title: A randomized phase III study evaluating pegylated liposomal doxorubicin versus capecitabine as first-line therapy for metastatic breast cancer: results of the PELICAN study.
abstract: The PELICAN trial evaluates for the first time efficacy and safety of pegylated liposomal doxorubicin (PLD) versus capecitabine as first-line treatment of metastatic breast cancer (MBC).
  
  
  
  This randomized, phase III, open-label, multicenter trial enrolled first-line MBC patients who were ineligible for endocrine or trastuzumab therapy. Cumulative adjuvant anthracyclines of 360 mg/m2doxorubicin or equivalent were allowed. Left ventricular ejection fraction of >50 % was required. Patients received PLD 50 mg/m2every 28 days or capecitabine 1250 mg/m2twice daily for 14 days every 21 days. The primary endpoint was time-to-disease progression (TTP).
  
  
  
  210 patients were randomized (n = 105, PLD and n = 105, capecitabine). Adjuvant anthracyclines were given to 37 % (PLD) and 36 % (capecitabine) of patients. No significant difference was observed in TTP [HR = 1.21 (95 % confidence interval, 0.838-1.750)]. Median TTP was 6.0 months for both PLD and capecitabine. Comparing patients with or without prior anthracyclines, no significant difference in TTP was observed in the PLD arm (log-rank P = 0.64). For PLD versus capecitabine, respectively, overall survival (median, 23.3 months vs. 26.8 months) and time-to-treatment failure (median, 4.6 months vs. 3.7 months) were not statistically significantly different. Compared to PLD, patients on capecitabine experienced more serious adverse events (P = 0.015) and more cardiac events among patients who had prior anthracycline exposure (18 vs. 8 %; P = 0.31).
  
  
  
  Both PLD and capecitabine are effective first-line agents for MBC.
authors: Breast Center, Department of Obstetrics and Gynecology and CCC of LMU, University of Munich, Munich, Germany. nadia.harbeck@med.uni-muenchen.de.
authors: Nadia
authors: N
authors: Harbeck
authors: Department of Obstetrics and Gynecology, Technical University of Munich, Munich, Germany.
authors: Steffen
authors: S
authors: Saupe
authors: Oncology and Hematology, Krankenhaus Nordwest, Frankfurt, Germany.
authors: Elke
authors: E
authors: Jäger
authors: Department of Obstetrics and Gynecology, Johannes Gutenberg University, Mainz, Germany.
authors: Marcus
authors: M
authors: Schmidt
authors: Universitätsfrauenklinik, Ulm, Germany.
authors: Rolf
authors: R
authors: Kreienberg
authors: Onkologische Schwerpunktpraxis, Leer, Germany.
authors: Lothar
authors: L
authors: Müller
authors: Onkologische Praxis Oldenburg, Oldenburg, Germany.
authors: Burkhard Joerg
authors: BJ
authors: Otremba
authors: MSD Sharp & Dohme, Haar, Germany.
authors: Dirk
authors: D
authors: Waldenmaier
authors: Department of Obstetrics and Gynecology, Technical University of Munich, Munich, Germany.
authors: Julia
authors: J
authors: Dorn
authors: Brustzentrum, Krankenhaus Köln-Holweide, Cologne, Germany.
authors: Mathias
authors: M
authors: Warm
authors: Trium Analysis Online GmbH, Munich, Germany.
authors: Michael
authors: M
authors: Scholz
authors: Helios Klinikum Berlin-Buch, Berlin, Germany.
authors: Michael
authors: M
authors: Untch
authors: Vivantes Klinikum Neukoelln, Berlin, Germany.
authors: Maike
authors: M
authors: de Wit
authors: Dr.-Horst-Schmidt-Kliniken Wiesbaden, Wiesbaden, Germany.
authors: Jana
authors: J
authors: Barinoff
authors: Dr.-Horst-Schmidt-Kliniken Wiesbaden, Wiesbaden, Germany.
authors: Hans-Joachim
authors: HJ
authors: Lück
authors: Kliniken Essen-Mitte, Essen, Germany.
authors: Philipp
authors: P
authors: Harter
authors: Klinikum des Landkreises Deggendorf, Deggendorf, Germany.
authors: Doris
authors: D
authors: Augustin
authors: Crown Princess Mary Cancer Centre Westmead, Sydney, Australia.
authors: Paul
authors: P
authors: Harnett
authors: Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, University Hospital Erlangen, Erlangen, Germany.
authors: Matthias W
authors: MW
authors: Beckmann
authors: Oncology and Hematology, Krankenhaus Nordwest, Frankfurt, Germany.
authors: Salah-Eddin
authors: SE
authors: Al-Batran
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D000069287:Capecitabine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018450:Disease Progression; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D011788:Quality of Life; D012307:Risk Factors; D016019:Survival Analysis; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000964:Antimetabolites, Antineoplastic; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D000069287:Capecitabine; D004317:Doxorubicin
keywords: Capecitabine; Metastatic breast cancer; PELICAN; Pegylated liposomal doxorubicin