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 This is an original JCO publication from 2014. Please visit the JCO website to access the full article.


Recommendations on Disease Management for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases: American Society of Clinical Oncology Clinical Practice Guideline


 

 Authors

Naren Ramakrishna, Sarah Temin, Sarat Chandarlapaty, Jennie R. Crews, Nancy E. Davidson, Francisco J. Esteva, Sharon H. Giordano, Ana M. Gonzalez-Angulo, Jeffrey J. Kirshner, Ian Krop, Jennifer Levinson, Shanu Modi, Debra A. Patt, Edith A. Perez, Jane Perlmutter, Eric P. Winer and Nancy U. Lin

 

 

THE BOTTOM LINE

Recommendations on Disease Management for Patients With Advanced HER2-Positive Breast Cancer and Brain Metastases: ASCO Clinical Practice Guideline

Target Population

  • Individuals with advanced human epidermal growth factor receptor (HER2) –positive breast cancer and brain metastases

Target Audience

  • Medical oncologists, radiation oncologists, neurosurgeons, oncology nurses, patients/caregivers

Methods

  • An Expert Panel was convened to develop clinical practice guideline recommendations using an expert consensus process. The Expert Panel was supplemented by a Consensus Ratings Panel

Key Recommendations

  • For patients with a favorable prognosis for survival and a single brain metastasis, treatment options include surgery with postoperative radiation, stereotactic radiosurgery (SRS), whole-brain radiotherapy (WBRT; SRS), fractionated stereotactic radiotherapy (FSRT), and SRS ( WBRT), depending on metastasis size, resectability, and symptoms. After treatment, serial imaging every 2 to 4 months may be used to monitor for local and distant brain failure.

  • For patients with a favorable prognosis for survival and limited (two to four) metastases, treatment options include resection for large symptomatic lesion(s) plus postoperative radiotherapy, SRS for additional smaller lesions, WBRT ( SRS), SRS ( WBRT), and FSRT for metastases 3 to 4 cm. For metastases 3 to 4 cm, treatment options include resection with postoperative radiotherapy. In both cases, available options depend on resectability and symptoms.

  • For patients with diffuse disease/extensive metastases and a more favorable prognosis and those with symptomatic leptomeningeal metastasis in the brain, WBRT may be offered.

  • For patients with poor prognosis, options include WBRT, best supportive care, and/or palliative care.

  • For patients with progressive intracranial metastases despite initial radiation therapy, options include SRS, surgery, WBRT, a trial of systemic therapy, or enrollment onto a clinical trial, depending on initial treatment. For patients in this group who also have diffuse recurrence, best supportive care is an additional option.

  • For patients whose systemic disease is not progressive at the time of brain metastasis diagnosis, systemic therapy should not be switched. 

  • For patients whose systemic disease is progressive at the time of brain metastasis diagnosis, clinicians should offer HER2-targeted therapy according to the algorithms for treatment of HER2-positive metastatic breast cancer.

  • If a patient does not have a known history or symptoms of brain metastases, routine surveillance with brain magnetic resonance imaging (MRI) should not be performed.

  • Clinicians should have a low threshold for performing diagnostic brain MRI testing in the setting of any neurologic symptoms suggestive of brain involvement.

 

 

SUMMARY OF RECOMMENDATIONS


Clinical Question

Recommendation

Evidence Rating

What is the appropriate course of treatments for patients with HER2-positive advanced breast cancer and brain metastases?

 

Does the approach to local therapy of brain metastases differ in patients with HER2-positive breast cancer? (single brain metastasis, favorable prognosis)

 

If a patient has a favorable prognosis for survival and a single brain metastasis, he/she should be evaluated by an experienced neurosurgeon for discussion of the option of surgical resection, particularly if the metastasis is >3-4 cm and/or if there is evidence of symptomatic mass effect.  

Type: Formal Consensus

Evidence Quality: Intermediate

Recommendation Strength: Strong

If a patient has a favorable prognosis and a single brain metastasis of less than < 3-4 cm without symptomatic mass effect, clinicians may offer either SRS or surgical resection, depending upon the location and surgical accessibility of the tumor, need for tissue diagnosis, and other considerations such as medical risk factors for surgery, and patient preference. 

Type: Formal Consensus

Evidence Quality: Intermediate

Recommendation Strength: Weak

If these patients choose to undergo SRS, clinicians may discuss the options of adding WBRT to SRS versus SRS alone. 

Type: Formal Consensus

Evidence Quality: Intermediate

Recommendation Strength: Weak

For most patients with brain metastases who undergo surgical resection, clinicians should recommend postoperative radiotherapy to the resection bed to reduce the risk of local recurrence.

Type: Formal Consensus

Evidence Quality: Intermediate

Recommendation Strength: Weak

If a patient has a favorable prognosis and a single brain metastasis of greater than 3-4 cm. which is deemed unresectable and unsuitable for SRS, clinicians may discuss the options of WBRT or fractionated stereotactic radiotherapy (FRST).

Type: Formal Consensus

Evidence Quality: Low

Recommendation Strength: Weak

After treatment, serial imaging every 2-4 months may be used to monitor for local and distant brain failure.

Type: Formal Consensus

Evidence Quality: Low

Recommendation Strength: Weak

What is the appropriate course of treatments for patients with HER2-positive advanced breast cancer and brain metastases?

 

Does the approach to local therapy of brain metastases differ in patients with HER2-positive breast cancer? (limited metastases [2-4 metastases] and favorable prognosis)

 

If a patient has a favorable prognosis and presents with multiple, but limited metastases (2-4), treatment options depend on the size, resectability, and mass effect of the lesions.

 

 

In a patient who presents with limited metastases suitable for SRS, clinicians may discuss SRS with or without WBRT.

Type: Formal Consensus

Evidence Quality: Intermediate

Recommendation Strength: Weak

In a patient who has a large (>3-4 cm) lesion associated with symptomatic mass effect, clinicians may discuss surgical resection of the larger lesion, if the lesion is deemed resectable. The remaining lesions may be treated with SRS with or without WBRT.

Type: Formal Consensus

Evidence Quality: Intermediate

Recommendation Strength: Weak

In a patient with lesions that are unresectable and unsuitable for SRS, clinicians may recommend WBRT and may discuss SRS following WBRT

Type: Formal Consensus

Evidence Quality: Low

Recommendation Strength: Weak

What is the appropriate course of treatments for patients with HER2-positive advanced breast cancer and brain metastases?

 

Does the approach to local therapy of brain metastases differ in patients with HER2-positive breast cancer? (diffuse disease/extensive metastases)

If a patient has symptomatic leptomeningeal metastases (specifically in the brain), clinicians may recommend WBRT.  The management of leptomeningeal metastases is complex and recommendations regarding intrathecal therapy or systemic therapy for leptomeningeal metastases are outside the scope of these practice guidelines. 

Type: Formal Consensus

Evidence Quality: Low

Recommendation Strength: Moderate

If a patient has a more favorable prognosis and presents with many diffuse/brain metastases (≥5 metastases), clinicians may recommend WBRT. Patients with favorable prognoses are those with good performance status and effective systemic therapy options. The criteria may include KPS ≥70, age, controlled extracranial disease, and/or if good salvage systemic therapy options for extracranial disease are available.

Type: Formal Consensus

Evidence Quality: Low

Recommendation Strength: Weak

What is the appropriate course of treatments for patients with HER2-positive advanced breast cancer and brain metastases?

 

Does the approach to local therapy of brain metastases differ in patients with HER2-positive breast cancer? (patients with poor prognosis)

If a patient has brain metastases) and a poor prognosis, clinicians should discuss the options of best supportive care and/or palliative care, which may or may not include radiation therapy, on a case-by-case basis. 

Type: Formal Consensus

Evidence Quality: Low

Recommendation Strength: Weak

For a patient with symptomatic brain metastases and poor prognosis, WBRT may be offered if there is a reasonable expectation of symptomatic improvement which outweighs the acute and subacute treatment-related toxicities including fatigue and decline in neurocognitive function. 

Type: Formal Consensus

Evidence Quality: Low

Recommendation Strength: Weak

What is the appropriate course of treatments for patients with HER2-positive advanced breast cancer and brain metastases?

 

Does the approach to local therapy of brain metastases differ in patients with HER2-positive breast cancer? (patients with progressive intracranial metastases despite initial therapy)

If a patient has progressive intracranial metastases, treatment options will depend on the patient’s prior therapies, burden of disease, performance status, and overall prognosis. 

 

What is the appropriate course of treatments for patients with HER2-positive advanced breast cancer and brain metastases?

 

Does the approach to local therapy of brain metastases differ in patients with HER2-positive breast cancer? (brain recurrence and radiation; limited recurrence)

For a patient with a favorable prognosis and limited recurrence that follows treatment with WBRT, clinicians may discuss SRS, surgery, a trial of systemic therapy, or enrollment onto a clinical trial.  For a patient with a favorable prognosis and limited recurrence that follows treatment with SRS, clinicians may discuss repeat SRS, surgery, WBRT, a trial of systemic therapy, or enrollment onto a clinical trial.

Type: Formal Consensus

Evidence Quality:  Low

Recommendation Strength: Moderate

What is the appropriate course of treatments for patients with HER2-positive advanced breast cancer and brain metastases?

 

Does the approach to local therapy of brain metastases differ in patients with HER2-positive breast cancer? (brain recurrence and radiation; diffuse recurrence)

If a patient has diffuse recurrence that follows treatment with WBRT, clinicians may discuss palliative options such as repeat reduced dose WBRT, a trial of systemic therapy, enrollment onto a clinical trial, or best supportive care.  

Type: Formal Consensus

Evidence Quality:  Low

Recommendation Strength: Weak

If a patient has diffuse recurrence that follows treatment with SRS, clinicians may discuss palliative options such as WBRT, a trial of systemic therapy, enrollment onto a clinical trial, or best supportive care.

Type: Formal Consensus

Evidence Quality:  Low

Recommendation Strength: Moderate

How should systemic therapy be managed in patients with HER2-positive brain metastases (including how to manage systemic therapy when the brain is the only site of progression versus when progression is in both the brain and elsewhere)? (Brain recurrence and Systemic therapy)

For a patient who receives standard surgical or radiotherapy-based approaches to treat brain metastases and are receiving anti-HER2 based therapy and whose systemic disease is not progressive at the time of brain metastasis diagnosis, clinicians should not switch the systemic therapy.

Type: Formal Consensus

Evidence Quality: Low

Recommendation Strength: Moderate

For a patient who receives standard surgical and/or radiotherapy-based approaches to treatment of brain metastases and whose systemic disease is progressive at the time of brain metastasis diagnosis, clinicians should offer HER2-targeted therapy according to the algorithms for treatment of HER2-positive metastatic breast cancer.

Type: Formal Consensus

Evidence Quality: Intermediate

Recommendation Strength: Moderate

Is there a role for systemic therapy specifically to treat brain metastases in HER2-positive breast cancer? (systemic treatment for brain metastases)

If a patient has asymptomatic, low volume brain metastases and has not received radiation therapy, clinicians may discuss upfront therapy with lapatinib and capecitabine as an option. Clinicians should discuss the most recent data and inform patients that radiation therapy in this setting is still the primary option.

Type: Formal Consensus

Evidence Quality:  Low

Recommendation Strength: Weak

If a patient develops intracranial disease progression following WBRT or SRS, including one who is not a candidate for re-irradiation, clinicians may discuss offering systemic therapy as an alternative, using a regimen with some evidence of activity in the setting of CNS disease.

Type: Formal Consensus

Evidence Quality:  Low

Recommendation Strength: Weak

Should patients with HER2-positive breast cancer be screened for development of brain metastases? (screening)

If a patient does not have a known history of or symptoms of brain metastases, clinicians should not perform routine surveillance with brain MRI. 

Type: Formal Consensus

Evidence Quality:  Low

Recommendation Strength: Weak

Clinicians should have a low threshold to perform diagnostic brain MRI testing in the setting of any neurologic symptoms suggestive of brain involvement, such as new onset headaches, unexplained nausea/vomiting, or change in motor/sensory function.

Type: Formal Consensus

Evidence Quality: Low

Recommendation Strength: 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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