title: Lapatinib-plus-pegylated liposomal doxorubicin in advanced HER2-positive breast cancer following trastuzumab: a phase II trial.
abstract: BACKGROUND
  Trastuzumab, one important treatment option for HER2-positive metastatic breast cancer (MBC) is limited by its cardiotoxic potential. Lapatinib and pegylated liposomal doxorubicin (PLD) represent a cardiosparing alternative that can cross the blood brain barrier. This is important, because one third of breast cancer patients develop brain metastases.
  
  
  METHODS
  We included 24 patients with HER2-positive MBC progressing under trastuzumab. They received 1,250 mg lapatinib daily until progression plus PLD (40 mg/m(2)) every 4 weeks for maximal 6 cycles. The primary end-point was the overall response rate (ORR). Secondary end-points were progression-free survival (PFS), overall survival (OS), 1-year PFS and 1-year OS rates.
  
  
  RESULTS
  ORR was 54%. Median PFS was 5.8 and median OS 23.3 months. The one-year PFS rate was 27% and 1-year OS rate 76%.
  
  
  CONCLUSIONS
  Lapatinib-plus-PLD is active and safe in HER2-positive MBC, especially suitable for patients with cardiological risk or brain metastases.
authors.affiliation: 3rd Medical Department with Haematology, Medical Oncology, Hemostaseology, Infectious Diseases, Rheumatology, Oncologic Centre, Salzburg Cancer Research Institute (SCRI) with the Laboratory of Immunological and Molecular Cancer Research (SCRI-LIMCR) and the Center for Clinical Cancer and Immunology Trials (SCRI-CCCIT), Paracelsus Medical University Salzburg, Salzburg, Austria.
authors.forename: Magdalena
authors.initials: M
authors.lastname: Pircher
authors.affiliation: 3rd Medical Department with Haematology, Medical Oncology, Hemostaseology, Infectious Diseases, Rheumatology, Oncologic Centre, Salzburg Cancer Research Institute (SCRI) with the Laboratory of Immunological and Molecular Cancer Research (SCRI-LIMCR) and the Center for Clinical Cancer and Immunology Trials (SCRI-CCCIT), Paracelsus Medical University Salzburg, Salzburg, Austria.
authors.forename: Brigitte
authors.initials: B
authors.lastname: Mlineritsch
authors.affiliation: 3rd Medical Department with Haematology and Medical Oncology, General Hospital Linz, Linz, Austria.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Fridrik
authors.affiliation: Ludwig Boltzmann Institute for Applied Cancer Research (LBI-ACR VIEnna)-LB-CTO and ACR-ITR VIEnna, Vienna, Austria.
authors.forename: Christian
authors.initials: C
authors.lastname: Dittrich
authors.affiliation: Medical Department E with Oncology, General Hospital Rankweil, Rankweil, Austria.
authors.forename: Alois
authors.initials: A
authors.lastname: Lang
authors.affiliation: Department of Gynaecology, Medical University Graz, Graz, Austria.
authors.forename: Edgar
authors.initials: E
authors.lastname: Petru
authors.affiliation: Ist Medical Department, General Hospital Elisabethinen Linz, Linz, Austria.
authors.forename: Ansgar
authors.initials: A
authors.lastname: Weltermann
authors.affiliation: 4th Medical Department, Hospital Wels-Grieskirchen, Grieskirchen, Austria.
authors.forename: Josef
authors.initials: J
authors.lastname: Thaler
authors.affiliation: 3rd Medical Department with Haematology, Medical Oncology, Hemostaseology, Infectious Diseases, Rheumatology, Oncologic Centre, Salzburg Cancer Research Institute (SCRI) with the Laboratory of Immunological and Molecular Cancer Research (SCRI-LIMCR) and the Center for Clinical Cancer and Immunology Trials (SCRI-CCCIT), Paracelsus Medical University Salzburg, Salzburg, Austria.
authors.forename: Clemens
authors.initials: C
authors.lastname: Hufnagl
authors.affiliation: 3rd Medical Department with Haematology, Medical Oncology, Hemostaseology, Infectious Diseases, Rheumatology, Oncologic Centre, Salzburg Cancer Research Institute (SCRI) with the Laboratory of Immunological and Molecular Cancer Research (SCRI-LIMCR) and the Center for Clinical Cancer and Immunology Trials (SCRI-CCCIT), Paracelsus Medical University Salzburg, Salzburg, Austria.
authors.forename: Simon Peter
authors.initials: SP
authors.lastname: Gampenrieder
authors.affiliation: 3rd Medical Department with Haematology, Medical Oncology, Hemostaseology, Infectious Diseases, Rheumatology, Oncologic Centre, Salzburg Cancer Research Institute (SCRI) with the Laboratory of Immunological and Molecular Cancer Research (SCRI-LIMCR) and the Center for Clinical Cancer and Immunology Trials (SCRI-CCCIT), Paracelsus Medical University Salzburg, Salzburg, Austria.
authors.forename: Gabriel
authors.initials: G
authors.lastname: Rinnerthaler
authors.affiliation: 3rd Medical Department with Haematology, Medical Oncology, Hemostaseology, Infectious Diseases, Rheumatology, Oncologic Centre, Salzburg Cancer Research Institute (SCRI) with the Laboratory of Immunological and Molecular Cancer Research (SCRI-LIMCR) and the Center for Clinical Cancer and Immunology Trials (SCRI-CCCIT), Paracelsus Medical University Salzburg, Salzburg, Austria.
authors.forename: Sigrun
authors.initials: S
authors.lastname: Ressler
authors.affiliation: Department of Medical Statistics and Informatics Medical University Innsbruck, Innsbruck, Austria.
authors.forename: Hanno
authors.initials: H
authors.lastname: Ulmer
authors.affiliation: 3rd Medical Department with Haematology, Medical Oncology, Hemostaseology, Infectious Diseases, Rheumatology, Oncologic Centre, Salzburg Cancer Research Institute (SCRI) with the Laboratory of Immunological and Molecular Cancer Research (SCRI-LIMCR) and the Center for Clinical Cancer and Immunology Trials (SCRI-CCCIT), Paracelsus Medical University Salzburg, Salzburg, Austria r.greil@salk.at.
authors.forename: Richard
authors.initials: R
authors.lastname: Greil
mesh_terms: D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000494:pharmacology; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000401:mortality / Q000556:secondary; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000401:mortality / Q000473:pathology; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage / Q000031:analogs & derivatives; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D000077341:Lapatinib; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage; D011799:Quinazolines / Q000008:administration & dosage; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism*; D000068878:Trastuzumab; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D004317:Doxorubicin; D000077341:Lapatinib; D011092:Polyethylene Glycols; D011799:Quinazolines; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab; C506643:liposomal doxorubicin; C508053:ERBB2 protein, human
keywords: Her2-positive; Metastatic breast cancer; lapatinib; pegylated liposomal doxorubicin