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NCCN Flash Update: NCCN Guidelines® and NCCN Compendium® Updated

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) and the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for Melanoma. These NCCN Guidelines® are currently available as Version 1.2015.

  • Pathology Report (ME-1)
    • Footnote "c" is new to the algorithm: "While there is interest in newer prognostic molecular techniques, such as gene expression profiling to differentiate melanomas at low versus high risk for metastasis, routine (baseline) genetic testing of primary melanomas (before or following SLNB) is not recommended outside of a clinical trial. Mutational analysis is recommended if patients are being considered for either routine treatment or clinical trials, but not recommended for patients who are otherwise NED."
  • Clinical Stage (ME-2)
    • The following characteristics were changed:
      • Stage IA (≤0.75 mm thick, no ulceration, mitotic rate <1 0 per mm2)
      • Stage IA (0.76-1.0 mm thick, no ulceration, mitotic rate <1  0 per mm2)
  • Adjuvant Treatment (ME-3)
    • Footnote “n” regarding interferon alfa for stage IIB or IIC was revised: “Interferon can be given as High-dose alfa interferon for one year or as peginterferon alfa-2b for up to 5 years. Adjuvant interferon has been shown to improve disease free survival (DFS) (category 1); its impact on overall survival remains unclear (category 2B)."
  • Primary Treatment (ME-4)
    • The option “Clinical Trial” and the corresponding footnote have been removed for stage III (sentinel node positive) disease.
  • Follow-up (ME-7)
    • Stage IIB-V NED
      • Third bullet revised: "Consider chest x-ray, CT, and/or PET/CT scans every 4-12 3-12 mo (unless otherwise mandated by clinical trial participation) to screen for recurrent/metastatic disease (category 2B)."
      • Last bullet revised: "Routine radiologic imaging to screen for asymptomatic recurrent/metastatic disease is not recommended after 3-5 years."
    • Footnote “v” was revised:
      • Second bullet: "Educate patient in regular self skin exam and lymph node self exam for Stage IA - IV NED."
      • Fifth bullet: "Regional lymph node ultrasound may be considered in patients with an equivocal lymph node physical exam, patients who were offered but did not undergo SLNB, patients in whom SLNB was not possible (or not successful), or patients with a positive SLNB who did not undergo complete lymph node dissection. At this point, nodal basin ultrasound is not has not been shown to be a substitute for SLNB or complete lymph node dissection (CLND)."
    • Footnote “y” revised:  "Surveillance for higher risk patients should be more frequent than for lower risk patients, especially for the first two years. The frequency of follow-up and intensity of cross-sectional imaging should be based on the conditional probability of recurrence at any point in time after initial treatment."
  • Principles of Radiation (ME-A)
    • This section and the supporting references were revised extensively.
  • Systemic Therapy Options for Advanced or Metastatic Melanoma (ME-E)
    • Preferred Regimens
      • “Dabrafenib + trametinib” changed from category 2A to category 1.
      • The following agents were moved from the list of "Preferred Regimens" to "Other Active Regimens":
        • Vemurafenib (category 1)
        • Dabrafenib (category 1)
        • High-dose IL-2
      • Other Active Regimens: 
        • Pembrolizumab was added to the list of options along with a corresponding footnote: "Pembrolizumab is indicated for disease progression after treatment with ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Pembrolizumab may cause immune-mediated adverse reactions. Depending on the severity of the reaction, pembrolizumab should be discontinued and corticosteroids administered for immune-mediated: pneumonitis, colitis, hepatitis, hypophysitis, nephritis, and hyperthyroidism. For patients with pre-existent hypophysitis due to ipilimumab, pembrolizumab may be administered if patients are on appropriate physiologic replacement endocrine therapy."
    • Footnote "1" is new to the algorithm: "The order of listed regimens does not indicate preference. The choice of a preferred treatment is based on evaluation of the individual patient."
    • Footnote "2" is new to the algorithm: "Combination chemotherapy and immunotherapy should not be undertaken outside of a clinical trial."
    • Footnote "5" is new to the algorithm: "Regular dermatologic evaluation and referral to a dermatologist or provider experienced in the diagnosis and management of cutaneous manifestations of targeted therapy and/or immunotherapy is recommended. Patients should also be educated to report the development of other adverse reactions such as joint pain and swelling.
    • Footnote "7" was revised: "The combination of dabrafenib with trametinib was associated with improved progression-free survival (PFS) compared to dabrafenib monotherapy in a phase I/II trial; however, improvement in overall survival has not been demonstrated. Combination therapy may be associated with less cutaneous toxicity than monotherapy, but systemic toxicity may be increased."
    • Footnote "10" was revised: "Dabrafenib administration can be associated with significant episodic and recurrent fevers that should be managed by discontinuation of dabrafenib and institution of antipyretics such as acetaminophen, low-dose prednisone, and/or NSAIDs. Dabrafenib is associated with keratoacanthoma/low grade squamous carcinomas and little if any significant less photosensitivity than vemurafenib.  Regular dermatologic evaluation and referral to a dermatologist is recommended. Patients should also be educated to report the development of other adverse reactions such as joint pain and swelling.”

For the complete updated versions of the NCCN Guidelines, the NCCN Compendium®, and the NCCN Chemotherapy Order Templates (NCCN Templates®), please visit NCCN.org.

To access the NCCN Biomarkers Compendium®, please visit NCCN.org/biomarkers.

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

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

 

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