Trastuzumab Retreatment after Relapse on Adjuvant Trastuzumab Therapy for Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: Final Results of the Retreatment after Herceptin Adjuvant Trial |
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| Affiliation: | 1. National Institute of Oncology, Budapest, Hungary;2. Andrew Love Cancer Centre, Geelong Hospital, Geelong, Victoria, Australia;3. Cancer Institute and Hospital, CAMS, Beijing, China;4. National Oncology Institute, Panama, Republic of Panama;5. N. N. Petrov Research Institute of Oncology, St Petersburg, Russia;7. F. Hoffmann-La Roche Ltd, Basel, Switzerland;11. R. S. McLaughlin Durham Regional Cancer Centre, Oshawa, Ontario, Canada;1. University Medical Center Mannheim of Heidelberg University, Mannheim, Germany;2. La Maddalena Clinic for Cancer, University of Palermo, Palermo, Italy;3. Medizinische Universitaetsklinik und Poliklinik, Tuebingen, Germany;4. Hospital del Mar, Barcelona, Spain;5. Hospital Universitari Arnau de Vilanova, Lleida, Spain;6. Athens School of Medicine, Athens, Greece;7. Jeroen Bosch Ziekenhuis, ’s-Hertogenbosch, The Netherlands;8. Lilly Deutschland GmbH, Bad Homburg, Germany;9. Eli Lilly and Company, Copenhagen, Denmark;10. Eli Lilly France, Suresnes, France;11. Eli Lilly and Company, Indianapolis, USA;12. Eli Lilly Oncology, Houten, The Netherlands;13. Krankenhaus Martha-Maria Halle-Doelau, Halle, Germany;1. Oncology Center, Hospital Sírio-Libanês, Rua Dona Adma Jafet, 91, 01308-050, São Paulo, SP, Brazil;2. Nuclear Medicine Center, Hospital Sírio-Libanês, Rua Dona Adma Jafet, 91, 01308-050, São Paulo, SP, Brazil;1. Fred Hutchinson Cancer Research Center, Seattle, WA, USA;2. Roswell Park Cancer Institute, Buffalo, NY, USA;3. Hospices Civils de Lyon, Université Lyon-1, Pierre Bénite, France;4. Jewish General Hospital, Montreal, QC, Canada;5. BC Cancer Agency, Centre for Lymphoid Cancer, Vancouver, BC, Canada;6. Sarah Cannon Research Institute and Tennessee Oncology, Nashville, TN, USA;7. Sarah Cannon Research Institute and Florida Cancer Specialists, Sarasota, FL, USA;8. Cross Cancer Institute, Edmonton, AB, Canada;9. Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands;10. Stanford Cancer Center, Stanford, CA, USA;11. Hematology, Centre Henri Becquerel, Université de Rouen, Rouen, France;12. Hematology, CHU Dijon, Dijon, France;13. Genentech, South San Francisco, CA, USA;14. Hematology, Hôpital Claude Huriez, Unité GRITA, Université de Lille, Lille Cedex, France;1. Hospital Universitario Gregorio Marañón, Universidad Complutense, Calle de Maiquez 7, 28009 Madrid, Spain;2. Centre Oscar Lambret, 3 Rue Frédéric Combemale, 59000 Lille, France;3. University of Texas Southwestern Medical Center, 5303 Harry Hines Boulevard, Dallas, TX, USA;4. The Cancer Institute Hospital of JFCR, 3-8-31 Ariake, Koto ward, Tokyo, Japan;5. National Cancer Center, 323 Ilsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do 410-769, Republic of Korea;6. National Institute of Oncology, H-1122 Budapest Ráth György u. 7-9, Budapest, Hungary;7. Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul 138-736, Republic of Korea;8. Novartis Pharma S.A.S. Oncology Global Development, 14 Boulevard Richelieu, F-92500 Rueil-Malmaison, France;9. Pfizer Inc., 35 CambridgePark Drive, Cambridge, MA, USA;10. Bristol-Meyers Squibb Oncology, 100 Nassau Park Blvd, Princeton, NJ, USA;11. Jules Bordet Institute, Université Libre de Bruxelles, 121 bd de Waterloo, 1000 Brussels, Belgium;1. Department of Medicine, Division of Oncology, Washington University School of Medicine in St. Louis, St. Louis, MO;2. Department of Medicine, University of Michigan, Ann Arbor, MI;3. Luxembourg Centre for Systems Biomedicine (LCSB), Université du Luxembourg and Internal Medicine II, Saarland University Medical Center at Homburg/Saar, Germany;4. Department of Medicine, Division of Oncology, Vanderbilt University, Nashville, TN;5. Developmental Therapeutics, Siteman Cancer Center, Washington University School of Medicine in St. Louis, St. Louis, MO;6. Department of Pathology and Immunology, Division of Laboratory and Genomic Medicine, Washington University School of Medicine in St. Louis, St. Louis, MO |
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| Abstract: | AimsTrastuzumab, in combination with chemotherapy, is the standard of care for patients with early and metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer. The Retreatment after HErceptin Adjuvant trial assessed the efficacy and safety of trastuzumab plus a taxane as first-line treatment for patients with metastatic breast cancer (MBC) who had relapsed after adjuvant trastuzumab for HER2-positive early breast cancer.Materials and methodsIn total, 43 patients with HER2-positive MBC who had received previous adjuvant trastuzumab for ≥10 months, with a relapse-free interval of ≥6 months after the last adjuvant trastuzumab dose, were recruited. Eligible patients (n = 41) were assigned to receive trastuzumab, either weekly or every 3 weeks, in combination with docetaxel or paclitaxel until disease progression.ResultsAt the final analysis, with a median follow-up time of 40 months, a positive response was observed in 25/41 patients (61%; 95% confidence interval: 48.7–80.4%), stable disease in 7/41 (17.1%) and progressive disease in 6/41 (14.6%). Three patients had missing response assessments (one had no measurable lesions at baseline and two had no post-baseline tumour assessments). The median progression-free survival (PFS) was 8.0 months (95% confidence interval: 6–11 months) and the median overall survival was 25.0 months (16–33 months). No correlation was found between response rate, PFS or overall survival and the duration of adjuvant trastuzumab treatment, trastuzumab-free interval, relapse-free interval, hormone receptor status or type of pre-metastatic treatment. The most common adverse events (all grades) were alopecia (32%) and diarrhoea (32%). Six patients (14.6%) developed at least one serious adverse event. No congestive heart failure or any unexpected adverse events were reported.ConclusionTrastuzumab, in combination with a taxane, is an effective and well-tolerated first-line treatment for MBC in patients who relapse after trastuzumab-based adjuvant therapy. |
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| Keywords: | HER2-positive metastatic breast cancer retreatment taxane trastuzumab |
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