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National Comprehensive Cancer Network

About NCCN

NCCN Flash Updates: NCCN Guidelines®, NCCN Compendium®, and NCCN Templates® Updated for Breast Cancer, NCCN Templates®, NCCN Guidelines, NCCN Compendium, and NCCN Imaging AUC™ Updated for Penile Cancer

NCCN has published updates to the following NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) with NCCN Evidence Blocks™:

  • Hepatobiliary Cancers, Version 4.2019

NCCN has published updates to the NCCN Guidelines® and the NCCN Drugs and Biologics Compendium (NCCN Compendium®) for Breast Cancer. These NCCN Guidelines are currently available as Version 1.2020.

  • Invasive Breast Cancer
    • Criteria have been clarified for consideration of preoperative systemic therapy to include patients with >T2 or >N1 disease. (BINV-1 and BINV-11)
    • Modified/clarified the histologies for which each treatment algorithm applies. (BINV-4 through BINV-10)
    • Hormone receptor-negative, HER-2 negative disease:
      • For those with tumors <0.5cm and pN0, the following footnote has been added: In select patients with high-risk features (eg, very young women with high-grade histology), adjuvant chemotherapy may be considered (category 2B). See (BINV-L). (BINV-9)
      • Modified treatment recommendation for favorable histologies (adenoid cystic carcinoma, salivary secretory carcinoma and other rare types): Limited available data support local therapy only with consideration for systemic/targeted therapies only in node-positive disease. (BINV-10)
    • Axillary assessment has been added to the workup prior to preoperative systemic therapy, and footnote vv has been modified: At the time of axillary node sampling, a clip or tattoo should be placed to permit verification that the biopsy-positive lymph node has been removed at the time of definitive surgery. (BINV-11)
    • Adjuvant therapy recommendations after preoperative systemic therapy have been significantly reorganized. (BINV-13 through BINV-15)
    • For recommendations on the treatment of brain metastases, a link has been added to the NCCN Guidelines for Central Nervous System Cancers. (BINV-17)
    • Footnote qqq: The optimal dosing schedule for zolendronic acid has been changed to every 12 weeks. (BINV-19)
    • Systemic treatment options have been modified for recurrent or stage IV (M1) disease if hormone receptor-positive/HER2-negative disease and progression or unacceptable toxicity on first-line endocrine therapy: If not endocrine therapy refractory, consider additional line of endocrine therapy ± targeted therapy (see second-line therapy options on BINV-P) or systemic therapy. (BINV-21)
    • A new section on Hormone Receptor Testing has been added to the Principles of Biomarker Testing. (BINV-A, 2 of 2)
    • The surgical axillary staging recommendations have been significantly revised to include recommendations for patients who have received preoperative chemotherapy. (BINV-D)
    • The following has been added to the special considerations for breast cancer in men: Newer agents such as CDK4/6 inhibitors in combination with an aromatase inhibitor or fulvestrant, mTOR inhibitors, and PIK3CA inhibitors have not been systematically evaluated in clinical trials in men with breast cancer. However, available real-world data suggest comparable efficacy and safety profiles and it is reasonable to recommend these agents to men based on extrapolation of data from studies comprised largely of female participants with advanced breast cancer. (BINV-J)
    • Following adjuvant therapy with an aromatase inhibitor for 5 y, the recommended duration to continue an aromatase inhibitor has been modified from an additional 5 y to an additional 3-5 y for patients who were postmenopausal at diagnosis. (BINV-K)
    • Weekly paclitaxel + carboplatin, and docetaxel + carboplatin have been added as other recommended preoperative chemotherapy options for select patients with triple-negative breast cancer, with the following footnote:
      • The inclusion of platinum agents as neoadjuvant chemotherapy for TNBC remains controversial. Several studies have shown improved pCR rates with incorporation of platinum. However, long-term outcomes remain unknown. The routine use of platinum agents as part of neoadjuvant therapy for TNBC is not recommended for most patients (including BRCA mutation carriers), but it may be considered in select patients (such as those for whom achieving better local control is necessary). The use of platinum agents in the adjuvant setting is not recommended. If platinum agents are included in an anthracycline-based regimen, the optimal sequence of chemotherapy and choice of taxane agent is not established. (BINV-L, 1 of 6)
    • Gene Expression Assays for Consideration of Addition of Adjuvant Systemic Chemotherapy to Adjuvant Endocrine Therapy (BINV-N)
      • Based on new data, the following has been added to the 12-gene assay under treatment implications: The risk score is predictive of chemo-benefit based on a prospective analysis of 3,746 archived, HR-positive, HER2-negative, T1–T3 tumors from chemo-endocrine and endocrine-only cohorts, that included women with lymph node-negative and lymph node-positive disease. (Sestak I, Martin M, Dubsky P, et al. Breast Cancer Res Treat 2019;176(2):377-386.)
      • Based on new data, the following has been added to the Breast Cancer Index assay under treatment implications: Results of a secondary analysis of the aTTom trial demonstrated that in patients with hormone-receptor positive, node-positive breast cancer, patients with a high BCI (HOXB13/IL17BR) (H/I) derived significant benefit from extending tamoxifen therapy to 10 years versus 5 years. In contrast, BCI (H/I) low patients derived no benefit from extended adjuvant therapy. (Bartlett JMS, Sgroi DC, Treuner K, et al. Ann Oncol 2019 Nov 1;30(11):1776-1783.)
    • Systemic Therapy for ER- and/or PR-positive Recurrent or Stage IV (M1) Disease; HER2-Negative and Postmenopausal or Premenopausal Receiving Ovarian Ablation or Suppression (BINV-P)
      • Separated preferred regimens for first-line therapy from preferred regimens for second- and subsequent-line therapy.
      • Preferred first-line option added: Selective ER down-regulator (fulvestrant, category 1) + non-steroidal aromatase inhibitor (anastrozole, letrozole) (category 1)
      • Useful in certain circumstances, option removed: ribociclib + tamoxifen (category 1)
    • Chemotherapy and Targeted Therapy Regimens for Recurrent or Stage IV (M1) Disease (BINV-Q)
      • Carboplatin + paclitaxel or albumin-bound paclitaxel has been added to the useful in certain circumstances options for HER-2 negative disease.
      • Neratinib + capecitabine (category 2B) has been added to the other recommended regimens for HER2-positive disease.
      • For additional targeted therapy options for HER2-negative and HER2-positive disease, a link has been added to BINV-R.
      • Footnote d has been added: Assess for germline BRCA1/2 mutations in all patients with recurrent or metastatic breast cancer to identify candidates for PARP inhibitor therapy.
    • For the trastuzumab + vinorelbine regimen, alternate vinorelbine dosing has been added: 25–30 mg/m2 IV days 1, 8, and 15; cycled every 28 days. (BINV-Q, 4 of 6)
    • A new section has been added: Additional Targeted Therapies and Associated Biomarker Testing for Recurrent or Stage IV (M1) Disease. (BINV-R)
      • Larotrectinib, and entrectinib have been added as a category 2A, useful in certain circumstances options with the following footnote:
        • Larotrectinib and entrectinib are indicated for the treatment of solid tumors that have an NTRK gene fusion without a known acquired resistance mutation and have no satisfactory alternative treatments or that have progressed following treatment.
      • Pembrolizumab has been added as a category 2A, useful in certain circumstances option with the following footnote:
        • Pembrolizumab is indicated for the treatment of patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options.

NCCN has published updates to the NCCN Templates® for Breast Cancer to reflect the NCCN Guidelines for Breast Cancer v1.2020.

  • The following NCCN Template has been removed:
    • BRS143: Ribociclib + Tamoxifen

NCCN has published updates to the NCCN Guidelines, NCCN Compendium®, and the NCCN Imaging Appropriate Use Criteria (NCCN Imaging AUC™) for Penile Cancer. These NCCN Guidelines are currently available as Version 1.2020.

  • Management of Non-Palpable Inguinal Lymph Nodes (PN-3)
    • Low risk treatment: “Dynamic sentinel node biopsy” was removed.
  • Management of Palpable Non-Bulky Inguinal Lymph Nodes (PN-4)
    • Treatment for unilateral lymph node(s) <4 cm (mobile), high-risk primary lesion or positive percutaneous lymph node biopsy, "Consider neoadjuvant chemotherapy followed by ILND" was added.
  • Management of Palpable Bulky Lymph Nodes (PN-5)
    • Unilateral lymph nodes ≥4 cm pathway
      • Treatment options for patients with a positive percutaneous lymph node biopsy were updated:
        • Cisplatin-based neoadjuvant chemotherapy followed by ILND (preferred), consider PLND
          ILND (preferred), consider PLND (in patients not eligible for cisplatin-based chemotherapy)
      • PLND was removed as an option for ≥2 positive nodes or extranodal extension.
    • Unilateral lymph nodes (fixed) or bilateral lymph nodes (fixed or mobile)
      • Response following neoadjuvant chemotherapy options were updated:
        • ILND and PLND are now preferred options.
        • RT and chemoradiotherapy are new options.
  • Management of Recurrent Disease (PN-8)
    • Options for invasive recurrent disease were updated:
      • Partial and total penectomy were removed
      • "Treat according to recurrence stage (See PN-2)" was added
    • Single, mobile, <4 cm lymph node: "Percutaneous lymph node biopsy" and Negative/Positive bifurcation is new.
  • Principles of Penile Organ-Sparing Approaches (PN-A, 2 of 2)
    • Wide Local Excision, 4th bullet: "for low grade disease" was removed.
  • Principles of Surgery (PN-B)
    • Surgical Management of Inguinal and Pelvic Lymph Nodes, 4th bullet was updated: "...following ILND in patients with ≥3 ≥2 positive inguinal nodes..."
  • Principles of Systemic Therapy (PN-D, 1 of 4)
    • Neoadjuvant Chemotherapy Prior to ILND or PLND, 2nd sub-bullet is new: "Patients not eligible to receive TIP and are surgical candidates should undergo surgery without neoadjuvant chemotherapy."