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Guideline Updates

NCCN Updates Clinical Practice Guideline for Breast Cancer

March 16, 2021

On March 12, 2021, the National Comprehensive Cancer Network (NCCN) released an update to its clinical practice guideline for breast cancer.

An algorithm was added for HR-positive – HER2-negative disease, postmenopausal patients with pT1-3 and pN0 or pN+ tumors. The branches were modified to tumor ≤0.5 cm and pN0; tumor >0.5 cm or pN1 mi (≤2 mm axillary node metastases) or pN1 (1-3 positive nodes); and pN2/pN3 (≥4 ipsilateral metastases >2 mm).

For tumor >0.5 cm or pN1 mi (≤2 mm axillary node metastases) or pN1 (1-3 positive nodes), the next step was modified to “strongly consider 21-gene RT-PCR assay if candidate for chemotherapy (category 1).”

For treatment, the pathways for recurrence score 26-30 and ≥31 were replaced with a single pathway for recurrence score ≥26. For recurrence score <26, adjuvant endocrine therapy was changed to a category 1 recommendation. For recurrence score ≥26, adjuvant chemotherapy followed by endocrine therapy was changed to a category 1 recommendation.

An algorithm was added for HR-positive – HER2-negative disease, premenopausal patients with pT1-3 and pN+ tumors

Additionally, an algorithm was added for HR-positive – HER2-negative disease, premenopausal patients with pT1-3 and pN0 tumors. For patients not a candidate for chemotherapy, treatment was modified to adjuvant endocrine therapy + ovarian suppression/ablation. For candidate for chemotherapy, consider gene expression assay to assess prognosis was added, and treatment was modified to adjuvant chemotherapy followed by endocrine therapy or adjuvant endocrine therapy + ovarian suppression/ablation.

Under gene expression assays for consideration of adjuvant systemic therapy, the table was updated based on the RxPONDER trial. Assay was modified to 21-gene (Oncotype Dx) for pN1 (1-3 positive nodes), predictive was changed to “yes,” and NCCN category of preference/evidence consensus was modified to “postmenopausal: Preferred; 1” and “premenopausal: other; 2A.”

Under systemic therapy regimens for recurrent unresectable (local or regional) or stage IV (M1) disease, the table was reorganized to list regimens by setting/line of therapy. For third-line therapy and beyond, margetuximab-cmkb + chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine) was added. Additionally, doing was added for margetuximab-cmkb + capecitabine, margetuximab-cmkb + eribulin, margetuximab-cmkb + gemcitabine, and margetuximab-cmkb + vinorelbine.—Janelle Bradley

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