title: Pegylated liposomal doxorubicin plus carboplatin in patients with metastatic breast cancer: a phase II study.
abstract: BACKGROUND
  We determined the objective response rates produced by pegylated liposomal doxorubicin (PLD) plus carboplatin with/without trastuzumab (Herceptin).
  
  
  METHODS
  Patients with measurable disease were stratified by taxane treatment history and human epidermal growth factor receptor-2 status.
  
  
  METHODS
  PLD 30 mg/m(2) followed by carboplatin, day 1 of each 28-day cycle; human epidermal growth factor receptor-2 (HER2)-positive patients also received trastuzumab.
  
  
  RESULTS
  Arm 1 received PLD plus carboplatin (N = 41 arm 1a, taxane naive; N = 42 arm 1b, taxane pretreated); Arm 2 patients received PLD plus carboplatin + Herceptin (N = 46). Overall response rates: 31%, 31%, and 56%, respectively. Median overall survival durations were not reached in arm 1a and were 13 and 33 months for arms 1b and 2. Median progression-free survival: 8, 5, 10 months, respectively. Grades 3-4 treatment-related toxic effects for arms 1a, 1b, 2, respectively, were neutropenia 22%, 31%, 35%; thrombocytopenia 34%, 26%, 17%; and fatigue 2%, 14%, 13%.
  
  
  CONCLUSIONS
  PLD plus carboplatin has moderate antitumor activity and excellent tolerability. Herceptin and PLD plus carboplatin in HER2-positive patients have antitumor activity without significant cardiac toxicity. Toxicity results suggest that PLD can be combined with Herceptin with minimal cardiac toxicity.
authors.affiliation: US Oncology Research, McKesson Specialty Health, The Woodlands; New York Oncology Hematology Center, Albany. Electronic address: rufus.collea@usoncology.com.
authors.forename: R P
authors.initials: RP
authors.lastname: Collea
authors.affiliation: US Oncology Research, McKesson Specialty Health, The Woodlands; Alliance Hematology-Oncology PA, Westminster.
authors.forename: F W
authors.initials: FW
authors.lastname: Kruter
authors.affiliation: US Oncology Research, McKesson Specialty Health, The Woodlands; Birmingham Hematology-Oncology, Birmingham.
authors.forename: J E
authors.initials: JE
authors.lastname: Cantrell
authors.affiliation: US Oncology Research, McKesson Specialty Health, The Woodlands; Texas Oncology, Odessa.
authors.forename: T K
authors.initials: TK
authors.lastname: George
authors.affiliation: US Oncology Research, McKesson Specialty Health, The Woodlands; Virginia Oncology Associates, Hampton.
authors.forename: S
authors.initials: S
authors.lastname: Kruger
authors.affiliation: US Oncology Research, McKesson Specialty Health, The Woodlands; Northern Virginia Hematology-Oncology, Fairfax.
authors.forename: A M
authors.initials: AM
authors.lastname: Favret
authors.affiliation: US Oncology Research, McKesson Specialty Health, The Woodlands; Arizona Oncology, Sedona.
authors.forename: D L
authors.initials: DL
authors.lastname: Lindquist
authors.affiliation: US Oncology Research, McKesson Specialty Health, The Woodlands; Texas Oncology, Abilene.
authors.forename: A M
authors.initials: AM
authors.lastname: Melnyk
authors.affiliation: US Oncology Research, McKesson Specialty Health, The Woodlands; Kansas City Cancer Center, Kansas City.
authors.forename: R E
authors.initials: RE
authors.lastname: Pluenneke
authors.affiliation: US Oncology Research, McKesson Specialty Health, The Woodlands; Northwest Cancer Specialists, Portland.
authors.forename: S H
authors.initials: SH
authors.lastname: Shao
authors.affiliation: US Oncology Research, McKesson Specialty Health, The Woodlands.
authors.forename: M W
authors.initials: MW
authors.lastname: Crockett
authors.affiliation: US Oncology Research, McKesson Specialty Health, The Woodlands.
authors.forename: L
authors.initials: L
authors.lastname: Asmar
authors.affiliation: US Oncology Research, McKesson Specialty Health, The Woodlands; Texas Oncology, PA, Baylor-Charles A. Sammons Cancer Center, Dallas, USA.
authors.forename: J
authors.initials: J
authors.lastname: O'Shaughnessy
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016190:Carboplatin / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D009362:Neoplasm Metastasis; D011092:Polyethylene Glycols / Q000008:administration & dosage
chemical_list: C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin; D016190:Carboplatin