Abstract
8015 Background: To assess quality of life (QL) in a multicentre phase III randomised trial evaluating the benefit of adding CT and/or OS to adjuvant TAM in pre/perimenopausal women, and of adding CT to TAM in postmenopausal women. Key QL outcomes included systemic and menopausal symptoms, mood, sexual functioning, body image, role functioning and global QL. Methods: Patients reported QL using the EORTC QLQ-C30, BR23 breast cancer module, Hospital Anxiety and Depression Scale (HADS) and Menopausal Symptom Scale (MSS), before randomisation and at 3, 6, 9, 18, 30, 48 and 72 months. Results: From 1997–2000, 436/3854 patients in the ABC trial were recruited to the QL study (247 in +/-CT comparison, 199 in +/-OS comparison), median age 49 (range 28–79). Compliance with QL forms was high; 99.8% at baseline ranging to 86.3% at 30 months. The addition of CT was associated with worse QL during the first 9 months for depression (p=0.007), role function (p=0.003) and global QL (p=0.001) and a trend to worse QL for body image concerns (p=0.02), and sexual enjoyment (p=0.08). Systemic side effects (p=0.001) and menopausal problems (p=0.02) were worse over 30 months. The addition of OS resulted in increased menopausal symptoms (p<0.0001), depression (p=0.05) and anxiety (p=0.04) over 30 months but no deterioration in role function, global QL, body image or sexual function. Conclusions: Adverse QL counters the potential benefits of additional CT; therefore treatment choice should consider possible health gains and QL losses. The negative QL effect of OS is paralleled by a lack of clinical benefit in the ABC trial. No significant financial relationships to disclose.
Published Version
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