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.
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Authors | J A van Dongen, A C Voogd, I S Fentiman, C Legrand, R J Sylvester, D Tong, E van der Schueren, P A Helle, K van Zijl, H Bartelink |
Journal | Journal of the National Cancer Institute
(J Natl Cancer Inst)
Vol. 92
Issue 14
Pg. 1143-50
(Jul 19 2000)
ISSN: 0027-8874 [Print] United States |
PMID | 10904087
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Topics |
- Breast Neoplasms
(pathology, radiotherapy, surgery)
- 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
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