| Titre : | Overview of the main outcomes in breast-cancer prevention trials. (2003) |
| Auteurs : | J. CUZICK ; S. ASHLEY ; P. BOYLE ; R. EDWARDS ; FORBES (J.) : AUS. Australia New Zealand Trials Group. Newcastle. ; T. POWLES ; U. VERONESI ; Cancer Research Uk. London. GBR ; European Institute of Oncology. Milan. ITA ; Royal Marsden Hospital. Institute of Cancer Research. London. GBR |
| Type de document : | Article |
| Dans : | Lancet (The) (vol. 361, n° 9354, 2003) |
| Pagination : | 296-300 |
| Langues: | Anglais |
| Mots-clés : | Cancer ; Sein ; Prévention thérapeutique ; Evolution ; Survie ; Etude comparée ; Essai comparatif ; Essai thérapeutique ; Homme ; Femme ; Glande mammaire [pathologie] |
| Résumé : | [BDSP. Notice produite par INIST-CNRS jR0x0gU7. Diffusion soumise à autorisation]. Background Early findings on the use of tamoxifen or raloxifene as prophylaxis against breast cancer have been mixed ; we update available data and overview the combined results. Methods All five randomised prevention trials comparing tamoxifen or raloxifene with placebo were included. Relevant data on contralateral breast tumours and side-effects were included from an overview of adjuvant trials of tamoxifen versus control. Findings The tamoxifen prevention trials showed a 38% (95% Cl 28-46 ; p<0.0001) reduction in breast-cancer incidence. There was no effect for breast cancers negative for oestrogen receptor (ER ; hazard ratio 1.22 [0.09-1.67] ; p=0.21), but ER-positive cancers were decreased by 48% (36-58 ; p<0.0001) in the tamoxifen prevention trials. Age had no apparent effect. Rates of endometrial cancer were increased in all tamoxifen prevention trials (consensus relative risk 2.4 [1.5-4.0] ; p=0.0005) and the adjuvant trials (relative risk 3.4 [1.8-6.4] ; p=0.0002) ; no increase has been seen so far with raloxifene. Venous thromboembolic events were increased in all tamoxifen studies (relative risk 1.9 [1.4-2.6] in the prevention trials ; p<0.0001) and with raloxifene. Overall, there was no effect on non-breast-cancer mortality ; the only cause showing a mortality increase was pulmonary embolism (six vs two). Interpretation The evidence now clearly shows that tamoxifen can reduce the risk of ER-positive breast cancer. New approaches are needed to prevent ER-negative breast cancer and to reduce the side-effects of tamoxifen. Newer agents such as raloxifene and the aromatase inhibitors need to be evaluated. Although tamoxifen cannot yet be recommended as a preventive agent (except possibly in women at very high risk with a low risk of side-effects), continued follow-up of the current trials is essential for identification of a subgroup of high-risk, healthy women for whom the risk-benefit ratio is sufficiently positive. |
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