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

Welslau, Manfred; Diéras, Veronique; Sohn, Joo‐Hyuk; Hurvitz, Sara A.; Lalla, Deepa; Fang, Liang; Althaus, Betsy; Guardino, Ellie; Miles, David

doi:10.1002/cncr.28465

Cited by 126HER2/EGFR in Cancer ResearchCancer survivorship and careHealth Systems, Economic Evaluations, Quality of Life

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

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Welslau, Manfred, Diéras, Veronique, Sohn, Joo‐Hyuk, Hurvitz, Sara A., Lalla, Deepa, Fang, Liang, Althaus, Betsy, Guardino, Ellie +1 more·2014·Cancer

DOI 10.1002/cncr.28465

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Abstract

BACKGROUND: 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. METHODS: 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). RESULTS: 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. CONCLUSIONS: 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.

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In the field testing, T-DM1 compared with lapatinib plus capecitabine in second-line metastatic breast cancer after trastuzumab failure was assigned ESMO-MCBS grade 5.
“T-DM1 versus lapatinib + | EMILIA | Second-line metastatic after | PFS and OS | 6.4 months | 3.2 months 0.65 (0.55-0.77) 25 months | 6.8 months 0.68 (0.55-0.85) Delayed deterioration | 5 | [57, 58]”
From A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) (2015) · cites this paper as [58]

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Patient-Reported Outcomes (PROS) From EMILIA, a Phase 3 Study of Trastuzumab Emtansine (T-DM1) vs Capecitabine and Lapatinib (XL) In HER2-Positive Locally Advanced or MBC
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Abstract P4-14-01: Trastuzumab emtansine improves overall survival versus capecitabine plus lapatinib in patients with previously treated HER2-positive advanced breast cancer: Final results from the phase 3 EMILIA study
Dieras, V. C., Miles, D., Verma, S., Pegram, M. D., Welslau, M., Baselga, J. M., Krop, I. E., Blackwell, K., Kang, B., Xu, J., et al. (2016) · Cancer Research · doi:10.1158/1538-7445.sabcs15-p4-14-01
Trastuzumab emtansine (Kadcyla™) for previously treated patients with HER2-positive advanced/metastatic breast cancer
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EMILIA: A phase III, randomized, multicenter study of trastuzumab-DM1 (T-DM1) compared with lapatinib (L) plus capecitabine (X) in patients with HER2-positive locally advanced or metastatic breast cancer (MBC) and previously treated with a trastuzumab-based regimen.
Verma, S., Dieras, V. C., Gianni, L., Miles, D. W., Welslau, M., Pegram, M. D., Baselga, J. M., Guardino, E., Fang, L., Linehan, C. M., et al. (2011) · Journal of Clinical Oncology · doi:10.1200/jco.2011.29.15_suppl.tps116 · Cited by 6 · see citing works

Authors: Welslau, M., Diéras, V., Sohn, J., Hurvitz, S. A., Lalla, D., Fang, L., Althaus, B., Guardino, E., & Miles, D.
Affiliations: Klinikum Aschaffenburg (DE)
Institut Curie Paris France
Yonsei University College of Medicine Seoul South Korea
University of California, Los Angeles (US)
Genentech (US)
Mount Vernon Hospital (GB)
Corresponding author: Welslau, Manfred
ORCID: Hurvitz, Sara A.
Guardino, Ellie
Miles, David
Venue: Cancer
Publisher: Wiley
Published: 2013-11-12
Volume: 120
Issue: 5
Pages: 642-651
ISSN: 0008-543X (ISSN-L)
1097-0142
DOI: 10.1002/cncr.28465
OpenAlex: W1923236865
Cited by: 126
References: 23
Citations by year: 2026: 3 · 2025: 2 · 2024: 6 · 2023: 4 · 2022: 11 · 2021: 8 · 2020: 3 · 2019: 7 · 2018: 15 · 2017: 18 · 2016: 19 · 2015: 17 · 2014: 10 · 2013: 3
FWCI: 8.74
Type: journal article
Language: en
Open access: green
ir.ymlib.yonsei.ac.kr
Licence: cc-by-nc-nd
onlinelibrary.wiley.com/termsAndConditions#vor (vor)
Locations: Cancer (publishedVersion)
PubMed (publishedVersion)
YUHSpace (Yonsei University Medical Library) (submittedVersion, cc-by-nc-nd)
Funders: Genentech
Topics: Health Sciences › Medicine › Oncology › HER2/EGFR in Cancer Research
Health Sciences › Medicine › Oncology › Cancer survivorship and care
Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
Keywords: trastuzumab emtansine, HER2-positive breast cancer, metastatic breast cancer, locally advanced breast cancer, capecitabine, lapatinib, patient-reported outcomes, diarrhea, health-related quality of life, antibody-drug conjugates
MeSH terms: Trastuzumab, Capecitabine, Lapatinib, Ado-Trastuzumab Emtansine, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Deoxycytidine, Diarrhea, Drug Administration Schedule, Female, Fluorouracil, Health Status, Humans, Maytansine, Middle Aged, Quality of Life, Surveys and Questionnaires, Quinazolines, Time Factors, Biomarkers, Tumor, Treatment Outcome, Drug Monitoring, Disease-Free Survival, Erb-b2 Receptor Tyrosine Kinases, Self Report, Antibodies, Monoclonal, Humanized

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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

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