Belinda Kiely, MD; Martin Stockler, MD
In patients with early breast cancer, does 5 years of adjuvant tamoxifen therapy reduce long-term recurrence and mortality?
Included studies compared adjuvant tamoxifen therapy for approximately 5 years with no tamoxifen in women with early breast cancer and provided individual patient data. Trials of women with ductal carcinoma in situ were excluded. Outcomes were breast cancer recurrence, death, and other second primary cancer over 15 years of follow-up.
Individual patient data meta-analysis of 20 randomized controlled trials (n = 21 457) that met the selection criteria. 10 645 women had estrogen receptor (ER)–positive disease.
Tamoxifen reduced recurrence in patients with ER-positive breast cancer (Table) but not in those with ER-negative cancer (relative risk reduction 3%, CI −7 to 12). Among patients with ER-positive cancer, tamoxifen reduced overall and breast cancer mortality (Table) but did not affect non–breast cancer mortality (relative risk increase [RRI] 2%, P = 0.79). In ER-positive cancer, tamoxifen increased risk for cancer of the uterus (excluding the cervix) (RRI 140%, P < 0.001).
In patients with early breast cancer, 5 years of adjuvant tamoxifen therapy reduced 15-year risk for recurrence and mortality in patients with estrogen receptor (ER)–positive cancer. Tamoxifen did not improve 15-year risk for recurrence in patients with ER-negative cancer.
*NS = not significant; n/a = data not available; other abbreviations defined in Glossary. RRRs calculated from rate ratios in article; NNTs calculated from rate ratios and control event rates in article.
†CIs provided by author.
Belinda Kiely, Martin Stockler. Meta-analysis: Adjuvant tamoxifen reduces recurrence and death at 15 years in ER-positive early breast cancer. Ann Intern Med. 2012;156:JC2–4. doi: 10.7326/0003-4819-156-6-201202210-02004
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Published: Ann Intern Med. 2012;156(6):JC2-4.
Breast Cancer, Hematology/Oncology.
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