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Clinical Trial
. 2015 Dec;154(3):509-20.
doi: 10.1007/s10549-015-3633-7. Epub 2015 Nov 14.

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

Javier Cortes  1   2 , Stacie Hudgens  3 , Chris Twelves  4 , Edith A Perez  5 , Ahmad Awada  6 , Louise Yelle  7 , Susan McCutcheon  8 , Peter A Kaufman  9 , Anna Forsythe  10 , Galina Velikova  11
Affiliations
Clinical Trial

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

Javier Cortes et al. Breast Cancer Res Treat. 2015 Dec.

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.

Keywords: Breast cancer; Eribulin; Minimally important difference; Quality of life; Side effects.

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Figures

Fig. 1
Fig. 1
Effects of eribulin and capecitabine on physical symptom scales of the EORTC QLQ-C30 and QLQ-BR23 a differences in mean scores; b proportion of patients with worsened symptoms; c differences in median time to symptom worsening
Fig. 2
Fig. 2
Effects of eribulin and capecitabine on function scales of the EORTC QLQ-C30 and QLQ-BR23. a differences in mean scores; b proportion of patients with worsened symptoms; c differences in median time to symptom worsening
Fig. 3
Fig. 3
Effects of eribulin and capecitabine, in terms of time to symptom worsening, on overall global health status/quality-of-life scale of the EORTC QLQ-C30 in patients with triple-negative disease
See this image and copyright information in PMC

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