NCCN Flash Updates: NCCN Guidelines and NCCN Templates Updated

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) and the NCCN Drugs and Biologics Compendium (NCCN Compendium^®) for Breast Cancer Risk Reduction. These NCCN Guidelines^® are currently available as Version 1.2022.

Link directly to the Updates section of the NCCN Guidelines:
Breast Cancer Risk Reduction

• Global
  • NCCN recommendations have been developed to be inclusive of individuals of all sexual and gender identities to the greatest extent possible. The term females refers to sex assigned at birth.
• Familial Risk Assessment (BRISK-1)
  • Individuals who are identified as having a variant of uncertain significance should be managed on the basis of their family history is a new footnote corresponding to “Known pathogenic/likely pathogenic gene mutations conferring high risk for breast cancer”
  • Column 3 modified: Referral to genetic counselor or other health a similarly trained professional with expertise and experience in cancer genetics recommended.
• Elements of Risk (BRISK-3)
  • Footnote “m”, modified: There are differences in risk based on associated with race and ethnicity. Further studies are needed for social determinants of health and existing health care disparities to better understand this relationship
  • 4th sub-bullet, Lifestyle factors: Based on the available data, hormonal IUDs have very low systemic absorption and associated breast cancer risk is a new footnote corresponding to “Current or prior estrogen and progesterone hormone agent"
  • Prior oophorectomy changed to Menopause before age 45 y for elements that decrease risk
• Risk Management (BRISK-4)
  • Counsel individuals on healthy lifestyles See BRISK-A is new to the page
• Risk Assessment (BRISK-4)
  • Column 1, 3rd pathway: Breast cancer risk elevated based on validated risk estimation models see BRISK-C replaces “Breast cancer risk by modified Gail Model for females ≥35 y of age or IBIS (version 8) ˃5% See BRISK-C” with the following footnote: A change in family history would affect risk estimate and should prompt re-calculation of breast cancer risk
• Risk-Reducing Intervention (BRISK-5)
  • Lower pathway off “Normal” modified: Discuss option of risk-reducing surgery for only those women females meeting criteria
• Clinical Scenarios/Management while on Risk-Reducing Agent (BRISK-8)
  • Acupuncture and exercise is a new bullet corresponding to Arthralgias
  • Added “while on” before tamoxifen under clinical scenarios
    • Pause tamoxifen during evaluation, is new in column 2
  • Vaginal symptom management, modified: Consider non-hormonal moisturizers as well as lubricants or low-dose topical vaginal estrogen preparations
• Components of Risk/Benefit Assessment and Counseling (BRISK-A)
  • Bullet 1, modified to include the header, Genetic Testing and modified as follows: If an individual is at high risk due to a personal history of ovarian cancer, pancreatic cancer, or early onset of breast cancer, or if secondary to the individual has a strong family history of cancer or very or ovarian cancer, genetic counseling should be offered
  • Bullet 2, modified header: Healthy lifestyle for breast cancer risk reduction
• Breast Cancer Risk-Reducing Agents (BRISK-B)
  • Tamoxifen only:
    • Bullet 2: 10 mg every other day since 5-mg dose is not available in the United States is a new footnote corresponding to “Low-dose tamoxifen (5 mg per day for 3 years)” is an option only if patient is symptomatic on the 20-mg dose or patient is unwilling or unable to take the standard-dose tamoxifen”
    • Bullet 3, 2nd sentence modified: Limited data suggest there may be a benefit, likely a larger benefit, for BRCA-2 carriers
• Comparison of Predictive Models of Risk of Breast Cancer and Risk of Carrying “Pathogenic/Likely Pathogenic Variants of BRCA” a Mutation in BRCA/1/2
  • Gail Model (BRISK-C, 1 of 4)
    • Description, bullet 2, last sentence modified: Five-year risk assessment ≥1,67% used to assess eligibility for risk-reducing agent chemoprevention
    • Benefits, bullet 3 modified: Only model Available to assess eligibility for risk-reducing agent chemoprevention
    • Limitations, bullet 4, first sub-bullet: Those with mutations in known breast cancer predisposition genes such as BRCA1/2 carriers
  • Tyrer-Cuzick (version 8) (BRISK-C, 2 of 4)
    • Description, bullet 4, modified to include “v7+”
    • Limitations, bullet 2, first sub-bullet is new, Hispanic individuals as this model was validated in primarily Caucasian females in the United Kingdom
  • Claus (BRISK-C, 3 of 4)
    • Limitations, bullet 1 is new, The population data used to construct this model are now nearly 30 years old and may be outdated for current risk estimation 
    • UPENNII Model Deleted from the guideline
  • CanRisk Tool (BOADICEA v5) (BRISK-C 4 of 4)
    • Factors Included:
      • Models the risks of breast and ovarian cancer based on family history and genotypes for variants in BRCA1 and BRCA2
      • Incorporates the effects of pathogenic variants in other genes, common genetic variants (summarized as polygenic risk scores, PRS), lifestyle, hormonal and clinical features, breast density, and disease pathology prospectively validated, both for the prediction of carrier probabilities and prediction of subsequent cancer risk
    • Benefits
      • Accessible online
      • Includes personal and lifestyle risk factors
      • Includes FH of breast/non-breast cancers in immediate/distant relatives
      • Provides risk estimates for breast and ovarian cancer
      • Inclusive of patients with personal history of breast cancer (tumor pathology)
      • Can be used with susceptibility variants high/moderate risk other than BRCA1/2
      • Incorporates risk estimates from SNPs (PRS), if available
    • Limitations
      • Routine use of PRS in risk assessment is not encouraged
      • Non-Caucasian population
      • Overestimation of risk
      • Does not take into account personal risk factors such as breastfeeding, prior breast biopsy, atypia, etc.
      • Does not include mantle radiation

NCCN has published updates to the NCCN Chemotherapy Order Templates (NCCN Templates^®) for Hepatobiliary Cancers to reflect the currently published NCCN Guidelines for Hepatobiliary Cancers v.3.2021.

• Changes to the Chemotherapy Regimen section have been made on the following template:
  • HEP10: CISplatin/Gemcitabine

NCCN has published updates to the NCCN Templates^® for Melanoma: Cutaneous to reflect the currently published NCCN Guidelines for Melanoma: Cutaneous v2.2022.

• The following NEW NCCN Templates^® have been published:
  • MEL42: Lenvatinib + Pembrolizumab
  • MEL43: Nivolumab (Nivo 3) + Ipilimumab (Ipi 1) followed by Nivolumab
  • MEL44: Intralesional Talimogene Laherparepvec (T-VEC)/Ipilimumab
• The following NCCN Template^® has been archived:
  • MEL23: High-Dose Ipilimumab
• Changes to the Indication section have been made to the following templates:
  • MEL4: High-Dose Aldesleukin (Interleukin-2)
  • MEL14: Ipilimumab
  • MEL15: Vemurafenib
  • MEL16: Imatinib
  • MEL17: Dabrafenib
  • MEL20: Pembrolizumab
  • MEL21: Dabrafenib/Trametinib
  • MEL22: Nivolumab
  • MEL24: Nivolumab (Nivo 1) + Ipilimumab (Ipi 3) followed by Nivolumab
  • MEL25: Vemurafenib/Cobimetinib
  • MEL26: Intralesional Aldesleukin (Interleukin-2)
  • MEL29: Intralesional Talimogene Laherparepvec
  • MEL30: Topical Imiquimod
  • MEL31: Encorafenib/Binimetinib
  • MEL32: Larotrectinib
  • MEL33: Entrectinib
  • MEL34: Binimetinib
  • MEL38: Vemurafenib/Cobimetinib + Atezolizumab
  • MEL40: Encorafenib
• Changes to the Reference section have been made to the following templates:
  • MEL14: Ipilimumab
  • MEL16: Imatinib
  • MEL20: Pembrolizumab
  • MEL22: Nivolumab
  • MEL24: Nivolumab (Nivo 1) + Ipilimumab (Ipi 3) followed by Nivolumab
  • MEL30: Topical Imiquimod
• Changes to the Emetic Risk section have been made to the following templates:
  • MEL16: Imatinib
  • MEL26: Intralesional Aldesleukin (Interleukin-2)
  • MEL31: Encorafenib/Binimetinib
• Changes to the Chemotherapy Regimen section have been made on the following templates:
  • MEL14: Ipilimumab
  • MEL20: Pembrolizumab
  • MEL22: Nivolumab
  • MEL24: Nivolumab (Nivo 1) + Ipilimumab (Ipi 3) followed by Nivolumab
  • MEL25: Vemurafenib/Cobimetinib
  • MEL36: CISplatin/VinBLAStine/Dacarbazine
  • MEL39: Pembrolizumab/Low-dose Ipilimumab
• Drug information notes for the following agents have been updated in the Chemotherapy Regimen, Supportive Care, Monitoring and Hold Parameters, and/or Safety Parameters and Special Instructions sections:
  • Atezolizumab
  • Intralesional Aldesleukin (Interleukin-2)
  • Ipilimumab
  • Nivolumab
  • Pembrolizumab
  • Topical Imiquimod
  • VinBLAStine

For the complete updated versions of the NCCN Guidelines, NCCN Guidelines with NCCN Evidence Blocks™, the NCCN Drugs & Biologics Compendium (NCCN Compendium^®), the NCCN Biomarkers Compendium^®, the NCCN Chemotherapy Order Templates (NCCN Templates^®), the NCCN Radiation Therapy Compendium™, and the NCCN Imaging Appropriate Use Criteria (NCCN Imaging AUC™), please visit NCCN.org.

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

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

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