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.