Journal article
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.
- Rabaglio M IBCSG Coordinating Center and Inselspital, Bern, Switzerland. Electronic address: manuela.rabaglio@ibcsg.org.
- Sun Z IBCSG Statistical Center, Dana-Farber Cancer Institute, Boston, MA.
- Price KN IBCSG Statistical Center and Frontier Science and Technology Research Foundation, Boston, MA, USA.
- Castiglione-Gertsch M IBCSG Coordinating Center, Bern.
- Hawle H IBCSG Coordinating Center, Bern.
- Thürlimann B Senology Center of Eastern Switzerland and Swiss Group for Clinical Cancer Research (SAKK), Kantonsspital, St Gallen, Switzerland, Swiss Group for Clinical Cancer Research (SAKK).
- Mouridsen H Danish Breast Cancer Cooperative Group, Rigshospitalet, Copenhagen, Denmark.
- Campone M Institut du Cancer Nantes Atlantique, CLCC René Gauducheau, Saint Herblain, Fédération Nationale des Centres de Lutte Contre le Cancer, France.
- Forbes JF Australian New Zealand Breast Cancer Trials Group, University of Newcastle, Calvary Mater Newcastle, Newcastle, New South Wales, Australia.
- Paridaens RJ Department of Medical Oncology, University Hospital Gasthuisberg, Catholic University of Leuven, Leuven, Belgium.
- Colleoni M Research Unit in Medical Senology, Department of Medicine, European Institute of Oncology, Milan, Italy.
- Pienkowski T Cancer Center Maria Sklodowska-Curie Memorial Institute of Oncology, Warsaw, Poland.
- Nogaret JM Department of Mammary and Pelvic Surgery, Jules Bordet Institute; Brussels, Belgium.
- Láng I Department of Medical Oncology, National Institute of Oncology, Budapest, Hungary.
- Smith I Breast Unit, The Royal Marsden Hospital, London, UK.
- Gelber RD IBCSG Statistical Center, Dana-Farber Cancer Institute, Harvard School of Public Health and Harvard Medical School, Boston, MA, USA.
- Goldhirsch A Department of Medicine, European Institute of Oncology, Milan, Italy; Oncology Institute of Southern Switzerland, Bellinzona, Switzerland.
- Coates AS International Breast Cancer Study Group and University of Sydney, Sydney, New South Wales, Australia.
- 2009-05-29
Published in:
- Annals of oncology : official journal of the European Society for Medical Oncology. - 2009
Aged
Antineoplastic Agents
Breast Neoplasms
Double-Blind Method
Female
Fractures, Bone
Humans
Incidence
Letrozole
Middle Aged
Nitriles
Postmenopause
Risk Factors
Tamoxifen
Triazoles
English
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.
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.
- Language
-
- English
- Open access status
- bronze
- Identifiers
-
- DOI 10.1093/annonc/mdp033
- PMID 19474112
- Persistent URL
- https://folia.unifr.ch/global/documents/178838
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