Abstract
Background:The Intergroup Exemestane Study (IES) (ISRCTN11883920) demonstrated improved survival for postmenopausal women with ER-positive/unknown primary breast cancer who switched to exemestane after 2–3 years tamoxifen, compared with those continuing on tamoxifen to complete 5 years therapy. This was achieved without detriment to on-treatment quality-of-life (QoL). We report on- and post-treatment QoL impact in IES.Methods:A total of 582 patients from 8 countries participated in the QoL substudy. Functional Assessment of Cancer Therapy–Breast (FACT-B) and endocrine symptom subscale (ES) were completed at baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 months. The primary endpoint was FACT-B Trial Outcome Index (TOI); secondary endpoints included severity of individual endocrine symptoms.Results:Both the groups showed gradual improvement in overall QoL and lessening of total endocrine symptoms post treatment compared with baseline (P<0.002). There was no evidence of any between-group differences in TOI. Vasomotor complaints remained high on treatment. Vaginal discharge was more frequent (P<0.01) with tamoxifen up to 24 months from baseline. In both the groups, post-treatment libido did not recover to baseline levels.Conclusion:Clinical benefits of switching to exemestane are accompanied by good overall QoL. Although some symptoms persist, the majority of endocrine symptoms improve after treatment completion.
Highlights
The Intergroup Exemestane Study (IES) (ISRCTN11883920) demonstrated improved survival for postmenopausal women with ER-positive/unknown primary breast cancer who switched to exemestane after 2 – 3 years tamoxifen, compared with those continuing on tamoxifen to complete 5 years therapy
To take into account multiple timepoints, repeated measures modelling using generalised estimating equations (GEE) was performed on Trial Outcome Index (TOI), endocrine symptom subscale (ES), Functional Assessment of Cancer Therapy – Breast (FACT-B) þ ES scores adjusting for allocated treatment, baseline QoL score, time from randomisation and the a priori specified factors of ER status, nodal status, chemotherapy use, and HRT use before random assignment
Previous reports from the IES QoL substudy have shown the temporal relationship of symptom development
Summary
The Intergroup Exemestane Study (IES) (ISRCTN11883920) demonstrated improved survival for postmenopausal women with ER-positive/unknown primary breast cancer who switched to exemestane after 2 – 3 years tamoxifen, compared with those continuing on tamoxifen to complete 5 years therapy. This was achieved without detriment to on-treatment quality-of-life (QoL). Functional Assessment of Cancer Therapy – Breast (FACT-B) and endocrine symptom subscale (ES) were completed at baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 months. RESULTS: Both the groups showed gradual improvement in overall QoL and lessening of total endocrine symptoms post treatment compared with baseline (Po0.002). British Journal of Cancer (2012) 106, 1062 – 1067. doi:10.1038/bjc.2012.43 www.bjcancer.com Published online 21 February 2012 & 2012 Cancer Research UK
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