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 This is an original JCO publication from 2016. Please visit the JCO website to access the full article.


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


 

 Authors

Harold J. Burstein, Christina Lacchetti, Holly Anderson, Thomas A. Buchholz, Nancy E. Davidson, Karen E. Gelmon, Sharon H. Giordano, Clifford A. Hudis, Alexander J. Solky, Vered Stearns, Eric P. Winer, and Jennifer J. Griggs

THE BOTTOM LINE

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

Guideline Questions

1. Should premenopausal women with estrogen receptor (ER)–positive tumors receive adjuvant ovarian suppression in addition to standard adjuvant therapy and, if so, in which subsets of patients?

2. If ovarian suppression is recommended, should ovarian suppression be administered in combination with tamoxifen or an aromatase inhibitor (AI)?

Target Population

Premenopausal women with stage I to III hormone receptor–positive breast cancer.

Target Audience

Medical, surgical, and radiation oncologists; oncology nurses and physician assistants; obstetrician/gynecologists; general practitioners; and patients.

Methods

An Update Panel was convened to develop and update clinical practice guideline recommendations based on a systematic review of the medical literature.

Recommendations

1. Should premenopausal women with ER-positive tumors receive adjuvant ovarian suppression in addition to standard adjuvant therapy and, if so, in which subsets of patients?

1.1 The Panel recommends that higher-risk patients should receive ovarian suppression in addition to adjuvant endocrine therapy, whereas lower-risk patients should not.

Qualifying Statement

The Panel notes that two prospective studies did not show overall clinical benefit for the addition of ovarian suppression to tamoxifen in premenopausal, ER-positive breast cancer. However, in a large subset of women with higher-risk cancers, nearly all of whom received chemotherapy but remained premenopausal, ovarian suppression added to tamoxifen reduced the risk of breast cancer recurrence. Because of the design of the clinical trials, there are few definitive criteria by which to define risk.

1.2 Women with stage II or stage III breast cancers who would ordinarily be advised to receive adjuvant chemotherapy should receive ovarian suppression in addition to endocrine therapy.

1.3 Women with stage I or II breast cancers at higher risk of recurrence, who might consider chemotherapy, may also be offered ovarian suppression in addition to endocrine therapy.

1.4 Women with stage I breast cancers not warranting chemotherapy should receive endocrine therapy but not receive ovarian suppression.

1.5 Women with node-negative cancers 1 cm or less (T1a, T1b) should receive endocrine therapy but not receive ovarian suppression.

[Benefits: increasing disease-free survival (DFS), freedom from breast cancer, and freedom from distance recurrence. Harms: worse menopausal symptoms and sexual functioning, including hot flashes, sweating, weight gain, vaginal dryness, and decreased libido.]

Evidence quality: Intermediate

Recommendation type: Evidence based and consensus

Recommendation strength: Moderate

Qualifying Statements

• The standard duration of ovarian suppression in the included trials was 5 years. With no comparative data available on alternative durations, the Panel supports ovarian suppression for 5 years.

• To date there is no adequate evidence for assessing the benefit of adjuvant ovarian suppression in women at sufficient risk to warrant chemotherapy compared with 10 years of tamoxifen.

• There is no current role for ovarian suppression as adjuvant therapy in ER-negative breast cancers.

• There are substantial adverse effects to ovarian suppression. Clinicians and patients should consider the tradeoffs of adverse effects when choosing ovarian suppression.

• The long-term effects of ovarian suppression on breast cancer risk and survival are not yet established.

2. If ovarian suppression is recommended, should ovarian suppression be administered in combination with tamoxifen or an AI?

• Ovarian suppression may be administered with either tamoxifen or an AI.

[Benefits: increasing disease-free survival, freedom from breast cancer, and freedom from distance recurrence; Harms: worse menopausal symptoms and sexual functioning, including hot flashes, sweating, weight gain, vaginal dryness, and decreased libido; osteopenia/osteoporosis]

Evidence quality: High

Recommendation type: Evidence based

Recommendation strength: Strong

Qualifying Statements

• Tamoxifen and AI therapy differ in their adverse-effect profiles, which may affect patient preferences.

• Clinicians should be alert to the possibility of incomplete ovarian suppression with gonadotropin-releasing hormone agonist therapy and evaluate patients in whom there is concern for residual ovarian function.

ASCO believes that cancer clinical trials are vital to inform medical decisions and improve cancer care, and that all patients should have the opportunity to participate.

Additional Resources: More information, including a Data Supplement with additional evidence tables, a Methodology Supplement with information about evidence quality and strength of recommendations, slide sets, and clinical tools and resources, is available at www.asco.org/guidelines/endocrinebreast and www.asco.org/guidelineswiki. Patient information is available at www.cancer.net.

SUMMARY OF RECOMMENDATIONS

Clinical QuestionRecommendationEvidence Rating
Should premenopausal women with ER-positive tumors receive adjuvant ovarian suppression in addition to standard adjuvant therapy and, if so, in which subsets of patients?The Panel recommends that higher risk patients should receive ovarian suppression in addition to adjuvant endocrine therapy while lower risk patients should not.

Recommendation Type: Evidence-Based and Panel Consensus; Benefits Outweigh Harms

Evidence Quality: Intermediate

Strength of Recommendation: Moderate

Women with Stage II or Stage III breast cancers who would ordinarily be advised to receive adjuvant chemotherapy should receive ovarian suppression in addition to endocrine therapy.

Recommendation Type: Evidence-Based and Panel Consensus; Benefits Outweigh Harms

Evidence Quality: High

Strength of Recommendation: Moderate

Women with Stage I or II breast cancers at higher risk of recurrence, who might consider chemotherapy, may also be offered ovarian suppression in addition to endocrine therapy.

Recommendation Type: Evidence-Based and Panel Consensus; Benefits Outweigh Harms

Evidence Quality: High

Strength of Recommendation: Moderate

Women with Stage I breast cancers not warranting chemotherapy should receive endocrine therapy but not receive ovarian suppression

Recommendation Type: Evidence-Based; Harms Outweigh Benefits

Evidence Quality: High

Strength of Recommendation: Strong

Women with node-negative cancers 1 centimeter or less (T1a, T1b) should receive endocrine therapy but not receive ovarian suppression.

Recommendation type: Evidence-Based; Harms Outweigh Benefits

Evidence Quality: High

Strength of Recommendation: Strong

If ovarian suppression is recommended, should ovarian suppression be administered in combination with tamoxifen or an aromatase inhibitor (AI)?The Panel recommends that ovarian suppression may be administered with either tamoxifen or an AI.

Recommendation type: Evidence-Based; Benefits Outweigh Harms

Evidence Quality: High

Strength of Recommendation: Strong

 

 

 

   

 

 

 

ASCO Guideline Disclaimer: The clinical practice guidelines and other guidance published herein are provided by the American Society of Clinical Oncology, Inc. (“ASCO”) to assist practitioners in clinical decision making. The information therein should not be relied upon as being complete or accurate, nor should it be considered as inclusive of all proper treatments or methods of care or as a statement of the standard of care. With the rapid development of scientific knowledge, new evidence may emerge between the time information is developed and when it is published or read. The information is not continually updated and may not reflect the most recent evidence. The information addresses only the topics specifically identified therein and is not applicable to other interventions, diseases, or stages of diseases. This information does not mandate any particular course of medical care. Further, the information is not intended to substitute for the independent professional judgment of the treating physician, as the information does not account for individual variation among patients. Recommendations reflect high, moderate or low confidence that the recommendation reflects the net effect of a given course of action.  The use of words like “must,” “must not,” “should,” and “should not” indicate that a course of action is recommended or not recommended for either most or many patients, but there is latitude for the treating physician to select other courses of action in individual cases. In all cases, the selected course of action should be considered by the treating physician in the context of treating the individual patient. Use of the information is voluntary.  ASCO provides this information on an “as is” basis, and makes no warranty, express or implied, regarding the information. ASCO specifically disclaims any warranties of merchantability or fitness for a particular use or purpose. ASCO assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of this information or for any errors or omissions.


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