title: Health-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.
abstract: The 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 (ClinicalTrials.gov 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.
authors.affiliation: Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.|Oncology Department, Ramon y Cajal University Hospital, Madrid, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Cortes
authors.affiliation: Department of Quantitative Science, Clinical Outcomes Solutions, 3709 North Campbell, Tucson, AZ, USA.
authors.forename: Stacie
authors.initials: S
authors.lastname: Hudgens
authors.affiliation: Department of Oncology, Leeds Institute of Cancer and Pathology, and St James's Institute of Oncology, University of Leeds, Leeds, LS9 7TF, England, UK.
authors.forename: Chris
authors.initials: C
authors.lastname: Twelves
authors.affiliation: Division of Hematology/Oncology, Department of Cancer Biology, Mayo Clinic, Jacksonville, FL, USA.
authors.forename: Edith A
authors.initials: EA
authors.lastname: Perez
authors.affiliation: Medical Oncology Clinic, Medicine Department, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
authors.forename: Ahmad
authors.initials: A
authors.lastname: Awada
authors.affiliation: Department of Medicine, University of Montreal, Montreal, QC, Canada.
authors.forename: Louise
authors.initials: L
authors.lastname: Yelle
authors.affiliation: Formerly of Eisai Ltd, Hatfield, England, UK.
authors.forename: Susan
authors.initials: S
authors.lastname: McCutcheon
authors.affiliation: Section of Hematology/Oncology, Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.
authors.forename: Peter A
authors.initials: PA
authors.lastname: Kaufman
authors.affiliation: Department of Global Value and Access Strategy, Eisai Inc., Woodcliff Lake, NJ, USA.
authors.forename: Anna
authors.initials: A
authors.lastname: Forsythe
authors.affiliation: Department of Oncology, Leeds Institute of Cancer and Pathology, and St James's Institute of Oncology, University of Leeds, Leeds, LS9 7TF, England, UK. g.velikova@leeds.ac.uk.
authors.forename: Galina
authors.initials: G
authors.lastname: Velikova
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000069287:Capecitabine / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005663:Furans / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007659:Ketones / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D011788:Quality of Life; D000095662:Polyether Polyketides
chemical_list: D000970:Antineoplastic Agents; D000069287:Capecitabine; D005663:Furans; D007659:Ketones; C490954:eribulin; D000095662:Polyether Polyketides
keywords: Breast cancer; Eribulin; Minimally important difference; Quality of life; Side effects