Management of Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases: ASCO Guideline Update

Ramakrishna, Naren; Anders, Carey K.; Lin, Nancy U.; Morikawa, Aki; Temin, Sarah; Chandarlapaty, Sarat; Crews, Jennie R.; Davidson, Nancy E.; Franzoi, Maria Alice; Kirshner, Jeffrey J.; Krop, Ian E.; Patt, Debra A.; Perlmutter, Jane; Giordano, Sharon H.

doi:10.1200/jco.22.00520

Cited by 46 publications

(30 citation statements)

References 35 publications

(107 reference statements)

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“…The companion guideline addresses the management of HER2-positive advanced breast cancer and brain metastases. 27 In the third-line or greater setting, endocrine therapy may be a better option for those patients with hormone receptor-positive disease who have not received prior hormonal therapy. The literature review found three studies of biosimilar trastuzumab; this section describes the two larger ones.…”

Section: Discussionmentioning

confidence: 99%

“…The Expert Panel notes the companion guideline on when CNS metastases are the site of progression. 27…”

Section: Recommendationsmentioning

confidence: 99%

“…Integration of Palliative Care into Standard Oncology Care 50 (http://ascopubs.org/doi/10.1200/JCO.2016.70.1474)Patient-Clinician Communication 35 (http://ascopubs.org/doi/10.1200/JCO.2017.75.2311)Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer 51 (https://ascopubs.org/doi/10.1200/JCO.2018.77.8738)Management of Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases 27 (https://ascopubs.org/doi/10.1200/JCO.22.00520)…”

Section: Additional Resourcesmentioning

confidence: 99%

“…One of the secondary outcomes was time to symptomatic and/or progressive CNS metastases (2.5% v 5.1% at baseline); the results for this subgroup are discussed separately in the companion guideline on when CNS metastases are the site of progression. 27 No benefit in overall systemic efficacy (either PFS or objective response rate [ORR]) or safety was found. 6 Another study, originally found in the systematic review for the 2017 update for which survival results were published in 2019, that the authors wish to note examined the use of T-DM1 in first-line treatment.…”

Section: Clinical Questionmentioning

confidence: 99%

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Systemic Therapy for Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: ASCO Guideline Update

Giordano

Franzoi

Temin

et al. 2022

JCO

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PURPOSE To update evidence-based guideline recommendations to practicing oncologists and others on systemic therapy for patients with human epidermal growth factor receptor 2 (HER2)–positive advanced breast cancer. METHODS An Expert Panel conducted a targeted systematic literature review (for both systemic treatment and CNS metastases) and identified 545 articles. Outcomes of interest included efficacy and safety. RESULTS Of the 545 publications identified and reviewed, 14 were identified to form the evidentiary basis for the guideline recommendations. RECOMMENDATIONS HER2-targeted therapy is recommended for patients with HER2-positive advanced breast cancer, except for those with clinical congestive heart failure or significantly compromised left ventricular ejection fraction, who should be evaluated on a case-by-case basis. Trastuzumab, pertuzumab, and taxane for first-line treatment and trastuzumab deruxtecan for second-line treatment are recommended. In the third-line setting, clinicians should offer other HER2-targeted therapy combinations. There is a lack of head-to-head trials; therefore, there is insufficient evidence to recommend one regimen over another. The patient and the clinician should discuss differences in treatment schedule, route, toxicities, etc during the decision-making process. Options include regimens with tucatinib, trastuzumab emtansine, trastuzumab deruxtecan (if either not previously administered), neratinib, lapatinib, chemotherapy, margetuximab, hormonal therapy, and abemaciclib plus trastuzumab plus fulvestrant, and may offer pertuzumab if the patient has not previously received it. Optimal duration of chemotherapy is at least 4-6 months or until maximum response, depending on toxicity and in the absence of progression. HER2-targeted therapy can continue until time of progression or unacceptable toxicities. For patients with HER2-positive and estrogen receptor–positive or progesterone receptor–positive breast cancer, clinicians may recommend either standard first-line therapy or, for selected patients, endocrine therapy plus HER2-targeted therapy or endocrine therapy alone. Additional information is available at www.asco.org/breast-cancer-guidelines .

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Section: Discussionmentioning

confidence: 99%

“…The Expert Panel notes the companion guideline on when CNS metastases are the site of progression. 27…”

Section: Recommendationsmentioning

confidence: 99%

Section: Additional Resourcesmentioning

confidence: 99%

Section: Clinical Questionmentioning

confidence: 99%

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Systemic Therapy for Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: ASCO Guideline Update

Giordano

Franzoi

Temin

et al. 2022

JCO

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“…Despite the large burden of symptomatic BRM on patients and the health care system, current guidelines do not recommend the use of neuroimaging to routinely screen for BRM in women with early-stage or metastatic breast cancer (MBC). 11 , 12 , 13 , 14 We hypothesize that early detection of BRM in patients with MBC via a magnetic resonance imaging (MRI)-based screening program may allow for early intervention and improved outcomes. However, appropriate data to inform clinical trials or policies of screening MBC patients for BRM are lacking.…”

Section: Introductionmentioning

confidence: 99%

Analysis of Rates of Brain Metastases and Association With Breast Cancer Subtypes in Ontario, Canada

et al. 2022

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Brain Radiotherapy With Pyrotinib and Capecitabine in Patients With ERBB2-Positive Advanced Breast Cancer and Brain Metastases

Yang,

Meng,

Mei

et al. 2024

JAMA Oncol

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ImportanceThe potential benefit of combining intracranial effective systemic therapy with radiotherapy for patients with breast cancer with brain metastases remains unclear.ObjectiveTo assess the activity and safety of combining radiotherapy with pyrotinib and capecitabine in patients with ERBB2-positive breast cancer and brain metastases.Design, Setting, and ParticipantsThis was a single-arm, single-center, phase 2 nonrandomized clinical trial with a safety run-in phase. Between January 2020 and August 2022, patients with ERBB2-positive breast cancer and brain metastases were enrolled. The data cutoff date was February 1, 2023.InterventionsPatients received either fractionated stereotactic radiotherapy or whole-brain radiotherapy. Treatment with pyrotinib (400 mg, once daily) and capecitabine (1000 mg/m2, twice daily, on days 1-14 of each 21-day cycle) was initiated from the first day of radiotherapy to the seventh day after the completion of radiotherapy and continued until disease progression or unacceptable toxic effects.Main Outcomes and MeasuresThe primary end point was 1-year central nervous system (CNS) progression-free survival (PFS) rate. Secondary end points included CNS objective response rate (ORR), PFS, overall survival (OS), safety, and changes in neurocognitive function.ResultsA total of 40 female patients (median age, 50.5 years [IQR, 46-59 years]) were enrolled and received treatment, including 3 patients in safety run-in phase. With a median follow-up of 17.3 months (IQR, 10.3-26.9), the 1-year CNS PFS rate was 74.9% (95% CI, 61.9%-90.7%), and the median CNS PFS was 18.0 months (95% CI, 15.5 to not reached). The 1-year PFS rate was 66.9% (95% CI, 53.1%-84.2%), and the median PFS was 17.6 months (95% CI, 12.8-34.1). The CNS objective response rate was 85% (34 of 40). Median overall survival was not reached. The most common grade 3 or 4 treatment-related adverse event was diarrhea (7.5%). Asymptomatic radiation necrosis was identified in 4 of 67 lesions (6.0%) treated with fractionated stereotactic radiotherapy. Most patients maintained neurocognitive function, as evaluated by the Mini-Mental State Examination at different points.Conclusions and RelevanceThe results of this trial suggest that radiotherapy combined with pyrotinib and capecitabine is associated with long intracranial survival benefit in patients with ERBB2-positive advanced breast cancer and brain metastases with an acceptable safety profile. This combination deserves further validation.Trial RegistrationClinicalTrials.gov Identifier: NCT04582968

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Management of Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases: ASCO Guideline Update

Cited by 46 publications

References 35 publications

Systemic Therapy for Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: ASCO Guideline Update

Systemic Therapy for Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: ASCO Guideline Update

Analysis of Rates of Brain Metastases and Association With Breast Cancer Subtypes in Ontario, Canada

Brain Radiotherapy With Pyrotinib and Capecitabine in Patients With ERBB2-Positive Advanced Breast Cancer and Brain Metastases

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