Patient-reported outcomes from EMILIA, a randomized phase 3 study of trastuzumab emtansine (T-DM1) versus capecitabine and lapatinib in human epidermal growth factor receptor 2–positive locally advanced or metastatic breast cancer
Article first published online: 12 NOV 2013
© 2013 American Cancer Society
Volume 120, Issue 5, pages 642–651, 1 March 2014
How to Cite
Welslau, M., Diéras, V., Sohn, J.-H., Hurvitz, S. A., Lalla, D., Fang, L., Althaus, B., Guardino, E. and Miles, D. (2014), Patient-reported outcomes from EMILIA, a randomized phase 3 study of trastuzumab emtansine (T-DM1) versus capecitabine and lapatinib in human epidermal growth factor receptor 2–positive locally advanced or metastatic breast cancer. Cancer, 120: 642–651. doi: 10.1002/cncr.28465
- Issue published online: 19 FEB 2014
- Article first published online: 12 NOV 2013
- Manuscript Accepted: 1 OCT 2013
- Manuscript Revised: 17 SEP 2013
- Manuscript Received: 5 JUN 2013
- ado-trastuzumab emtansine;
- quality of life;
- breast cancer;
- antibody–drug conjugate
This report describes the results of an analysis of patient-reported outcomes from EMILIA (TDM4370g/BO21977), a randomized phase 3 study of the antibody–drug conjugate trastuzumab emtansine (T-DM1) versus capecitabine and lapatinib in human epidermal growth factor receptor 2 (HER2)–positive locally advanced or metastatic breast cancer.
A secondary endpoint of the EMILIA study was time to symptom worsening (time from randomization to the first documentation of a ≥ 5-point decrease from baseline) as measured by the Trial Outcome Index Physical/Functional/Breast (TOI-PFB) subset of the Functional Assessment of Cancer Therapy–Breast questionnaire. Predefined exploratory patient-reported outcome endpoints included proportion of patients with a clinically significant improvement in symptoms (per TOI-PFB) and proportion of patients with diarrhea symptoms (per Diarrhea Assessment Scale).
In the T-DM1 arm, 450 of 495 patients had a baseline and ≥ 1 postbaseline TOI-PFB score versus 445 of 496 patients in the capecitabine-plus-lapatinib arm. Time to symptom worsening was delayed in the T-DM1 arm versus the capecitabine-plus-lapatinib arm (7.1 months versus 4.6 months, respectively; hazard ratio = 0.796; P = .0121). In the T-DM1 arm, 55.3% of patients developed clinically significant improvement in symptoms from baseline versus 49.4% in the capecitabine-plus-lapatinib arm (P = .0842). Although similar at baseline, the number of patients reporting diarrhea symptoms increased 1.5- to 2-fold during treatment with capecitabine and lapatinib but remained near baseline levels in the T-DM1 arm.
Together with the EMILIA primary data, these results support the concept that T-DM1 has greater efficacy and tolerability than capecitabine plus lapatinib, which may translate into improvements in health-related quality of life. Cancer 2014;120:642–651. © 2013 American Cancer Society.