title: Pegylated liposomal doxorubicin in combination with gemcitabine: a phase II study in anthracycline-naïve and anthracycline pretreated metastatic breast cancer patients.
abstract: BACKGROUND
  The aim of the study was to assess the toxicity profile, activity in terms of response rate, time to progression, overall survival, and quality of life of pegylated liposomal doxorubicin (PLD) and gemcitabine combination in chemo-naïve and pretreated metastatic breast cancer (MBC) women.
  
  
  METHODS
  Patients were eligible if they had disease progression to prior chemotherapy (anthracycline-including or not) for early breast cancer or MBC. Patients received PLD 25 mg/m(2) intravenously on day 1 plus gemcitabine 800 mg/m(2) intravenously on days 1 and 8 of each 21-day cycle.
  
  
  RESULTS
  Of 50 patients enrolled, 37 had received prior adjuvant chemotherapy (24 with an anthracycline) and 23 prior chemotherapy for metastatic disease (6 with an anthracycline). Two complete responses and 20 partial responses were achieved in 46 assessable patients (overall response rate: 47.8%). Responses were observed in 14 (46.6%) of 30 patients with previous anthracycline exposure. Median response duration was 7 months, median duration of clinical benefit 8 months, time to progression 7 months. At a median follow-up of 10 months, 79.4% patients were alive at 1 year. No neutropenic complication was observed. Non-hematological toxicities were mild. One patient previously treated with an anthracycline developed a transient decrease (26%) in the left ventricular ejection fraction, with cardiac function recovering within 6 months.
  
  
  CONCLUSIONS
  Because of the non-overlapping toxicity profiles of both PLD and gemcitabine, this combination can be regarded as a reliable therapeutic option for patients who have failed previous treatments, including anthracycline, for MBC.
authors.affiliation: Division of Medical Oncology "A", Regina Elena Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy. alessandra.fabi@virgilio.it
authors.forename: Alessandra
authors.initials: A
authors.lastname: Fabi
authors.forename: Gianluigi
authors.initials: G
authors.lastname: Ferretti
authors.forename: Paola
authors.initials: P
authors.lastname: Papaldo
authors.forename: Nello
authors.initials: N
authors.lastname: Salesi
authors.forename: Mariangela
authors.initials: M
authors.lastname: Ciccarese
authors.forename: Vito
authors.initials: V
authors.lastname: Lorusso
authors.forename: Paolo
authors.initials: P
authors.lastname: Carlini
authors.forename: Armando
authors.initials: A
authors.lastname: Carpino
authors.forename: Marcella
authors.initials: M
authors.lastname: Mottolese
authors.forename: Anna Maria
authors.initials: AM
authors.lastname: Cianciulli
authors.forename: Diana
authors.initials: D
authors.lastname: Giannarelli
authors.forename: Isabella
authors.initials: I
authors.lastname: Sperduti
authors.forename: Alessandra
authors.initials: A
authors.lastname: Felici
authors.forename: Francesco
authors.initials: F
authors.lastname: Cognetti
mesh_terms: D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018450:Disease Progression; D004317:Doxorubicin / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage; D011788:Quality of Life; D015996:Survival Rate; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D018943:Anthracyclines; C506643:liposomal doxorubicin; D003841:Deoxycytidine; D011092:Polyethylene Glycols; D004317:Doxorubicin; D000093542:Gemcitabine