This is the current release of the guideline.

This guideline updates a previous version: Winer EP, Hudis C, Burstein HJ, Chlebowski RT, Ingle JN, Edge SB, Mamounas EP, Gralow J, Goldstein LJ, Pritchard KI, Braun S, Cobleigh MA, Langer AS, Perotti J, Powles TJ, Whelan TJ, Browman GP. American Society of Clinical Oncology technology assessment on the use of aromatase inhibitors as adjuvant therapy for women with hormone receptor-positive breast cancer: status report 2002. J Clin Oncol 2002 Aug 1;20(15):3317-27.

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, to 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.

None provided

The type of evidence supporting the recommendations is not specifically stated. The recommendations were based primarily on the results from four large randomized phase III clinical trials (see original guideline document for details). Testimony was also collected from invited experts and interested parties.

Not applicable: The guideline was not adapted from another source.

2002 Aug 1 (revised 2005 Jan 20)

American Society of Clinical Oncology - Medical Specialty Society

American Society of Clinical Oncology

American Society of Clinical Oncology Aromatase Inhibitors Expert Panel

Expert Panel Members: Eric P. Winer, MD (Chair), Dana-Farber Cancer Institute; George P. Browman, MD, Tom Baker Cancer Centre, Calgary; Susan Braun, Susan G. Komen Breast Cancer Foundation; John Bryant, PhD, University of Pittsburgh; Harold J. Burstein, MD, PhD, Dana-Farber Cancer Institute; Rowan T. Chlebowski, MD, PhD, Harbor UCLA Medical Center; Melody A. Cobleigh, MD, Rush Presbyterian-St Luke´s Medical Center; Stephen B. Edge, MD, Roswell Park Cancer Institute; Richard D. Gelber, PhD, Dana-Farber Cancer Institute; Lori J. Goldstein, MD, Fox Chase Cancer Center; Julie Gralow, MD, Seattle Cancer Center Alliance; Clifford Hudis, MD, Memorial Sloan-Kettering Cancer Center; James N. Ingle, MD, Mayo Clinic; Amy S. Langer, Patient advocate and educator; former Executive Director, National Alliance of Breast Cancer Organizations (NABCO); Eleftherios P. Mamounas, MD, Aultman Cancer Center; Cheryl L. Perkins, MD, RPH, Susan G. Komen Breast Cancer Foundation; Judy Perotti, Research Advocacy Network; Trevor S. Powles, MD, PhD, Parkside Oncology Clinic, London; Kathleen I. Pritchard, MD, Toronto-Sunnybrook Regional Cancer Center; Timothy J. Whelan, BM, BCh, MSc, Cancer Care Ontario; Antonio C. Wolff, MD, FACP, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

The following authors or their immediate family members have indicated a financial interest. No conflict exists for drugs or devices used in a study if they are not being evaluated as part of the investigation. Consultant/Advisory Role: Clifford Hudis, AstraZeneca, Novartis, Pfizer; Kathleen I. Pritchard, AstraZeneca, Aventis, Novartis, OrthoBiotech, Pfizer, Roche, YM Biosciences; James N. Ingle, Novartis, Pfizer; Rowan T. Chlebowski, AstraZeneca, Novartis, Pfizer; Julie Gralow, AstraZeneca, Novartis, Pharmacia/Pfizer; Eleftherios P. Mamounas, AstraZeneca, Pfizer, Novartis; Lori J. Goldstein, Pfizer, Novartis. Honoraria: Clifford Hudis, AstraZeneca; Antonio C. Wolff, AstraZeneca; Kathleen I. Pritchard, AstraZeneca, Novartis, Pfizer, Roche/Genentech; James N. Ingle, Novartis, Pfizer; Rowan T. Chlebowski, AstraZeneca, Novartis, Pfizer; Eleftherios P. Mamounas, AstraZeneca, Pfizer, Novartis; Lori J. Goldstein, Pfizer, Novartis; Timothy J. Whelan, AstraZeneca. Research Funding: Eric P. Winer, AstraZeneca; Clifford Hudis, AstraZeneca, Novartis, Pfizer; Kathleen I. Pritchard, AstraZeneca; Richard Gelber, International Breast Cancer Study Group (IBCSG). Expert Testimony: Kathleen I. Pritchard, Aventis. For a detailed description of these categories, or for more information about American Society of Clinical Oncology's conflict of interest policy, please refer to the Author Disclosure Declaration form and the "Disclosures of Potential Conflicts of Interest" section of Information for Contributors found in the front of every issue.

This is the current release of the guideline.

This guideline updates a previous version: Winer EP, Hudis C, Burstein HJ, Chlebowski RT, Ingle JN, Edge SB, Mamounas EP, Gralow J, Goldstein LJ, Pritchard KI, Braun S, Cobleigh MA, Langer AS, Perotti J, Powles TJ, Whelan TJ, Browman GP. American Society of Clinical Oncology technology assessment on the use of aromatase inhibitors as adjuvant therapy for women with hormone receptor-positive breast cancer: status report 2002. J Clin Oncol 2002 Aug 1;20(15):3317-27.

This NGC summary was completed by ECRI on February 27, 2003. The information was verified by the guideline developer on March 14, 2003. This NGC summary was updated by ECRI on May 6, 2005. The information was verified by the guideline developer on May 10, 2005.

This summary is based on the original guideline, which is subject to the American Society of Clinical Oncology's copyright restrictions.