[Sequential changes in hormone levels in postmenopausal breast cancer patients under long-term treatment with an aromatase inhibitor. Kanagawa AI Study Group]

Author(s): Fukuda M, Watanabe H, Suda T, Shimizu S

Affiliation(s): Breast and Endocrine Surgery, Dept. of Surgery, St. Marianna University School of Medicine.

Publication date & source: 1999-12, Gan To Kagaku Ryoho., 26(14):2201-8.

Publication type: Clinical Trial; Multicenter Study

Sequential changes in hormone levels were assessed for one year in postmenopausal breast cancer patients administered the aromatase inhibitor fodrozole hydrochloride hydrate (Afema) in order to evaluate its efficacy and safety in long-term treatment. Forty patients received Afema alone as postoperative adjuvant therapy, while 30 received it with 5-FU. Plasma estrone and estradiol levels decreased significantly in both groups (p < 0.001) and were not affected by body mass index (BMI). Plasma androstenedione and testosterone levels increased within the normal range. Aldosterone levels hit bottom 3 months after treatment was started, and tended to return to the pre-treatment baseline thereafter. Plasma cortisol levels increased significantly within the normal range. FDP and alpha 2-PIPC, parameters related to blood coagulation and fibrinolysis, showed no significant change. Adverse reactions, mainly nausea and elevation of LDH levels, were all slight. Thus, long-term administration of Afema resulted in significant decreases in estrogen levels with few adverse reactions regardless of the BMI, suggesting that it can be safely used as effective postoperative adjuvant therapy.