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

Abstract

BACKGROUND

We have shown previously that lumpectomy with radiation therapy was more effective than lumpectomy alone for the treatment of ductal carcinoma in situ (DCIS). We did a double-blind randomised controlled trial to find out whether lumpectomy, radiation therapy, and tamoxifen was of more benefit than lumpectomy and radiation therapy alone for DCIS.

METHODS

1804 women with DCIS, including those whose resected sample margins were involved with tumour, were randomly assigned lumpectomy, radiation therapy (50 Gy), and placebo (n=902), or lumpectomy, radiation therapy, and tamoxifen (20 mg daily for 5 years, n=902). Median follow-up was 74 months (range 57-93). We compared annual event rates and cumulative probability 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 breast, and 0.2% at regional or distant sites. The risk of ipsilateral-breast cancer was lower in the tamoxifen group even when sample margins contained tumour and when DCIS was associated with comedonecrosis.

INTERPRETATION

The combination of lumpectomy, radiation therapy, and tamoxifen was effective in the prevention of invasive cancer.

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  • Authors+Show Affiliations

    ,

    National Surgical Adjuvant Breast and Bowel Project, Allegheny University of the Health Sciences, Pittsburgh, PA 15212-5234, USA. bfisher@aherf.edu

    , , , , , , , , , , , ,

    Source

    Lancet (London, England) 353:9169 1999 Jun 12 pg 1993-2000

    MeSH

    Antineoplastic Agents, Hormonal
    Breast Neoplasms
    Carcinoma in Situ
    Carcinoma, Intraductal, Noninfiltrating
    Carcinoma, Lobular
    Combined Modality Therapy
    Double-Blind Method
    Female
    Humans
    Mastectomy, Segmental
    Middle Aged
    Survival Rate
    Tamoxifen

    Pub Type(s)

    Clinical Trial
    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, U.S. Gov't, P.H.S.

    Language

    eng

    PubMed ID

    10376613

    Citation

    Fisher, B, et al. "Tamoxifen in Treatment of Intraductal Breast Cancer: National Surgical Adjuvant Breast and Bowel Project B-24 Randomised Controlled Trial." Lancet (London, England), vol. 353, no. 9169, 1999, pp. 1993-2000.
    Fisher B, Dignam J, Wolmark N, et al. Tamoxifen in treatment of intraductal breast cancer: National Surgical Adjuvant Breast and Bowel Project B-24 randomised controlled trial. Lancet. 1999;353(9169):1993-2000.
    Fisher, B., Dignam, J., Wolmark, N., Wickerham, D. L., Fisher, E. R., Mamounas, E., ... Oishi, R. H. (1999). Tamoxifen in treatment of intraductal breast cancer: National Surgical Adjuvant Breast and Bowel Project B-24 randomised controlled trial. Lancet (London, England), 353(9169), pp. 1993-2000.
    Fisher B, et al. Tamoxifen in Treatment of Intraductal Breast Cancer: National Surgical Adjuvant Breast and Bowel Project B-24 Randomised Controlled Trial. Lancet. 1999 Jun 12;353(9169):1993-2000. PubMed PMID: 10376613.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Tamoxifen in treatment of intraductal breast cancer: National Surgical Adjuvant Breast and Bowel Project B-24 randomised controlled trial. AU - Fisher,B, AU - Dignam,J, AU - Wolmark,N, AU - Wickerham,D L, AU - Fisher,E R, AU - Mamounas,E, AU - Smith,R, AU - Begovic,M, AU - Dimitrov,N V, AU - Margolese,R G, AU - Kardinal,C G, AU - Kavanah,M T, AU - Fehrenbacher,L, AU - Oishi,R H, PY - 1999/6/22/pubmed PY - 1999/6/22/medline PY - 1999/6/22/entrez SP - 1993 EP - 2000 JF - Lancet (London, England) JO - Lancet VL - 353 IS - 9169 N2 - BACKGROUND: We have shown previously that lumpectomy with radiation therapy was more effective than lumpectomy alone for the treatment of ductal carcinoma in situ (DCIS). We did a double-blind randomised controlled trial to find out whether lumpectomy, radiation therapy, and tamoxifen was of more benefit than lumpectomy and radiation therapy alone for DCIS. METHODS: 1804 women with DCIS, including those whose resected sample margins were involved with tumour, were randomly assigned lumpectomy, radiation therapy (50 Gy), and placebo (n=902), or lumpectomy, radiation therapy, and tamoxifen (20 mg daily for 5 years, n=902). Median follow-up was 74 months (range 57-93). We compared annual event rates and cumulative probability 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 breast, and 0.2% at regional or distant sites. The risk of ipsilateral-breast cancer was lower in the tamoxifen group even when sample margins contained tumour and when DCIS was associated with comedonecrosis. INTERPRETATION: The combination of lumpectomy, radiation therapy, and tamoxifen was effective in the prevention of invasive cancer. SN - 0140-6736 UR - https://www.unboundmedicine.com/medline/citation/10376613/full_citation L2 - https://linkinghub.elsevier.com/retrieve/pii/S0140-6736(99)05036-9 DB - PRIME DP - Unbound Medicine ER -