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.

Autor: Conte P; DiSCOG, University of Padova and Division of Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padova, Italy., Schneeweiss A; National Center for Tumor Diseases, Heidelberg University Hospital and German Cancer Research Center, Heidelberg, Germany., Loibl S; GBG, Neu-Isenburg, Germany.; Centre for Haematology and Oncology Bethanien, Frankfurt, Germany., Mamounas EP; NSABP Foundation and Orlando Health University of Florida Health Cancer Center, Orlando, Florida., von Minckwitz G; GBG, Neu-Isenburg, Germany., Mano MS; Instituto do Câncer do Estado de São Paulo, São Paulo, Brazil., Untch M; AGO-B and HELIOS Klinikum Berlin Buch, Berlin, Germany., Huang CS; National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan., Wolmark N; NSABP Foundation and University of Pittsburgh, Pittsburgh, Pennsylvania., Rastogi P; NSABP Foundation and University of Pittsburgh, Pittsburgh, Pennsylvania., D'Hondt V; Institut Régional du Cancer de Montpellier, Montpellier, France., Redondo A; Hospital Universitario La Paz-IdiPAZ, Madrid, Spain., Stamatovic L; Institute for Oncology and Radiology of Serbia, Belgrade, Serbia., Bonnefoi H; Institut Bergonié Unicancer and Bordeaux University, Bordeaux, France., Castro-Salguero H; Grupo Medico Angeles, Guatemala City, Guatemala., Fischer HH; GBG and Evangelische Kliniken Gelsenkirchen, Gelsenkirchen, Germany., Wahl T; Swedish Cancer Institute, Issaquah, Washington., Song C; Genentech, Inc., South San Francisco, California., Boulet T; F. Hoffmann-La Roche, Basel, Switzerland., Trask P; Genentech, Inc., South San Francisco, California., Geyer CE Jr; NSABP Foundation and Houston Methodist Cancer Center, Houston, Texas.
Jazyk: angličtina
Zdroj: Cancer [Cancer] 2020 Jul 01; Vol. 126 (13), pp. 3132-3139. Date of Electronic Publication: 2020 Apr 14.
DOI: 10.1002/cncr.32873
Abstrakt: 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.)
Databáze: MEDLINE
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