Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings.
Vol 23, No 16S (June 1 Supplement), 2005: 528
© 2005 American Society of Clinical Oncology

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Abstract

Updated results of a randomized trial of 2 versus 5 years of adjuvant tamoxifen for women aged 50 years or older with early breast cancer: Italian Interdisciplinary Group for Cancer Care Evaluation study of adjuvant treatment in breast cancer 01 (SITAM 01)

Consorzio Mario Negri Sud, S. Maria Imbaro, Italy

528

Background: The study results in terms of disease-free survival (DFS) were already published (J Clin Oncol, 2003;21:2276–81). This is an update of the data relative to overall survival (OS) after 10 years of follow up. Methods: Women with breast carcinoma T1–3, N0–3, M0, aged between 50 and 70 years, were eligible for this multicentre randomized phase III trial. Patients event-free after 2 years of tamoxifen therapy (TAM) were randomly assigned to stop or continue TAM (20 mg/die) for additional 3 years. Primary end point was DFS. Secondary end points included OS and toxicity. A number of events of 514 was needed to detect a difference of 25% (log-rank test, P <.05) between the two treatment arms (1 - ß = 0.90). Results: From 1989 through 1996, 1,901 patients were randomly assigned either to stop treatment (n = 958) or to receive TAM for 3 additional years (n = 943). Overall, 98% of patients had updated information about OS, of whom 549 had died. The median duration of postrandomization follow-up was 115 months (interquartile range 86–137). No statistically significant differences between the two arms was detected in the whole population (HR, 1.02; 95% CI, 0.86 to 1.22) as well as in ER-positive patients (HR, 0.90; 95% CI, 0.72 to 1.13). In the latter group, survival curves started to diverge only after 90 months, showing a trend in favor of the 5-year arm. The benefit of longer TAM was evident only in younger (age 55 yrs) ER-positive patients (HR, 0.56; 95% CI, 0.31 to 1.01), but not in older ones (HR, 0.98; 95% CI, 0.77 to 1.25). Conclusions: The benefits of longer TAM on OS start to emerge only after 9 years from diagnosis and seem to be more relevant in younger ER-positive women.

No significant financial relationships to disclose.

Abstract presentation from the 2005 ASCO Annual Meeting