Five-Year Results of a Randomized Clinical Trial Comparing Total Mastectomy and Segmental Mastectomy with or without Radiation in the Treatment of Breast Cancer

Abstract

In 1976 we began a randomized trial to evaluate breast conservation by a segmental mastectomy in the treatment of Stage I and II breast tumors less than or equal to 4 cm in size. The operation removes only sufficient tissue to ensure that margins of resected specimens are free of tumor. Women were randomly assigned to total mastectomy, segmental mastectomy alone, or segmental mastectomy followed by breast irradiation. All patients had axillary dissections, and patients with positive nodes received chemotherapy. Life-table estimates based on data from 1843 women indicated that treatment by segmental mastectomy, with or without breast irradiation, resulted in disease-free, distant-disease-free, and overall survival at five years that was no worse than that after total breast removal. In fact, disease-free survival after segmental mastectomy plus radiation was better than disease-free survival after total mastectomy (P = 0.04), and overall survival after segmental mastectomy, with or without radiation, was better than overall survival after total mastectomy (P = 0.07, and 0.06, respectively). A total of 92.3 per cent of women treated with radiation remained free of breast tumor at five years, as compared with 72.1 per cent of those receiving no radiation (P less than 0.001). Among patients with positive nodes 97.9 per cent of women treated with radiation and 63.8 per cent of those receiving no radiation remained tumor-free (P less than 0.001), although both groups received chemotherapy. We conclude that segmental mastectomy, followed by breast irradiation in all patients and adjuvant chemotherapy in women with positive nodes, is appropriate therapy for Stage I and II breast tumors less than or equal to 4 cm, provided that margins of resected specimens are free of tumor.

Variations in the management and survival of women under 50 years with breast cancer in the South East Thames region

“…Whereas a radical or modified radical mastectomy used to be the standard treatment, it is now clear that in appropriate cases breast-conserving treatment achieves equivalent long-term survival rates (Veronesi et al, 1981;Sarrazin et al, 1983;Fisher et al, 1985;Van Dongen et al, 1991;Lichter et al, 1992). Furthermore, in the past 10 years it has become increasingly apparent that systemic adjuvant therapy following surgery leads to a reduction in recurrence rates and mortality (Early Breast Cancer Trialists' Collaborative Group, 1992).…”

A survey of the management of breast cancer in England and Wales

“…The only area where there was > 80% consensus on management was in the treatment of the primary tumour, where most surgeons now agree that the primary tumour (in selected patients) can be treated safely by local excision as opposed to mastectomy. It must be emphasised that the major reason that this consensus has arisen is because of the publication of the results of large randomised clinical trials (9,10). In our study it can be seen that breast cancer is managed in most hospitals by more than one consultant.…”

“…The publication of these studies resulted in a change in the surgical management of breast cancer in this country. In 1984, Gazet et al (11) showed that 84% of surgeons in England and Wales would regularly perform mastectomy, but by 1987 Morris et al (12) had shown that this figure had fallen to 43%, and in a follow-up study in 1991 (13) 10 Whether the surgeon performed regular follow-up investigations on their breast cancer patients (eg bone scans) if the patient remained asymptomatic. 11 The frequency that the surgeon would perform mammography after breast-conserving surgery and radiotherapy for breast cancer.…”

A computational model of reasoning from the clinical literature

“…The following verbatim transcript shows Roundsman discussing the relevance of a publication by Fisher [11]. "Fisher85a was a randomized, controlled trial conducted at multiple NSABP centers.…”