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Previous Volume 349:1793-1802 November 6, 2003 Number 19 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Editorial by Bryant, J. Editorial by Burstein, H. J. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

ABSTRACT

Background In hormone-dependent breast cancer, five years of postoperative tamoxifen therapy — but not tamoxifen therapy of longer duration — prolongs disease-free and overall survival. The aromatase inhibitor letrozole, by suppressing estrogen production, might improve the outcome after the discontinuation of tamoxifen therapy.

Methods We conducted a double-blind, placebo-controlled trial to test the effectiveness of five years of letrozole therapy in postmenopausal women with breast cancer who have completed five years of tamoxifen therapy. The primary end point was disease-free survival.

Results A total of 5187 women were enrolled (median follow-up, 2.4 years). At the first interim analysis, there were 207 local or metastatic recurrences of breast cancer or new primary cancers in the contralateral breast — 75 in the letrozole group and 132 in the placebo group — with estimated four-year disease-free survival rates of 93 percent and 87 percent, respectively, in the two groups (P0.001 for the comparison of disease-free survival). A total of 42 women in the placebo group and 31 women in the letrozole group died (P=0.25 for the comparison of overall survival). Low-grade hot flashes, arthritis, arthralgia, and myalgia were more frequent in the letrozole group, but vaginal bleeding was less frequent. There were new diagnoses of osteoporosis in 5.8 percent of the women in the letrozole group and 4.5 percent of the women in the placebo group (P=0.07); the rates of fracture were similar. After the first interim analysis, the independent data and safety monitoring committee recommended termination of the trial and prompt communication of the results to the participants.

Conclusions As compared with placebo, letrozole therapy after the completion of standard tamoxifen treatment significantly improves disease-free survival.

Source Information

From the Division of Hematology–Oncology, Princess Margaret Hospital, Toronto (P.E.G.); the Mayo Clinic, Rochester, Minn. (J.N.I.); the John Wayne Cancer Institute, Santa Monica, Calif. (S.M.); the Inova Fairfax Hospital, Falls Church, Va. (N.J.R.); the University of Vermont, Burlington (H.B.M); Institut Jules Bordet, Brussels, Belgium (M.J. Piccart); the International Breast Cancer Study Group Coordinating Center, Bern, Switzerland (M.C.); the National Cancer Institute of Canada, Clinical Trials Group, Kingston, Ont. (D.T., L.E.S., M.J. Palmer, J.L.P.); the Toronto–Sunnybrook Regional Cancer Centre, Toronto (K.I.P.); the University of Washington, Seattle (R.B.L.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore (N.E.D.); the Memorial Sloan-Kettering Cancer Center, New York (L.N.); the Mayo Clinic, Jacksonville, Fla. (E.A.P); the Cancer Therapy Evaluation Program, Clinical Investigations Branch, National Cancer Institute, Rockville, Md. (J.S.A.); and the European Organization for Research and Treatment of Cancer Data Center, Brussels, Belgium (P.T.).

This article was published at www.nejm.org on October 9, 2003.

Address reprint requests to Dr. Goss at the Division of Hematology–Oncology, Princess Margaret Hospital, 610 University Ave., Toronto, ON M5G 2M9, Canada, or at pegoss{at}interlog.com.

Full Text of this Article

Related Letters:

Letrozole in Breast Cancer
Buzdar A. U., Hietanen P., Mäkelä M., Shahab N., Harris S. R., Hellman S., Hellman D., Goss P. E., Ingle J. N., Pater J. L., Bryant J., Wolmark N., Burstein H. J.
Extract | Full Text | PDF  
N Engl J Med 2004; 350:727-730, Feb 12, 2004. Correspondence

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