Zoledronic acid inhibits adjuvant letrozole-induced bone loss in postmenopausal women with early breast cancer

被引:234
作者
Brufsky, Adam
Harker, W. Graydon
Beck, J. Thaddeus
Carroll, Robert
Tan-Chiu, Elizabeth
Seidler, Christopher
Hohneker, John
Lacerna, Leo
Petrone, Stephanie
Perez, Edith A.
机构
[1] Univ Pittsburgh, Inst Canc, Magee Womens Hosp, Pittsburgh, PA 15123 USA
[2] Utah Canc Specialists, Salt Lake City, UT USA
[3] Highlands Oncol Grp, Springdale, AK USA
[4] N Florida Reg Med Ctr, Gainesville, FL USA
[5] Mayo Clin, Canc Res Network Plantat, Jacksonville, FL 32224 USA
[6] Novartis Oncol, E Hanover, NJ USA
[7] Fallon Clin Hematol Oncol, Worcester, MA USA
关键词
D O I
10.1200/JCO.2005.05.3744
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose Treatment with aromatase inhibitors decreases bone mineral density (BMD) and may increase the risk of fractures in postmenopausal women with early-stage breast cancer. The addition of zoledronic acid to adjuvant letrozole therapy may protect against bone loss. Patients and Methods Patients receiving adjuvant letrozole were randomly assigned to receive either upfront or delayed-start zoledronic acid (4 mg intravenously every 6 months). The delayed group received zoledronic acid when lumbar spine (LS) or total hip (TH) T score decreased to less than -2.0 or when a nontraumatic fracture occurred. The primary end point of this study was to compare the change in LS BMD at month 12 between the groups. Secondary end points included change in TH BMD and changes in serum bone turnover markers at month 12. Results The upfront and delayed groups each included 301 patients. At month 12, LS BM was 4.4% higher in the upfront group than in the delayed group (95% CI, 3.7% to 5.0%; P < .0001), and TH BMD was 3.3% higher (95% CI, 2.8% to 3.8%; P < .0001). In the upfront group, mean serum N-telopeptide and bone-specific alkaline phosphatase concentrations decreased by 15.1% (P < .0001) and 8.8% (P = .0006), respectively, at month 12, whereas concentrations increased significantly in the delayed group by 19.9% (P = .013) and 24.3% (P < .0001), respectively. Conclusion With 1 year of follow-up, results of the primary end point of the Zometa-Femara Adjuvant Synergy Trial (Z-FAST) indicate that upfront zoledronic acid therapy prevents bone loss in the LS in postmenopausal women receiving adjuvant letrozole for early-stage breast cancer.
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收藏
页码:829 / 836
页数:8
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