Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 22, No 14S (July 15 Supplement), 2004: 531
© 2004 American Society of Clinical Oncology

This Article Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Download to citation manager Rights & Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Geisler, J. Articles by Massimini, G. Search for Related Content PubMed Articles by Geisler, J. Articles by Massimini, G.

Abstract

Estrogens and bone metabolism in postmenopausal women with early breast cancer at low risk treated with exemestane: a randomized placebo-controlled study

Haukeland Sykehus, Bergen, Norway; Sentralsjukehuset i Rogaland, Stavanger, Norway; Det Norske Radiumhospital, Oslo, Norway; Universitetssykehuset i Nord-Norge, Tromso, Norway; St. Olavs Hospital, Trondheim, Norway; Ulleval Universitetssykehus, Oslo, Norway; Center for Clinical Trials, Bergen, Norway; Pharmacia Italia S.p.A., Pfizer Group, Nerviano, Italy

531

Background: Estrogens (Es) reduction in menopause increases osteoporosis and fractures risk. Aromatase inhibitors are being introduced for treating postmenopausal early breast cancer (EBC). Exemestane (E, Aromasin®), a steroidal aromatase inactivator, inhibits peripheral aromatase by 98%, markedly reducing Es. We report the effect of E on Es and bone metabolism in postmenopausal EBC patients (pts). Methods: We conducted a randomized, double blind study of E vs. placebo (P) on bone metabolism, endocrinological and metabolic parameters in postmenopausal pT1N0 or T2N0 (with no other risk factors) or ductal carcinoma in situ (DCIS) pts. ER and/or PgR+ve or unknown pts with bone mineral density (BMD) within 2 SD of the mean for 65-year (yr) women, were randomized to E 25 mg or P p.o. daily for 2 yrs, with a 1-yr follow-up. Primary objective was non-inferiority on BMD. Planned sample size was 128 BMD-evaluable pts. Estradiol (E2), estrone (E1), bone alkaline phosphatase (ALP), PINP, osteocalcin (OC), serum CTX (s-CTX), urinary CTX (u-CTX) and NTX (u-NTX) were evaluated at baseline (BS), 6, 12 and 24 months (mos). Results: 147 pts have been enrolled, 73 E and 74 P. Median age: 61 yrs (E) and 60 yrs (P). Median time from menopause: 9.7 yrs E, 8.0 yrs P. ER and/or PgR: +ve 130 pts, unknown 17 (15 with DCIS). E was well tolerated, 70% of pts had drug-related events on E, 73% on P. Nine pts withdrew on E and 3 on P for adverse events. Three withdrew consent on E and 2 on P. The % change from baseline on Es and bone metabolism markers are described in the Table.

View larger version (12K): [in this window] [in a new window]

Author Disclosure

Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Pfizer Italia S.p.A. Pfizer Co. Pfizer Co.

Abstract presentation from the 2004 ASCO Annual Meeting