Conservative treatment for breast cancer of limited extent. Results of a randomized trial.

From 1973 to 1980, a controlled clinical trial was carried out at the National Cancer Institute of Milan to compare the Halsted mastectomy with breast quadrantectomy and axillary dissection followed by radiotherapy in patients with breast cancer of less than 2 cm in size. Cases of breast cancer classified as T1N0 were randomized into the two treatment procedures: 349 cases were treated with the Halsted mastectomy and 352 with the quadrantectomy technique. The two series were comparable with regard to age distribution, size, site of primary tumor, menopausal status and frequency of axillary metastases. Three local recurrences occurred in the Halsted group and one in the quadrantectomy group. Actuarial curves showed no difference in the two series with regard to disease-free and overall survival. In view of these results, mastectomy appears to be an unnecessary mutilation for patients with breast carcinomas less than 2 cm in size and no palpable axillary nodes.