Patient-reported outcomes from KATHERINE: A phase 3 study of adjuvant trastuzumab emtansine versus trastuzumab in patients with residual invasive disease after neoadjuvant therapy for human epidermal growth factor receptor 2–positive breast cancer
Journal
Cancer
Journal Volume
126
Journal Issue
13
Pages
3132-3139
Date Issued
2020
Author(s)
Conte P.
Schneeweiss A.
Loibl S.
Mamounas E.P.
von Minckwitz G.
Mano M.S.
Untch M.
Wolmark 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.
Abstract
Background: 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 Society
Subjects
ado-trastuzumab emtansine; antibody-drug conjugate; breast neoplasms; neoadjuvant therapy; patient-reported outcome; quality of life; T-DM1; trastuzumab
SDGs
Other Subjects
anthracycline 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; Trastuzumab
Publisher
John Wiley and Sons Inc.
Type
journal article