Abstract
8599 Background: The oral fluoropyrimidine capecitabine is highly active and well tolerated as single-agent therapy and extends survival when added to docetaxel in pretreated MBC. QoL data would enhance understanding of X’s pt benefits. Methods: QoL was evaluated in women with anthracycline ± taxane-pretreated MBC while receiving X (baseline, before cycle 1, at weeks 7 and 13, and at treatment end) using EORTC QLQ C-30 (v3.0) and BR-23 questionnaires. We used linear models with repeated measures (generalized estimating questions technique) and SAS (v8.2) to determine improvement, stabilization or worsening of QoL scores from week 7 onwards. Each questionnaire item was analyzed as a function of pts’ ECOG status before first cycle and the evaluation periods. Results: Baseline characteristics of the 1,464 evaluable pts were: median age 54 years (range 22–92); 42% had ECOG 0. As expected, pts with worse initial PS (ECOG ≥2) had lower mean scores during treatment. Regardless of baseline ECOG score, X therapy was associated with significant (p<0.0001 unless stated) improvements in pts’ perception of: role functioning (p=0.001), pain, nausea/vomiting, fatigue, constipation, emotional functioning, and global health status. Capecitabine was also associated with significant improvements in pts’ perception of systemic therapy side effects (p<0.0001), breast symptoms (p<0.0001), arm symptoms (p=0.0047), hair loss (p<0.0001), and future perspective (p<0.0001). Conclusions: Pts receiving X had substantial improvements in almost all functional and symptomatic QoL domains. 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 early use of X in MBC would be of benefit to pts. No significant financial relationships to disclose.
Published Version
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