC
authors.lastname: Becker
authors.forename: Baktiar
authors.initials: B
authors.lastname: Hasan
authors.forename: Matthias
authors.initials: M
authors.lastname: Karrasch
authors.forename: Sean
authors.initials: S
authors.lastname: Whittaker
authors.forename: Stephen
authors.initials: S
authors.lastname: Morris
authors.forename: Michael
authors.initials: M
authors.lastname: Weichenthal
authors.forename: Rudolf
authors.initials: R
authors.lastname: Stadler
authors.forename: Martine
authors.initials: M
authors.lastname: Bagot
authors.forename: Antonio
authors.initials: A
authors.lastname: Cozzio
authors.forename: Maria G
authors.initials: MG
authors.lastname: Bernengo
authors.forename: Robert
authors.initials: R
authors.lastname: Knobler
mesh_terms: D061605:Administration, Intravenous; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004305:Dose-Response Relationship, Drug; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D006801:Humans; D008875:Middle Aged; D009182:Mycosis Fungoides / Q000188:drug therapy* / Q000473:pathology; D009367:Neoplasm Staging; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D012074:Remission Induction; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome
chemical_list: C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin