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

Pier Franco Conte, Andreas Schneeweiss, Sibylle Loibl, Eleftherios P. Mamounas, Gunter von Minckwitz, Max S. Mano, Michael Untch, Chiun Sheng Huang, Norman Wolmark, Priya Rastogi, Veronique D’Hondt, Andrés Redondo, Ljiljana Stamatovic, Hervé Bonnefoi, Hugo Castro-Salguero, Hans H. Fischer, Tanya Wahl, Chunyan Song, Thomas Boulet, Peter TraskCharles E. Geyer

Research output: Contribution to journalArticlepeer-review

3 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)3132-3139
Number of pages8
JournalCancer
Volume126
Issue number13
DOIs
StatePublished - Jul 1 2020

Keywords

  • T-DM1
  • ado-trastuzumab emtansine
  • antibody-drug conjugate
  • breast neoplasms
  • neoadjuvant therapy
  • patient-reported outcome
  • quality of life
  • trastuzumab

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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