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

2002 ◽  
Vol 20 (15) ◽  
pp. 3317-3327 ◽  
Author(s):  
Eric P. Winer ◽  
Clifford Hudis ◽  
Harold J. Burstein ◽  
Rowan T. Chlebowski ◽  
James N. Ingle ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Oncology ◽  
Aromatase Inhibitors ◽  
Technology Assessment ◽  
Hormone Receptor ◽  
Status Report ◽  
Care Providers ◽  
Hormone Receptor Positive ◽  
American Society ◽  
Positive Breast Cancer

OBJECTIVE: To conduct an evidence-based technology assessment to determine whether the routine use of anastrozole or any of the aromatase inhibitors in the adjuvant breast cancer setting is appropriate for broad-based conventional use in clinical practice. POTENTIAL INTERVENTIONS: Anastrozole, letrozole, and exemestane. OUTCOMES: Outcomes of interest include breast cancer incidence, breast cancer-specific survival, overall survival, and net health benefit. EVIDENCE: A comprehensive, formal literature review was conducted for relevant topics and is detailed in the text. Testimony was collected from invited experts and interested parties. The American Society of Clinical Oncology (ASCO)–prescribed technology assessment procedure was followed. BENEFITS/HARMS: The ASCO panel recognizes that a woman and her physician’s decision regarding adjuvant hormonal therapy is complex and will depend on the importance and weight attributed to information regarding both cancer and non–cancer-related risks and benefits. CONCLUSION: The panel was influenced by the compelling, extensive, and long-term data available on tamoxifen. Overall, the panel considers the results of the Arimidex (anastrozole) or Tamoxifen Alone or in Combination (ATAC) trial and the extensive supporting data to be very promising but insufficient to change the standard practice at this time (May 2002). A 5-year course of adjuvant tamoxifen remains the standard therapy for women with hormone receptor–positive breast cancer. The panel recommends that physicians discuss the available information with patients, and, in making a decision, acknowledge that treatment approaches can change over time. Individual health care providers and their patients will need to come to their own conclusions, with careful consideration of all of the available data. (Specific questions addressed by the panel are summarized in Appendix 3.) VALIDATION: The conclusions of the panel were endorsed by the ASCO Health Services Research Committee and the ASCO Board of Directors. SPONSOR: American Society of Clinical Oncology.

scholarly journals American Society of Clinical Oncology Clinical Practice Guideline Update on Adjuvant Endocrine Therapy for Women With Hormone Receptor–Positive Breast Cancer

2010 ◽  
Vol 6 (5) ◽  
pp. 243-246 ◽  
Author(s):  
Harold J. Burstein ◽  
Jennifer J. Griggs ◽  
Ann A. Prestrud ◽  
Sarah Temin
Keyword(s):  
Breast Cancer ◽  
Clinical Practice ◽  
Aromatase Inhibitors ◽  
Clinical Practice Guideline ◽  
Technology Assessment ◽  
Practice Guideline ◽  
Adjuvant Setting ◽  
Hormone Receptor Positive ◽  
American Society ◽  
Positive Breast Cancer

ASCO's technology assessment of the use of aromatase inhibitors in the adjuvant setting was last updated in 2004. ASCO's Update Committee on Aromatase Inhibitors reconvened in May 2009 to update this guideline.

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

2005 ◽  
Vol 23 (3) ◽  
pp. 619-629 ◽  
Author(s):  
Eric P. Winer ◽  
Clifford Hudis ◽  
Harold J. Burstein ◽  
Antonio C. Wolff ◽  
Kathleen I. Pritchard ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Therapy ◽  
Aromatase Inhibitor ◽  
Postmenopausal Women ◽  
Aromatase Inhibitors ◽  
Hormone Receptor ◽  
Aromatase Inhibitor Therapy ◽  
Hormone Receptor Positive ◽  
American Society ◽  
Positive Breast Cancer

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.

scholarly journals American Society of Clinical Oncology Clinical Practice Guideline: Update on Adjuvant Endocrine Therapy for Women With Hormone Receptor–Positive Breast Cancer

2010 ◽  
Vol 28 (23) ◽  
pp. 3784-3796 ◽  
Author(s):  
Harold J. Burstein ◽  
Ann Alexis Prestrud ◽  
Jerome Seidenfeld ◽  
Holly Anderson ◽  
Thomas A. Buchholz ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adverse Effect ◽  
Postmenopausal Women ◽  
Endocrine Therapy ◽  
Clinical Oncology ◽  
Adjuvant Treatment ◽  
Hormone Receptor ◽  
Hormone Receptor Positive ◽  
American Society ◽  
Positive Breast Cancer

PurposeTo develop evidence-based guidelines, based on a systematic review, for endocrine therapy for postmenopausal women with hormone receptor–positive breast cancer.MethodsA literature search identified relevant randomized trials. Databases searched included MEDLINE, PREMEDLINE, the Cochrane Collaboration Library, and those for the Annual Meetings of the American Society of Clinical Oncology (ASCO) and the San Antonio Breast Cancer Symposium (SABCS). The primary outcomes of interest were disease-free survival, overall survival, and time to contralateral breast cancer. Secondary outcomes included adverse events and quality of life. An expert panel reviewed the literature, especially 12 major trials, and developed updated recommendations.ResultsAn adjuvant treatment strategy incorporating an aromatase inhibitor (AI) as primary (initial endocrine therapy), sequential (using both tamoxifen and an AI in either order), or extended (AI after 5 years of tamoxifen) therapy reduces the risk of breast cancer recurrence compared with 5 years of tamoxifen alone. Data suggest that including an AI as primary monotherapy or as sequential treatment after 2 to 3 years of tamoxifen yields similar outcomes. Tamoxifen and AIs differ in their adverse effect profiles, and these differences may inform treatment preferences.ConclusionThe Update Committee recommends that postmenopausal women with hormone receptor–positive breast cancer consider incorporating AI therapy at some point during adjuvant treatment, either as up-front therapy or as sequential treatment after tamoxifen. The optimal timing and duration of endocrine treatment remain unresolved. The Update Committee supports careful consideration of adverse effect profiles and patient preferences in deciding whether and when to incorporate AI therapy.

The Aromatase Inhibitors as Adjuvant Therapy for Hormone Receptor-Positive Breast Cancer

2003 ◽  
Vol 1 (2) ◽  
pp. 215-221
Author(s):  
Jennifer A. Ligibel ◽  
Eric P. Winer
Keyword(s):  
Breast Cancer ◽  
Aromatase Inhibitors ◽  
Hormonal Therapy ◽  
Hormone Receptor ◽  
Uterine Cancer ◽  
Adjuvant Hormonal Therapy ◽  
Adjuvant Setting ◽  
Modest Improvement ◽  
Hormone Receptor Positive ◽  
Positive Breast Cancer

Adjuvant hormonal therapy has been shown to decrease the risk of breast cancer recurrence and overall mortality in patients with hormone receptor-positive breast cancer. Tamoxifen has been used in this setting for many years, both in premenopausal and postmenopausal patients. Tamoxifen is not devoid of toxicity, and attempts have been made to develop newer hormonal agents with better efficacy and less toxicity. The aromatase inhibitors have shown equivalent or superior efficacy to tamoxifen in the treatment of metastatic breast cancer, and efforts are underway to determine the role of these agents in early breast cancer. The ATAC trial recently showed that use of the third-generation aromatase inhibitor anastrozole in the adjuvant setting led to a modest improvement in relapse-free survival as compared with tamoxifen. Patients treated with anastrozole were also less likely to develop uterine cancer or experience a thromboembolic event. However, patients treated with anastrozole were more likely than those treated with tamoxifen to suffer a fracture or other musculosketal problem. An ASCO technology assessment panel reviewed the relevant data and issued a consensus statement regarding the use of aromatase inhibitors in the adjuvant setting. In general, the panel favored the continued use of tamoxifen as adjuvant hormonal therapy for most postmenopausal women. Within the next few years, further data from the ATAC trial and from other trials of aromatase inhibitors in the adjuvant setting should be available to guide treatment recommendations for this patient population.

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