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A correction has been published: N Engl J Med 2004;351(23):2461.
A correction has been published: N Engl J Med 2006;355(16):1746.
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Background Tamoxifen, taken for five years, is the standard adjuvant treatment for postmenopausal women with primary, estrogen-receptor–positive breast cancer. Despite this treatment, however, some patients have a relapse.
Methods We conducted a double-blind, randomized trial to test whether, after two to three years of tamoxifen therapy, switching to exemestane was more effective than continuing tamoxifen therapy for the remainder of the five years of treatment. The primary end point was disease-free survival.
Results Of the 4742 patients enrolled, 2362 were randomly assigned to switch to exemestane, and 2380 to continue to receive tamoxifen. After a median follow-up of 30.6 months, 449 first events (local or metastatic recurrence, contralateral breast cancer, or death) were reported — 183 in the exemestane group and 266 in the tamoxifen group. The unadjusted hazard ratio in the exemestane group as compared with the tamoxifen group was 0.68 (95 percent confidence interval, 0.56 to 0.82; P<0.001 by the log-rank test), representing a 32 percent reduction in risk and corresponding to an absolute benefit in terms of disease-free survival of 4.7 percent (95 percent confidence interval, 2.6 to 6.8) at three years after randomization. Overall survival was not significantly different in the two groups, with 93 deaths occurring in the exemestane group and 106 in the tamoxifen group. Severe toxic effects of exemestane were rare. Contralateral breast cancer occurred in 20 patients in the tamoxifen group and 9 in the exemestane group (P=0.04).
Conclusions Exemestane therapy after two to three years of tamoxifen therapy significantly improved disease-free survival as compared with the standard five years of tamoxifen treatment.
Source Information
From the Department of Cancer Medicine, Imperial College and Charing Cross Hospital, London (R.C.C., L.J.G., C.F.S.); Institute of Cancer Research, Sutton (E.H., J.M.B.); South West Wales Cancer Institute, Swansea (G.B.); Cookridge Hospital, Leeds (D.D.); Cancer Research Centre, Weston Park Hospital, Sheffield (R.E.C.); Psychosocial Oncology Group, University of Sussex, Brighton (L.J.F.); Christie Hospital, Manchester (A.S.); and Ysbyty Gwynedd, Bangor, Gwynedd (N.S.) — all in the United Kingdom; Universitair Ziekenhuis, Leuven, Belgium (R.P.); Medical University of Gdansk, Gdansk, Poland (J.J.); Centre François Baclesse, Caen, France (T.D.); U.S. Oncology Research, Houston (S.E.J.); Hospital Donostia, San Sebastián, Spain (I.A.); University of Regensburg, Regensburg, Germany (O.O.); University of Sydney, Sydney, Australia (A.S.C.); Istituto Nazionale per lo Studio e la Cura dei Tumori, Milan, Italy (E.B.); Instituto Angel Roffo, Buenos Aires, Argentina (E.M.); Århus University Hospital, Århus, Denmark (J.A.); Haukeland Hospital, University of Bergen, Bergen, Norway (P.E.L.); University Hospital, Parma, Italy (G.C.); and Pharmacia Italia, Pfizer Group, Nerviano, Italy (M.C., G.M.).
Address reprint requests to Dr. Coombes at the Department of Cancer Medicine, Imperial College London, 6th Fl., Cyclotron Bldg., Hammersmith Hospital, Du Cane Rd., London W12 0NN, United Kingdom.
Related Letters:
Adjuvant Treatment of Breast Cancer with Exemestane
Kunkler I. H., Vakaet L. A.M.L., De Neve W., Tanvetyanon T., Coombes R. C., Bliss J. M., Hall E.
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N Engl J Med 2004;
351:100-102, Jul 1, 2004.
Correspondence
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