According to a new study published in the Journal of Clinical Oncology, tamoxifen plus ovarian function suppression cause more menopausal symptoms and sexual dysfunction compared with tamoxifen alone when used as treatment for patients with node-negative, hormone receptor-positive breast cancer.
For the phase 3 study, researchers randomly assigned 345 premenopausal women with axillary node-negative, estrogen receptor-positive breast cancer to received either tamoxifen alone or tamoxifen plus ovarian function suppression. Types of ovarian function suppression include therapy with drugs like leuprolide or goserelin, or surgery.
Researchers found no significant difference between groups for primary endpoints disease-free survival (log-rank P = 0.62) or overall survival (log-rank P = 0.67). Researchers observed significantly more grade 3 or higher adverse effects in the tamoxifen plus ovarian function suppression group (22.4% versus 12.3%; P = 0.004).
Patients in the combination arm experienced significantly more menopausal symptoms, sexual dysfunction, and decreased health-related quality of life compared with those treated with tamoxifen alone (P < 0.01). The researchers note that this study was stopped early and is therefore underpowered. As a result, conclusions about the combination therapy's effect on survival in patients with node-negative, estrogen receptor-positive breast cancer cannot be determined.
The effects of ovarian function suppression (OFS) on survival and patient–reported outcomes were evaluated in a phase III trial in which premenopausal women were randomly assigned to tamoxifen with or without OFS.
When added to tamoxifen, OFS results in more menopausal symptoms and sexual dysfunction, which contributes to inferior self–reported health–related quality of life. Because of early closure, this study is underpowered for drawing conclusions about the impact on survival when adding OFS to tamoxifen.