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Bending the Curve Trial by Trial
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Milan I

Radical (Halsted) mastectomy versus quadrantectomy with axillary dissection and radiotherapy in small breast cancers

N = 701

Population
Women with breast cancer measuring no more than 2 cm in diameter (2002 report; the 1981 abstract says less than 2 cm) and no palpable axillary lymph nodes.
Design
Randomised controlled trial at the National Cancer Institute, Milan; 701 women randomised between 1973 and 1980; after 1976, node-positive patients in both groups also received CMF chemotherapy.
Arms
  • Halsted radical mastectomy (control, n = 349): Halsted radical mastectomy
  • Quadrantectomy + axillary dissection + RT (experimental, n = 352): Quadrantectomy with axillary dissection and radiotherapy to the ipsilateral residual breast tissue
People
Veronesi U, National Cancer Institute, Milan
Δ Local recurrence+6.5 pointsΔ Breast cancer mortality+1.8 pointsΔ All-cause mortality+0.5 points
Show the numbers
Results reported for Milan I
EndpointAnalysisQuadrantectomy + axillary dissection + RTHalsted radical mastectomyEffect
Local recurrenceRandomised women (701)Crude cumulative incidence of tumour recurrence in the same breast (breast-conserving arm) or local recurrence (radical-mastectomy arm), at 20 yearslong term-updateVeronesi 20028.8%2.3%P<0.001
Breast cancer mortalityRandomised women (701)Rate of death from breast cancer after a median follow-up of 20 yearslong term-updatemedian follow-up 20 yearsVeronesi 200226.1%24.3%P=0.8
All-cause mortalityRandomised women (701)Rate of death from all causes after a median follow-up of 20 yearslong term-updatemedian follow-up 20 yearsVeronesi 200241.7%41.2%P=1.0
Results reported for Milan I
EndpointAnalysisQuadrantectomy + axillary dissection + RTHalsted radical mastectomyEffect
Local recurrenceRandomised women (701)Crude cumulative incidence of tumour recurrence in the same breast (breast-conserving arm) or local recurrence (radical-mastectomy arm), at 20 yearslong term-updateVeronesi 20028.8%2.3%P<0.001
Breast cancer mortalityRandomised women (701)Rate of death from breast cancer after a median follow-up of 20 yearslong term-updatemedian follow-up 20 yearsVeronesi 200226.1%24.3%P=0.8
All-cause mortalityRandomised women (701)Rate of death from all causes after a median follow-up of 20 yearslong term-updatemedian follow-up 20 yearsVeronesi 200241.7%41.2%P=1.0
Primary publication: Veronesi U, Saccozzi R, Del Vecchio M, Banfi A, Clemente C, De Lena M, et al. Comparing radical mastectomy with quadrantectomy, axillary dissection, and radiotherapy in patients with small cancers of the breast. N Engl J Med. 1981;305(1):6-11. PubMedDOI

Appears in

Sources

  1. Veronesi U, Saccozzi R, Del Vecchio M, Banfi A, Clemente C, De Lena M, et al. Comparing radical mastectomy with quadrantectomy, axillary dissection, and radiotherapy in patients with small cancers of the breast. N Engl J Med. 1981;305(1):6-11.

    PubMedDOI

  2. Veronesi U, Cascinelli N, Mariani L, Greco M, Saccozzi R, Luini A, et al. Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. N Engl J Med. 2002;347(16):1227-32.

    PubMedDOI