© 2000 by Oxford University Press
Journal of the National Cancer Institute, Vol. 92, No. 14, 1143-1150,
July 19, 2000
© 2000 Oxford University Press
Long-Term Results of a Randomized Trial Comparing Breast-Conserving Therapy With Mastectomy: European Organization for Research and Treatment of Cancer 10801 Trial
Affiliations of authors: J. A. van Dongen (Department of Surgery), H. Bartelink (Department of Radiotherapy), The Netherlands Cancer Institute, Amsterdam; A. C. Voogd, Comprehensive Cancer Center South, Eindhoven, The Netherlands; I. S. Fentiman (Hedley Atkins Breast Unit), D. Tong (Guy's and St. Thomas' Cancer Center), Guy's Hospital, London, U.K.; C. Legrand, R. J. Sylvester, European Organization for Research and Treatment of Cancer Data Center, Brussels, Belgium; E. van der Schueren (deceased March 1998), Department of Radiotherapy, University Hospital Gasthuisberg, Leuven, Belgium; P. A. Helle, Department of Radiotherapy, Dr. Daniël den Hoed Cancer Center, Rotterdam, The Netherlands; K. van Zijl, Breast Unit, University of Stellenbosch, Tijgersberg, South Africa.
Correspondence to: Harry Bartelink, M.D., Ph.D., Department of Radiotherapy, The Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX Amsterdam, The Netherlands (e-mail: hbart{at}nki.nl).
Background: Breast-conserving therapy (BCT) has been shown to be as effective as mastectomy in the treatment of tumors 2 cm or smaller. However, evidence of its efficacy, over the long term, in patients with tumors larger than 2 cm is limited. From May 1980 to May 1986, the European Organization for Research and Treatment of Cancer carried out a randomized, multicenter trial comparing BCT with modified radical mastectomy for patients with tumors up to 5 cm. In this analysis, we investigated whether the treatments resulted in different overall survival, time to distant metastasis, or time to locoregional recurrence. Methods: Of 868 eligible breast cancer patients randomly assigned to the BCT arm or to the modified radical mastectomy arm, 80% had a tumor of 2.1–5 cm. BCT comprised lumpectomy with an attempted margin of 1 cm of healthy tissue and complete axillary clearance, followed by radiotherapy to the breast and a supplementary dose to the tumor bed. The median follow-up was 13.4 years. All P values are two-sided. Results: At 10 years, there was no difference between the two groups in overall survival (66% for the mastectomy patients and 65% for the BCT patients; P = .11) or in their distant metastasis-free rates (66% for the mastectomy patients and 61% for the BCT patients; P = .24). The rate of locoregional recurrence (occurring before or at the same time as distant metastasis) at 10 years did show a statistically significant difference (12% of the mastectomy and 20% of the BCT patients; P = .01). Conclusions: BCT and mastectomy demonstrate similar survival rates in a trial in which the great majority of the patients had stage II breast cancer.
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