Document Detail

Bone effect of adjuvant tamoxifen, letrozole or letrozole plus zoledronic acid in early-stage breast cancer: the randomized phase 3 HOBOE study.
MedLine Citation:
PMID:  22412041     Owner:  NLM     Status:  Publisher    
BACKGROUND: To measure bone mineral density (BMD) reduction produced by letrozole as compared with tamoxifen and the benefit of the addition of zoledronic acid. PATIENTS AND METHODS: A phase 3 trial comparing tamoxifen, letrozole or letrozole + zoledronic acid in patients with hormone receptor-positive early breast cancer was conducted; triptorelin was given to premenopausal patients. Two comparisons were planned: letrozole versus tamoxifen and letrozole + zoledronic acid versus letrozole. Primary end point was the difference in 1-year change of T-score at lumbar spine (LTS) measured by dual energy X-ray absorptiometry scan. RESULTS: Out of 483 patients enrolled, 459 were available for primary analyses. Median age was 50 (range 28-80). The estimated mean difference (95% confidence interval [CI]) in 1-year change of LTS was equal to -0.30 (95% CI -0.44 to -0.17) in the letrozole versus tamoxifen comparison (P < 0.0001) and to +0.60 (95% CI +0.46 to +0.77) in the letrozole + zoledronic acid versus letrozole comparison (P < 0.0001). Bone damage by letrozole decreased with increasing baseline body mass index in premenopausal, but not postmenopausal, patients (interaction test P = 0.004 and 0.47, respectively). CONCLUSIONS: In the HOBOE (HOrmonal BOne Effects) trial, the positive effect of zoledronic acid on BMD largely counteracts damage produced by letrozole as compared with tamoxifen. Letrozole effect is lower among overweight/obese premenopausal patients.
F Nuzzo; C Gallo; S Lastoria; M Di Maio; M C Piccirillo; A Gravina; G Landi; E Rossi; C Pacilio; V Labonia; F Di Rella; A Bartiromo; G Buonfanti; G De Feo; G Esposito; R D'Aniello; P Maiolino; S Signoriello; E De Maio; V Tinessa; G Colantuoni; M De Laurentiis; M D'Aiuto; M Di Bonito; G Botti; P Giordano; G Daniele; A Morabito; N Normanno; A de Matteis; F Perrone
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-3-12
Journal Detail:
Title:  Annals of oncology : official journal of the European Society for Medical Oncology / ESMO     Volume:  -     ISSN:  1569-8041     ISO Abbreviation:  -     Publication Date:  2012 Mar 
Date Detail:
Created Date:  2012-3-13     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9007735     Medline TA:  Ann Oncol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Medical Oncology, Department of Senology, National Cancer Institute, Napoli.
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