1. San Antonio Breast Cancer Symposium, December 6-10, 2016
Menopausal symptoms as predictors of long- term adherence in the International Breast Cancer Intervention Study (IBIS-1)
Samuel G. Smith*1,2, Ivana Sestak*2, Anthony Howell3,
John Forbes4, Jack Cuzick2
* Joint lead authors
1. Leeds Institute of Health Sciences, University of Leeds, Leeds, UK
2. Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK
3. Institute of Cancer Sciences, University of Manchester, Manchester, UK
4. Department of Surgical Oncology, Calvary Mater Newcastle Hospital, Newcastle, Australia
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2. Conflict of interest None to declare
San Antonio Breast Cancer Symposium, December 6-10, 2016
Conflict of interest
None to declare
This presentation is the intellectual property of the author/presenter. Contact them at for permission to reprint and/or distribute.

3. Background Nine randomised SERM primary prevention trials
San Antonio Breast Cancer Symposium, December 6-10, 2016
Background
Nine randomised SERM primary prevention trials
Reduction in breast cancer incidence of at least 30%
IBIS 1 data show effects persist for at least 20 years
Increased risk of thromboembolic events, endometrial cancer and menopausal side-effects
Aim: To assess the role of menopausal symptoms on adherence in the IBIS-1 trial
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4. Methods Inclusion criteria: Exclusion criteria:
San Antonio Breast Cancer Symposium, December 6-10, 2016
Methods
Inclusion criteria:
UK women aged at increased risk of breast cancer
Exclusion criteria:
Death or invasive cancer diagnosis (excl NMSC)
Experienced serious thromboembolic event or DVT
Underwent prophylactic mastectomy
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5. Methods Menopausal symptoms prior to trial entry
San Antonio Breast Cancer Symposium, December 6-10, 2016
Methods
Menopausal symptoms prior to trial entry
Menopausal symptoms (6M)
Nausea / vomiting
Irregular bleeding/ vaginal dryness/ vaginal discharge
Headaches
Hot flashes
Adherence defined as 4.5 years on therapy for this analysis
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6. Results: baseline sample
San Antonio Breast Cancer Symposium, December 6-10, 2016
Results: baseline sample
Placebo
(n=2000)
Tamoxifen
(n=1987)
P-value
Age (years), median
49.2 ( )
49.3 ( )
0.4
BMI
25.9 ( )
25.7 ( )
0.9
Family history
0.7
One relative
39.1%
39.6%
2+ relatives
60.9%
60.4%
Tyrer-Cuzick risk (%), median
5.7 ( )
5.7 ( )
0.15
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7. Results: adherence Overall Placebo Tamoxifen OR (95% CI) P-value
San Antonio Breast Cancer Symposium, December 6-10, 2016
Results: adherence
Overall
Placebo
Tamoxifen
OR (95% CI)
P-value
Adherent 4.5 years
2663 (66.8%)
1430
(71.5%)
1233
(62.1%)
1.53 ( )
<0.0001
Mean time on study (years (SD))
4.1 (1.6)
4.3 (1.5)
3.9 (1.7)
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8. Results: symptoms Mild (%) Moderate (%) Severe (%) Total (%)
San Antonio Breast Cancer Symposium, December 6-10, 2016
Results: symptoms
Mild (%)
Moderate (%)
Severe (%)
Total (%)
Nausea / vomiting
4.0
0.8
0.3
5.0
Headache
4.3
1.5
1.2
7.0
Hot flashes
17.7
8.7
5.1
31.5
Gynecologic
16.8
3.1
1.0
20.9
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9. Results: symptoms and adherence
San Antonio Breast Cancer Symposium, December 6-10, 2016
Results: symptoms and adherence
P<0.001
P=0.01
P=0.20
P=0.07
Adjusted for age, T-C risk, smoking status, HRT, menopausal status, baseline symptoms and treatment arm
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10. Results: symptoms and adherence
San Antonio Breast Cancer Symposium, December 6-10, 2016
Results: symptoms and adherence
Odds Ratio (95% CI)
Test for heterogeneity
Nausea/vomiting
0.55 ( )
P=0.98
0.54 ( )
0.59 ( )
Headaches
P=0.23
0.83 ( )
0.99 ( )
Hot flashes
P=0.48
0.88 ( )
0.99 ( )
Gynecologic
P=0.21
Placebo
0.77 ( )
Tamoxifen
0.5 1
1.5
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11. Discussion Interventions needed to manage menopausal symptoms
San Antonio Breast Cancer Symposium, December 6-10, 2016
Discussion
Interventions needed to manage menopausal symptoms
Drop-out rates suggest targeting first 6-12 months
Addressing medication concerns prior to initiation may:
Encourage realistic expectations & prevent misattribution
CBT effective in adjuvant setting
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12. Acknowledgements IBIS-1 participants IBIS-1 recruitment sites
San Antonio Breast Cancer Symposium, December 6-10, 2016
Acknowledgements
IBIS-1 participants
IBIS-1 recruitment sites
IBIS-1 trial steering committee
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