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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

 Manfred Welslau  ;  Veronique Diéras  ;  Joo-Hyuk Sohn  ;  Sara A. Hurvitz  ;  Deepa Lalla  ;  Liang Fang  ;  Betsy Althaus  ;  Ellie Guardino  ;  David Miles 
 CANCER, Vol.120(5) : 642-651, 2014 
Journal Title
Issue Date
Adult ; Aged ; Antibodies, Monoclonal, Humanized/administration & dosage ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use* ; Biomarkers, Tumor/analysis* ; Breast Neoplasms/chemistry* ; Breast Neoplasms/drug therapy* ; Breast Neoplasms/pathology ; Capecitabine ; Deoxycytidine/administration & dosage ; Deoxycytidine/analogs & derivatives ; Diarrhea/chemically induced ; Disease-Free Survival ; Drug Administration Schedule ; Female ; Fluorouracil/administration & dosage ; Fluorouracil/analogs & derivatives ; Health Status ; Humans ; Maytansine/administration & dosage ; Maytansine/analogs & derivatives ; Medication Adherence/statistics & numerical data ; Middle Aged ; Quality of Life ; Quinazolines/administration & dosage ; Receptor, ErbB-2/analysis* ; Self Report ; Surveys and Questionnaires ; Time Factors ; Trastuzumab ; Treatment Outcome
HER2-positive ; T-DM1 ; ado-trastuzumab emtansine ; antibody-drug conjugate ; breast cancer ; quality of life
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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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Sohn, Joo Hyuk(손주혁) ORCID logo https://orcid.org/0000-0002-2303-2764
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