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Kenemans and colleagues have recently reported the effects of tibolone, as compared to placebo, on risk of recurrence in breast cancer patients with climacteric complaints [1]. During 2002–2004, in the prospective multicenter LIBERATE trial, as many as 3148 women, after surgery for confirmed breast cancer and with vasomotor symptoms, were randomized to receive either tibolone 2.5 mg daily or placebo. Their mean age was 52.7 ± 7.3 years, the mean time since surgery was 2.1 ± 1.3 years, 58% were node-positive, 78% were estrogen receptor-positive, 67% used tamoxifen and 6.5% used aromatase inhibitors. The mean daily number of hot flushes was 6.4 ± 5.1.


After a median follow-up of 3.1 years (range 0.01–4.99 years), 237 of 1556 (15.2%) women on tibolone had a recurrence, compared with 165 of 1542 (10.7%) on placebo (hazard ratio (HR) 1.40; 95% confidence interval (CI) 1.14–1.70; p = 0.001). Tibolone was not different from placebo with regard to other safety outcomes, such as mortality, cardiovascular events or gynecological cancers. Vasomotor symptoms and bone mineral density improved significantly with tibolone compared with placebo.


  • Bo von Schoultz
    Department of Obstetrics and Gynecology, Karolinska Institutet and University Hospital, Stockholm, Sweden


  1. Kenemans P, Bundred NJ, Foidart JM, et al. Safety and efficacy of tibolone in breast-cancer patients with vasomotor symptoms: a double-blind, randomized, non-inferiority trial. Lancet Oncol 2009;10:135-46. Published February 2009.
  2. Hickey M, Saunders CM, Stuckey BG. Management of menopausal symptoms in patients with breast cancer: an evidence-based approach. Lancet Oncol 2005;6:687-95.
  3. von Schoultz E, Rutqvist LE; Stockholm Breast Cancer Study Group. Menopausal hormone therapy after breast cancer: the Stockholm randomized trial. J Natl Cancer Inst 2005;97:533-5.
  4. Holmberg L, Anderson H; HABITS steering and data monitoring committees. HABITS (hormonal replacement therapy after breast cancer is it safe?), a randomized comparison trial stopped.Lancet 2004;363:453-55.
  5. Holmberg L, Iversen OE, Rudenstam CM. Increased risk of recurrence after hormone replacement in breast cancer surviviors. J Natl Cancer Inst 2008;100:475-82. Published April 2, 2008.
  6. Lundström E, Christow A, Kersemaekers W, et al. Effects of tibolone and continuous hormone replacement therapy on mammographic breast density. Am J Obstet Gynecol 2002;186:717-22.
  7. Conner P, Christow A, Kersemaekers W, et al. A comparative study of breast cell proliferation during hormone replacement: effects of tibolone and continuous combined estrogenprogestogen treatment. Climacteric 2004;7:50-8.
  8. Cummings SR, Ettinger B, Delmas PD, et al. The effects of tibolone in older postmenopausal women. N Engl J Med 2008;359:697-708. Published August 14, 2008.
  9. Opatrny L, DellAniello S, Assouline S, Suissa S. Hormone replacement therapy use and variations in the risk of breast cancer. Br J Obstet Gynaecol 2008;115:169-75. Published January 2008.
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