title: A multicentric observational trial of pegylated liposomal doxorubicin for metastatic breast cancer.
abstract: BACKGROUND
  Pegylated liposomal doxorubicin (PLD) is active in metastatic breast cancer. This observational study evaluated the efficacy and safety of PLD in patients treated during routine clinical practice.
  
  
  METHODS
  Eligible patients had metastatic breast cancer and were treated with PLD according to the dose and schedule determined by their physician as part of routine practice. The primary objectives were to analyze the efficacy and toxicity of PLD therapy.
  
  
  RESULTS
  125 patients were assessable. Median age was 62 years, 78% had performance status 0-1, and 60% had estrogen-receptor-positive disease. PLD treatment was second- or third-line in 69% of patients. Prior anthracyclines (adjuvant or metastatic) had been used in 56% of patients. The majority of patients (79%) received PLD every 4 weeks at a median dose of 40 mg/m2. Overall response rate was 43% in all patients and 34% in those previously treated with anthracyclines. The most common grade 3/4 adverse events were skin toxicity/hand-foot syndrome (6%), and leukopenia (3%).
  
  
  CONCLUSIONS
  This observational study supports the activity and tolerability of PLD in metastatic breast cancer as demonstrated in PLD clinical trials.
authors.affiliation: Breast Center Kantonsspital, St Gallen, Switzerland. jens.huober@kssg.ch
authors.forename: Jens
authors.initials: J
authors.lastname: Huober
authors.forename: Werner
authors.initials: W
authors.lastname: Fett
authors.forename: Arnd
authors.initials: A
authors.lastname: Nusch
authors.forename: Michael
authors.initials: M
authors.lastname: Neise
authors.forename: Marcus
authors.initials: M
authors.lastname: Schmidt
authors.forename: Arthur
authors.initials: A
authors.lastname: Wischnik
authors.forename: Steffen
authors.initials: S
authors.lastname: Gerhardt
authors.forename: Thomas
authors.initials: T
authors.lastname: Goehler
authors.forename: Hans-Joachim
authors.initials: HJ
authors.lastname: Lück
authors.forename: Andreas
authors.initials: A
authors.lastname: Rost
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D019370:Observation; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000903:Antibiotics, Antineoplastic; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin