Cited 99 times in
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
DC Field | Value | Language |
---|---|---|
dc.contributor.author | 손주혁 | - |
dc.date.accessioned | 2015-01-06T17:24:39Z | - |
dc.date.available | 2015-01-06T17:24:39Z | - |
dc.date.issued | 2014 | - |
dc.identifier.issn | 0008-543X | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/99927 | - |
dc.description.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. | - |
dc.description.statementOfResponsibility | open | - |
dc.format.extent | 642~651 | - |
dc.relation.isPartOf | CANCER | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Aged | - |
dc.subject.MESH | Antibodies, Monoclonal, Humanized/administration & dosage | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols/adverse effects | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols/therapeutic use* | - |
dc.subject.MESH | Biomarkers, Tumor/analysis* | - |
dc.subject.MESH | Breast Neoplasms/chemistry* | - |
dc.subject.MESH | Breast Neoplasms/drug therapy* | - |
dc.subject.MESH | Breast Neoplasms/pathology | - |
dc.subject.MESH | Capecitabine | - |
dc.subject.MESH | Deoxycytidine/administration & dosage | - |
dc.subject.MESH | Deoxycytidine/analogs & derivatives | - |
dc.subject.MESH | Diarrhea/chemically induced | - |
dc.subject.MESH | Disease-Free Survival | - |
dc.subject.MESH | Drug Administration Schedule | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Fluorouracil/administration & dosage | - |
dc.subject.MESH | Fluorouracil/analogs & derivatives | - |
dc.subject.MESH | Health Status | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Maytansine/administration & dosage | - |
dc.subject.MESH | Maytansine/analogs & derivatives | - |
dc.subject.MESH | Medication Adherence/statistics & numerical data | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Quality of Life | - |
dc.subject.MESH | Quinazolines/administration & dosage | - |
dc.subject.MESH | Receptor, ErbB-2/analysis* | - |
dc.subject.MESH | Self Report | - |
dc.subject.MESH | Surveys and Questionnaires | - |
dc.subject.MESH | Time Factors | - |
dc.subject.MESH | Trastuzumab | - |
dc.subject.MESH | Treatment Outcome | - |
dc.title | 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 | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학) | - |
dc.contributor.googleauthor | Manfred Welslau | - |
dc.contributor.googleauthor | Veronique Diéras | - |
dc.contributor.googleauthor | Joo-Hyuk Sohn | - |
dc.contributor.googleauthor | Sara A. Hurvitz | - |
dc.contributor.googleauthor | Deepa Lalla | - |
dc.contributor.googleauthor | Liang Fang | - |
dc.contributor.googleauthor | Betsy Althaus | - |
dc.contributor.googleauthor | Ellie Guardino | - |
dc.contributor.googleauthor | David Miles | - |
dc.identifier.doi | 10.1002/cncr.28465 | - |
dc.admin.author | false | - |
dc.admin.mapping | false | - |
dc.contributor.localId | A01995 | - |
dc.relation.journalcode | J00434 | - |
dc.identifier.eissn | 1097-0142 | - |
dc.identifier.pmid | 24222194 | - |
dc.identifier.url | http://onlinelibrary.wiley.com/doi/10.1002/cncr.28465/abstract | - |
dc.subject.keyword | HER2-positive | - |
dc.subject.keyword | T-DM1 | - |
dc.subject.keyword | ado-trastuzumab emtansine | - |
dc.subject.keyword | antibody-drug conjugate | - |
dc.subject.keyword | breast cancer | - |
dc.subject.keyword | quality of life | - |
dc.contributor.alternativeName | Sohn, Joo Hyuk | - |
dc.contributor.affiliatedAuthor | Sohn, Joo Hyuk | - |
dc.rights.accessRights | free | - |
dc.citation.volume | 120 | - |
dc.citation.number | 5 | - |
dc.citation.startPage | 642 | - |
dc.citation.endPage | 651 | - |
dc.identifier.bibliographicCitation | CANCER, Vol.120(5) : 642-651, 2014 | - |
dc.identifier.rimsid | 53892 | - |
dc.type.rims | ART | - |
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