Randomized Clinical Trial to Assess the Effectiveness of Breast Irradiation Following Lumpectomy and Axillary Disection for Node-Negative Breast Cancer

作者：Roy M. Clark, P. B. McCulloch, Mark N. Levine, Michael Lipa, Robert H. Wilkinson, Leo J. Mahoney, V. Basrur, Bhavani D. Nair, Rebecca S.R. McDermot, C. Shun Wong, P J Corbett · 发表于：JNCI Journal of the National Cancer Institute · 年份：1992 · DOI：10.1093/jnci/84.9.683 · 被引用次数：397 · 研究领域：Breast Cancer Treatment Studies、Breast Implant and Reconstruction、Breast Lesions and Carcinomas

BACKGROUND: Although the conservation management of breast cancer has become a routine method of treatment in most centers, there is still considerable controversy surrounding the ultimate minimum treatment required for node-negative breast cancer to achieve adequate local control. PURPOSE: Our purpose was to assess the value of breast irradiation in reducing breast relapse following conservation surgery for node-negative breast cancer. We attempted to define low-risk groups of women for breast and distant site relapse (i.e., recurrence outside the breast) who might be spared breast irradiation or adjuvant systemic therapy. METHODS: Eight hundred thirty-seven patients were randomly assigned to receive radiation therapy or no radiation therapy following lumpectomy and axillary dissection for node-negative breast cancer. RESULTS: Breast irradiation reduced relapse in the breast from 25.7% in the controls to 5.5% in the irradiated patients. There was no difference in survival between the two groups (median follow-up, 43 months). A low-risk group (less than 5% chance of relapse in the breast without irradiation) could not be defined. Tumor size (greater than 2 cm), age (less than 40 years), and poor nuclear grade were important predictors for breast relapse. Age (less than 50 years) and poor nuclear grade were important predictors for mortality. The presence of ductal carcinoma in situ did not predict breast relapse. CONCLUSIONS: Breast irradiation significantly reduces breast re...