| Title | Long-term results of a randomized trial comparing breast-conserving therapy with mastectomy: European Organization for Research and Treatment of Cancer 10801 trial. | | Author(s) | van Dongen JA, Voogd AC, Fentiman IS, Legrand C, Sylvester RJ, Tong D, van der Schueren E, Helle PA, van Zijl K, Bartelink H | | Institution | Department of Surgery, The Netherlands Cancer Institute, Amsterdam. | | Source | J Natl Cancer Inst 2000 Jul 19; 92(14):1143-50. | | MeSH | Breast Neoplasms
Europe
Female
Follow-Up Studies
Humans
Lymphatic Metastasis
Mastectomy, Modified Radical
Mastectomy, Segmental
Middle Aged
Neoplasm Staging
Proportional Hazards Models
Radiotherapy, Adjuvant
Risk
Survival Analysis
Time Factors
Treatment Outcome
| | Abstract | 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. | | Language | eng | | Pub Type(s) | Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
| | PubMed ID | 10904087 |
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