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Neoadjuvant chemotherapy is the treatment of choice for newly diagnosed inflammatory or unresectable breast cancer, as well as locally advanced disease that might be rendered operable with neoadjuvant therapy, according to a new guideline from the American Society of Clinical Oncology (ASCO).

A limited number of factors have sufficient evidence to support routine use of clinical decision-making: tumor histology, grade, stage, and hormone receptor (HR) status (estrogen, progesterone, and HER2). Data remain insufficient to support use of other markers or genomic profiling to inform decisions about neoadjuvant chemotherapy, stated guideline panel co-chairs Larissa A. Korde, MD, of the National Cancer Institute in Bethesda, Maryland, and Dawn L. Hershman, MD, of Columbia University in New York City, and co-authors in the .

Outlining decades of research and progress in neoadjuvant chemotherapy, the panel emphasized the need to optimize patient selection and treatment choices.

"As our understanding of the biology of breast cancer has evolved in recent decades, it has become clear that optimal therapy for breast cancer is driven by subtype," they wrote. "Thus, older neoadjuvant trials that used a one-size-fits-all approach to therapy selection are less relevant in the current era of biologically driven treatment selection."

Developed from a review of 41 published articles, the recommendations address five clinical questions:

• Which patients are appropriate candidates for neoadjuvant systemic therapy?
• How should response be measured?
• What neoadjuvant regimens should patients with triple-negative breast cancer (TNBC) receive?
• What neoadjuvant treatment should be recommended for HR-positive/HER2-negative disease?
• What neoadjuvant treatment should be recommended for HER2-positive disease?

Beyond routine use for inflammatory, unresectable, and potentially resectable disease, selected clinical situations warrant recommendation of neoadjuvant systemic therapy: high-risk HER2-positive or TNBC, for whom residual disease would guide recommendations related to adjuvant therapy; minimize extent of surgery; and when delay in surgery is preferable or unavoidable.

The panelists recommended clinical evaluation, breast imaging, and assessment of pathologic complete response (pCR) for determining response to neoadjuvant therapy and to guide decision making. They recommended against use of blood- or tissue-based biomarkers.

Therapy recommendations for TNBC vary by stage. Patients with clinical T1a or T1bN0 disease should not routinely receive neoadjuvant therapy. Patients with clinically node-positive or T1c disease should be offered an anthracycline- and taxane-containing regimen. Carboplatin might be considered to increase the likelihood of pCR in TNBC. Data remain insufficient for routine consideration of immune checkpoint inhibitors.

For patients with HR-positive/HER2-negative breast cancer, neoadjuvant chemotherapy can be substituted for adjuvant therapy for whom the chemotherapy decision can be made without surgical pathology data or tumor genomic testing. Endocrine therapy with an aromatase inhibitor may be offered to postmenopausal patients to increase locoregional treatment options or for disease control. Premenopausal women should not receive neoadjuvant endocrine therapy outside of a clinical trial, according to the guideline panel.

Patients with node-positive or high-risk node-negative HER2-positive breast cancer should receive combination therapy with an anthracycline and a taxane or a non-anthracycline regimen plus trastuzumab (Herceptin). Pertuzumab (Perjeta) may be used in addition to trastuzumab. Patients with T1aN0 or T1bN0 disease should not routinely receive neoadjuvant chemotherapy or anti-HER2 agents outside of a clinical trial.

The guideline panel emphasized that clinicians should make sure that patients understand the reasoning and objectives for recommending neoadjuvant systemic therapy. Clinicians should clarify the goals of treatment, so patients understand the likely outcomes, and ensure that patients understand the potential benefits and burdens of any proposed treatment.

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