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.

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.

• Authors: PierFranco 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 Trask, Charles E Geyer Jr
• Journal: Cancer (Cancer) Vol. 126 Issue 13 Pg. 3132-3139 (07 01 2020) ISSN: 1097-0142 [Electronic] United States
• PMID: 32286687 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2020 The Authors. Cancer published by Wiley Periodicals LLC on behalf of American Cancer Society.

Chemical References

• Immunoconjugates
• ERBB2 protein, human
• Receptor, ErbB-2
• Trastuzumab
• Ado-Trastuzumab Emtansine

Topics

• Ado-Trastuzumab Emtansine (administration & dosage, adverse effects)
• Adult
• Aged
• Breast Neoplasms (drug therapy, epidemiology, genetics, pathology)
• Female
• Humans
• Immunoconjugates (administration & dosage, adverse effects)
• Middle Aged
• Neoadjuvant Therapy (adverse effects)
• Neoplasm, Residual (drug therapy, epidemiology, pathology)
• Patient Reported Outcome Measures
• Quality of Life
• Receptor, ErbB-2 (genetics)
• Trastuzumab (administration & dosage, adverse effects)