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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
biochemistry, genetics and molecular biology
An open randomised trial of second-line endocrine therapy in advanced breast cancer: Comparison of the aromatase inhibitors letrozole and anastrozole
European Journal of Cancer, Volume 39, No. 16, Year 2003
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Description
It was previously shown that letrozole (Femara®) was significantly more potent than anastrozole (Arimidex®) in inhibiting aromatase activity in vitro and in inhibiting total body aromatisation in patients with breast cancer. The objective of this study was to compare letrozole (2.5 mg per day) and anastrozole (1 mg per day) as endocrine therapy in postmenopausal women with advanced breast cancer previously treated with an anti-oestrogen. This randomised, multicentre and multinational open-label phase IIIb/IV study enrolled 713 patients. Treatment was for advanced breast cancer that had progressed either during anti-oestrogen therapy or within 12 months of completing that therapy. Patients had tumours that were either positive for oestrogen and/or progesterone receptors (48%) or of unknown receptor status (52%). The primary efficacy endpoint was time to progression (TTP). Secondary endpoints included objective response, duration of response, rate and duration of overall clinical benefit (responses and long-term stable disease), time to treatment failure, and overall survival, as well as general safety. There was no difference between the treatment arms in TTP; median times were the same for both treatments. Letrozole was significantly superior to anastrozole in the overall response rate (ORR) (19.1% versus 12.3%, P=0.013), including in predefined subgroups (receptor status-unknown, and soft-tissue- and viscera-dominant site of disease). There were no significant differences between the treatment arms in the rate of clinical benefit, median duration of response, duration of clinical benefit, time to treatment failure or overall survival. Both agents were well tolerated and there were no significant differences in safety. These results support previous data documenting the greater aromatase-inhibiting activity of letrozole and indicate that advanced breast cancer is more responsive to letrozole than to anastrozole as second-line endocrine therapy. © 2003 Elsevier Ltd. All rights reserved.
Authors & Co-Authors
Rose, Carsten G.
Sweden, Lund
Skånes Universitetssjukhus
Vtoraya, O.
Russian Federation, Arkhangelsk
Arkhangelsk Clinical Oncological Dispensary
Pluzanska, A.
Poland, Bydgoszcz
Regional Oncology Centre, Bydgoszcz
Davidson, Neville G.P.
United Kingdom, London
North Middlesex University Hospital
Gershanovich, M.
Russian Federation, Saint Petersburg
N.n. Petrov Research Institute of Oncology of the Ussr Ministry of Health
Thomas, R.
United Kingdom, Cambridge
Addenbrooke's Hospital
Johnson, S.
United Kingdom, London
The Royal Marsden Hospital
Caicedo, J. J.
Colombia, Bogota
Instituto Nacional de Cancerología
Gervásio, Helena
Portugal, Coimbra
Portuguese Oncology Institute of Coimbra
Manikhas, Georgiy Moiseevich
Russian Federation, Saint Petersburg (ex Leningrad)
St Petersburg City Oncology Dispensary
Ben-Ayed, Farhat
Tunisia, Tunis
Institut Salah Azaiez de Tunis
Burdette-Radoux, S.
Canada, Montreal
Mcgill University Health Centre, Royal Victoria Hospital
Chaudri-Ross, H. A.
Switzerland, Basel
Novartis International ag
Lang, R.
Switzerland, Basel
Novartis International ag
Statistics
Citations: 170
Authors: 14
Affiliations: 13
Identifiers
Doi:
10.1016/S0959-8049(03)00630-0
ISSN:
09598049
Research Areas
Cancer
Participants Gender
Female