Neelima Denduluri1, Mark R Somerfield2, Mariana Chavez-MacGregor3, Amy H Comander4, Zoneddy Dayao5, Andrea Eisen6,7, Rachel A Freedman8, Ragisha Gopalakrishnan9, Stephanie L Graff10, Michael J Hassett8, Tari A King8,11, Gary H Lyman12, Gillian Rice Maupin13, Raquel Nunes14, Cheryl L Perkins15, Melinda L Telli16, Maureen E Trudeau6,7, Antonio C Wolff14, Sharon H Giordano3. 1. Virginia Cancer Specialists, US Oncology, Arlington, VA. 2. American Society of Clinical Oncology, Alexandria, VA. 3. The University of Texas MD Anderson Cancer Center, Houston, TX. 4. Massachusetts General Hospital Center at Newton-Wellesley, Newton, MA. 5. University of New Mexico Hospital, Albuquerque, NM. 6. Sunnybrook Odette Cancer Centre, Toronto, Ontario, Canada. 7. Ontario Health (Cancer Care Ontario), Toronto, Ontario, Canada. 8. Dana-Farber Cancer Institute, Boston, MA. 9. Rocky Mountain Cancer Centers, Colorado Springs, CO. 10. Sarah Cannon Cancer Institute, HCA Midwest Health, Kansas City, MO. 11. Brigham & Women's Cancer Center, Boston, MA. 12. Fred Hutchinson Cancer Research Center, Seattle, WA. 13. Virginia Hospital Center, Arlington, VA Lowe & Carlo, Alexandria, VA. 14. Sidney Kimmel Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD. 15. Patient representative, Dallas, TX. 16. Stanford University School of Medicine, Stanford, CA.
Abstract
PURPOSE: The aim of this work is to update key recommendations of the ASCO guideline adaptation of the Cancer Care Ontario guideline on the selection of optimal adjuvant chemotherapy regimens for early breast cancer and adjuvant targeted therapy for breast cancer. METHODS: An Expert Panel conducted a targeted systematic literature review guided by a signals approach to identify new, potentially practice-changing data that might translate into revised guideline recommendations. RESULTS: The Expert Panel reviewed abstracts from the literature review and identified one article for inclusion that reported results of the phase III, open-label KATHERINE trial. In the KATHERINE trial, patients with stage I to III human epidermal growth factor receptor 2 (HER2)-positive breast cancer with residual invasive disease in the breast or axilla after completing neoadjuvant chemotherapy and HER2-targeted therapy were allocated to adjuvant trastuzumab emtansine (T-DM1; n = 743) or to trastuzumab (n = 743). Invasive disease-free survival was significantly higher in the T-DM1 group than in the trastuzumab arm (hazard ratio, 0.50; 95% CI, 0.39 to 0.64; P < .001), and risk of distant recurrence was lower in patients who received T-DM1 than in patients who received trastuzumab (hazard ratio, 0.60; 95% CI, 0.45 to 0.79). Grade 3 or higher adverse events occurred in 190 patients (25.7%) who received T-DM1 and in 111 patients (15.4%) who received trastuzumab. RECOMMENDATIONS: Patients with HER2-positive breast cancer with pathologic invasive residual disease at surgery after standard preoperative chemotherapy and HER2-targeted therapy should be offered 14 cycles of adjuvant T-DM1, unless there is disease recurrence or unmanageable toxicity. Clinicians may offer any of the available and approved formulations of trastuzumab, including trastuzumab, trastuzumab and hyaluronidase-oysk, and available biosimilars.Additional information can be found at www.asco.org/breast-cancer-guidelines.
PURPOSE: The aim of this work is to update key recommendations of the ASCO guideline adaptation of the Cancer Care Ontario guideline on the selection of optimal adjuvant chemotherapy regimens for early breast cancer and adjuvant targeted therapy for breast cancer. METHODS: An Expert Panel conducted a targeted systematic literature review guided by a signals approach to identify new, potentially practice-changing data that might translate into revised guideline recommendations. RESULTS: The Expert Panel reviewed abstracts from the literature review and identified one article for inclusion that reported results of the phase III, open-label KATHERINE trial. In the KATHERINE trial, patients with stage I to III human epidermal growth factor receptor 2 (HER2)-positive breast cancer with residual invasive disease in the breast or axilla after completing neoadjuvant chemotherapy and HER2-targeted therapy were allocated to adjuvant trastuzumab emtansine (T-DM1; n = 743) or to trastuzumab (n = 743). Invasive disease-free survival was significantly higher in the T-DM1 group than in the trastuzumab arm (hazard ratio, 0.50; 95% CI, 0.39 to 0.64; P < .001), and risk of distant recurrence was lower in patients who received T-DM1 than in patients who received trastuzumab (hazard ratio, 0.60; 95% CI, 0.45 to 0.79). Grade 3 or higher adverse events occurred in 190 patients (25.7%) who received T-DM1 and in 111 patients (15.4%) who received trastuzumab. RECOMMENDATIONS: Patients with HER2-positive breast cancer with pathologic invasive residual disease at surgery after standard preoperative chemotherapy and HER2-targeted therapy should be offered 14 cycles of adjuvant T-DM1, unless there is disease recurrence or unmanageable toxicity. Clinicians may offer any of the available and approved formulations of trastuzumab, including trastuzumab, trastuzumab and hyaluronidase-oysk, and available biosimilars.Additional information can be found at www.asco.org/breast-cancer-guidelines.
Authors: Melanie Erices-Leclercq; Sabine Lubig; Frank Förster; Robert Förster; Stefan Baldus; Christian Rudlowski; Lars Schröder Journal: J Cancer Res Clin Oncol Date: 2021-05-15 Impact factor: 4.553
Authors: Larissa A Korde; Mark R Somerfield; Lisa A Carey; Jennie R Crews; Neelima Denduluri; E Shelley Hwang; Seema A Khan; Sibylle Loibl; Elizabeth A Morris; Alejandra Perez; Meredith M Regan; Patricia A Spears; Preeti K Sudheendra; W Fraser Symmans; Rachel L Yung; Brittany E Harvey; Dawn L Hershman Journal: J Clin Oncol Date: 2021-01-28 Impact factor: 44.544
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Authors: L van Walle; K Punie; E Van Eycken; E de Azambuja; H Wildiers; F P Duhoux; P Vuylsteke; A Barbeaux; N Van Damme; D Verhoeven Journal: ESMO Open Date: 2021-07-14