San Antonio Breast Cancer Symposium, December 6-10, 2016

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Presentation transcript:

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 This presentation is the intellectual property of the author/presenter. Contact them at s.smith1@leeds.ac.uk for permission to reprint and/or distribute.

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 s.smith1@leeds.ac.uk for permission to reprint and/or distribute.

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 This presentation is the intellectual property of the author/presenter. Contact them at s.smith1@leeds.ac.uk for permission to reprint and/or distribute.

Methods Inclusion criteria: Exclusion criteria: San Antonio Breast Cancer Symposium, December 6-10, 2016 Methods Inclusion criteria: UK women aged 35-70 at increased risk of breast cancer Exclusion criteria: Death or invasive cancer diagnosis (excl NMSC) Experienced serious thromboembolic event or DVT Underwent prophylactic mastectomy This presentation is the intellectual property of the author/presenter. Contact them at s.smith1@leeds.ac.uk for permission to reprint and/or distribute.

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 This presentation is the intellectual property of the author/presenter. Contact them at s.smith1@leeds.ac.uk for permission to reprint and/or distribute.

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 (45.9-53.9) 49.3 (45.6-53.6) 0.4 BMI 25.9 (23.2-29.3) 25.7 (23.1-29.4) 0.9 Family history 0.7 One relative 39.1% 39.6% 2+ relatives 60.9% 60.4% Tyrer-Cuzick risk (%), median 5.7 (4.6-7.3) 5.7 (4.6-7.2) 0.15 This presentation is the intellectual property of the author/presenter. Contact them at s.smith1@leeds.ac.uk for permission to reprint and/or distribute.

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 (1.34-1.75) <0.0001 Mean time on study (years (SD)) 4.1 (1.6) 4.3 (1.5) 3.9 (1.7) This presentation is the intellectual property of the author/presenter. Contact them at s.smith1@leeds.ac.uk for permission to reprint and/or distribute.

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 This presentation is the intellectual property of the author/presenter. Contact them at s.smith1@leeds.ac.uk for permission to reprint and/or distribute.

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 This presentation is the intellectual property of the author/presenter. Contact them at s.smith1@leeds.ac.uk for permission to reprint and/or distribute.

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 (0.35-0.86) P=0.98 0.54 (0.36-0.82) 0.59 (0.40-0.86) Headaches P=0.23 0.83 (0.57-1.19) 0.99 (0.76-1.30) Hot flashes P=0.48 0.88 (0.71-1.08) 0.99 (0.73-1.35) Gynecologic P=0.21 Placebo 0.77 (0.61-0.96) Tamoxifen 0.5 1 1.5 This presentation is the intellectual property of the author/presenter. Contact them at s.smith1@leeds.ac.uk for permission to reprint and/or distribute.

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 This presentation is the intellectual property of the author/presenter. Contact them at s.smith1@leeds.ac.uk for permission to reprint and/or distribute.

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 This presentation is the intellectual property of the author/presenter. Contact them at s.smith1@leeds.ac.uk for permission to reprint and/or distribute.