Institut za onkologiju i radiologiju Srbije / Institute for Oncology and Radiology of Serbia
Published July 1, 2020 | Version v.1.
Journal article Open

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

Creators

  • 1. DiSCOG, University of Padova and Division of Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padova, Italy
  • 2. National Center for Tumor Diseases, Heidelberg University Hospital and German Cancer Research Center, Heidelberg, Germany.
  • 3. GBG, Neu-Isenburg, Germany; Centre for Haematology and Oncology Bethanien, Frankfurt, Germany
  • 4. NSABP Foundation and Orlando Health University of Florida Health Cancer Center, Orlando, Florida
  • 5. GBG, Neu-Isenburg, Germany.
  • 6. Instituto do Câncer do Estado de São Paulo, São Paulo, Brazil
  • 7. AGO-B and HELIOS Klinikum Berlin Buch, Berlin, Germany
  • 8. National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan
  • 9. NSABP Foundation and University of Pittsburgh, Pittsburgh, Pennsylvania
  • 10. Institut Régional du Cancer de Montpellier, Montpellier, France.
  • 11. Hospital Universitario La Paz-IdiPAZ, Madrid, Spain
  • 12. Institute for Oncology and Radiology of Serbia, Belgrade, Serbia.
  • 13. Institut Bergonié Unicancer and Bordeaux University, Bordeaux, France.
  • 14. Grupo Medico Angeles, Guatemala City, Guatemala
  • 15. GBG and Evangelische Kliniken Gelsenkirchen, Gelsenkirchen, Germany
  • 16. Swedish Cancer Institute, Issaquah, Washington.
  • 17. Genentech, Inc., South San Francisco, California
  • 18. F. Hoffmann-La Roche, Basel, Switzerland
  • 19. NSABP Foundation and Houston Methodist Cancer Center, Houston, Texas.

Description

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.

 

Notes

This study was funded by F. Hoffmann–La Roche/Genentech

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Patient Reported Outcomes From KATHERINE. Conte...CNCR-126-3132.pdf

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Additional details

Related works

Is identical to
PMC7317721 (pmcid)
Is part of
gnd:1097-0142. (gnd)