title: Reduced incidence of severe palmar-plantar erythrodysesthesia and mucositis in a prospective multicenter phase II trial with pegylated liposomal doxorubicin at 40 mg/m2 every 4 weeks in previously treated patients with metastatic breast cancer.
abstract: OBJECTIVE
  The aim of this study was to assess whether the reduction in the total dose of pegylated liposomal doxorubicin (PLD) per cycle from 50 mg/m(2) every 4 weeks to 40 mg/m(2) every 4 weeks can effectively lower the incidence of treatment-related palmar-plantar erythrodysesthesia (PPE) and mucositis.
  
  
  METHODS
  Patients received PLD 40 mg/m(2) every 4 weeks, and were evaluated for toxicity prior to each treatment and for response every 8 weeks.
  
  
  RESULTS
  All patients were previously treated with at least one chemotherapy regimen for metastatic disease, and 72% of the patients had a prior exposure to an anthracycline. Forty-six evaluable patients received a median of four PLD cycles, with a median dose intensity of 10 mg/m(2)/week and a median cumulative dose of 160 mg/m(2). No National Cancer Institute Common Toxicity Criteria (NCI-CTC) grade 3 or 4 PPE was observed in these patients. NCI-CTC grade 3 or 4 mucositis occurred in 4.3% of patients, only. Response rates and survival results observed here were comparable to those observed with PLD 50 mg/m(2) every 4 weeks in a matched patient population. However, patients treated with PLD 40 mg/m(2) every 4 weeks experienced less PPE and mucositis and required clearly less dose reductions and treatment delays.
  
  
  CONCLUSIONS
  The favorable safety profile observed in this study leads us to recommend the use of PLD 40 mg/m(2) every 4 weeks for patients with advanced breast cancer.
authors.affiliation: Krankenhaus Nordwest, Frankfurt, Deutschland. albatran@aol.com
authors.forename: Salah-Eddin
authors.initials: SE
authors.lastname: Al-Batran
authors.forename: Hans-Gerd
authors.initials: HG
authors.lastname: Meerpohl
authors.forename: Gunter
authors.initials: G
authors.lastname: von Minckwitz
authors.forename: Akin
authors.initials: A
authors.lastname: Atmaca
authors.forename: Ulrich
authors.initials: U
authors.lastname: Kleeberg
authors.forename: Nadia
authors.initials: N
authors.lastname: Harbeck
authors.forename: Werner
authors.initials: W
authors.lastname: Lerbs
authors.forename: Detlef
authors.initials: D
authors.lastname: Hecker
authors.forename: Jalid
authors.initials: J
authors.lastname: Sehouli
authors.forename: Alexander
authors.initials: A
authors.lastname: Knuth
authors.forename: Elke
authors.initials: E
authors.lastname: Jager
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004334:Drug Administration Schedule; D004890:Erythema / Q000139:chemically induced / Q000453:epidemiology*; D005260:Female; D005528:Foot; D006225:Hand; D006801:Humans; D015994:Incidence; D008875:Middle Aged; D052016:Mucositis / Q000139:chemically induced / Q000453:epidemiology*; D010292:Paresthesia / Q000139:chemically induced / Q000453:epidemiology*; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects*; D011446:Prospective Studies
chemical_list: D000903:Antibiotics, Antineoplastic; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin