Annals of Oncology Advance Access originally published online on May 27, 2009
Annals of Oncology 2009 20(9):1489-1498; doi:10.1093/annonc/mdp033
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breast cancer |
Bone fractures among postmenopausal patients with endocrine-responsive early breast cancer treated with 5 years of letrozole or tamoxifen in the BIG 1-98 trial
1 IBCSG Coordinating Center and Inselspital, Bern, Switzerland
2 IBCSG Statistical Center, Dana-Farber Cancer Institute, Boston, MA
3 IBCSG Statistical Center and Frontier Science and Technology Research Foundation, Boston, MA, USA
4 IBCSG Coordinating Center, Bern
5 Senology Center of Eastern Switzerland and Swiss Group for Clinical Cancer Research (SAKK), Kantonsspital, St Gallen, Switzerland, Swiss Group for Clinical Cancer Research (SAKK)
6 Danish Breast Cancer Cooperative Group, Rigshospitalet, Copenhagen, Denmark
7 Institut du Cancer Nantes Atlantique, CLCC René Gauducheau, Saint Herblain, Fédération Nationale des Centres de Lutte Contre le Cancer, France
8 Australian New Zealand Breast Cancer Trials Group, University of Newcastle, Calvary Mater Newcastle, Newcastle, New South Wales, Australia
9 Department of Medical Oncology, University Hospital Gasthuisberg, Catholic University of Leuven, Leuven, Belgium
10 Research Unit in Medical Senology, Department of Medicine, European Institute of Oncology, Milan, Italy
11 Cancer Center Maria Sklodowska-Curie Memorial Institute of Oncology, Warsaw, Poland
12 Department of Mammary and Pelvic Surgery, Jules Bordet Institute; Brussels, Belgium
13 Department of Medical Oncology, National Institute of Oncology, Budapest, Hungary
14 Breast Unit, The Royal Marsden Hospital, London, UK
15 IBCSG Statistical Center, Dana-Farber Cancer Institute, Harvard School of Public Health and Harvard Medical School, Boston, MA, USA
16 Department of Medicine, European Institute of Oncology, Milan, Italy
17 Oncology Institute of Southern Switzerland, Bellinzona, Switzerland
18 International Breast Cancer Study Group and University of Sydney, Sydney, New South Wales, Australia
* Correspondence to: M. Rabaglio, International Breast Cancer Study Group Coordinating Center, Effingerstrasse 40, CH-3008 Bern, Switzerland; Tel: +41 31 389 93 91; Fax: +41 31 389 93 92; E-mail: manuela.rabaglio{at}ibcsg.org.
Background: To compare the incidence and timing of bone fractures in postmenopausal women treated with 5 years of adjuvant tamoxifen or letrozole for endocrine-responsive early breast cancer in the Breast International Group (BIG) 1-98 trial.
Methods: We evaluated 4895 patients allocated to 5 years of letrozole or tamoxifen in the BIG 1-98 trial who received at least some study medication (median follow-up 60.3 months). Bone fracture information (grade, cause, site) was collected every 6 months during trial treatment.
Results: The incidence of bone fractures was higher among patients treated with letrozole [228 of 2448 women (9.3%)] versus tamoxifen [160 of 2447 women (6.5%)]. The wrist was the most common site of fracture in both treatment groups. Statistically significant risk factors for bone fractures during treatment included age, smoking history, osteoporosis at baseline, previous bone fracture, and previous hormone replacement therapy.
Conclusions: Consistent with other trials comparing aromatase inhibitors to tamoxifen, letrozole was associated with an increase in bone fractures. Benefits of superior disease control associated with letrozole and lower incidence of fracture with tamoxifen should be considered with the risk profile for individual patients.
Key words: aromatase inhibitor, bone fracture, hormonal therapy, letrozole, tamoxifen
Received for publication December 2, 2008. Revision received January 15, 2009. Accepted for publication January 19, 2009.
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