Long-Term Results of a Randomized Trial Comparing Breast-Conserving Therapy With Mastectomy: European Organization for Research and Treatment of Cancer 10801 Trial

Joop A. van Dongen, Adri C. Voogd, Ian S. Fentiman, et al.
Abramson Cancer Center of the University of Pennsylvania
Last Modified: November 1, 2001

Reviewers: Li Liu, MD
Source: Journal of the National Cancer Institute, Volume 92(14):1143-1150, (July) 2000

Précis: Survival is similar after mastectomy, breast-conserving therapy for stage II tumors


It has been well established that either radical mastectomy or breast-conserving therapy results in the same long-term survival and local control in women with early-stage breast cancer (i.e., tumors ? 2cm). Several studies have suggested that breast-conserving therapy might also be effective in patients with stage II tumors larger than 2 cm (New England Journal of Medicine, 1989; Mar 30;320(13):822-8), but that research has had limitations. In this study, researchers reviewed long-term follow-up data on patients with stage II breast cancer in the European Organization for Research and Treatment of Cancer Breast Cancer Cooperative Group trial.


A total of 868 eligible patients, of whom 80% had tumor 2.1 cm to 5.0 cm in size had been randomly assigned to undergo either breast-conserving therapy or radical mastectomy. Ten-year follow-up analysis was performed.


After a median follow-up of 13.4 years,
  • Overall survival rate and the distant metastasis-free survival rate were not statistically different between the two groups at 10 years.
  • There was a significantly higher rate of locoregional recurrence in the breast-conserving therapy group.


In the study, breast-conserving therapy and radical mastectomy gave similar survival rates in women with breast cancers larger than 2.0 cm. Although the locoregional recurrence rate was higher in the breast-conserving therapy group, the number of locoregional recurrences was small in both treatment arms relative to the number of distant recurrences.