Conte P.Schneeweiss A.Loibl S.Mamounas E.P.von Minckwitz G.Mano M.S.Untch M.CHIUN-SHENG HUANGWolmark N.Rastogi P.D’Hondt V.Redondo A.Stamatovic L.Bonnefoi H.Castro-Salguero H.Fischer H.H.Wahl T.Song C.Boulet T.Trask P.Geyer C.E.Jr.2021-04-262021-04-2620200008-543Xhttps://www.scopus.com/inward/record.uri?eid=2-s2.0-85083380575&doi=10.1002%2fcncr.32873&partnerID=40&md5=ebb98386117ab2fbcf5056801f162932https://scholars.lib.ntu.edu.tw/handle/123456789/557886Background: The phase 3 KATHERINE trial demonstrated significantly improved invasive disease–free survival with adjuvant trastuzumab emtansine (T-DM1) versus trastuzumab in patients with HER2-positive early breast cancer and residual invasive disease after neoadjuvant chemotherapy plus HER2-targeted therapy. Methods: Patients who received taxane- and trastuzumab-containing neoadjuvant therapy (with/without anthracyclines) and had residual invasive disease (breast and/or axillary nodes) at surgery were randomly assigned to 14 cycles of adjuvant T-DM1 (3.6?mg/kg intravenously every 3?weeks) or trastuzumab (6?mg/kg intravenously every 3?weeks). The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–Core 30 (QLQ-C30) and breast cancer module (QLQ-BR23) were completed at screening, at day 1 of cycles 5 and 11, within 30?days after study drug completion, and at 6- and 12-month follow-up visits. Results: Of patients who were randomly assigned to T-DM1 (n?=?743) and trastuzumab (n?=?743), 612 (82%) and 640 (86%), respectively, had valid baseline and ?1 postbaseline assessments. No clinically meaningful changes (?10 points) from baseline in mean QLQ-C30 and QLQ-BR23 scores occurred in either arm. More patients receiving T-DM1 reported clinically meaningful deterioration at any assessment point in role functioning (49% vs 41%), appetite loss (38% vs 28%), constipation (47% vs 38%), fatigue (66% vs 60%), nausea/vomiting (39% vs 30%), and systemic therapy side effects (49% vs 36%). These differences were no longer apparent at the 6-month follow-up assessment, except for role functioning (23% vs 16%). Conclusion: These data suggest that health-related quality of life was generally maintained in both study arms over the course of treatment. ? 2020 The Authors. Cancer published by Wiley Periodicals LLC on behalf of American Cancer Societyado-trastuzumab emtansine; antibody-drug conjugate; breast neoplasms; neoadjuvant therapy; patient-reported outcome; quality of life; T-DM1; trastuzumab[SDGs]SDG3anthracycline derivative; taxane derivative; trastuzumab; trastuzumab emtansine; antibody conjugate; epidermal growth factor receptor 2; ERBB2 protein, human; trastuzumab; trastuzumab emtansine; adjuvant therapy; Article; constipation; controlled study; diarrhea; drug substitution; drug withdrawal; dyspnea; European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; fatigue; follow up; functional assessment; human; human epidermal growth factor receptor 2 positive breast cancer; insomnia; loss of appetite; major clinical study; minimal residual disease; multiple cycle treatment; nausea and vomiting; pain; patient-reported outcome; phase 3 clinical trial; priority journal; quality of life; randomized controlled trial; treatment duration; adult; adverse event; aged; breast tumor; clinical trial; female; genetics; middle aged; minimal residual disease; multicenter study; neoadjuvant therapy; pathology; patient-reported outcome; Ado-Trastuzumab Emtansine; Adult; Aged; Breast Neoplasms; Female; Humans; Immunoconjugates; Middle Aged; Neoadjuvant Therapy; Neoplasm, Residual; Patient Reported Outcome Measures; Quality of Life; Receptor, ErbB-2; Trastuzumabjournal article10.1002/cncr.32873322866872-s2.0-85083380575