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NCCN Flash Updates: NCCN Guidelines®, NCCN Compendium®, & NCCN Templates® for Breast Cancer

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) and the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for Breast Cancer. These NCCN Guidelines® are currently available as Version 3.2017.

  • Workup of clinical stages I-III (BINV-1, BINV-10, and BINV-14) added:
    • Pregnancy test in all women of childbearing potential
  • Locoregional treatment of clinical stage I, IIA, or IIB disease or T3,N1,M0 (BINV-3)
    • Divided negative axillary nodes and tumor >5 cm or margins positive, into two pathways.
      • Following margins positive added, “Re-excision to negative margins is preferred. If not feasible, strongly consider radiation therapy to chest wall, ± infraclavicular region, ± supraclavicular area, ± internal mammary nodes and any part of the axillary bed at risk. It is common for radiation therapy to follow chemotherapy when chemotherapy is indicated.”
  • Systemic adjuvant treatment, hormone receptor-positive, HER2-positive disease (BINV-5)
    • Node positive (one or more metastases >2 mm to one or more ipsilateral axillary lymph nodes), added treatment option of adjuvant pertuzumab along with trastuzumab (also applies to BINV-7)
    • Footnote “ff” is new: “Consider extended adjuvant neratinib following adjuvant trastuzumab-containing therapy in HR-positive patients with a perceived high risk of recurrence (such as stage II-III). The benefit or toxicities associated with extended neratinib in patients who have received pertuzumab is unknown.” (also applies to BINV-13 and BINV-15)
  • Preoperative Systemic Therapy: Adjuvant therapy (BINV-13 and BINV-15)
    • Added a new bullet “Consider adjuvant capecitabine in patients with triple-negative breast cancer and residual invasive cancer following standard neoadjuvant treatment with taxane-, alkylator-, and anthracycline-based chemotherapy.”
    • Added option of adjuvant pertuzumab- "If HER2-positive, complete up to one year of HER-2 targeted therapy with trastuzumab (category 1) ± pertuzumab. HER2-targeted therapy may be administered concurrently with radiation therapy and with endocrine therapy if indicated."
  • Recurrent/Stage IV disease (BINV-17)
    • Added, “Discuss goals of therapy, adopt shared decision-making, and document course of care” to the workup.
  • Treatment of Recurrent/Stage IV disease, separated treatment algorithms based on hormone receptor status, HER2 status, and prior endocrine therapy. (BINV-19)
  • Systemic treatment of Recurrent/Stage IV disease, ER and/or PR positive; HER2 negative (BINV-20)
    • No prior endocrine therapy within 1 y, postmenopausal:
      • Changed "Palbociclib + letrozole aromatase inhibitor (category 1)"
      • Changed "Ribociclib + letrozole aromatase inhibitor (category 1)"
  • Systemic treatment of Recurrent/Stage IV disease, ER and/or PR positive; HER2 negative (BINV-21)
    • Modified footnote hhh, “If there is disease progression while on a CDK4/6 inhibitor + an aromatase inhibitor letrozole, there are no data to support an additional line of therapy with another palbociclib CDK4/6-containing regimen. Likewise, if there is disease progression while on an everolimus-containing regimen, there are no data to support an additional line of therapy with another everolimus regimen.
  • Principles of radiation therapy (BINV-I)
    • “The whole breast should receive a dose of 45–50.4 Gy in 25–28 fractions or 40–42.5 Gy in 15–16 fractions (hypofractionation is preferred).
    • "Dose is 45–50.4 Gy in 25–28 fractions to the chest wall +/- scar boost at 1.8–2 Gy per fraction to a total dose of approximately 60 Gy."
  • Preoperative/adjuvant therapy regimens (BINV-K)
    • Removed the following regimens and corresponding dosing:
      • FEC (fluorouracil/epirubicin/cyclophosphamide) followed by docetaxel + trastuzumab + pertuzumab
      • FEC followed by paclitaxel + trastuzumab + pertuzumab
      • Pertuzumab + trastuzumab + docetaxel followed by FEC
      • Pertuzumab + trastuzumab + paclitaxel  followed by FEC
  • Systemic therapy for ER and/or PR-positive Recurrent or Stage IV disease (BINV-N)
    • Separated treatment algorithms based on HER2-status.
    • Postmenopausal and HER2-negative, added:
      • Everolimus + fulvestrant
      • Everolimus + tamoxifen
      • Abemaciclib + fulvestrant (category 1) with footnote “Indicated after progression on prior endocrine therapy”
      • Abemaciclib with footnote "Indicated after progression on prior endocrine therapy and prior chemotherapy in the metastatic setting."
    • Postmenopausal and HER2-negative, changed:
      • Palbociclib + letrozole aromatase inhibitor (category 1)
      • Ribociclib + letrozole aromatase inhibitor (category 1)
      • NCCN Category of fulvestrant from 2A to 1
    • Premenopausal and HER2-positive, added:
      • Tamoxifen ± trastuzumab
      • Ovarian ablation or suppression plus therapy as for post-menopausal women.
    • Postmenopausal and HER2-positive, added:
      • Aromatase inhibitor ± trastuzumab
      • Aromatase inhibitor ± lapatinib
      • Aromatase inhibitor ± lapatinib + trastuzumab
      • Fulvestrant ± trastuzumab
      • Tamoxifen ± trastuzumab.
  • Chemotherapy regimens for recurrent or metastatic breast cancer (BINV-O)
    • Added Olaparib (option for HER2-negative, BRCA 1/2-positive tumors) with a footnote, "Patients with HER2-negative disease eligible for single-agent therapy are eligible for germline BRCA 1/2 testing."

*For your reference, the previous update (Version 2.2017) to the NCCN Guidelines for Breast Cancer, published on April 16, 2017, is available at the following link: https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf

 

The following NCCN Chemotherapy Order Templates (NCCN Templates®) have been deleted to reflect the NCCN Guidelines for Breast Cancer Version 3.2017:

  • Preoperative/Adjuvant Therapy Regimens
    • BRS94a: FEC (Fluorouracil/EPIrubicin/Cyclophosphamide) followed by Pertuzumab + Trastuzumab + DOCEtaxel – FEC (Fluorouracil/EPIrubicin/Cyclophosphamide) Course
    • BRS94b: FEC (Fluorouracil/EPIrubicin/Cyclophosphamide) followed by Pertuzumab + Trastuzumab + DOCEtaxel – Pertuzumab + Trastuzumab + DOCEtaxel Course
    • BRS95a: FEC (Fluorouracil/EPIrubicin/Cyclophosphamide) followed by Pertuzumab + Trastuzumab + PACLItaxel – FEC (Fluorouracil/EPIrubicin/Cyclophosphamide) Course
    • BRS95b: FEC (Fluorouracil/EPIrubicin/Cyclophosphamide) followed by Pertuzumab + Trastuzumab + PACLItaxel – Pertuzumab + Trastuzumab + PACLItaxel Course
    • BRS97a: Pertuzumab + Trastuzumab + DOCEtaxel followed by FEC (Fluorouracil/EPIrubicin/Cyclophosphamide) followed by Trastuzumab - Pertuzumab + Trastuzumab + DOCEtaxel Course
    • BRS97b: Pertuzumab + Trastuzumab + DOCEtaxel followed by FEC (Fluorouracil/EPIrubicin/Cyclophosphamide) followed by Trastuzumab - FEC (Fluorouracil/EPIrubicin/Cyclophosphamide) Course
    • BRS98a: Pertuzumab + Trastuzumab + PACLItaxel followed by FEC (Fluorouracil/EPIrubicin/Cyclophosphamide) followed by Trastuzumab - Pertuzumab + Trastuzumab + PACLItaxel Course
    • BRS98b: Pertuzumab + Trastuzumab + PACLItaxel followed by FEC (Fluorouracil/EPIrubicin/Cyclophosphamide) followed by Trastuzumab - FEC (Fluorouracil/EPIrubicin/Cyclophosphamide) Course

NCCN has published updates to the NCCN Templates® for Melanoma to reflect the currently published NCCN Guidelines for Melanoma Version 1.2018.

  • The following NEW NCCN Templates have been published:
    • MEL3: CISplatin/VinBLAStine/Dacarbazine/Aldesleukin (Interleukin-2)/Interferon alfa
    • MEL23: High Dose Ipilimumab
    • MEL24: Ipilimumab + Nivolumab
    • MEL25: Vemurafenib/Cobimetinib
    • MEL26: Intralesional Aldesleukin (interleukin-2)
    • MEL27: Intralesional BCG (Bacillus Calmette-Guérin)
    • MEL28: Intralesional Interferon alfa-2b
    • MEL29: Intralesional Talimogene laherparepvec
    • MEL30: Topical Imiquimod

 

  • Indications for the following NCCN Templates have been updated:
    • MEL1: Dacarbazine
    • MEL4: High-Dose Aldesleukin (Interleukin-2)
    • MEL5: Temozolomide
    • MEL7: PACLitaxel
    • MEL9: PACLitaxel/CARBOplatin
    • MEL12: High-Dose Interferon alfa-2b
    • MEL13: PEGinterferon alfa-2b
    • MEL14: Ipilimumab
    • MEL15: Vemurafenib
    • MEL16: Imatinib
    • MEL17: Dabrafenib
    • MEL19: Albumin-bound PACLitaxel
    • MEL20: Pembrolizumab
    • MEL21: Dabrafenib/Trametinib
    • MEL22: Nivolumab

 

  • Cycle information for the following templates has been updated to a total of 1 year of therapy in the adjuvant setting
    • MEL12: High-Dose Interferon alfa-2b
    • MEL21: Dabrafenib/Trametinib
    • MEL22: Nivolumab
  • The following NEW note for nivolumab and pembrolizumab has been added to the Other Supportive Therapy section: “This agent may cause new onset type 1 diabetes mellitus with ketoacidosis. Blood glucose should be monitored prior to each dose and as clinically indicated. Modification or discontinuation of therapy may be warranted. Patients may require insulin replacement therapy according to specific recommendations in the drug package insert.”
    • MEL20: Pembrolizumab
    • MEL22: Nivolumab
  • The following NEW note for nivolumab and pembrolizumab has been added to the Monitoring and Hold Parameters section: “Serum glucose should be monitored prior to each dose and as clinically indicated.”
    • MEL20: Pembrolizumab
    • MEL22: Nivolumab

 

NCCN has published updates to the NCCN Templates for Cervical Cancer to reflect the currently published NCCN Guidelines for Cervical Cancer v1.2018.

  • The following NEW NCCN Templates have been published:
    • CRV27: PACLitaxel/CARBOplatin + Bevacizumab
    • CRV28: Albumin-bound PACLitaxel
    • CRV29: Pembrolizumab

 

NCCN has published updates to the NCCN Templates for Vulvar Cancer to reflect the currently published NCCN Guidelines for Vulvar Cancer v1.2018.

  • The following NEW NCCN Templates have been published:
    • VUL7: CARBOplatin
    • VUL8: PACLitaxel/CARBOplatin
    • VUL9: Erlotinib
    • VUL10: PACLitaxel
    • VUL11: CISplatin/Gemcitabine
    • VUL12: Pembrolizumab

 

NCCN has published updates to the NCCN Templates for Occult Primary to reflect the currently published NCCN Guidelines for Occult Primary v1.2018.

  • The following NEW note for carboplatin has been added to the Monitoring and Hold Parameters section: “Electrolytes (eg, magnesium, potassium) should be monitored as clinically indicated.”
    • OCP1: PACLitaxel/CARBOplatin
    • OCP2: PACLitaxel/CARBOplatin/Oral Etoposide
    • OCP3: DOCEtaxel/CARBOplatin
    • OCP13: DOCEtaxel/CARBOplatin
    • OCP17: Irinotecan/CARBOplatin
  • The following NEW note for docetaxel has been added to the Monitoring and Hold Parameters section: “This agent may cause changes to fingernails and toenails including color, texture, and shape. This is usually a reversible side effect, but should be monitored throughout treatment.”
    • OCP3: DOCEtaxel/CARBOplatin
    • OCP5: Gemcitabine/DOCEtaxel
    • OCP7: DOCEtaxel/CISplatin/Fluorouracil
    • OCP13: DOCEtaxel/CARBOplatin
    • OCP14: DOCEtaxel/CISplatin
    • OCP16: DOCEtaxel/CISplatin
  • The following NEW note for gemcitabine has been added to the Safety Parameters and Special Instructions section: “This agent is an irritant.”
    • OCP4: Gemcitabine/CISplatin
    • OCP5: Gemcitabine/DOCEtaxel
    • OCP18: Irinotecan/Gemcitabine
  • The following NEW note for irinotecan has been added to the Safety Parameters and Special Instructions section: “This agent has multiple potential drug-drug and/or drug-food interactions. Review patient medical profile and drug package insert for specific drug and food interactions and recommendations.”
    • OCP17: Irinotecan/CARBOplatin
    • OCP18: Irinotecan/Gemcitabine

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 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/patients.

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

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