A Randomized Trial of Exemestane after Two to Three Years of Tamoxifen Therapy in Postmenopausal Women with Primary Breast Cancer

Coombes, R. Charles; Hall, Emma; Gibson, Lorna J.; Paridaens, Robert; Jassem, Jacek; Delozier, Thierry; Jones, Stephen E.; Alvarez, Isabel; Bertelli, Gianfilippo; Ortmann, Olaf; Coates, Alan S.; Bajetta, Emilio; Dodwell, David; Coleman, Robert E.; Fallowfield, Lesley J.; Mickiewicz, Elizabeth; Andersen, Jorn; Lønning, Per E.; Cocconi, Giorgio; Stewart, Alan; Stuart, Nick; Snowdon, Claire F.; Carpentieri, Marina; Massimini, Giorgio; Bliss, Judith M.

doi:10.1056/nejmoa040331

Cited by 1,759Breast Cancer Treatment StudiesEstrogen and related hormone effectsEndometrial and Cervical Cancer Treatments

A Randomized Trial of Exemestane after Two to Three Years of Tamoxifen Therapy in Postmenopausal Women with Primary Breast Cancer

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Coombes, R. Charles, Hall, Emma, Gibson, Lorna J., Paridaens, Robert, Jassem, Jacek, Delozier, Thierry, Jones, Stephen E., Alvarez, Isabel +17 more·2004·New England Journal of Medicine

DOI 10.1056/nejmoa040331

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Abstract

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.

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Authors: Coombes, R. C., Hall, E., Gibson, L. J., Paridaens, R., Jassem, J., Delozier, T., Jones, S. E., Alvarez, I., Bertelli, G., Ortmann, O., Coates, A. S., Bajetta, E., Dodwell, D., Coleman, R. E., Fallowfield, L. J., Mickiewicz, E., Andersen, J., Lønning, P. E., Cocconi, G., Stewart, A., Stuart, N., Snowdon, C. F., Carpentieri, M., Massimini, G., & Bliss, J. M.
Affiliations: Charing Cross Hospital (GB)
Institute of Cancer Research (GB)
Universitair Ziekenhuis Leuven (BE)
Gdańsk Medical University (PL)
Centre François Baclesse (FR)
University of Regensburg (DE)
The University of Sydney (AU)
Fondazione IRCCS Istituto Nazionale dei Tumori (IT)
Weston Park Cancer Centre (GB)
University of Sussex (GB)
Haukeland University Hospital (NO)
University of Parma (IT)
The Christie Hospital (GB)
Ysbyty Gwynedd Hospital NHS Trust (GB)
Pfizer (Italy) (IT)
ORCID: Coombes, R. Charles
Hall, Emma
Jassem, Jacek
Jones, Stephen E.
Bertelli, Gianfilippo
Ortmann, Olaf
Coates, Alan S.
Dodwell, David
Coleman, Robert E.
Fallowfield, Lesley J.
Lønning, Per E.
Snowdon, Claire F.
Bliss, Judith M.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2004-03-11
Volume: 350
Issue: 11
Pages: 1081-1092
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa040331
OpenAlex: W2163688875
Cited by: 1,759
References: 43
Citations by year: 2026: 9 · 2025: 8 · 2024: 16 · 2023: 33 · 2022: 19 · 2021: 19 · 2020: 25 · 2019: 27 · 2018: 32 · 2017: 45 · 2016: 43 · 2015: 60 · 2014: 50 · 2013: 66 · 2012: 60
FWCI: 100.73
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
University of Regensburg Publication Server (University of Regensburg) (acceptedVersion)
LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
Figshare (submittedVersion, cc-by)
Funders: Massachusetts Medical Society
Topics: Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Breast Cancer Treatment Studies
Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Estrogen and related hormone effects
Health Sciences › Medicine › Obstetrics and Gynecology › Endometrial and Cervical Cancer Treatments
Keywords: exemestane, tamoxifen, aromatase inhibitors, adjuvant endocrine therapy, estrogen receptor-positive breast cancer, postmenopausal women, disease-free survival, breast cancer recurrence, contralateral breast cancer, overall survival, treatment switching
MeSH terms: Administration, Oral, Aged, Androstadienes, Breast Neoplasms, Double-Blind Method, Estrogen Antagonists, Female, Humans, Middle Aged, Neoplasms, Hormone-Dependent, Receptors, Estrogen, Tamoxifen, Chemotherapy, Adjuvant, Postmenopause, Disease-Free Survival, Antineoplastic Agents, Hormonal, Aromatase Inhibitors

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A Randomized Trial of Exemestane after Two to Three Years of Tamoxifen Therapy in Postmenopausal Women with Primary Breast Cancer

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