Skip Navigation

This Article
Right arrow Full Text Freely available
Right arrow FREE Full Text (PDF) Freely available
Right arrow E-letters: Submit a response
Right arrow Alert me when this article is cited
Right arrow Alert me when E-letters are posted
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in ISI Web of Science
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My Personal Archive
Right arrow Download to citation manager
Right arrow Search for citing articles in:
ISI Web of Science (2)
Right arrowRequest Permissions
Right arrow Disclaimer
Google Scholar
Right arrow Articles by Tominaga, T.
Right arrow Articles by Ohashi, Y.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Tominaga, T.
Right arrow Articles by Ohashi, Y.
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us  
What's this?

Annals of Oncology 14:62-70, 2003
© 2003 European Society for Medical Oncology

Original Paper

Double-blind randomised trial comparing the non-steroidal aromatase inhibitors letrozole and fadrozole in postmenopausal women with advanced breast cancer

T. Tominaga1,+, I. Adachi2, Y. Sasaki3, T. Tabei4, T. Ikeda5, Y. Takatsuka6, M. Toi7, T. Suwa8 and Y. Ohashi9

1 Breast Cancer Center, Toyosu Hospital, Showa University School of Medicine, Tokyo; 2 Department of Medical Oncology, National Cancer Center Hospital, Tokyo; 3 Division of Oncology–Hematology, National Cancer Center Hospital East, Chiba; 4 First Department of Internal Medicine, Saitama Cancer Center, Saitama; 5 Department of Surgery, School of Medicine, Keio University, Tokyo; 6 Department of Surgery, Kansai Rosai Hospital, Hyogo; 7 Department of Surgery, Tokyo Metropolitan Komagome Hospital, Tokyo; 8 Department of Surgery, Omiya Red Cross Hospital, Saitama; 9 Department of Biostatistics, School of Health Sciences and Nursing, University of Tokyo, Tokyo, Japan

Received 7 February 2002; revised 27 June 2002; accepted 17 July 2002

Background:

To compare the efficacy, safety and tolerability of letrozole, an advanced non-steroidal aromatase inhibitor, and fadrozole hydrochloride, an older-generation drug in this class, we conducted a randomised double-blind trial in postmenopausal women with advanced breast cancer.

Patients and methods:

One hundred and fifty-seven postmenopausal women with advanced breast cancer were enrolled and randomly assigned to receive letrozole or fadrozole in a multicentre, randomised double-blind trial in Japan. One hundred and fifty-four eligible patients were treated with either letrozole 1.0 mg once daily (n = 77) or fadrozole 1.0 mg twice daily (n = 77), for a minimum of 8 weeks.

Results:

Letrozole showed a significantly higher overall objective response rate [complete response (CR) + partial response (PR)] than fadrozole (31.2% and 13.0%, respectively; P = 0.011, Fisher’s exact test). Clinical benefits defined as CR, PR and stable disease (no change in status for more than 24 weeks) were also higher in patients treated with letrozole (50.6%) than fadrozole (35.1%). Letrozole was significantly superior to fadrozole in terms of the dominant lesion in soft tissue, bone and viscera (P = 0.011, stratified Mantel–Haenszel test). Median time to progression was 211 days in the letrozole group and 113 days in the fadrozole group with no significant difference (P = 0.175, log-rank test). Letrozole markedly reduced the estradiol, estrone and estrone sulfate levels in peripheral blood within 4 weeks. The suppressive effect of fadrozole on these hormone levels was insufficient. Adverse drug reactions were observed in 35.9% of the patients treated with letrozole and in 39.5% of those treated with fadrozole with no significant difference between the two groups (P = 0.74, Fisher’s exact test). Most of the adverse drug reactions were rated as grade 1 or 2.

Conclusions:

The results show letrozole at a dose of 1.0 mg once daily to be more effective in treating postmenopausal women with advanced breast cancer than fadrozole at 1.0 mg twice daily, with similar safety and tolerability profiles.

Key words: aromatase inhibitor, breast cancer, letrozole, randomised trial


Add to CiteULike CiteULike   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us    What's this?


This article has been cited by other articles:


Home page
 JCOHome page
E. Rossi, A. Morabito, F. Di Rella, G. Esposito, A. Gravina, V. Labonia, G. Landi, F. Nuzzo, C. Pacilio, E. De Maio, et al.
Endocrine Effects of Adjuvant Letrozole Compared With Tamoxifen in Hormone-Responsive Postmenopausal Patients With Early Breast Cancer: The HOBOE Trial
J. Clin. Oncol., July 1, 2009; 27(19): 3192 - 3197.
[Abstract] [Full Text] [PDF]

Home page
 Endocr. Rev.Home page
R. J. Santen, H. Brodie, E. R. Simpson, P. K. Siiteri, and A. Brodie
History of Aromatase: Saga of an Important Biological Mediator and Therapeutic Target
Endocr. Rev., June 1, 2009; 30(4): 343 - 375.
[Abstract] [Full Text] [PDF]

Home page
 Endocr Relat CancerHome page
R. Ponzone, P. Mininanni, E. Cassina, F. Pastorino, and P. Sismondi
Aromatase inhibitors for breast cancer: different structures, same effects?
Endocr. Relat. Cancer, March 1, 2008; 15(1): 27 - 36.
[Abstract] [Full Text] [PDF]


Disclaimer: Please note that abstracts for content published before 1996 were created through digital scanning and may therefore not exactly replicate the text of the original print issues. All efforts have been made to ensure accuracy, but the Publisher will not be held responsible for any remaining inaccuracies. If you require any further clarification, please contact our Customer Services Department.