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著者: H Eidtmann, R de Boer, N Bundred, A Llombart-Cussac, N Davidson, P Neven, G von Minckwitz, J Miller, N Schenk, R Coleman
雑誌名: Ann Oncol. 2010 Nov;21(11):2188-94. doi: 10.1093/annonc/mdq217. Epub 2010 May 5.
Abstract/Text
BACKGROUND: Aromatase inhibitors (AIs) are accepted as adjuvant therapy for postmenopausal women (PMW) with hormone-responsive early breast cancer (EBC) with superior efficacy to tamoxifen. However, increased bone loss is associated with AIs.
PATIENTS AND METHODS: PMW with EBC receiving letrozole (2.5 mg/day for 5 years) were randomly assigned to immediate zoledronic acid (ZOL; 4 mg every 6 months) or delayed ZOL (initiated only for fracture or high risk thereof).
RESULTS: Patients (N = 1065) had a median age of 58 years; 54% had received prior adjuvant chemotherapy. At 36 months, mean change in L2-L4 bone mineral density (BMD) was +4.39% for immediate versus -4.9% for delayed ZOL (P < 0.0001). Between-group differences were 5.27% at 12 months, 7.94% at 24 months, and 9.29% at 36 months (P < 0.0001 for all). At 36 months, the immediate-ZOL group had a significant 41% relative risk reduction for disease-free survival (DFS) events (P = 0.0314). Adverse events are consistent with the known safety profiles of the study drugs.
CONCLUSIONS: At 36 months, immediate ZOL was more effective in preserving BMD during letrozole therapy. Immediate versus delayed ZOL led to significantly improved DFS. Benefits are observed in the context of a favorable, well-established safety profile for letrozole and ZOL.
PMID 20444845 Ann Oncol. 2010 Nov;21(11):2188-94. doi: 10.1093/annonc/mdq217. Epub 2010 May 5.
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