Originally published as JCO Early Release 10.1200/JCO.2008.19.7129 on December 29 2008

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Radiotherapy After Segmental Resection of Breast Cancer With Favorable Prognostic Features: 12-Year Follow-Up Results of a Randomized Trial

From the Departments of Oncology and Surgery, Tampere University Hospital, Tampere University Medical School; and School of Public Health, Tampere University, Tampere; Department of Oncology, Helsinki University Central Hospital; and Finnish Medical Journal, Helsinki, Finland.

Corresponding author: Kaija Holli, MD, Medical School, Tampere University, Teiskontie 35, 33014 Tampere, Finland; e-mail: kaija.holli{at}uta.fi.

Purpose Postoperative breast irradiation is considered standard after breast-preserving surgery for cancer. We evaluated the efficacy of radiation therapy in the prevention of local recurrence in a patient population that had small-size breast cancer with features that suggested low biologic aggressiveness.

Patients and Methods Women (n = 264) older than 40 years who were treated by breast resection with 1 cm of tumor-free margin and axillary nodal dissection were randomly assigned to receive or not to receive breast irradiation (cumulative dose, 50 Gy) after surgery. The tumor was required to be 20 mm, node negative, progesterone receptor positive, well to moderately well differentiated and unifocal, and of low cell proliferation rate (ie, S phase fraction 7% or nuclear Ki-67 expression < 10%) and had to lack an extensive intraductal component. The median follow-up time was 12.1 years after random assignment.

Results Sixteen (11.6%) and 34 (27.2%) cancers recurred locally in the radiotherapy and the control arms, respectively (P = .0013). Time to local recurrence was longer in the radiotherapy arm (hazard ratio [HR], 0.36; 95% CI, 0.20 to 0.65; P = .00071). Twenty-one patients assigned to radiotherapy and 26 assigned to control died during the follow-up. There were no differences in overall survival time (HR, 0.63; 95% CI, 0.35 to 1.12; P = .11), distant disease-free survival (P = .94), or breast cancer–specific survival (P = .56) between the radiation therapy and control groups.

Conclusion Radiation therapy after breast resection reduces the frequency of ipsilateral breast recurrences, even among women with small-size breast cancers that have favorable histologic features and that are resected with at least a 1-cm margin. Postoperative radiotherapy did not significantly improve survival.

Supported by grants from research funding of the Pirkanmaa Hospital District, Tampere University Hospital, the Finnish Breast Cancer Group, Cancer Society of Finland, the Academy of Finland, and Sigrid Juselius Foundation.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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