title: Effect of adjuvant endocrine therapy on hormonal levels in premenopausal women with breast cancer: the ProBONE II study.
abstract: Endocrine therapy (ET) is a key treatment modality in hormone receptor positive (HR+) early breast cancer (BC) patients. Although the anticancer activity of adjuvant ET + zoledronic acid (ZOL) has been investigated, the potential effects of ET ± ZOL on endocrine hormones in premenopausal women with HR+ early BC are not well understood. ProBONE II was prospective, double-blind, randomized controlled trial. Premenopausal patients with histologically confirmed invasive BC with no evidence of metastases and a T score >-2.5 received ET ± ZOL 4 mg every 3 months for 2 years. Serum levels of estradiol (E2), follicle-stimulating hormone, anti-muellerian hormone (AMH), inhibins A and B, sex hormone-binding globulin, parathyroid hormone, total testosterone, and vitamin D were evaluated at baseline and at every scheduled visit. Of 71 women enrolled, 70 were evaluable (n = 34, ZOL; n = 36, placebo). No statistically significant differences were observed in hormone levels, except E2 and AMH, which showed minor differences. These included decreases in serum E2 levels, which reached a nadir after 3 and 9 months in placebo and ZOL groups, respectively, and decrease in serum AMH levels throughout the study with ZOL, but remained constant with placebo after 6 months. Adverse events in ZOL-treated group were influenza-like illness (32.4 %), bone pain (32.4 %), chills (20.6 %), and nausea (23.5 %). ET ± ZOL was well tolerated. This study showed no influence of ZOL on hormonal level changes that accompany ET, supporting inclusion of ZOL in adjuvant therapy for premenopausal women with HR + BC.
authors: Department of Endocrinology, Reproductive Medicine and Osteoporosis, Philipps - University of Marburg, Baldingerstrasse, 35033, Marburg, Germany, hadji@med.uni-marburg.de.
authors: Peyman
authors: P
authors: Hadji
authors: Annette
authors: A
authors: Kauka
authors: May
authors: M
authors: Ziller
authors: Katrin
authors: K
authors: Birkholz
authors: Monika
authors: M
authors: Baier
authors: Mathias
authors: M
authors: Muth
authors: Peter
authors: P
authors: Kann
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000097:blood; D001943:Breast Neoplasms / Q000097:blood* / Q000188:drug therapy* / Q000473:pathology; D017024:Chemotherapy, Adjuvant / Q000379:methods; D004164:Diphosphonates / Q000008:administration & dosage / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D017273:Goserelin / Q000008:administration & dosage / Q000009:adverse effects; D006728:Hormones / Q000097:blood*; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D017697:Premenopause / Q000097:blood / Q000187:drug effects*; D011446:Prospective Studies; D013629:Tamoxifen / Q000008:administration & dosage / Q000009:adverse effects; D055815:Young Adult; D000077211:Zoledronic Acid
chemical_list: D014408:Biomarkers, Tumor; D004164:Diphosphonates; D006728:Hormones; D007093:Imidazoles; D013629:Tamoxifen; D017273:Goserelin; D000077211:Zoledronic Acid