Tamoxifen in treatment of intraductal breast cancer: National Surgical Adjuvant Breast and Bowel Project B-24 randomised controlled trial

Citation
B. Fisher et al., Tamoxifen in treatment of intraductal breast cancer: National Surgical Adjuvant Breast and Bowel Project B-24 randomised controlled trial, LANCET, 353(9169), 1999, pp. 1993-2000
Citations number
26
Categorie Soggetti
General & Internal Medicine","Medical Research General Topics
Journal title
LANCET
ISSN journal
01406736 → ACNP
Volume
353
Issue
9169
Year of publication
1999
Pages
1993 - 2000
Database
ISI
SICI code
0140-6736(19990612)353:9169<1993:TITOIB>2.0.ZU;2-9
Abstract
Background: We have shown previously that lumpectomy with radiation therapy was more effective than lumpectomy alone for the treatment of ductal carci noma in situ (DCIS). We did a double-blind randomised controlled trial to f ind out whether lumpectomy, radiation therapy, and tamoxifen was of more be nefit than lumpectomy and radiation therapy alone for DCIS. Methods: 1804 women with DCIS, including those whose resected sample margin s were involved with tumour, were randomly assigned lumpectomy, radiation t herapy (50 Gy), and placebo (n = 902), or lumpectomy, radiation therapy, an d tamoxifen (20 mg daily for 5 years, n = 902). Median follow-up was 74 mon ths (range 57-93), We compared annual event rates and cumulative probabilit y of invasive or non-invasive ipsilateral and contralateral tumours over 5 years. Findings: Women in the tamoxifen group had fewer breast-cancer events at 5 years than did those on placebo (8.2 vs 13.4%, p = 0 0009). The cumulative incidence of all invasive breast-cancer events in the tamoxifen group was 4 .1% at 5 years: 2.1% in the ipsilateral breast, 1.8% in the contralateral b reast, and 0.2% at regional or distant sites. The risk of ipsilateral-breas t cancer was lower in the tamoxifen group even when sample margins containe d tumour and when DCIS was associated with comedonecrosis. Interpretation: The combination of lumpectomy, radiation therapy, and tamox ifen was effective in the prevention of invasive cancer.