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Titolo:
INTERIM ANALYSIS OF THE INCIDENCE OF BREAST-CANCER IN THE ROYAL-MARSDEN-HOSPITAL TAMOXIFEN RANDOMIZED CHEMOPREVENTION TRIAL
Autore:
POWLES T; EELES R; ASHLEY S; EASTON D; CHANG J; DOWSETT M; TIDY A; VIGGERS J; DAVEY J;
Indirizzi:
ROYAL MARSDEN NHS TRUST LONDON ENGLAND ROYAL MARSDEN NHS TRUST SUTTON SM2 5PT SURREY ENGLAND STRANGEWAYS LAB,CRC,CANC GENET TEAM CAMBRIDGE ENGLAND INST CANC RES,CANC GENET TEAM SUTTON SURREY ENGLAND
Titolo Testata:
Lancet
fascicolo: 9122, volume: 352, anno: 1998,
pagine: 98 - 101
SICI:
0140-6736(1998)352:9122<98:IAOTIO>2.0.ZU;2-3
Fonte:
ISI
Lingua:
ENG
Soggetto:
THERAPY; RISK;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Citazioni:
18
Recensione:
Indirizzi per estratti:
Citazione:
T. Powles et al., "INTERIM ANALYSIS OF THE INCIDENCE OF BREAST-CANCER IN THE ROYAL-MARSDEN-HOSPITAL TAMOXIFEN RANDOMIZED CHEMOPREVENTION TRIAL", Lancet, 352(9122), 1998, pp. 98-101

Abstract

Background Tamoxifen, a drug with antioestrogenic effects, is predicted to prevent the occurrence of breast cancer, We have undertaken a trial of tamoxifen in healthy women who are at increased risk of breast cancer because of family history. We report a planned interim analysis, Methods Between October, 1986, and April, 1996, we accrued 2494 healthy women aged between 30 and 70 with a family history of breast cancer, They have been randomised (double blind) to receive tamoxifen 20 mgper day orally or placebo for up to 8 years. Follow-up included clinical assessment, annual mammography, and assessment of toxicity and compliance. The primary endpoint was the occurrence of breast cancer, which was analysed on an intention-to-treat basis with a survival curve. Findings With a median follow-up of 70 months, 2471 women (tamoxifen 1238, placebo 1233) were suitable for analysis, The groups were evenly matched at baseline, and compliance was good. The overall frequency ofbreast cancer is the same for women on tamoxifen or placebo (tamoxifen 34, placebo 36, relative risk 1.06 [95% CI 0.7-1.7], p=0.8). Participants who were already on hormone-replacement therapy when they entered the study had an increased risk of breast cancer compared with nonusers. Those participants who started such therapy while on trial had a significantly reduced risk. The safety profile of tamoxifen was as expected. Interpretation We have been unable to show any effect of tamoxifen on breast-cancer incidence in healthy women, contrary to the report from the NSABP-P1 study showing a 45% reduction in healthy women given tamoxifen versus placebo. Differences in the study populations for the two trials may underlie these conflicting findings: eligibility inour trial was based predominantly on a strong family history of breast cancer whereas in the NSABP trial was mostly based on non-genetic risk factors. The importance of oestrogen promotion may vary between such populations.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 14/08/20 alle ore 08:24:59