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Breast conserving therapy versus mastectomy for stage I-II breast cancer: 20 year follow-up of the EORTC 10801 phase 3 randomised trial.

Abstract

BACKGROUND

The EORTC 10801 trial compared breast-conserving therapy (BCT) with modified radical mastectomy (MRM) in patients with tumours 5 cm or smaller and axillary node negative or positive disease. Compared with BCT, MRM resulted in better local control, but did not affect overall survival or time to distant metastases. We report 20-year follow-up results.

METHODS

The EORTC 10801 trial was open for accrual between 1980 and 1986 in eight centres in the UK, the Netherlands, Belgium, and South Africa. 448 patients were randomised to BCT and 420 to MRM. Randomisation was done centrally, stratifying patients by institute, carcinoma stage (I or II), and menopausal status. BCT comprised of lumpectomy and complete axillary clearance, followed by breast radiotherapy and a tumour-bed boost. The primary endpoint was time to distant metastasis. This analysis was done on all eligible patients, as they were randomised.

FINDINGS

After a median follow-up of 22·1 years (IQR 18·5-23·8), 175 patients (42%) had distant metastases in the MRM group versus 207 (46%) in the BCT group. Furthermore, 506 patients (58%) died (232 [55%] in the MRM group and 274 [61%] in the BCT group). No significant difference was observed between BCT and MRM for time to distant metastases (hazard ratio 1·13, 95% CI 0·92-1·38; p=0·23) or for time to death (1·11, 0·94-1·33; 0·23). Cumulative incidence of distant metastases at 20 years was 42·6% (95% CI 37·8-47·5) in the MRM group and 46·9% (42·2-51·6) in the BCT group. 20-year overall survival was estimated to be 44·5% (95% CI 39·3-49·5) in the MRM group and 39·1% (34·4-43·9) in the BCT group. There was no difference between the groups in time to distant metastases or overall survival by age (time to distant metastases: <50 years 1·09 [95% CI 0·79-1·51] vs ≥50 years 1·16 [0·90-1·50]; overall survival <50 years 1·17 [0·86-1·59] vs ≥50 years 1·10 [0·89-1·37]).

INTERPRETATION

BCT, including radiotherapy, offered as standard care to patients with early breast cancer seems to be justified, since long-term follow-up in this trial showed similar survival to that after mastectomy.

FUNDING

European Organisation for Research and Treatment of Cancer (EORTC).

Links

  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    European Organisation for Research and Treatment of Cancer, Brussels, Belgium.

    , , , , , , ,

    Source

    The Lancet. Oncology 13:4 2012 Apr pg 412-9

    MeSH

    Adult
    Aged
    Breast Neoplasms
    Female
    Follow-Up Studies
    Humans
    Mastectomy
    Middle Aged
    Neoplasm Metastasis
    Neoplasm Recurrence, Local
    Neoplasm Staging
    Survival Analysis

    Pub Type(s)

    Journal Article
    Randomized Controlled Trial
    Research Support, N.I.H., Extramural
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    22373563

    Citation

    Litière, Saskia, et al. "Breast Conserving Therapy Versus Mastectomy for Stage I-II Breast Cancer: 20 Year Follow-up of the EORTC 10801 Phase 3 Randomised Trial." The Lancet. Oncology, vol. 13, no. 4, 2012, pp. 412-9.
    Litière S, Werutsky G, Fentiman IS, et al. Breast conserving therapy versus mastectomy for stage I-II breast cancer: 20 year follow-up of the EORTC 10801 phase 3 randomised trial. Lancet Oncol. 2012;13(4):412-9.
    Litière, S., Werutsky, G., Fentiman, I. S., Rutgers, E., Christiaens, M. R., Van Limbergen, E., ... Bartelink, H. (2012). Breast conserving therapy versus mastectomy for stage I-II breast cancer: 20 year follow-up of the EORTC 10801 phase 3 randomised trial. The Lancet. Oncology, 13(4), pp. 412-9. doi:10.1016/S1470-2045(12)70042-6.
    Litière S, et al. Breast Conserving Therapy Versus Mastectomy for Stage I-II Breast Cancer: 20 Year Follow-up of the EORTC 10801 Phase 3 Randomised Trial. Lancet Oncol. 2012;13(4):412-9. PubMed PMID: 22373563.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Breast conserving therapy versus mastectomy for stage I-II breast cancer: 20 year follow-up of the EORTC 10801 phase 3 randomised trial. AU - Litière,Saskia, AU - Werutsky,Gustavo, AU - Fentiman,Ian S, AU - Rutgers,Emiel, AU - Christiaens,Marie-Rose, AU - Van Limbergen,Erik, AU - Baaijens,Margreet H A, AU - Bogaerts,Jan, AU - Bartelink,Harry, Y1 - 2012/02/27/ PY - 2012/3/1/entrez PY - 2012/3/1/pubmed PY - 2012/6/23/medline SP - 412 EP - 9 JF - The Lancet. Oncology JO - Lancet Oncol. VL - 13 IS - 4 N2 - BACKGROUND: The EORTC 10801 trial compared breast-conserving therapy (BCT) with modified radical mastectomy (MRM) in patients with tumours 5 cm or smaller and axillary node negative or positive disease. Compared with BCT, MRM resulted in better local control, but did not affect overall survival or time to distant metastases. We report 20-year follow-up results. METHODS: The EORTC 10801 trial was open for accrual between 1980 and 1986 in eight centres in the UK, the Netherlands, Belgium, and South Africa. 448 patients were randomised to BCT and 420 to MRM. Randomisation was done centrally, stratifying patients by institute, carcinoma stage (I or II), and menopausal status. BCT comprised of lumpectomy and complete axillary clearance, followed by breast radiotherapy and a tumour-bed boost. The primary endpoint was time to distant metastasis. This analysis was done on all eligible patients, as they were randomised. FINDINGS: After a median follow-up of 22·1 years (IQR 18·5-23·8), 175 patients (42%) had distant metastases in the MRM group versus 207 (46%) in the BCT group. Furthermore, 506 patients (58%) died (232 [55%] in the MRM group and 274 [61%] in the BCT group). No significant difference was observed between BCT and MRM for time to distant metastases (hazard ratio 1·13, 95% CI 0·92-1·38; p=0·23) or for time to death (1·11, 0·94-1·33; 0·23). Cumulative incidence of distant metastases at 20 years was 42·6% (95% CI 37·8-47·5) in the MRM group and 46·9% (42·2-51·6) in the BCT group. 20-year overall survival was estimated to be 44·5% (95% CI 39·3-49·5) in the MRM group and 39·1% (34·4-43·9) in the BCT group. There was no difference between the groups in time to distant metastases or overall survival by age (time to distant metastases: <50 years 1·09 [95% CI 0·79-1·51] vs ≥50 years 1·16 [0·90-1·50]; overall survival <50 years 1·17 [0·86-1·59] vs ≥50 years 1·10 [0·89-1·37]). INTERPRETATION: BCT, including radiotherapy, offered as standard care to patients with early breast cancer seems to be justified, since long-term follow-up in this trial showed similar survival to that after mastectomy. FUNDING: European Organisation for Research and Treatment of Cancer (EORTC). SN - 1474-5488 UR - https://www.unboundmedicine.com/medline/citation/22373563/full_citation L2 - https://linkinghub.elsevier.com/retrieve/pii/S1470-2045(12)70042-6 DB - PRIME DP - Unbound Medicine ER -