eBulletin Newsletter

NCCN Flash Updates: NCCN Guidelines

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®), and the NCCN Drugs and Biologics Compendium (NCCN Compendium^®) for Hematopoietic Cell Transplantation. These NCCN Guidelines^® are currently available as Version 5.2021.

Link directly to the Updates section of the NCCN Guidelines: 
Hematopoietic Cell Transplantation
 

• Suggested Systemic Agents for Steroid-Refractory Graft-Versus-Host Disease (GVHD)
  • Ruxolitinib changed from a category 2A to a category 1 option for chronic GVHD. (GVHD-E, 1 of 3) 
  • Footnote b modified: Ruxolitinib is FDA approved for the treatment of adult and pediatric patients (age ≥12 years) with either steroid-refractory acute GVHD, or chronic GVHD after failure of one or two lines of systemic therapy. (GVHD-E, 1 of 3)
  • Reference added: Zeiser R, Polverelli N, Ram R, et al. Ruxolitinib for glucocorticoid-refractory chronic graft-versus-host disease. N Engl J Med. 2021 Jul 15;385(3):228-238. (GVHD-E, 2 of 3)

Previous updates to the NCCN Guidelines for Hematopoietic Cell Transplantation can be found in the UPDATES section of the current version.




NCCN has published updates to the NCCN Guidelines and the NCCN Compendium^® for Hepatobiliary Cancers. These NCCN Guidelines are currently available as Version 5.2021.

Link directly to the Updates section of the NCCN Guidelines:
Hepatocellular Carcinoma

• Principles of Systemic Therapy  (HCC-G,1 of 2)
  • Subsequent-Line Therapy If Disease Progression
    • Dostarlimab-gxly was added as a treatment option for patients with MSI-H/dMMR tumors.  This is a category 2B, Useful in Certain Circumstances recommendation. 
    • Footnote l added:  Dostarlimab-gxly is a recommended treatment option for patients with MSI-H/dMMR recurrent or advanced tumors that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. 
• Principles of Systemic Therapy References (HCC-G 2 of 2)
  • The following references were added:
    • Andre T, Berton D, Curigliano G, et al. Safety and efficacy of anti–PD-1 antibody dostarlimab in patients (pts) with mismatch repair-deficient (dMMR) solid cancers: Results from GARNET study [abstract]. J Clin Oncol 2021;39:Abstract 9.  (Also on BIL-C, 4 of 4)
    • Berton D, Banerjee SN, Curigliano G, et al. Antitumor activity of dostarlimab in patients with mismatch repair-deficient/microsatellite  instability-high tumors: A combined analysis of two cohorts in the GARNET study [abstract]. J Clin Oncol 2021;39:Abstract 2564. (Also on BIL-C, 4 of 4)

Biliary Tract Cancer  

• Principles of Systemic Therapy (BIL-C, 2 of 4)
  • Subsequent-Line Therapy for Biliary Tract Cancers If Disease Progression
    • Dostarlimab-gxly was added as a treatment option for patients with MSI-H/dMMR recurrent or advanced tumors. This is a category 2B, Useful in Certain Circumstances recommendation.
  • Footnote g added:  For patients who have not been previously treated with a checkpoint inhibitor because there is a lack of data for subsequent use of immunotherapy in patients who have previously been treated with a checkpoint inhibitor.
  • Footnote h added:  Dostarlimab-gxly is a recommended treatment option for patients with MSI-H/dMMR recurrent or advanced tumors that have progressed on or following prior treatment and who have no satisfactory alternative treatment options
• The discussion section has been updated to reflect the changes in the algorithm (MS-1).

Previous updates to the NCCN Guidelines for Hepatobiliary Cancers can be found in the UPDATES section of the current version.
 

NCCN has published updates to the NCCN Guidelines, the NCCN Radiation Therapy Compendium™, and the NCCN Compendium for Pediatric Acute Lymphoblastic Leukemia. These NCCN Guidelines are currently available as Version 1.2022.

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

• Diagnosis (PEDALL-1):
  • Diagnosis, third bullet modified: Baseline characterization of leukemic clone to facilitate subsequent minimal residual disease (MRD) analysis Baseline flow cytometric and/or molecular characterization of leukemic clone to facilitate subsequent minimal residual disease (MRD) analysis. (see PEDALL-I)
• Workup (PEDALL-2):
  • Fifteenth bullet, third sub-bullet modified: Other germline mutations associated with ALL risk have been reported. A complete family history can help identify risk for a cancer predisposition syndrome, although de novo mutations have been reported.
  • Fifteenth bullet, fourth sub-bullet added: For patients with possible cancer predisposition syndromes, principles of cancer risk assessment and counseling should be taken into consideration (See NCCN Guidelines for Genetic/Familial High-Risk Assessment: Breast, Ovarian, and Pancreatic)
• MRD+ Post-Induction Therapy (PEDALL-4):
  • Footnote y was added: The role of allogeneic HCT following tisagenlecleucel is unclear. Persistence of tisagenlecleucel in peripheral blood and persistent B-cell aplasia has been associated with durable clinical responses without subsequent HCT. In the global registration trial, relapse-free survival was 59% at 12 months, with only 9% of patients proceeding to HS\CT (Maude SL, et al. N Engl J Med 2018;378:439-448). See Principles of Hematopoietic Cell Transplant (PEDALL-J). (Also on page PEDALL-5)
• Surveillance (PEDALL-8):
  • Second bullet modified: Year 2 (every 32–6 months)
• Principles of Supportive Care (PEDALL-B 1 of 9):
  • Prophylaxis guidelines:
    • Second bullet modified: Consider fluoroquinolone (levofloxacin, moxifloxacin) prophylaxis in patients receiving anthracyclines during induction therapy for newly diagnosed ALL or therapy for relapsed ALL who are anticipated to have expected neutropenia duration of >7 days until count recovery after expected hematologic nadir (ANC >200 or APC >500/mm3).
    • Third bullet modified: Consider micafungin or other echinocandin antifungal drugs during induction and potentially during other high-intensity phases.
• Principles of Supportive Care (PEDALL-B 2 of 9):
  • Fever and neutropenia (continued)
    • Third bullet, second sub-bullet added: Initiate or modify antimicrobial therapies accordingly, ensuring agents that penetrate into the CSF.
• Principles of Supportive Care (PEDALL-B 4 of 9):
  • Anthracycline-Related Cardiotoxicity:
    • Second bullet, first sub-bullet, third sub-bullet modified: Mitoxantrone: Multiply total dose by x 4-10 (mitoxantrone has been considered to be 4 to 5 times more cardiotoxic than doxorubicin, but newer data suggest it might be as much as 10 times more toxic).
• Principles of Supportive Care (PEDALL-B 6 of 9):
  • Behavior and Psychosocial Support: 
    • Second bullet added: Neurocognitive monitoring during therapy should be considered for all patients, given established risk for neurocognitive late effects associated with intrathecal chemotherapy.
    • Third Bullet added: Neurocognitive monitoring could occur at completion of treatment and/or at school entry or re-entry. Baseline assessment may be considered to provide a context in which to appreciate change.
    • Fourth bullet added: Consider referral for a comprehensive neuropsychological assessment if there is evidence of new concerns or change.
• Principles of Supportive Care (PEDALL-B 8 of 9):
  • Cerebral Thrombosis, Ischemia, or Stroke: First bullet modified: Discontinue asparaginase. Consider antithrombotic therapy. If symptoms/signs fully resolve, can resume asparaginase. Consider antithrombotic prophylaxis when resuming asparaginase.
• Evaluation and Treatment of Extramedullary Involvement (PEDALL-C):
  • Seventh bullet, sub-bullet removed: If TBI is done, recommended dosing is 12–14 Gy at 1.5–2 Gy/fraction.
• Risk Stratification Definitions, Post-Induction Therapy Risk Group Stratification (PEDALL-E 2 of 3):
  • Table headings modified: Low Favorable Risk and Standard Average Risk
• Principles of Systemic Therapy (PEDALL-F 5 of 12):
  • Ph-positive ALL:
    • Modified: Standard arm of COG AALL1631 (based on COG AALL1122/EsPhALL regimen): imatinib or dasatinib; combined with an HR backbone of the Berlin- Frankfurt-Münster regimen
  • Induction:
    • Removed: Cyclophosphamide, 6-MP, cytarabine, methotrexate, imatinib/dasatinib
    • Added: EsPhALL backbone (cyclophosphamide, mercaptopurine, cytarabine, methotrexate) + imatinib/dasatinib.
• Principles of Systemic Therapy (PEDALL-F 6 of 12):
  • Footnote added: For patients with MRD ≥5x10^-4 at the end of induction therapy, myeloid type consolidation therapy (eg, ADE/MAE) can be considered. (Stutterheim J, et al. J Clin Oncol 2021;39:652-662.)
• Principles of Systemic Therapy (PEDALL-F 7 of 12):
  • Ph-negative ALL
    •  Other Recommended Regimens:
      • First bullet modified: UKALL R3 backbone chemotherapy regimen
• Principles of Systemic Therapy (PEDALL-F 8 of 12):
  • Ph-Positive ALL
    • Other Recommended Regimens:
      • Bullet removed: Backbone chemotherapy + TKI, followed by HCT after CR achieved
  • Footnote added: HCT should be considered after CR achieved.
• Pharmacogenomics (PEDALL-G 1 & 2 of 3):
  • Dosing Guidelines for Thiopurines Based on TPMT/NUDT15 Phenotypes:
    • Homozygous for normal function alleles:
      • Dosing Recommendations for 6-MP:
        • Modified: Starting dose should be based on treatment protocol (typically 75 mg/m2/day).
      • Dosing Recommendations for 6-TG:
        • Modified: Starting dose should be based on treatment protocol (typically 60 mg/m2/day).
• Response Assessment (PEDALL-H):
  • Response Criteria for Blood and Bone Marrow:
    • Third bullet, first sub-bullet added: NOTE: MRD assessment is not included in morphologic assessment and should be obtained (See PEDALL-I)
• Minimal Residual Disease (PEDALL-I 1 of 2):
  • Second bullet modified: If a validated MRD assessment technology with appropriate sensitivity (at least 10^-4) is not available locally, there are commercially available tests.
  • Seventh bullet, first sub-bullet, fourth sub-bullet added: Serial monitoring frequency may be increased in patients with molecular relapse or persistent low-level disease burden.
• Principles of Hematopoietic Cell Transplant (PEDALL-J 3 of 5):
  • Conditioning Regimen:
    • First bullet modified: Retrospective studies Randomized controlled trials indicate that TBI may be is superior to non-TBI–containing regimens for children with ALL. 
    • Third bullet added: For infants: If donor available, prefer non-total body irradiation-based prep regimen and age ≥6 mo at time of HCT. See PEDALL-F, 2 of 12.

Previous updates to the NCCN Guidelines for Pediatric Acute Lymphoblastic Leukemia can be found in the UPDATES section of the current version.




NCCN has published updates to the NCCN Guidelines and the NCCN Compendium for Non-Small Cell Lung Cancer (NSCLC). These NCCN Guidelines are currently available as Version 6.2021. 

• EGFR exon 20 insertion mutation-positive advanced or metastatic NSCLC (NSCL-23)
  • Mobocertinib added as a subsequent therapy option for patients (PS 0-2) with advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, whose disease has progressed on or after initial systemic therapy options (NSCL-K 1 of 5, NSCL-K 2 of 5). This is a category 2A recommendation.
• Targeted Therapy or Immunotherapy for Advanced or Metastatic Disease (NSCL-J)
  • EGFR exon 20 insertion mutation positive; subsequent therapy
    • Mobocertinib added with reference 11 on NCSL-J 2 of 2
      EGFR exon 20 insertion mutation positive; subsequent therapy

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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