Efficacy and safety of subcutaneous trastuzumab and intravenous trastuzumab as part of adjuvant therapy for HER2-positive early breast cancer: Final analysis of the randomised,two-cohort PrefHer study |
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| Affiliation: | 1. University Hospital Jean Minjoz, INSERM 1098, Besançon, France;2. Tom Baker Cancer Centre, Department of Oncology, University of Calgary, AB, Canada;3. Sussex Health Outcomes Research & Education in Cancer (SHORE-C), Brighton and Sussex Medical School, University of Sussex, Falmer, UK;4. Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany;5. Department of Chemotherapy and Combined Therapy, N.N. Blokhin Cancer Research Center, Moscow, Russia;6. Investigación Clínica y Traslacional en Cáncer/Instituto de Investigaciones Biomédicas de Málaga (IBIMA)/Hospitales Universitarios Regional y Virgen de La Victoria de Málaga, Málaga, Spain;7. Global Product Development/Medical Affairs Oncology (PDMAO), F. Hoffmann-La Roche Ltd, Basel, Switzerland;8. PDMA Operations (Biometrics), F. Hoffmann-La Roche Ltd, Basel, Switzerland;9. Medical Oncology Department, APHP-Tenon, IUC-UPMC, Sorbonne University, Paris, France;1. EORTC-Headquarters, Medical Department, Brussels, Belgium;2. Acıbadem Üniversitesi İç Hastalıkları/Tıbbi Onkoloji, Turkey;3. EORTC-Headquarters, Statistical Department, Belgium;4. Institute Bergonie, Bordeaux, France;5. GZA Sint Augustinus, Antwerp, Belgium;6. Ctr Becquerel-Rouen, France;7. Radboudumc Nijmegen/Maastricht UMC+, Netherlands;8. ZNA Middelheim, Belgium;9. University Clinic Golnik, Slovenia;10. Institute Jules Bordet, Universite Libre de Bruxelles, Brussels, Belgium;11. NHS-Lothian, University of Edinburgh, Edinburgh, United Kingdom;1. Brustzentrum der Universität München and Comprehensive Cancer Center of the Ludwig-Maximilians-Universität München, Munich, Germany;2. National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan;3. Taiwan Breast Cancer Consortium, Taipei, Taiwan;4. University of California, Los Angeles, Los Angeles, CA, USA;5. Translational Research in Oncology, Los Angeles, CA, USA;6. Taichung Veterans General Hospital, Taichung, Taiwan;7. Fudan University Shanghai Cancer Center, Shanghai, China;8. Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea;9. Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea;10. Comprehensive Breast Health Center, Rui Jin Hospital, Shanghai, China;11. National Cancer Center, Goyang, South Korea;12. Medical University, Gdansk, Poland;13. Cancer Hospital of Harbin Medical University, Harbin, China;14. Samsung Medical Center, Seoul, South Korea;15. Comprehensive Cancer Centre, Medical University, Bialystok, Poland;p. Peking Union Medical College Hospital, Beijing, China;q. Chang Gung Memorial Hospital at Linkou, Chang Gung University College of Medicine, Taoyuan, Taiwan;r. Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany;s. Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China;t. Peking Union Medical College, Beijing, China;u. Institut Jules Bordet, Brussels, Belgium;1. IHE, The Swedish Institute for Health Economics, Box 2127, SE-220 20 Lund, Sweden;2. Department of Clinical Sciences, Lund University, Sweden;3. Department of Oncology, Skåne University Hospital, SE-221 85 Lund, Sweden;4. Karolinska Institutet, Department of Oncology-Pathology, Karolinska University Hospital Solna, Z1:00, SE-171 76 Stockholm, Sweden;1. Medical Oncology Dept, San Raffaele Scientific Institute, Via Olgettina, 60, 20132 Milan, Italy;2. Investigational and Clinical Oncology, Candiolo Cancer Institute, FPO-IRCCS, St. Prov. 142, 10060 Candiolo, Italy;3. Medical Oncology Dept., Azienda ULSS 12 "Veneziana", Ospedale Dell''Angelo, Via Paccagnella 11, 30174 Mestre-Venezia, Italy;4. SSD Medical Oncology Addari, Policlinico Sant''Orsola Malpighi, Via Pietro Albertoni, 15, 40138 Bologna, Italy;5. Medical Oncology Dept, AUSL Bologna-ISNB, Via Altura, 3, 40139 Bologna, Italy;6. IRCCS Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia, Viale Risorgimento, 80, 42123 Reggio Emilia, Italy;7. Division of Medical Oncology, "B.Ramazzini" Hospital, Via Molinari 2, 41012, Carpi, Italy;8. Division of Medical Oncology, Department of Oncology, Misericordia Hospital, Via Senese, 169, 58100 Grosseto, Italy;9. Oncology Dept. IRCCS Sacro Cuore Don Calabria Hospital, Via Don A. Sempreboni, 5, 37024 Negrar, Verona, Italy;10. SPARC Consulting Srl, Via Archimede 94, 20129 Milan, Italy;11. Roche S.p.A., Viale G.B. Stucchi,110, 20900 Monza, Italy;1. Sussex Health Outcomes Research and Education in Cancer (SHORE-C), Brighton & Sussex Medical School, University of Sussex, Falmer, Brighton BN1 9RX, United Kingdom;2. GMA Biometrics, F. Hoffmann-La Roche Ltd, Building 74, Grenzacherstrasse 124, CH-4070 Basel, Switzerland |
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| Abstract: | AimTo assess efficacy (event-free survival, EFS) and safety in patients followed up for 3 years in the PrefHer study (NCT01401166).Patients and methodsPost surgery and post chemotherapy in the (neo)adjuvant setting, patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer were randomised to receive four cycles of the subcutaneous form of trastuzumab (Herceptin® SC [H SC] via single-use injection device [Cohort 1] or delivery via a hand-held syringe from an SC Vial [Cohort 2]; 600 mg fixed dose) followed by four of the intravenous form of trastuzumab (Herceptin® [H IV]; 8 mg/kg loading, 6 mg/kg maintenance doses) in the adjuvant setting or vice versa every 3 weeks. Patients could have received H before randomisation. H was then continued to complete a total of 18 cycles, including any cycles received before randomisation.ResultsA total of 488 patients were randomised across both cohorts. After median follow-up of 36.1 months, 3-year EFS across both groups in the evaluable intention-to-treat population (467 patients) was 90.6% overall, 89.9% in Cohort 1, and 91.1% in Cohort 2. No new safety signals were identified during long-term follow-up, with only one cardiac serious adverse event in the safety population (483 patients).ConclusionsThree-year EFS data following H SC and H IV treatment are consistent with those reported by previous trials for H in the adjuvant setting. The overall safety profile during adjuvant treatment was as expected. |
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| Keywords: | Breast cancer HER2/neu Herceptin Patient preference Subcutaneous Trastuzumab |
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