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• W2326931481 abstract "Abstract Abstract #66 LIBERATE, a randomized, placebo controlled, double blind trial studied the effect of tibolone (Livial), a tissue selective hormone replacement therapy (HRT) on breast cancer (BC) recurrence, aiming to demonstrate non-inferiority of treatment compared to placebo. In the LIFT trial of osteoporotic women, tibolone prevented BC development.&#x2028; Design and Method: Women with surgically treated BC (T1-3, N0-2, M0) within the last 5 years complaining of vasomotor symptoms, were randomly assigned to tibolone 2.5mg daily or placebo treatment for a maximum of 5 years. Adequate sample size was estimated to be &gt;1500 in each arm. A bone mineral density (BMD) sub-study of 724 patients (454 Caucasian; 270 Asian) was enrolled utilizing DXA scanning at baseline and 2 years.&#x2028; Results: Between 2002 and 2004, 3,148 women were randomized in 31 countries; 1579 to tibolone and 1569 to placebo. Mean age at randomization was 52.7 years (28.0-75.0) and mean time since surgery was 2.1 years. In total 58% of women recruited were node positive and 78% ER positive. The trial closed prematurely in July 2007, with a median follow-up of 3.1 years (0.01-4.99) per patient, because an increased risk of BC recurrence occurred on tibolone HR 1.40 (1.14-1.70; p&lt;0.001); 15.2% (237/1556) women on tibolone recurred compared to 10.7% (165/1542) on placebo. Risk for distant recurrence on tibolone was HR 1.38 (95% CI 1.09-1.74 p=0.007).&#x2028; Aromatase inhibitor (AI) users had the highest risk of recurrence on tibolone HR 2.42 (1.01-5.79) compared to tamoxifen treated women HR 1.25 (0.98-1.59). Compared to ER positive cancers HR 1.56 (1.22-2.01), ER negative cancer had no increased risk of recurrence HR 1.15 (0.73-1.80). No differences in mortality occurred between groups.&#x2028; At entry to the bone sub-study, 298 (43%) women had normal BMD, 313 (45%) osteopenia (T-score between -1 and -2.5) and 81 (11.7%) osteoporosis. Low body mass index (&lt;0.001), Asian race (p&lt;0.001) and old age at menarche predicted for low bone mass after 2 years. Tibolone increased BMD by 3.5% at the lumbar spine and 2.9% at the hip compared to placebo (both p&lt;0.001) and reduced fracture rate in the Caucasian (p=0.036) but not the Asian population. Women with normal BMD (before or at day 1) had increased recurrence on tibolone 15.1% (21/139) compared to placebo 6.9% (11/159) p=0.036, whereas no increased BC recurrence was seen in women with low BMD; 7.5% (15/201) on tibolone and 6.7% (13/193) on placebo.&#x2028; Conclusion: HRT after breast cancer treatment increases BC recurrence especially in AI treated patients. Risk of BC recurrence is elevated in BC women with normal BMD (compared to low) who take HRT. Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 66." @default.
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• W2326931481 date "2009-01-01" @default.
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• W2326931481 title "Effect of tibolone on breast cancer recurrence: LIBERATE trial bone sub-study." @default.
• W2326931481 doi "https://doi.org/10.1158/0008-5472.sabcs-66" @default.
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