eBulletin Newsletter

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 Acute Lymphoblastic Leukemia. These NCCN Guidelines^® are currently available as Version 3.2021.

Link directly to the Updates section of the NCCN Guidelines: 
Acute Lymphoblastic Leukemia

• Relapsed/Refractory Disease (ALL-7):
  • Ph+ B-ALL
    • The following regimen has been added as a treatment option: Brexucabtagene autoleucel (following therapy that has included TKIs)
  • Ph- B-ALL
    • The following regimen has been added as a treatment option: Brexucabtagene autoleucel.
• Regimens for Relapsed or Refractory Ph-Positive B-ALL (ALL-D 3 of 10):
  • Other Recommended Regimens:
    • The following regimen has been added: Brexucabtagene autoleucel (following therapy that has included TKIs)
    • Reference added: Shah BD, Ghobadi A, Oluwole OO, et al. KTE-X19 for relapsed/refractory adult B-cell acute lymphoblastic leukemia. Lancet 2021;398:491-502. (Also on ALL-D 4 of 10)
• Regimens for Relapsed or Refractory Ph-Negative B-ALL (ALL-D 4 of 10)
  • Preferred Regimens:
    • The following regimen has been added: Brexucabtagene autoleucel (for B-ALL).

NCCN has published updates to the Guidelines, the NCCN Compendium^® , and the NCCN Radiation Therapy Compendium™,  for Gastric Cancer. These NCCN Guidelines are currently available as Version 1.2022.

Link directly to the Updates section of the NCCN Guidelines:
Gastric Cancer

• Workup (GAST-1)
  • 9th Bullet revised: Universal testing for MSI by PCR/MMR PCR/next-generation sequencing (NGS) or MMR by IHC is recommended in all newly diagnosed patients
  • 11th Bullet revised: If sufficient tissue is available after the above testing has been completed, NGS may be considered
  • New bullet added: If anemia is suspected, See NCCN Guidelines for Hematopoietic Growth Factors
• Clinical Stage; Locoregional (cM0) pathway; Additional Evaluation:  "Consider laparoscopy with cytology (category 2B) " was recommended for all patients in this pathway.  This recommendation was changed as follows:
  • Medically fit, potentially resectable: Changed to, Recommend laparoscopy with cytology.  
  • Medically fit, surgically unresectable: Consider laparoscopy with cytology changed from category 2B to category 2A
  • Non-surgical candidate: Changed to, Palliative Management (see GAST-9)
• Locoregional disease (cM0) pathway (GAST-2)
  • Medically fit, potentially resectable; cT2 or higher, Any N; Primary Treatment:  Revised, Perioperative chemotherapy (category 1) (preferred) (Also for GAST-3)
• Unresectable locally advanced, Locally recurrent or metastatic disease (GAST-9)
  • Third column revised
    • Perform HER2, PD-L1, MSI by PCR/MMR and microsatellite by IHC testing (if not done previously) if metastatic adenocarcinoma cancer is documented or suspected
    • Bullet revised: If sufficient tissue is available after the above testing has been completed, NGS may be considered via a validated assay
• Principles of Pathologic Review and Biomarker Testing (GAST-B)
  • Pathologic Review Table; Analysis/Interpretation/Reporting column: PCR/MMR changed to PCR/NGS or MMR throughout the table.
  • Assessment of Overexpression or Amplification of HER2 in Gastric Cancer
    • Revised: "...a traditional biopsy. It should be noted that NGS has several inherent limitations and thus whenever possible, The use of gold-standard assays (IHC/ISH) should be performed considered first, and if sufficient tissue is available, followed by additional NGS testing may be considered as appropriate. Repeat biomarker testing may be considered at clinical or radiologic progression for patients with advanced/metastatic gastric adenocarcinoma."
  • Microsatellite Instability (MSI) or Mismatch Repair (MMR) Testing
    • Revised: "Universal testing for MSI by polymerase chain reaction (PCR), NGS, or MMR ...in accordance with CAP DNA Mismatch Repair Biomarker Reporting Guidelines. MMR or MSI Testing should be performed only in CLIA-approved laboratories."
  • Footnote h: " PCR/NGS for MSI and IHC for MMR proteins ..."
  • Next-Generation Sequencing (NGS):
    • At present, three several targeted therapeutic agents, trastuzumab, ramucirumab, and pembrolizumab/nivolumab, and entrectinib/larotrectinib have been approved by the FDA for use in gastric cancer. Trastuzumab is based on testing for HER2 positivity overexpression. Pembrolizumab/nivolumab is are based on testing for MSI by PCR/MMR PCR or NGS/MMR by IHC, PD-L1 immunohistochemical expression by CPS, or high tumor mutational burden (TMB) by NGS...In these scenarios, comprehensive genomic profiling via a validated NGS assay performed in a CLIA-approved laboratory may be used for the identification of HER2 amplification, MSI status, MMR mutations deficiency, TMB, and NTRK gene fusions. It should be noted that NGS has several inherent limitations and thus whenever possible, The use of gold-standard assays (IHC/FISH/targeted PCR) should be performed considered first and if sufficient tissue is available, followed by additional NGS testing may be considered as appropriate.
  • Liquid Biopsy: Revised, "...Liquid biopsy is being used more frequently in patients with advanced disease, particularly those who are unable to have a clinical biopsy for disease surveillance and management...Therefore, for patients who have metastatic or advanced gastric cancer and are who may be unable to undergo a traditional biopsy, or for disease progression monitoring, testing using a validated NGS-based comprehensive genomic profiling assay..."
• Principles of Systemic Therapy (GAST-F)
  • 4th Bullet revised: Two-drug cytotoxic regimens are preferred for patients with advanced disease because of lower toxicity. Three-drug cytotoxic regimens should be reserved for medically fit patients with good PS and access to frequent toxicity evaluation. The use of three cytotoxic drugs in a regimen should be reserved for medically fit patients with excellent PS and easy access to frequent toxicity evaluations.
  • 8th Bullet revised: Perioperative chemotherapy or postoperative chemotherapy plus chemoradiation4 is the preferred approach for localized gastric cancer. Perioperative therapy is a category 1 recommendation for localized gastric cancer. Postoperative chemotherapy plus chemoradiation is an alternative option for patients who received less than a D2 lymph node dissection.
• Principles of Systemic Therapy for Unresectable Locally Advanced, Recurrent or Metastatic Disease (GAST-F)
  • First-Line Therapy, Useful in Certain Circumstances; HER2 overexpression negative: Revised, Fluoropyrimidine (fluorouracil or capecitabine), oxaliplatin, and nivolumab (PD-L1 CPS 1-4 <5) (category 2B)
  • Footnote k revised: For patients that have progressed whose cancer is progressing on or following prior treatment (that did not include a checkpoint inhibitor like PD-1i, PDL-1i, or CTLA4i) and who have no satisfactory alternative treatment options. Prior use of immuno-oncology therapy in these patients will make them ineligible for dostarlimab-gxly.
• Principles of Systemic Therapy-Regimens and Dosing Schedules (GAST-F)
  • Perioperative Chemotherapy; Preferred Regimens
    • Fluoropyrimidine and oxaliplatin: Revised, (3 4 cycles preoperative and 3 4
      cycles postoperative)
  • Postoperative Chemoradiation: Dosing for Fluorouracil and Capecitabine were revised to include the following statement, For cycles after chemoradiation, begin chemotherapy 1 month after chemoradiation.
  • First-line Therapy; Other recommended regimens:
    • Paclitaxel with or without cisplatin or carboplatin
      • The cisplatin dose was revised as follows: Cisplatin 75 mg/m2 IV on Day 2 1
• Principles of Radiation (GAST-G)
  • Simulation and Treatment Planning; First bullet revised: CT simulation and conformal treatment planning should be used with either 3D conformal radiation (3D-CRT) or. intensity-modulated radiation therapy (IMRT). may be used in clinical settings where reduction in dose to organs at risk (eg, heart, lungs, liver, kidneys, small bowel) is required, which cannot be achieved by 3-D techniques.
  • Normal Tissue Tolerance Dose-Limits: This section was extensively revised
  • RT Dosing revised: 45–50.4 Gy (1.8 Gy/day) (total 25–28 fractions)

NCCN has published updates to the NCCN Guidelines, and the NCCN Compendium for Breast Cancer. These NCCN Guidelines are currently available as Version 2.2022. 

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

• Principles of Radiation Therapy
  • Sequence of RT with systemic therapy (BINV-I, 2 of 3)
    • Bullet modified: Adjuvant olaparib can be given concurrently with RT (and endocrine therapy). Olaparib should be given after completion of RT.
• Adjuvant Endocrine Therapy (BINV-K)
  • Footnote d, modified for clarification: In patients with HR-positive/HER2-negative, high-risk breast cancer (ie, those with ≥4 positive lymph nodes, or 1–3 positive lymph nodes with one or more of the following: Grade 3 disease, tumor size ≥5 cm, or a Ki-67 score of ≥20%) 2 years of adjuvant abemaciclib can be considered in combination with endocrine therapy.

NCCN has published updates to the NCCN Guidelines for Distress Management. These NCCN Guidelines are currently available as Version 1.2022. 

Link directly to the Updates section of the NCCN Guidelines:
Distress Management

• Distress Thermometer and Problem List (DIS-A)
  • The Problem List has been significantly updated, including:
    • Reorganization and deletion of some physical concerns
    • Addition of and revisions to emotional and social concerns
    • Addition of specific spiritual or religious concerns
• Depressive Disorders (DIS-9)
  • Evaluation
    • Bullet added: Anxiety
    • Last bullet modified: Evaluate using PHQ-2 or PHQ-9 validated tool (eg, PHQ-2 or PHQ-9)

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.

About NCCN Flash Updates™

NCCN Flash Updates™ is a subscription service from NCCN that provides timely notification of updated and new information appearing in the NCCN Guidelines, the NCCN Compendium^®, and other NCCN Content.

Subscribe to NCCN Flash Updates™

Please  note:  1. Third Party Content. The NCCN Content may contain content (such as figures, tables or illustrations) that NCCN licenses from third parties as displayed on NCCN Third Party Content FTP site: ftp://ftp1.nccn.org (To access: user name:content; password is NCCNcontent) (“Third Party Content”). Licensee shall be solely responsible for obtaining permissions from each such third party to use any such Third Party Content in the Permitted Works.

Access information on permissions and licensing of NCCN Content

Users may unsubscribe from Flash Updates at any time by contacting us. NOTE: The subscription fee for NCCN Flash Updates™ is non-refundable.