Invasive breast cancer trials

Abstract

Patients were randomized to mastectomy or breastconserving therapy (BCT) consisting of complete tumour excision, axillary dissection and radiation treatment. Seventy-eight per cent of patients accepted the procedure chosen for them by randomization, leaving (after all other protocol violations and other exclusions are accounted for) two groups: 619 patients for whom treatments had been randomly allocated and 136 who had chosen their treatment. In the BCT arm, treatment consisted of removal of the tumour-bearing part of the breast with enough normal tissue to ensure tumour-free margins at gross examination. All BCT patients were referred to radiotherapy to begin within 2–4 weeks after surgery. The target volume involved the whole breast. Regional lymph nodes were included only in high-risk patients. The dose was 50 Gy in 25 fractions over 5 weeks plus a boost to the tumour bed. Mastectomy consisted of removal of the entire breast through a transverse incision plus dissection of lowand mid-axilla.