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NCCN Flash UpdatesTM: NCCN Guidelines® and NCCN Compendium® Updated

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) and the NCCN Compendium for Drugs and Biologics (NCCN Compendium®) for Breast Cancer. These NCCN Guidelines® are currently available as Version 1.2015. 

  • Locoregional Treatment 
    • "Close margins" was clarified as "negative margins but <1 mm." (BINV-3). The following statement was added on the page BINV-F: "The NCCN Panel accepts the definition of a negative margin as ‘No ink on the tumor,’ from the 2014 Society of Surgical Oncology-American Society for Radiation Oncology Consensus Guidelines on Margins.”
    • After mastectomy, for node-negative tumors less than or equal to 5cm, and surgical margins ≥1 mm a footnote was added stating, "Postmastectomy radiation therapy may be considered for patients with multiple high-risk recurrence factors." (BINV-3)
    • Principles of radiation therapy (BINV-I)
      • The panel updated the doses and fractions for whole breast radiation and indicated that the short course is preferred: "The breast should receive a dose of 45–50 Gy in 23–25 fractions, or 40–42.5 Gy in 15–16 fractions (short course is preferred)."
      • For those age < 50 or high-grade disease and focally positive margin after lumpectomy in the absence of extensive intraductal component, the panel updated the recommendation for radiation boost to include dose and fractions (BINVF): “This can be achieved with brachytherapy or electron beam or photon fields. Typical doses are 10–16 Gy at 2 Gy/fraction."
  • Systemic Therapy
    • Hormone receptor-positive and HER2-postive disease, tumors less than or equal to 0.5cm or microinvasive and pN0, consideration of “endocrine therapy + adjuvant chemotherapy with trastuzumab (category 2B)” was added as an option (BINV-5). Similarly, for hormone receptor-negative and HER2-postive disease, tumors less than or equal to 0.5cm or microinvasive and pN0, consideration of “adjuvant chemotherapy with trastuzumab (category 2B)” was added as an option (BINV-7).
    • For node-positive, hormone receptor-positive, HER2-negative disease, a footnote was adding stating: “The 21 gene RT-PCR assay recurrence score can be considered in selected patients with 1-3 involved ipsilateral axillary lymph nodes to guide the addition of combination chemotherapy to standard hormone therapy. A retrospective analysis of a prospective randomized trial suggests that the test is predictive in this group similar to its performance in node-negative disease.” (BINV-6)
    • Adjuvant endocrine therapy for premenopausal women a new footnote was added: "Aromatase inhibitor for 5 y + ovarian suppression may be considered as an alternative option based on SOFT and TEXT clinical trial outcomes. Pagani O, Regan MM, Walley BA, et al. Adjuvant exemestane with ovarian suppression in premenopausal breast cancer. N Engl J Med 2014;371:107-118." (BINV-J)
    • The page listing the Neoadjuvant/adjuvant chemotherapy (BINV-K) regimens was updated to include
      • "AC (doxorubicin/cyclophosphamide) every 3 weeks (category 2B)" regimen for HER2-negative disease
      • "Docetaxel + cyclophosphamide + trastuzumab" – regimen for HER2-positive disease
  • Preoperative Systemic Therapy and Axillary Evaluation
    • For those who fulfill criteria for breast-conserving surgery except for tumor size, a new footnote was added stating: "In cases where breast-conserving surgery may not be possible but patient will need chemotherapy, neoadjuvant treatment remains an acceptable option." (BINV-10)
    • Recommendations for management of the axilla were added when neoadjuvant chemotherapy is indicated (BINV-11) and page listing indications for axillary dissection was updated. (BINV-D)
    • The statement “endocrine therapy alone may be considered for receptor-positive disease in postmenopausal patients” was added. (BINV-15)
  • Fertility and birth control (BINV-C)
    • The statement "No therapy has been shown to preserve fertility in patients receiving chemotherapy" was replaced with the following: 
      • "Randomized trials have shown that ovarian suppression with GnRH agonist therapy administered during adjuvant chemotherapy in premenopausal women with ER-negative tumors may preserve ovarian function and diminish the likelihood of chemotherapy-induced amenorrhea."
      • "Smaller historical experiences in patients with ER-positive disease have reported conflicting results with regards to the protective effect of GNRH agonist therapy on fertility." (BINV-C)
  • Surveillance and Follow-up (BINV-16)
    • History and physical exam was changed from "every 4–6 mo for 5 y, then every 12 mo" to "1–4 times per year as clinically appropriate for 5 y, then annually."
    • Two new recommendations were added:
      • "Educate, monitor, and refer for lymphedema management."
      • "In the absence of clinical signs and symptoms suggestive of recurrent disease, there is no indication for laboratory or imaging studies for metastases screening." 
  • Recurrent/stage IV Disease
    • The footnote previously stating, “Determination of tumor ER/PR and HER2 status if unknown, originally negative or not overexpressed" was modified to "Determination of tumor ER/PR and HER2 status on metastatic site."
    • A new footnote was added under workup: "In clinical situations where a biopsy cannot be safely obtained but the clinical evidence is strongly supportive of recurrence, treatment may commence based on the ER/PR/HER2 status of the primary tumor." (BINV-17)
    • For de novo stage IV disease at diagnosis, the following footnote was added: “The role and timing of surgical removal of the primary in patients presenting with de novo stage IV disease is the subject of ongoing investigations.”
  • Paget’s disease (PAGET-2)
    • The surgical treatment options were updated to include:
      • Central lumpectomy including NAC with whole breast radiation therapy or
      • Total mastectomy ± sentinel node biopsy with or without breast reconstruction  or
      • Central lumpectomy including NAC ± sentinel node biopsy without radiation therapy (category 2B)
  • Inflammatory Breast Cancer (IBC-1
    • Added a new footnote to preoperative chemotherapy clarifying that “A pertuzumab-containing regimen may be administered preoperatively to patients with HER2-positive IBC.”

For the complete updated versions of the NCCN Guidelines, the NCCN Compendium®, and the NCCN Chemotherapy Order Templates (NCCN Templates®), please visit NCCN.org.

To access the NCCN Biomarkers Compendium®, please visit NCCN.org/biomarkers.

To view the NCCN Guidelines for Patients®, please visit NCCN.org/patients.

Free NCCN Guidelines apps iPhone, iPad, and Android devices are now available! Visit NCCN.org/apps

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