OBJECTIVE: To determine whether tumorectomy with tamoxifen in women over 70 years achieves the same treatment results as mastectomy plus tamoxifen. MATERIAL AND METHODS: Prospective randomized analysis of 121 patients over 70 with breast cancer clinically negative axilla and tumor up to 4 cm diameter. Randomization was according to even or odd birth month. Branch A: Madden operation + tamoxifen 20 mg OD (once/day). Branch B: Tumorectomy to disease free margins + tamoxifen 20 mg OD. RESULTS:Survival rate of five years for the Madden operation was 69% and for tumorectomy 71.4% with a mortality from other causes of 23.1%. Survival probability (specific death) at 5 years was of 93.4% for the Madden group and 95.2% for tumorectomy. A significant increase of the mortality was observed in those patients that had recurrences, no matter of treatment given. Specific death cause did not vary with age, but did for other causes, this being significant. CONCLUSIONS:Tumorectomy plus tamoxifen demonstrated to be as effective as Madden Op. plus tamoxifen in women over 70 years with T1-T2-N0 disease.
RCT Entities:
OBJECTIVE: To determine whether tumorectomy with tamoxifen in women over 70 years achieves the same treatment results as mastectomy plus tamoxifen. MATERIAL AND METHODS: Prospective randomized analysis of 121 patients over 70 with breast cancer clinically negative axilla and tumor up to 4 cm diameter. Randomization was according to even or odd birth month. Branch A: Madden operation + tamoxifen 20 mg OD (once/day). Branch B: Tumorectomy to disease free margins + tamoxifen 20 mg OD. RESULTS: Survival rate of five years for the Madden operation was 69% and for tumorectomy 71.4% with a mortality from other causes of 23.1%. Survival probability (specific death) at 5 years was of 93.4% for the Madden group and 95.2% for tumorectomy. A significant increase of the mortality was observed in those patients that had recurrences, no matter of treatment given. Specific death cause did not vary with age, but did for other causes, this being significant. CONCLUSIONS: Tumorectomy plus tamoxifen demonstrated to be as effective as Madden Op. plus tamoxifen in women over 70 years with T1-T2-N0 disease.
Authors: David McCready; Claire Holloway; Wendy Shelley; Nancy Down; Paula Robinson; Susan Sinclair; Douglas Mirsky Journal: Can J Surg Date: 2005-06 Impact factor: 2.089