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Originally published as JCO Early Release 10.1200/JCO.2005.09.121 on November 15 2004

Journal of Clinical Oncology, Vol 23, No 3 (January 20), 2005: pp. 619-629
© 2005 American Society of Clinical Oncology.

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ASCO SPECIAL ARTICLE

American Society of Clinical Oncology Technology Assessment on the Use of Aromatase Inhibitors As Adjuvant Therapy for Postmenopausal Women With Hormone Receptor–Positive Breast Cancer: Status Report 2004

Eric P. Winer, Clifford Hudis, Harold J. Burstein, Antonio C. Wolff, Kathleen I. Pritchard, James N. Ingle, Rowan T. Chlebowski, Richard Gelber, Stephan B. Edge, Julie Gralow, Melody A. Cobleigh, Eleftherios P. Mamounas, Lori J. Goldstein, Timothy J. Whelan, Trevor J. Powles, John Bryant, Cheryl Perkins, Judy Perotti, Susan Braun, Amy S. Langer, George P. Browman, Mark R. Somerfield

From Cancer Policy and Clinical Affairs, American Society of Clinical Oncology, Alexandria, VA

Address reprint requests to Eric P. Winer, MD, Dana-Farber Cancer Institute, 44 Binney St, D1210, Boston, MA 02115; e-mail: ewiner{at}partners.org

PURPOSE: To update the 2003 American Society of Clinical Oncology technology assessment on adjuvant use of aromatase inhibitors.

RECOMMENDATIONS: Based on results from multiple large randomized trials, adjuvant therapy for postmenopausal women with hormone receptor–positive breast cancer should include an aromatase inhibitor in order to lower the risk of tumor recurrence. Neither the optimal timing nor duration of aromatase inhibitor therapy is established. Aromatase inhibitors are appropriate as initial treatment for women with contraindications to tamoxifen. For all other postmenopausal women, treatment options include 5 years of aromatase inhibitors treatment or sequential therapy consisting of tamoxifen (for either 2 to 3 years or 5 years) followed by aromatase inhibitors for 2 to 3, or 5 years. Patients intolerant of aromatase inhibitors should receive tamoxifen. There are no data on the use of tamoxifen after an aromatase inhibitor in the adjuvant setting. Women with hormone receptor–negative tumors should not receive adjuvant endocrine therapy. The role of other biomarkers such as progesterone receptor and HER2 status in selecting optimal endocrine therapy remains controversial. Aromatase inhibitors are contraindicated in premenopausal women; there are limited data concerning their role in women with treatment-related amenorrhea. The side effect profiles of tamoxifen and aromatase inhibitors differ. The late consequences of aromatase inhibitor therapy, including osteoporosis, are not well characterized.

CONCLUSION: The Panel believes that optimal adjuvant hormonal therapy for a postmenopausal woman with receptor-positive breast cancer includes an aromatase inhibitor as initial therapy or after treatment with tamoxifen. Women with breast cancer and their physicians must weigh the risks and benefits of all therapeutic options.

Authors' disclosures of potential conflicts of interest are found at the end of this article.


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NEJMHome page
The Breast International Group (BIG) 1-98 Collabor
A Comparison of Letrozole and Tamoxifen in Postmenopausal Women with Early Breast Cancer
N. Engl. J. Med., December 29, 2005; 353(26): 2747 - 2757.
[Abstract] [Full Text] [PDF]


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JCOHome page
G. Demonty
Treatment Guidelines for Adjuvant Breast Cancer Are Moving Toward Double Standards: One for the Rich and One for the Poor
J. Clin. Oncol., December 20, 2005; 23(36): 9436 - 9437.
[Full Text] [PDF]


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Clin. Cancer Res.Home page
P. R. Hutson, R. R. Love, T. C. Havighurst, E. Rogers, and J. F. Cleary
Effect of Exemestane on Tamoxifen Pharmacokinetics in Postmenopausal Women Treated for Breast Cancer
Clin. Cancer Res., December 15, 2005; 11(24): 8722 - 8727.
[Abstract] [Full Text] [PDF]


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ANN INTERN MEDHome page
C. Crandall and J. P. Pregler
Update in Women's Health
Ann Intern Med, December 6, 2005; 143(11): 823 - 829.
[Full Text] [PDF]


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Ann OncolHome page
W. Kievit, M. J. Bolster, G. J. van der Wilt, P. Bult, F. B. J. M. Thunnissen, J. Meijer, L. J. A. Strobbe, J. H. G. Klinkenbijl, T. Wobbes, E. M. M. Adang, et al.
Cost-effectiveness of new guidelines for adjuvant systemic therapy for patients with primary breast cancer
Ann. Onc., December 1, 2005; 16(12): 1874 - 1881.
[Abstract] [Full Text] [PDF]


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JCOHome page
R. S. Punglia and H. J. Burstein
In Reply:
J. Clin. Oncol., November 20, 2005; 23(33): 8546 - 8547.
[Full Text] [PDF]


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NEJMHome page
N. E. Davidson, M. Morrow, D. B. Kopans, and F. C. Koerner
Case 35-2005 -- A 56-Year-Old Woman with Breast Cancer and Isolated Tumor Cells in a Sentinel Lymph Node
N. Engl. J. Med., November 17, 2005; 353(20): 2177 - 2185.
[Full Text] [PDF]


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The OncologistHome page
M. Cianfrocca and W. J. Gradishar
Controversies in the Therapy of Early Stage Breast Cancer
Oncologist, November 1, 2005; 10(10): 766 - 779.
[Abstract] [Full Text] [PDF]


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Clin. Cancer Res.Home page
A. M. Sieuwerts, M. E. Meijer-van Gelder, M. Timmermans, A. M.A.C. Trapman, R. R. Garcia, M. Arnold, A. J.W. Goedheer, H. Portengen, J. G.M. Klijn, and J. A. Foekens
How ADAM-9 and ADAM-11 Differentially From Estrogen Receptor Predict Response to Tamoxifen Treatment in Patients with Recurrent Breast Cancer: a Retrospective Study
Clin. Cancer Res., October 15, 2005; 11(20): 7311 - 7321.
[Abstract] [Full Text] [PDF]


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Ann OncolHome page
A. Goldhirsch, J. H. Glick, R. D. Gelber, A. S. Coates, B. Thurlimann, H.-J. Senn, and and Panel Members
Meeting Highlights: International Expert Consensus on the Primary Therapy of Early Breast Cancer 2005
Ann. Onc., October 1, 2005; 16(10): 1569 - 1583.
[Abstract] [Full Text] [PDF]


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JCOHome page
J. R. Benson
The Use of Aromatase Inhibitors in Postmenopausal Women With Hormone Receptor Positive Breast Cancer
J. Clin. Oncol., September 20, 2005; 23(27): 6807 - 6809.
[Full Text] [PDF]


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JNCI J Natl Cancer InstHome page
P. E. Goss, J. N. Ingle, S. Martino, N. J. Robert, H. B. Muss, M. J. Piccart, M. Castiglione, D. Tu, L. E. Shepherd, K. I. Pritchard, et al.
Randomized Trial of Letrozole Following Tamoxifen as Extended Adjuvant Therapy in Receptor-Positive Breast Cancer: Updated Findings from NCIC CTG MA.17
J Natl Cancer Inst, September 7, 2005; 97(17): 1262 - 1271.
[Abstract] [Full Text] [PDF]


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JCOHome page
I. E. Krop and E. P. Winer
Ovarian Suppression for Breast Cancer: An Effective Treatment in Search of a Home
J. Clin. Oncol., September 1, 2005; 23(25): 5869 - 5872.
[Full Text] [PDF]


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NEJMHome page
P. D. Ryan, D. B. Kopans, and D. C. Sgroi
Case 24-2005 - A 58-Year-Old Woman with Early-Stage Estrogen-Receptor-Positive Breast Cancer
N. Engl. J. Med., August 11, 2005; 353(6): 617 - 622.
[Full Text] [PDF]


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JCOHome page
C. L. Shapiro
Aromatase Inhibitors and Bone Loss: Risks in Perspective
J. Clin. Oncol., August 1, 2005; 23(22): 4847 - 4849.
[Full Text] [PDF]


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Endocr Relat CancerHome page
C. M Staka, R. I Nicholson, and J. M W Gee
Acquired resistance to oestrogen deprivation: role for growth factor signalling kinases/oestrogen receptor cross-talk revealed in new MCF-7X model
Endocr. Relat. Cancer, July 1, 2005; 12(Supplement_1): S85 - S97.
[Abstract] [Full Text] [PDF]


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JCOHome page
P. Tralongo, A. Di Mari, and F. Ferrau'
Cognitive Impairment, Aromatase Inhibitors, and Age
J. Clin. Oncol., June 20, 2005; 23(18): 4243 - 4243.
[Full Text] [PDF]


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Endocr. Rev.Home page
R. W. Brueggemeier, J. C. Hackett, and E. S. Diaz-Cruz
Aromatase Inhibitors in the Treatment of Breast Cancer
Endocr. Rev., May 1, 2005; 26(3): 331 - 345.
[Abstract] [Full Text] [PDF]


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CA Cancer J ClinHome page
R. Kudachadkar and R. M. O'Regan
Aromatase Inhibitors as Adjuvant Therapy for Postmenopausal Patients With Early Stage Breast Cancer
CA Cancer J Clin, May 1, 2005; 55(3): 145 - 163.
[Abstract] [Full Text] [PDF]


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Ann OncolHome page
C. Tondini and R. Labianca
Tailoring a tailored treatment: the importance of fine-tuning on the patient
Ann. Onc., May 1, 2005; 16(5): 683 - 685.
[Full Text] [PDF]


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JWatch Women's HealthHome page
When Should Aromatase Inhibitors Be Used as Adjuvant Therapy for Breast Cancer?
Journal Watch Women's Health, April 6, 2005; 2005(406): 1 - 1.
[Full Text]


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JCOHome page
K. Strasser-Weippl and P. E. Goss
Advances in Adjuvant Hormonal Therapy for Postmenopausal Women
J. Clin. Oncol., March 10, 2005; 23(8): 1751 - 1759.
[Full Text] [PDF]



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