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Livial and Breast Cancer Update

Livial and Breast Cancer Update. Associate Professor John Eden UNSW, Royal Hospital for Women, Sydney. A Multi centre RCT of 5 years duration Primary Objective To demonstrate non inferiority of tibolone 2.5mg daily compared to placebo regarding breast cancer recurrence.

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Livial and Breast Cancer Update

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  1. Livial and Breast Cancer Update Associate Professor John Eden UNSW, Royal Hospital for Women, Sydney

  2. A Multi centre RCT of 5 years duration Primary Objective To demonstrate non inferiority of tibolone 2.5mg daily compared to placebo regarding breast cancer recurrence

  3. 3148 women from 245 sites in 31 countries • 3133 received trial medication • 3098 included in Intention to Treat Analysis

  4. : External committees • Scientific Advisory Board • Data Safety Monitoring Board (DSMB) - Adjudication Committees - Cardiovascular Events - Breast and Gynecological cancers - Endometrial Tissue

  5. : Definition of Br Ca Recurrence • Local BC recurrence in and/or around the operated breast and or scar operation field • Distant BC recurrence (metastasis) • New Primary contralateral BC • Death due to BC recurrence All BC recurrences decided by an independent expert adjudication committee

  6. 10% 11.6%

  7. : Primary Outcome

  8. Breast Cancer recurrence (I.T.T)HR Livial v Placebo(95% CI)

  9. : Breast Cancer Recurrence by Node Status HR 1.36 (1.09 – 1.69)

  10. : Br Ca recurrence by E Receptor Status ER Positive ER Negative

  11. Secondary Endpoints • No increase in any other malignancy • No increase in cardiovascular disease • No increase in Stroke • No increase in Venous Thromboembolic disease • Significant reduction in Vasomotor Symptoms • Beneficial effect on bone density

  12. :Conclusions Tibolone, given for three years on average to women with vasomotor symptoms and a history of BC showed - • Overall an increased risk of BC recurrence vs placebo treated patients HR 1.40(95%CI 1.14-1.70) • No difference in other safety parameters. • A beneficial effect on BMD & vasomotor symptoms • The use of tibolone in conjunction with an aromatase inhibitor may lead to a greater risk of BC recurrence. • The contraindication to the use of tibolone in women with known, past or suspected BC must remain.

  13. Clinical Trials of tibolone Over 13,000 women in RCTs Outcomes assessed include bleeding patterns, symptom relief, bone density, fracture prevention, sexual response, endometrial safety and breast safety after breast cancer. All trials now concluded

  14. LIFT StudyLong-Term Intervention on Fractures with Tibolone

  15. Multi-centre RCT of Tibolone 1.25 mg or Placebo for 36 months. N=4538 osteoporotic postmenopausal women aged 60-85 years. Primary end-points - Vertebral and non-vertebral fracture rate & BMD Secondary end-points Cardiovascular events Breast, Bowel and gynae. cancers LIFT

  16. LIFT - Results Vertebral Fracture RR 0.57 (0.42 – 0.78) Non Vertebral Fracture RR 0.74 (0.58 – 0.93) Breast Cancer RR 0.32 (0.13 – 0.80) Colon Cancer RR 0.31 (0.10 – 0.96) VTE RR 0.57 (0.19 – 1.69) CHD RR 1.37 (0.76 – 2.45) Stroke RR 2.19 (1.14 – 4.23)

  17. Cumulative incidence of breast cancer by treatment group Absolute risk of breast cancer reduced by 1.9 cases / 1,000 person-years placebo tibolone

  18. Conclusions Tibolone reduced the risk of fracture, breast cancer and colon cancer in older women with osteoporosis. ‘Tibolone should not be initiated in older post-menopausal women because of the increased risk of stroke’

  19. Livial: Where are we now? In 10,000 women without proven breast cancer: • Alleviation of hot flushes & other menopause symptoms without endometrial stimulation • No VTE or adverse cardiac events; stroke risk increased (perhaps) • Fracture risk reduced • No increase in breast cancer or benign breast symptoms In 3000 women with a history of breast cancer: • Recurrence rate increased in a population where 80% were using endocrine therapy concurrently

  20. ‘Thus, whilst tibolone should not be used in women with breast cancer, the indication for symptom relief in post menopausal women remains unchanged’

  21. Managing flushes after BC • Review aggravators • Paced respiration, relaxation therapies • Stop endocrine therapy for 2-4 weeks • Avoid over heating, hot drinks, spicy foods • Remifemin 4/d • Non-Oestrogen drugs for flushes • SSRI,SNRI • Catapress • Gabapentin • combinations

  22. Genitourinary symptoms after BC • Vulval care • Soap-free washes, moisturisers • Replens • Non-hormonal vaginal moisturiser • Lubricants • Olive Oil, Sylk • Other strategies • Pelvic floor relaxation; Botox • Topical oestrogens (New study soon)

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