Effect of tibolone on breast cancer cell proliferation in postmenopausal ER+ patients: Results from STEM trial

Purpose: Tibolone is a selective tissue estrogenic activity regulator, approved for the treatment of vasomotor symptoms in postmenopausal women. We have done an exploratory, double-blind, randomized, placebo-controlled pilot trial to investigate the tissue-specific effects of 2.5 mg tibolone on breast cancer in postmenopausal women, in particular on tissue proliferation (STEM, Study of Tibolone Effects on Mamma carcinoma tissue). Experimental Design: Postmenopausal women with initially stage I/II, estrogen receptor-positive (ER+) primary breast cancer, were randomly assigned to 14 days of placebo or 2.5 mg/d tibolone. Core biopsies of the primary tumor were obtained before and after treatment. Ki-67 and apoptosis index were analyzed in baseline and corresponding posttreatment specimen. Results: Of 102 enrolled patients, 95 had evaluable data. Baseline characteristics were comparable between both treatment groups. Breast cancer cases are mainly invasive (99%), stage I or II (42% and 50% respectively), and ER+ (99%). Median intratumoral Ki-67 expression at baseline was 13.0%, in the tibolone group and 17.8% in the placebo group, and decreased to 12.0% after 14 days of tibolone while increasing to 19.0% in the placebo group. This change from baseline was not significantly different between tibolone and placebo (Wilcoxon test; P = 0.17). A significant difference was observed between the treatment groups when the median change from baseline apoptosis index was compared between the treatment groups (tibolone, 0.0%; placebo, +0.3%; Wilcoxon test; P = 0.031). The incidence of adverse effects was comparable. Conclusions: In ER+ breast tumors, 2.5 mg/d tibolone given for 14 days has no significant effect on tumor cell proliferation

Extended adjuvant therapy with anastrozole among postmenopausal breast cancer patients: results from the randomized Austrian Breast and

Five years of adjuvant tamoxifen has been the standard endocrine treatment for early-stage breast cancer for several decades. Adjuvant endocrine therapy following primary surgery for breast cancer reduces the risk of recurrence and increases overall survival beyond the period of treatment for women with estrogen receptor (ER) -positive disease ( 1 ). Mature meta-analysis data on 15-year recurrence and breast cancer mortality probabilities demonstrate substantial and persistent benefits of receiving adjuvant tamoxifen compared with no adjuvant treatment ( 1 ). Most of the effect of adjuvant tamoxifen on recurrence is seen during the first 5 years after surgery, when tamoxifen is generally still administered, with gains in recurrence-free survival of 11.4%. However, many women who are treated with 5 years of adjuvant tamoxifen still develop recurrent disease, and most of the effect of adjuvant tamoxifen on breast cancer mortality occurs after the fifth year after surgery

European Randomized multicenter study of goserelin (Zoladex) in the management of mastalgia

Background Breast pain is a common symptom in patients attending breast clinics. The purpose of this study was to evaluate the efficacy of goserelin (Zoladex) as compared with sham injection in patients with mastalgia. Study design One hundred forty-seven premenopausal women were randomized to treatment with either goserelin injection (3.6 mg/month) or sham injection for a total of 6 injections. Patients' daily self-assessment of breast pain using Cardiff breast pain chart was recorded during the 6-month treatment period and for 6 months in the posttreatment period. Results A significant treatment difference between the 2 groups in favor of goserelin was noted during the treatment period. Mean breast pain score improved by 67% in the goserelin group and 35% in the sham group during the treatment period. The mean pain scores increased in both groups in the posttreatment period. No significant posttreatment difference was found between the two groups. Side effects were more common with goserelin than sham injection. Patients receiving goserelin experienced vaginal dryness, hot flushes, decreased libido, oily skin or hair, and a decrease in breast size more frequently than sham patients. Conclusion Goserelin is an effective short-term treatment for mastalgia. However, side effects are common, and thus, goserelin should be kept in reserve for patients who are refractory to other forms of treatment. Potentially, goserelin could be used to induce a rapid relief of symptoms that could be maintained with alternative therapies