Reducing Risk for Invasive Breast Cancer With Low-Dose Tamoxifen
Posted: Tuesday, February 12, 2019
Andrea De Censi, PhD, of the National Hospital E.O. Ospedali Galliera, Genoa, Italy, and colleagues suggest that a low dose of tamoxifen (5 mg/d) may reduce the chance of disease recurrence as well as new disease in women who had been treated with surgery for breast intraepithelial neoplasia. The results were presented at the 2018 San Antonio Breast Cancer Symposium (SABCS; Abstract GS3-01). In addition, low-dose tamoxifen did not seem to cause more serious adverse events, based on evidence from the randomized phase III TAM-01 trial.
“Tamoxifen at the dose of 5 mg/d can halve the incidence of recurrence in women with operated hormone-sensitive ductal carcinoma in situ] or [lobular carcinoma in situ] with a limited toxicity, providing a valid treatment option in women with disease,” the investigators concluded. “In addition, this study has important implications for the preventive therapy of high-risk unaffected women.”
A total of 500 women were enrolled between November 2008 and March 2015. The women, who had operated hormone-sensitive breast intraepithelial neoplasia, received either 5 mg/d of tamoxifen or placebo for 3 years. They were seen every 6 months and underwent an annual mammography for the 5 years after randomization.
At a median follow-up of 5.1 years, there were 14 recurrences in the tamoxifen group and 29 recurrences in the placebo group, with most recurrences being invasive breast cancers. Additionally, there were 12 serious adverse events among the women in the low-dose tamoxifen arm and 16 serious adverse events among the women in the placebo arm. No significant differences between the study groups were observed in terms of menopausal symptoms, such as hot flashes, vaginal dryness, and pain during intercourse.
Disclosure: The study authors’ disclosures can be found at sabcs.org.
