[Is the clinical profile of women treated with tibolone similar to that of women receiving a classical estrogen-progestogen therapy? Data from a nationwide survey in France]. / Le profil clinique des femmes qui utilisent la tibolone est-il le même que celui des femmes utilisant un traitement hormonal classique ? Données d'une enquête nationale en France.

ABSTRACT

OBJECTIVES: To compare the pre-existing risk profiles for breast or endometrial cancer of menopaused women receiving tibolone or another hormone replacement therapy in France, with a view to examining the possibility of biases of selection of patients and of detection of these cancers in the Million Women Study. PATIENTS AND METHODS: Nationwide survey conducted in France among a representative sample of 153 gynaecologists. The particulars of the last two consulting menopaused women treated with tibolone (N = 306) and of the last two treated with a classical estrogen-progestogen therapy (N = 306) were collated then analysed. RESULTS: Compared to those treated with a classical estrogen-progestogen therapy, more women receiving tibolone were aged 60 years or over (40 vs 31%; P < 0.01). More of them had risk factors for breast cancer (history of mastodynia or mastopathy, elevated mammographic breast density) (6 vs 50%; P < 0.01). More of them had a history of uterine investigation or exploration or of irregular bleeding (61 vs 53% of women with a history of irregular bleeding; P < 0.05). Overall, 84% of women treated with tibolone had at least one risk factor for breast or endometrial cancer vs 75% of those receiving a classical estrogen-progestogen therapy (P < 0.01). DISCUSSION AND CONCLUSION: Owing to its specific properties, tibolone is generally prescribed to women with a higher risk profile for breast or endometrial cancer than those receiving a classical estrogen-progestogen therapy, which may entail patient selection and cancer detection biases in non-randomised, open-label, observational studies.