- Milan I study was a prospective randomized trial, conducted by the Milan Cancer Institute from 1973 to 1980
- Milan I played a critical role in the establishment of:
- BCT as a preferred mode of treatment for women with small breast cancers (≤ 2 cm)
- For this study, 701 women with tumors ≤ 2 cm and clinically negative axillary examinations were enrolled and randomized to:
- Radical mastectomy (n = 349) versus BCT (quadrantectomy and axillary node dissection) followed by radiotherapy (n = 352)
- Results from Milan I were concurrent with those from NSABP B-06 trial:
- Showing no appreciable differences in long-term survival between the groups, despite a higher cumulative incidence of recurrence at 20 years in patients treated with BCT
- Ipsilateral breast tumor recurrence rates after 20 years follow-up were:
- 8.8% for the BCT group compared to a 2.3% rate of local recurrence for the radical mastectomy group (P<0.001)
- Additionally, there were no significant differences between the two groups in the rates of:
- Contralateral breast cancer, distant metastases, or secondary primary cancers
- Overall, Milan I concluded that long-term survival was the same for women who underwent radical mastectomy as those who received BCT:
- Thus providing more evidence to support breast-conserving surgery as treatment for women with small cancers
- References
- 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):1227-1232.
- Julian TB, Venditti CA, Duggal S. Landmark clinical trials influencing surgical management of non-invasive and invasive breast cancer. Breast J. 2015:21(1);60-66.
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Rodrigo Arrangoiz MS, MD, FACS, FSSO 