First report of eribulin in combination with pertuzumab and trastuzumab for advanced HER2-positive breast cancer |
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| Affiliation: | 1. Breast Medical Oncology, The Cancer Institute Hospital Ariake of the Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan;2. Breast Oncology Center, The Cancer Institute Hospital Ariake of the Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan;3. Division of Pathology, The Cancer Institute Hospital Ariake of the Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan;4. Division of Pathology, The Cancer Institute of the Japanese Foundation for Cancer Research, Tokyo, Japan;5. Medical Oncology, The Cancer Institute Hospital Ariake of the Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan;1. Breast Medical Oncology, The Cancer Institute Hospital Ariake of the Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan;2. Breast Oncology Center, The Cancer Institute Hospital Ariake of the Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan;3. Division of Pathology, The Cancer Institute Hospital Ariake of the Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan;4. Division of Pathology, The Cancer Institute of the Japanese Foundation for Cancer Research, Tokyo, Japan;5. Medical Oncology, The Cancer Institute Hospital Ariake of the Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan;1. San Raffaele University and Research Hospital, Milano, Italy;2. Breast Unit, Champalimaud Foundation, Lisbon, Portugal;3. Department of Radiation Oncology, Institut Curie, Paris, France;1. Department of Surgery, Dalhousie University, 849-1276 South Park Street Street, Halifax, NS, B3H 2Y9, Canada;2. Surgical Oncology, BC Cancer Agency (SAH-CSI), 399 Royal Avenue, Kelowna, BC, V1Y 5L3, Canada;3. Surgical Oncology Network, Canada;4. Department of Surgery, University of British Columbia, Canada;5. BC Cancer Agency, 801 – 686 West Broadway, Vancouver, BC, V5Z 1G1, Canada;6. British Columbia Cancer Agency Research Centre, 703-686 West Broadway, Vancouver, BC, V5Z 1G1, Canada;1. Medica Scientia Innovation Research (MedSIR ARO), Barcelona, Spain;2. Hospital Arnau de Vilanova de Valencia, Valencia, Spain;3. Institut Regional du Cancer en Franche-Comté, Centre Hospitalier Universitaire de Besançon, Besançon, France;4. Sandro Pitigliani Medical Oncology Department, Nuovo Ospedale di Prato, Istituto Toscano Tumori, Prato, Italy;5. University Hospital 12 de Octubre, Madrid, Spain;6. Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, ON, Canada;7. Institut Curie, Université Paris Descartes, Paris, France;8. Royal Marsden Hospital and The Institute of Cancer Research, London, UK;9. Department of Gynaecology, Martin-Luther-Universität Halle-Wittenberg, Halle an der Saale, Germany;10. F Hoffmann-La Roche Ltd, Basel, Switzerland;11. Scienco Klinico, Barcelona, Spain;12. Vall d''Hebron University Hospital, Barcelona, Spain;1. Hospital General de Granollers, Barcelona, Spain;2. Hospital Vall d’Hebron, Barcelona, Spain;3. Hospital Miguel Servet, Zaragoza, Spain;4. Hospital Son Llatzer, Palma de Mallorca, Spain;5. IPO Porto, Porto, Portugal;6. Complejo Hospitalario Universitario A Coruña, A Coruña, Spain;7. Hospital Central de Asturias, Oviedo, Spain;8. Hospital del Mar, Barcelona, Spain;9. Hospital Universitario Infanta Cristina, Badajoz, Spain;10. Hospital Universitario La Paz, Madrid, Spain;11. Hospital Insular de Las Palmas, Las Palmas de Gran Canaria, Spain;12. Hospital General de Navarra, Pamplona, Spain;13. Hospital Universitario de Salamanca IBSAL, Salamanca, Spain;14. Medica Scientia Innovation Research (MedSIR), Barcelona, Spain;15. IOB Institute of Oncology, Quironsalud Group, Madrid and Barcelona, Spain;16. Ramon y Cajal University Hospital, Madrid, Spain;17. Vall d''Hebron Institute of Oncology, Barcelona, Spain;18. Hospital Arnau de Vilanova, Valencia, Spain;1. Department of Surgery, National Hospital Organization Nagasaki Medical Center, Omura, Nagasaki, Japan;2. Department of Surgery, Kitakyushu Municipal Medical Center, Kitakyushu, Fukuoka, Japan;3. Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan;4. Department of Breast Surgery, Urasoe General Hospital, Urasoe, Okinawa, Japan;5. Department of Breast and Endocrine Surgery, Kumamoto City Hospital, Kumamoto, Japan;6. Department of Breast Surgery, Ueo Breast Cancer Hospital, Oita, Japan;7. Department of Surgical Oncology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan;8. Department of Surgery, Oita Prefectural Hospital, Oita, Japan;9. Department of Cancer Information Center, National Hospital Organization Kyusyu Cancer Center, Fukuoka, Japan;10. Division of Medical Oncology, Hematology and Infectious Disease, Fukuoka University, Fukuoka, Japan |
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| Abstract: | BackgroundThe efficacy and safety of continuing multiple anti-HER2 therapies in advanced breast cancer (ABC) patients remains unclear. This study investigated eribulin in combination with pertuzumab and trastuzumab for both taxane- and trastuzumab-pretreated HER2-positive ABC patients.MethodsIn a single-institute, single-arm, open-label, phase II trial, HER2-positive ABC patients who had previously received taxanes and trastuzumab were treated with eribulin in combination with pertuzumab and trastuzumab. The pharmacokinetics of eribulin in this combination were assessed in 6 patients. Tumor assessments were conducted every 6 weeks for the first 6 cycles and every 12 weeks thereafter. The primary endpoint was objective response rate (ORR).ResultsA total of 30 patients (median age, 58 years; range, 31–76) were enrolled, with a median number of previous chemotherapy regimens of 3.5 (range: 1–9) in the metastatic setting. Pharmacokinetic parameters of eribulin in this combination were similar to previous reports of eribulin monotherapy. ORR was 34.8% (95% CI: 16.4–57.3, n = 23), and median progression-free survival was 42.6 weeks (95% CI: 20.3–51.9, n = 30). Clinical benefit rate was 60.9% (95% CI: 16.4–57.3). The most common grade 3/4 adverse event was neutropenia in 20 patients (66.7%). A dose reduction of eribulin was required in 27 patients due to adverse events, particularly grade 3 neutropenia.ConclusionsEribulin in combination with pertuzumab and trastuzumab was well tolerated in heavily pretreated patients. Eribulin may be a viable treatment option when used in combination with pertuzumab and trastuzumab for HER2-positive ABC patients (UMIN Clinical Trial Registry identification number, UMIN000012375). |
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| Keywords: | Eribulin HER2-positive advanced breast cancer Non-taxane microtubule dynamic inhibitor Pertuzumab Trastuzumab |
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