Milan I Study

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 breast conserving therapy (BCT):
  - As a preferred mode of treatment:
    - For women with small breast cancers:
      - ≤ 2 cm
For this study:
- 701 women with tumors ≤ 2 cm 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:
  - The 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
    - 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

Julian TB, Venditti CA, Duggal S. Landmark clinical trials influencing surgical management of non-invasive and invasive breast cancer. The Breast Journal. 2015:21;60-66.
Veronesi U, Cascinelli N, Mariani L, 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;347:1227-1232.

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Published by Rodrigo Arrangoiz MS, MD, FACS, FSSO