Effect of capecitabine (X) on quality of life (QoL) in patients (pts) with metastatic breast cancer (MBC)

Abstract

8130 Background: X (Xeloda®) has proven efficacy and favorable safety as monotherapy in MBC and improves survival when added to docetaxel in first line. However, clinical outcomes need to be balanced with pt QoL. Pt preference for oral therapy is well documented. QoL data would add to understanding the potential pt benefits of X. Methods: We monitored QoL on X in women pretreated with anthracycline +/− taxanes. QoL was evaluated at baseline, before cycle 1, at weeks 7 and 13, and at treatment end using EORTC QLQ C-30 (v3.0) and BR-23 questionnaires. The proportion of pts with improvement, stabilization or worsening of QoL scores was determined from week 7 and analyzed using linear models with repeated measures (generalized estimating questions technique) and SAS (v8.2). Results: There were 529 evaluable pts: median age 53 years (22–88); median ECOG PS 1 (0–4); majority Caucasian (86%). We detected significant improvements (p<0.0001 unless stated) in: global health status, role and emotional functioning, pain, appetite loss, constipation, future perspective, systemic therapy, breast symptoms, hair loss, body image (p=0.00012), fatigue (p=0.0004), insomnia (p=0.0004), nausea/vomiting (p<0.001), arm symptoms (p=0.00114), diarrhea (p=0.00154), and financial problems (p=0.0086). The proportion of pts with stable or improved QoL was ≥70% for most scales (none <60%). At least 40% of pts reported improvements from week 7 onwards as follows: pain (49%), fatigue (47%), emotional functioning (45%), arm symptoms (45%), global health status (43%), role functioning (41%), and future perspective (41%). Pts with a poor PS at baseline (ECOG ≥3) had a greater improvement in QoL than those with a good PS. Conclusions: X measurably improves QoL (global score and individual domains) in pts with MBC. These findings highlight the importance of considering QoL and other measurable benefits of oral treatments alongside well-established measures of clinical evaluation in pts with metastatic disease. The QoL benefits, together with other proven clinical outcomes, suggest that earlier use of X in MBC would be of benefit to pts. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Fundação Hospital Amaral Carvalho