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Trastuzumab-associated cardiac events at 8 years of median follow-up in the Herceptin Adjuvant trial (BIG 1-01).
Journal article

Trastuzumab-associated cardiac events at 8 years of median follow-up in the Herceptin Adjuvant trial (BIG 1-01).

  • de Azambuja E Evandro de Azambuja and Martine J. Piccart-Genhart, Institut Jules Bordet; Evandro de Azambuja, Breast European Adjuvant Study Team; Martine J. Piccart-Gebhart, Université Libre de Bruxelles, Brussels, Belgium; Marion J. Procter and Dominique Agbor-Tarh, Frontier Science Scotland, Kincraig, Kingussie; David A. Cameron, University of Edinburgh and Western General Hospital, Edinburgh; Ian E. Smith, Royal Marsden Hospital and the Institute of Cancer Research; Mitch Dowsett, the Royal Marsden National Health Service Trust, London, United Kingdom; Dirk J. van Veldhuisen, University of Groningen, Groningen, the Netherlands; Otto Metzger-Filho and Richard D. Gelber, Dana-Farber Cancer Institute, Boston, MA; Jutta Steinseifer, F. Hoffmann-La Roche, Basel; Thomas M. Suter, Swiss Cardiovascular Center, Inselspital, Bern University Hospital, Bern, Switzerland; Michael Untch, HELIOS Klinikum Berlin, Buch; Christian Jackisch, Klinikum Offenbach, Offenbach, Germany; Luca Gianni, San Raffaele Institute, Milan, Italy; Jose Baselga, Memorial Sloan Kettering Cancer Center, New York, NY; Richard Bell, Andrew Love Cancer Centre, Geelong Hospital, Geelong, Australia; and Brian Leyland-Jones, Edith Sanford Breast Cancer Research Institute, Sioux Falls, SD. evandro.azambuja@bordet.be.
  • Procter MJ Evandro de Azambuja and Martine J. Piccart-Genhart, Institut Jules Bordet; Evandro de Azambuja, Breast European Adjuvant Study Team; Martine J. Piccart-Gebhart, Université Libre de Bruxelles, Brussels, Belgium; Marion J. Procter and Dominique Agbor-Tarh, Frontier Science Scotland, Kincraig, Kingussie; David A. Cameron, University of Edinburgh and Western General Hospital, Edinburgh; Ian E. Smith, Royal Marsden Hospital and the Institute of Cancer Research; Mitch Dowsett, the Royal Marsden National Health Service Trust, London, United Kingdom; Dirk J. van Veldhuisen, University of Groningen, Groningen, the Netherlands; Otto Metzger-Filho and Richard D. Gelber, Dana-Farber Cancer Institute, Boston, MA; Jutta Steinseifer, F. Hoffmann-La Roche, Basel; Thomas M. Suter, Swiss Cardiovascular Center, Inselspital, Bern University Hospital, Bern, Switzerland; Michael Untch, HELIOS Klinikum Berlin, Buch; Christian Jackisch, Klinikum Offenbach, Offenbach, Germany; Luca Gianni, San Raffaele Institute, Milan, Italy; Jose Baselga, Memorial Sloan Kettering Cancer Center, New York, NY; Richard Bell, Andrew Love Cancer Centre, Geelong Hospital, Geelong, Australia; and Brian Leyland-Jones, Edith Sanford Breast Cancer Research Institute, Sioux Falls, SD.
  • van Veldhuisen DJ Evandro de Azambuja and Martine J. Piccart-Genhart, Institut Jules Bordet; Evandro de Azambuja, Breast European Adjuvant Study Team; Martine J. Piccart-Gebhart, Université Libre de Bruxelles, Brussels, Belgium; Marion J. Procter and Dominique Agbor-Tarh, Frontier Science Scotland, Kincraig, Kingussie; David A. Cameron, University of Edinburgh and Western General Hospital, Edinburgh; Ian E. Smith, Royal Marsden Hospital and the Institute of Cancer Research; Mitch Dowsett, the Royal Marsden National Health Service Trust, London, United Kingdom; Dirk J. van Veldhuisen, University of Groningen, Groningen, the Netherlands; Otto Metzger-Filho and Richard D. Gelber, Dana-Farber Cancer Institute, Boston, MA; Jutta Steinseifer, F. Hoffmann-La Roche, Basel; Thomas M. Suter, Swiss Cardiovascular Center, Inselspital, Bern University Hospital, Bern, Switzerland; Michael Untch, HELIOS Klinikum Berlin, Buch; Christian Jackisch, Klinikum Offenbach, Offenbach, Germany; Luca Gianni, San Raffaele Institute, Milan, Italy; Jose Baselga, Memorial Sloan Kettering Cancer Center, New York, NY; Richard Bell, Andrew Love Cancer Centre, Geelong Hospital, Geelong, Australia; and Brian Leyland-Jones, Edith Sanford Breast Cancer Research Institute, Sioux Falls, SD.
  • Agbor-Tarh D Evandro de Azambuja and Martine J. Piccart-Genhart, Institut Jules Bordet; Evandro de Azambuja, Breast European Adjuvant Study Team; Martine J. Piccart-Gebhart, Université Libre de Bruxelles, Brussels, Belgium; Marion J. Procter and Dominique Agbor-Tarh, Frontier Science Scotland, Kincraig, Kingussie; David A. Cameron, University of Edinburgh and Western General Hospital, Edinburgh; Ian E. Smith, Royal Marsden Hospital and the Institute of Cancer Research; Mitch Dowsett, the Royal Marsden National Health Service Trust, London, United Kingdom; Dirk J. van Veldhuisen, University of Groningen, Groningen, the Netherlands; Otto Metzger-Filho and Richard D. Gelber, Dana-Farber Cancer Institute, Boston, MA; Jutta Steinseifer, F. Hoffmann-La Roche, Basel; Thomas M. Suter, Swiss Cardiovascular Center, Inselspital, Bern University Hospital, Bern, Switzerland; Michael Untch, HELIOS Klinikum Berlin, Buch; Christian Jackisch, Klinikum Offenbach, Offenbach, Germany; Luca Gianni, San Raffaele Institute, Milan, Italy; Jose Baselga, Memorial Sloan Kettering Cancer Center, New York, NY; Richard Bell, Andrew Love Cancer Centre, Geelong Hospital, Geelong, Australia; and Brian Leyland-Jones, Edith Sanford Breast Cancer Research Institute, Sioux Falls, SD.
  • Metzger-Filho O Evandro de Azambuja and Martine J. Piccart-Genhart, Institut Jules Bordet; Evandro de Azambuja, Breast European Adjuvant Study Team; Martine J. Piccart-Gebhart, Université Libre de Bruxelles, Brussels, Belgium; Marion J. Procter and Dominique Agbor-Tarh, Frontier Science Scotland, Kincraig, Kingussie; David A. Cameron, University of Edinburgh and Western General Hospital, Edinburgh; Ian E. Smith, Royal Marsden Hospital and the Institute of Cancer Research; Mitch Dowsett, the Royal Marsden National Health Service Trust, London, United Kingdom; Dirk J. van Veldhuisen, University of Groningen, Groningen, the Netherlands; Otto Metzger-Filho and Richard D. Gelber, Dana-Farber Cancer Institute, Boston, MA; Jutta Steinseifer, F. Hoffmann-La Roche, Basel; Thomas M. Suter, Swiss Cardiovascular Center, Inselspital, Bern University Hospital, Bern, Switzerland; Michael Untch, HELIOS Klinikum Berlin, Buch; Christian Jackisch, Klinikum Offenbach, Offenbach, Germany; Luca Gianni, San Raffaele Institute, Milan, Italy; Jose Baselga, Memorial Sloan Kettering Cancer Center, New York, NY; Richard Bell, Andrew Love Cancer Centre, Geelong Hospital, Geelong, Australia; and Brian Leyland-Jones, Edith Sanford Breast Cancer Research Institute, Sioux Falls, SD.
  • Steinseifer J Evandro de Azambuja and Martine J. Piccart-Genhart, Institut Jules Bordet; Evandro de Azambuja, Breast European Adjuvant Study Team; Martine J. Piccart-Gebhart, Université Libre de Bruxelles, Brussels, Belgium; Marion J. Procter and Dominique Agbor-Tarh, Frontier Science Scotland, Kincraig, Kingussie; David A. Cameron, University of Edinburgh and Western General Hospital, Edinburgh; Ian E. Smith, Royal Marsden Hospital and the Institute of Cancer Research; Mitch Dowsett, the Royal Marsden National Health Service Trust, London, United Kingdom; Dirk J. van Veldhuisen, University of Groningen, Groningen, the Netherlands; Otto Metzger-Filho and Richard D. Gelber, Dana-Farber Cancer Institute, Boston, MA; Jutta Steinseifer, F. Hoffmann-La Roche, Basel; Thomas M. Suter, Swiss Cardiovascular Center, Inselspital, Bern University Hospital, Bern, Switzerland; Michael Untch, HELIOS Klinikum Berlin, Buch; Christian Jackisch, Klinikum Offenbach, Offenbach, Germany; Luca Gianni, San Raffaele Institute, Milan, Italy; Jose Baselga, Memorial Sloan Kettering Cancer Center, New York, NY; Richard Bell, Andrew Love Cancer Centre, Geelong Hospital, Geelong, Australia; and Brian Leyland-Jones, Edith Sanford Breast Cancer Research Institute, Sioux Falls, SD.
  • Untch M Evandro de Azambuja and Martine J. Piccart-Genhart, Institut Jules Bordet; Evandro de Azambuja, Breast European Adjuvant Study Team; Martine J. Piccart-Gebhart, Université Libre de Bruxelles, Brussels, Belgium; Marion J. Procter and Dominique Agbor-Tarh, Frontier Science Scotland, Kincraig, Kingussie; David A. Cameron, University of Edinburgh and Western General Hospital, Edinburgh; Ian E. Smith, Royal Marsden Hospital and the Institute of Cancer Research; Mitch Dowsett, the Royal Marsden National Health Service Trust, London, United Kingdom; Dirk J. van Veldhuisen, University of Groningen, Groningen, the Netherlands; Otto Metzger-Filho and Richard D. Gelber, Dana-Farber Cancer Institute, Boston, MA; Jutta Steinseifer, F. Hoffmann-La Roche, Basel; Thomas M. Suter, Swiss Cardiovascular Center, Inselspital, Bern University Hospital, Bern, Switzerland; Michael Untch, HELIOS Klinikum Berlin, Buch; Christian Jackisch, Klinikum Offenbach, Offenbach, Germany; Luca Gianni, San Raffaele Institute, Milan, Italy; Jose Baselga, Memorial Sloan Kettering Cancer Center, New York, NY; Richard Bell, Andrew Love Cancer Centre, Geelong Hospital, Geelong, Australia; and Brian Leyland-Jones, Edith Sanford Breast Cancer Research Institute, Sioux Falls, SD.
  • Smith IE Evandro de Azambuja and Martine J. Piccart-Genhart, Institut Jules Bordet; Evandro de Azambuja, Breast European Adjuvant Study Team; Martine J. Piccart-Gebhart, Université Libre de Bruxelles, Brussels, Belgium; Marion J. Procter and Dominique Agbor-Tarh, Frontier Science Scotland, Kincraig, Kingussie; David A. Cameron, University of Edinburgh and Western General Hospital, Edinburgh; Ian E. Smith, Royal Marsden Hospital and the Institute of Cancer Research; Mitch Dowsett, the Royal Marsden National Health Service Trust, London, United Kingdom; Dirk J. van Veldhuisen, University of Groningen, Groningen, the Netherlands; Otto Metzger-Filho and Richard D. Gelber, Dana-Farber Cancer Institute, Boston, MA; Jutta Steinseifer, F. Hoffmann-La Roche, Basel; Thomas M. Suter, Swiss Cardiovascular Center, Inselspital, Bern University Hospital, Bern, Switzerland; Michael Untch, HELIOS Klinikum Berlin, Buch; Christian Jackisch, Klinikum Offenbach, Offenbach, Germany; Luca Gianni, San Raffaele Institute, Milan, Italy; Jose Baselga, Memorial Sloan Kettering Cancer Center, New York, NY; Richard Bell, Andrew Love Cancer Centre, Geelong Hospital, Geelong, Australia; and Brian Leyland-Jones, Edith Sanford Breast Cancer Research Institute, Sioux Falls, SD.
  • Gianni L Evandro de Azambuja and Martine J. Piccart-Genhart, Institut Jules Bordet; Evandro de Azambuja, Breast European Adjuvant Study Team; Martine J. Piccart-Gebhart, Université Libre de Bruxelles, Brussels, Belgium; Marion J. Procter and Dominique Agbor-Tarh, Frontier Science Scotland, Kincraig, Kingussie; David A. Cameron, University of Edinburgh and Western General Hospital, Edinburgh; Ian E. Smith, Royal Marsden Hospital and the Institute of Cancer Research; Mitch Dowsett, the Royal Marsden National Health Service Trust, London, United Kingdom; Dirk J. van Veldhuisen, University of Groningen, Groningen, the Netherlands; Otto Metzger-Filho and Richard D. Gelber, Dana-Farber Cancer Institute, Boston, MA; Jutta Steinseifer, F. Hoffmann-La Roche, Basel; Thomas M. Suter, Swiss Cardiovascular Center, Inselspital, Bern University Hospital, Bern, Switzerland; Michael Untch, HELIOS Klinikum Berlin, Buch; Christian Jackisch, Klinikum Offenbach, Offenbach, Germany; Luca Gianni, San Raffaele Institute, Milan, Italy; Jose Baselga, Memorial Sloan Kettering Cancer Center, New York, NY; Richard Bell, Andrew Love Cancer Centre, Geelong Hospital, Geelong, Australia; and Brian Leyland-Jones, Edith Sanford Breast Cancer Research Institute, Sioux Falls, SD.
  • Baselga J Evandro de Azambuja and Martine J. Piccart-Genhart, Institut Jules Bordet; Evandro de Azambuja, Breast European Adjuvant Study Team; Martine J. Piccart-Gebhart, Université Libre de Bruxelles, Brussels, Belgium; Marion J. Procter and Dominique Agbor-Tarh, Frontier Science Scotland, Kincraig, Kingussie; David A. Cameron, University of Edinburgh and Western General Hospital, Edinburgh; Ian E. Smith, Royal Marsden Hospital and the Institute of Cancer Research; Mitch Dowsett, the Royal Marsden National Health Service Trust, London, United Kingdom; Dirk J. van Veldhuisen, University of Groningen, Groningen, the Netherlands; Otto Metzger-Filho and Richard D. Gelber, Dana-Farber Cancer Institute, Boston, MA; Jutta Steinseifer, F. Hoffmann-La Roche, Basel; Thomas M. Suter, Swiss Cardiovascular Center, Inselspital, Bern University Hospital, Bern, Switzerland; Michael Untch, HELIOS Klinikum Berlin, Buch; Christian Jackisch, Klinikum Offenbach, Offenbach, Germany; Luca Gianni, San Raffaele Institute, Milan, Italy; Jose Baselga, Memorial Sloan Kettering Cancer Center, New York, NY; Richard Bell, Andrew Love Cancer Centre, Geelong Hospital, Geelong, Australia; and Brian Leyland-Jones, Edith Sanford Breast Cancer Research Institute, Sioux Falls, SD.
  • Jackisch C Evandro de Azambuja and Martine J. Piccart-Genhart, Institut Jules Bordet; Evandro de Azambuja, Breast European Adjuvant Study Team; Martine J. Piccart-Gebhart, Université Libre de Bruxelles, Brussels, Belgium; Marion J. Procter and Dominique Agbor-Tarh, Frontier Science Scotland, Kincraig, Kingussie; David A. Cameron, University of Edinburgh and Western General Hospital, Edinburgh; Ian E. Smith, Royal Marsden Hospital and the Institute of Cancer Research; Mitch Dowsett, the Royal Marsden National Health Service Trust, London, United Kingdom; Dirk J. van Veldhuisen, University of Groningen, Groningen, the Netherlands; Otto Metzger-Filho and Richard D. Gelber, Dana-Farber Cancer Institute, Boston, MA; Jutta Steinseifer, F. Hoffmann-La Roche, Basel; Thomas M. Suter, Swiss Cardiovascular Center, Inselspital, Bern University Hospital, Bern, Switzerland; Michael Untch, HELIOS Klinikum Berlin, Buch; Christian Jackisch, Klinikum Offenbach, Offenbach, Germany; Luca Gianni, San Raffaele Institute, Milan, Italy; Jose Baselga, Memorial Sloan Kettering Cancer Center, New York, NY; Richard Bell, Andrew Love Cancer Centre, Geelong Hospital, Geelong, Australia; and Brian Leyland-Jones, Edith Sanford Breast Cancer Research Institute, Sioux Falls, SD.
  • Cameron DA Evandro de Azambuja and Martine J. Piccart-Genhart, Institut Jules Bordet; Evandro de Azambuja, Breast European Adjuvant Study Team; Martine J. Piccart-Gebhart, Université Libre de Bruxelles, Brussels, Belgium; Marion J. Procter and Dominique Agbor-Tarh, Frontier Science Scotland, Kincraig, Kingussie; David A. Cameron, University of Edinburgh and Western General Hospital, Edinburgh; Ian E. Smith, Royal Marsden Hospital and the Institute of Cancer Research; Mitch Dowsett, the Royal Marsden National Health Service Trust, London, United Kingdom; Dirk J. van Veldhuisen, University of Groningen, Groningen, the Netherlands; Otto Metzger-Filho and Richard D. Gelber, Dana-Farber Cancer Institute, Boston, MA; Jutta Steinseifer, F. Hoffmann-La Roche, Basel; Thomas M. Suter, Swiss Cardiovascular Center, Inselspital, Bern University Hospital, Bern, Switzerland; Michael Untch, HELIOS Klinikum Berlin, Buch; Christian Jackisch, Klinikum Offenbach, Offenbach, Germany; Luca Gianni, San Raffaele Institute, Milan, Italy; Jose Baselga, Memorial Sloan Kettering Cancer Center, New York, NY; Richard Bell, Andrew Love Cancer Centre, Geelong Hospital, Geelong, Australia; and Brian Leyland-Jones, Edith Sanford Breast Cancer Research Institute, Sioux Falls, SD.
  • Bell R Evandro de Azambuja and Martine J. Piccart-Genhart, Institut Jules Bordet; Evandro de Azambuja, Breast European Adjuvant Study Team; Martine J. Piccart-Gebhart, Université Libre de Bruxelles, Brussels, Belgium; Marion J. Procter and Dominique Agbor-Tarh, Frontier Science Scotland, Kincraig, Kingussie; David A. Cameron, University of Edinburgh and Western General Hospital, Edinburgh; Ian E. Smith, Royal Marsden Hospital and the Institute of Cancer Research; Mitch Dowsett, the Royal Marsden National Health Service Trust, London, United Kingdom; Dirk J. van Veldhuisen, University of Groningen, Groningen, the Netherlands; Otto Metzger-Filho and Richard D. Gelber, Dana-Farber Cancer Institute, Boston, MA; Jutta Steinseifer, F. Hoffmann-La Roche, Basel; Thomas M. Suter, Swiss Cardiovascular Center, Inselspital, Bern University Hospital, Bern, Switzerland; Michael Untch, HELIOS Klinikum Berlin, Buch; Christian Jackisch, Klinikum Offenbach, Offenbach, Germany; Luca Gianni, San Raffaele Institute, Milan, Italy; Jose Baselga, Memorial Sloan Kettering Cancer Center, New York, NY; Richard Bell, Andrew Love Cancer Centre, Geelong Hospital, Geelong, Australia; and Brian Leyland-Jones, Edith Sanford Breast Cancer Research Institute, Sioux Falls, SD.
  • Leyland-Jones B Evandro de Azambuja and Martine J. Piccart-Genhart, Institut Jules Bordet; Evandro de Azambuja, Breast European Adjuvant Study Team; Martine J. Piccart-Gebhart, Université Libre de Bruxelles, Brussels, Belgium; Marion J. Procter and Dominique Agbor-Tarh, Frontier Science Scotland, Kincraig, Kingussie; David A. Cameron, University of Edinburgh and Western General Hospital, Edinburgh; Ian E. Smith, Royal Marsden Hospital and the Institute of Cancer Research; Mitch Dowsett, the Royal Marsden National Health Service Trust, London, United Kingdom; Dirk J. van Veldhuisen, University of Groningen, Groningen, the Netherlands; Otto Metzger-Filho and Richard D. Gelber, Dana-Farber Cancer Institute, Boston, MA; Jutta Steinseifer, F. Hoffmann-La Roche, Basel; Thomas M. Suter, Swiss Cardiovascular Center, Inselspital, Bern University Hospital, Bern, Switzerland; Michael Untch, HELIOS Klinikum Berlin, Buch; Christian Jackisch, Klinikum Offenbach, Offenbach, Germany; Luca Gianni, San Raffaele Institute, Milan, Italy; Jose Baselga, Memorial Sloan Kettering Cancer Center, New York, NY; Richard Bell, Andrew Love Cancer Centre, Geelong Hospital, Geelong, Australia; and Brian Leyland-Jones, Edith Sanford Breast Cancer Research Institute, Sioux Falls, SD.
  • Dowsett M Evandro de Azambuja and Martine J. Piccart-Genhart, Institut Jules Bordet; Evandro de Azambuja, Breast European Adjuvant Study Team; Martine J. Piccart-Gebhart, Université Libre de Bruxelles, Brussels, Belgium; Marion J. Procter and Dominique Agbor-Tarh, Frontier Science Scotland, Kincraig, Kingussie; David A. Cameron, University of Edinburgh and Western General Hospital, Edinburgh; Ian E. Smith, Royal Marsden Hospital and the Institute of Cancer Research; Mitch Dowsett, the Royal Marsden National Health Service Trust, London, United Kingdom; Dirk J. van Veldhuisen, University of Groningen, Groningen, the Netherlands; Otto Metzger-Filho and Richard D. Gelber, Dana-Farber Cancer Institute, Boston, MA; Jutta Steinseifer, F. Hoffmann-La Roche, Basel; Thomas M. Suter, Swiss Cardiovascular Center, Inselspital, Bern University Hospital, Bern, Switzerland; Michael Untch, HELIOS Klinikum Berlin, Buch; Christian Jackisch, Klinikum Offenbach, Offenbach, Germany; Luca Gianni, San Raffaele Institute, Milan, Italy; Jose Baselga, Memorial Sloan Kettering Cancer Center, New York, NY; Richard Bell, Andrew Love Cancer Centre, Geelong Hospital, Geelong, Australia; and Brian Leyland-Jones, Edith Sanford Breast Cancer Research Institute, Sioux Falls, SD.
  • Gelber RD Evandro de Azambuja and Martine J. Piccart-Genhart, Institut Jules Bordet; Evandro de Azambuja, Breast European Adjuvant Study Team; Martine J. Piccart-Gebhart, Université Libre de Bruxelles, Brussels, Belgium; Marion J. Procter and Dominique Agbor-Tarh, Frontier Science Scotland, Kincraig, Kingussie; David A. Cameron, University of Edinburgh and Western General Hospital, Edinburgh; Ian E. Smith, Royal Marsden Hospital and the Institute of Cancer Research; Mitch Dowsett, the Royal Marsden National Health Service Trust, London, United Kingdom; Dirk J. van Veldhuisen, University of Groningen, Groningen, the Netherlands; Otto Metzger-Filho and Richard D. Gelber, Dana-Farber Cancer Institute, Boston, MA; Jutta Steinseifer, F. Hoffmann-La Roche, Basel; Thomas M. Suter, Swiss Cardiovascular Center, Inselspital, Bern University Hospital, Bern, Switzerland; Michael Untch, HELIOS Klinikum Berlin, Buch; Christian Jackisch, Klinikum Offenbach, Offenbach, Germany; Luca Gianni, San Raffaele Institute, Milan, Italy; Jose Baselga, Memorial Sloan Kettering Cancer Center, New York, NY; Richard Bell, Andrew Love Cancer Centre, Geelong Hospital, Geelong, Australia; and Brian Leyland-Jones, Edith Sanford Breast Cancer Research Institute, Sioux Falls, SD.
  • Piccart-Gebhart MJ Evandro de Azambuja and Martine J. Piccart-Genhart, Institut Jules Bordet; Evandro de Azambuja, Breast European Adjuvant Study Team; Martine J. Piccart-Gebhart, Université Libre de Bruxelles, Brussels, Belgium; Marion J. Procter and Dominique Agbor-Tarh, Frontier Science Scotland, Kincraig, Kingussie; David A. Cameron, University of Edinburgh and Western General Hospital, Edinburgh; Ian E. Smith, Royal Marsden Hospital and the Institute of Cancer Research; Mitch Dowsett, the Royal Marsden National Health Service Trust, London, United Kingdom; Dirk J. van Veldhuisen, University of Groningen, Groningen, the Netherlands; Otto Metzger-Filho and Richard D. Gelber, Dana-Farber Cancer Institute, Boston, MA; Jutta Steinseifer, F. Hoffmann-La Roche, Basel; Thomas M. Suter, Swiss Cardiovascular Center, Inselspital, Bern University Hospital, Bern, Switzerland; Michael Untch, HELIOS Klinikum Berlin, Buch; Christian Jackisch, Klinikum Offenbach, Offenbach, Germany; Luca Gianni, San Raffaele Institute, Milan, Italy; Jose Baselga, Memorial Sloan Kettering Cancer Center, New York, NY; Richard Bell, Andrew Love Cancer Centre, Geelong Hospital, Geelong, Australia; and Brian Leyland-Jones, Edith Sanford Breast Cancer Research Institute, Sioux Falls, SD.
  • Suter TM Evandro de Azambuja and Martine J. Piccart-Genhart, Institut Jules Bordet; Evandro de Azambuja, Breast European Adjuvant Study Team; Martine J. Piccart-Gebhart, Université Libre de Bruxelles, Brussels, Belgium; Marion J. Procter and Dominique Agbor-Tarh, Frontier Science Scotland, Kincraig, Kingussie; David A. Cameron, University of Edinburgh and Western General Hospital, Edinburgh; Ian E. Smith, Royal Marsden Hospital and the Institute of Cancer Research; Mitch Dowsett, the Royal Marsden National Health Service Trust, London, United Kingdom; Dirk J. van Veldhuisen, University of Groningen, Groningen, the Netherlands; Otto Metzger-Filho and Richard D. Gelber, Dana-Farber Cancer Institute, Boston, MA; Jutta Steinseifer, F. Hoffmann-La Roche, Basel; Thomas M. Suter, Swiss Cardiovascular Center, Inselspital, Bern University Hospital, Bern, Switzerland; Michael Untch, HELIOS Klinikum Berlin, Buch; Christian Jackisch, Klinikum Offenbach, Offenbach, Germany; Luca Gianni, San Raffaele Institute, Milan, Italy; Jose Baselga, Memorial Sloan Kettering Cancer Center, New York, NY; Richard Bell, Andrew Love Cancer Centre, Geelong Hospital, Geelong, Australia; and Brian Leyland-Jones, Edith Sanford Breast Cancer Research Institute, Sioux Falls, SD.
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  • 2014-06-11
Published in:
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology. - 2014
Adult
Aged
Antibodies, Monoclonal, Humanized
Antineoplastic Agents
Biomarkers, Tumor
Breast Neoplasms
Chemotherapy, Adjuvant
Drug Administration Schedule
Female
Follow-Up Studies
Heart Failure
Humans
Incidence
Logistic Models
Mastectomy, Segmental
Middle Aged
Neoplasm Staging
Radiotherapy, Adjuvant
Receptor, ErbB-2
Trastuzumab
Ventricular Function, Left
English PURPOSE
To document the rate and outcome of trastuzumab-associated cardiac dysfunction in patients following 1 or 2 years of adjuvant therapy.


PATIENTS AND METHODS
The Herceptin Adjuvant (HERA) trial is a three-arm, randomized trial comparing 2 years or 1 year of trastuzumab with observation in 5,102 patients with human epidermal growth factor receptor 2 (HER2) -positive early-stage breast cancer. Cardiac function was closely monitored. Eligible patients had left ventricular ejection fraction (LVEF) ≥ 55% at study entry following neoadjuvant chemotherapy with or without radiotherapy. This 8-year median follow-up analysis considered patients randomly assigned to 2 years or 1 year of trastuzumab or observation.


RESULTS
The as-treated safety population for 2 years of trastuzumab (n = 1,673), 1 year of trastuzumab (n = 1,682), and observation (n = 1,744) is reported. Cardiac adverse events leading to discontinuation of trastuzumab occurred in 9.4% of patients in the 2-year arm and 5.2% of patients in the 1-year arm. Cardiac death, severe congestive heart failure (CHF), and confirmed significant LVEF decrease remained low in all three arms. The incidence of severe CHF (0.8%, 0.8%, and 0.0%, respectively) and confirmed significant LVEF decrease (7.2%, 4.1%, and 0.9%, respectively) was significantly higher in the 2-year and 1-year trastuzumab arms compared with the observation arm. Severe CHF was the same for 2-year and 1-year trastuzumab. Of patients with confirmed LVEF decrease receiving 2-year trastuzumab, 87.5% reached acute recovery. Of patients with confirmed LVEF decrease receiving 1-year trastuzumab, 81.2% reached acute recovery.


CONCLUSION
Long-term assessment at 8-year median follow-up confirms the low incidence of cardiac events for trastuzumab given sequentially after chemotherapy and radiotherapy, and cardiac events were reversible in the vast majority of patients.
Language
  • English
Open access status
closed
Identifiers
Persistent URL
https://folia.unifr.ch/global/documents/71408
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