Twenty-Year Follow-up of a Randomized Study Comparing Breast-Conserving Surgery with Radical Mastectomy for Early Breast Cancer
- Study type
- Clinical trial
- Design
- Randomised trial comparing breast-conserving surgery with radical mastectomy, with a median follow-up of 20 years
- Sample size
- 701 patients
- Source
- N Engl J Med · 2002
In plain words
In this study, women with small breast cancers (up to 2 cm) were randomly assigned either to have the whole breast removed or to have only part of the breast removed followed by radiotherapy. After 20 years, survival was almost the same in the two groups. The only difference was that the chance of the tumour coming back in the same breast was higher in the breast-conserving group. For women with small tumours, keeping the breast is a good choice.
Key results
Treatment arms and regimens
349 patients; Halsted radical mastectomy. After 1976, patients with positive axillary lymph nodes also received adjuvant chemotherapy with cyclophosphamide, methotrexate and fluorouracil (CMF); the dose, schedule and number of cycles of CMF are not stated in the available sources.
352 patients; quadrantectomy with axillary dissection followed by radiotherapy to the ipsilateral breast tissue (QUART). The radiotherapy dose and fractionation are not stated in the available sources. After 1976, patients with positive axillary lymph nodes also received adjuvant CMF (dose not stated in the available sources).
Source of the regimen details: Abstract of the paper and a historical review of the Milan I trial (Corso et al., ecancermedicalscience 2017; PMC5481191); the full text was not available, and the radiotherapy dose and the CMF regimen and doses are not stated in the available sources
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
701 women with invasive breast carcinoma up to 2 cm in diameter and no palpable axillary lymph nodes (cT1N0), enrolled in the Milan I trial from 1973 to 1980.
Endpoints
The primary endpoint is not explicitly stated in the abstract. Reported outcomes include local recurrence in the same breast, contralateral breast cancer, distant metastases, second primary cancers, death from any cause and death from breast cancer.
Safety and side effects
The abstract reports no data on treatment adverse effects (such as complications of surgery, radiotherapy or chemotherapy). Local recurrence in the same breast was more frequent in the breast-conserving surgery group (8.8% versus 2.3%).
Clinical significance and place in guidelines
With long-term follow-up, this study showed that survival after breast-conserving surgery with radiotherapy equals that after radical mastectomy, and the authors regarded breast-conserving surgery as the treatment of choice for relatively small breast cancers. Local recurrence in the same breast was more frequent after breast-conserving surgery. Its status in current guidelines should be checked separately.
Limitations
Based on the abstract, only patients with tumours up to 2 cm were enrolled, so the results cannot be generalised to larger tumours. Adjuvant chemotherapy was given only after 1976 and to patients with positive lymph nodes. Current surgical, radiotherapy and systemic approaches differ from those of the study era (1973 to 1980). The abstract gives no information on treatment complications or cosmetic results.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.