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dc.contributor.authorCortes, Javier
dc.contributor.authorHudgens, Stacie
dc.contributor.authorTwelves, Chris
dc.contributor.authorPerez, Edith A
dc.contributor.authorAwada, Ahmad
dc.contributor.authorYelle, Louise
dc.contributor.authorMcCutcheon, Susan
dc.contributor.authorKaufman, Peter A
dc.contributor.authorForsythe, Anna
dc.contributor.authorVelikova, Galina
dc.identifier.citationBreast Cancer Res. Treat..2015 Dec;(154)3:509-20
dc.description.abstractThe clinical benefit of eribulin versus capecitabine was evaluated using health-related quality of life (HRQoL) data from a phase 3 randomized trial in patients with pretreated advanced/metastatic breast cancer ( identifier: NCT00337103). The study population has been described previously (Kaufman et al. in J Clin Oncol 33:594-601, 2015). Eligible patients received eribulin (1.4 mg/m(2) intravenously on days 1 and 8) or capecitabine (1.25 g/m(2) orally twice daily on days 1-14) per 21-day cycles. HRQoL was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-life Questionnaire-Core 30 questions (QLQ-C30) and breast module-23 questions (QLQ-BR23), administered at baseline through 24 months, until disease progression or other antitumor treatment initiation. Minimally important difference (MID) and time to symptom worsening (TSW) were investigated. 1062 (96.4 %) Patients completed the EORTC questionnaire at baseline; overall, compliance was ≥80 %. Patients receiving capecitabine versus eribulin had significantly worse symptoms (higher scores) for nausea/vomiting (MID 8; P < 0.05) and diarrhea (MID 7; P < 0.05). Treatment with eribulin versus capecitabine, led to worse systemic therapy side-effects (dry mouth, different tastes, irritated eyes, feeling ill, hot flushes, headaches, and hair loss; MID 10; P < 0.01). Clinically meaningful worsening was observed for future perspective (MID 10; P < 0.05) with capecitabine and for systemic therapy side-effects scale (MID 10; P < 0.01) with eribulin. Patients receiving capecitabine experienced more-rapid deterioration in body image (by 2.9 months) and future perspective (by 1.4 months; P < 0.05) compared with those on eribulin; the opposite was observed for systemic side-effects where patients receiving eribulin experienced more-rapid deterioration than those receiving capecitabine (by 2 months; P < 0.05). Eribulin and capecitabine were found to have similar impact on patient functioning with no overall difference in HRQoL. Patients receiving eribulin reported worse systemic side-effects of chemotherapy but reduced gastrointestinal toxicity compared with capecitabine.
dc.subjectBreast cancer
dc.subjectMinimally important difference
dc.subjectQuality of life
dc.subjectSide effects
dc.subject.meshAged, 80 and over
dc.subject.meshAntineoplastic Agents
dc.subject.meshBreast Neoplasms
dc.subject.meshMiddle Aged
dc.subject.meshQuality of Life
dc.titleHealth-related quality of life in patients with locally advanced or metastatic breast cancer treated with eribulin mesylate or capecitabine in an open-label randomized phase 3 trial.
dc.identifier.journalBreast cancer research and treatment
dc.pubmedtypeClinical Trial, Phase III
dc.pubmedtypeJournal Article
dc.pubmedtypeMulticenter Study
dc.pubmedtypeRandomized Controlled Trial
dc.pubmedtypeResearch Support, Non-U.S. Gov't
Appears in Collections:Fundaciones e Institutos de Investigación > IIS H. U. Ramón y Cajal > Artículos

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