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Randomized Controlled Trial
. 2012 Mar 13;106(6):1062-7.
doi: 10.1038/bjc.2012.43. Epub 2012 Feb 21.

Long-term assessment of quality of life in the Intergroup Exemestane Study: 5 years post-randomisation

L J Fallowfield  1 , L S Kilburn, C Langridge, C F Snowdon, J M Bliss, R C Coombes; IES Trial Steering Committee
Collaborators, Affiliations
Randomized Controlled Trial

Long-term assessment of quality of life in the Intergroup Exemestane Study: 5 years post-randomisation

L J Fallowfield et al. Br J Cancer. .

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.

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Figures

Figure 1
Figure 1
CONSORT flow diagram.
Figure 2
Figure 2
Mean change from baseline TOI scores within treatment groups. Error bars denote 95% CIs. Between treatment group: positive mean change in QoL favours exemestane. Within treatment group: positive mean change in QoL indicates improvement from baseline. Mean (s.d.) baseline TOI scores are exemestane=73.1 (10.9); tamoxifen=72.1 (11.5).
Figure 3
Figure 3
Mean change from baseline ES scores within treatment groups. Error bars denote 95% CIs. Between treatment group: positive mean change in QoL favours exemestane. Within treatment group: positive mean change in QoL indicates improvement from baseline. Mean (s.d.) baseline ES scores are exemestane=57.0 (9.1); tamoxifen=56.7 (9.8).
Figure 4
Figure 4
Mean change from baseline FACT B+ES scores within treatment groups Error bars denote 95% CIs. Between treatment group: positive mean change in QoL favours exemestane. Within treatment group: positive mean change in QoL indicates improvement from baseline. Mean (s.d.) baseline TOI scores are exemestane=180.8 (23.5); tamoxifen=178.9 (24.7).
Figure 5
Figure 5
(A) Vasomotor and neuropsychological symptoms. (B) Gastrointestinal and gynaecological symptoms.
Figure 6
Figure 6
Reporting of severe vaginal discharge over time in the QoL study. Key: Solid bars indicate % patients reporting severe vaginal discharge on treatment; Hatched bars indicate % patients reporting severe vaginal discharge post treatment.
Figure 7
Figure 7
Reporting of severe loss of libido over time in the QoL study. Key: Solid bars indicate % patients reporting severe loss of libido on treatment; Hatched bars indicate % patients reporting severe loss of libido post treatment.
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