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UPDATES: NCCN Guidelines® and NCCN Compendium®

NCCN Flash Update sent February 10, 2014

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 3.2014.

  • Systemic Therapy Options for Advanced or Metastatic Melanoma (ME-E)
    • Based on the recent FDA approval, the combination of dabrafenib + trametinib was added to the list of preferred systemic therapy options for advanced or metastatic melanoma. A corresponding footnote was also added: "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."
    • Footnote "9" was revised: "Single-agent trametinib is not indicated for the treatment of patients who have experienced progression of disease on prior BRAF inhibitor therapy. Single-agent trametinib can be used for the treatment of BRAF-mutated melanoma in patients who are intolerant to single-agent BRAF inhibitorsThe principal indication for the primary treatment of BRAF-mutated melanoma with trametinib is intolerance to BRAF-inhibitors.  While trametinib may have some clinical activity when used in combinaition with BRAF inhibitors, the efficacy of combination therapy remains under investigation

*For your reference, the announcement of the previous update (Version 2.2014) to the NCCN Guidelines for Melanoma, distributed on September 11, 2013, is included below:

NCCN has published updates to the NCCN Guidelines for Melanoma. These NCCN Guidelines are currently available as Version 2.2014.

  • Footnote “l” is new to the algorithm: “Consider nodal basin ultrasound prior to SLNB for melanoma patients with an equivocal regional lymph node physical exam. Nodal basin ultrasound is not a substitute for SLNB.  Abnormalities or suspicious lesions on nodal basin ultrasound should be confirmed histologically.” (ME-3)
  • Workup
    • For Stage III (sentinel node positive), the recommendation changed to “Consider baseline imaging for staging (category 2B) and to evaluate specific signs or symptoms (CT, PET/CT, MRI).” (ME-4)
  • Follow-up (ME-7)
    • Stage IA-IIA NED; Second bullet: For H&P, the recommendation changed from “every 3-12 mo for 5 y...” to “every 6-12 mo for 5y...”
    • Stage IIB-IV NED; Third bullet: The recommendation changed from “Consider chest x-ray, CT, and/or PET/CT scans every 3-12  mo to screen for recurrent/metastatic disease (category 2B)” to “Consider chest x-ray, CT, and/or PET/CT scans every 4-12 mo (unless otherwise mandated by clinical trial participation) to screen...”
    • Footnote “v” (Common Follow-up Recommendations for All Patients): The following statement was added: “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, or patients with a positive SLNB who did not undergo complete lymph node dissection. Nodal basin ultrasound is not a substitute for SLNB.”
    • Footnote “w” was revised as follows: Consider more frequent imaging for higher-risk patients. Surveillance for higher risk patients should be more frequent than for lower risk patients, especially for the first two years.
  • Systemic Therapy Options for Advanced or Metastatic Melanoma (ME-E)
    • The following footnotes were revised:
      • Footnote 4: “Vemurafenib and dabrafenib has the potential for significant dermatologic complications including cutaneous squamous cell carcinoma and extreme photosensitivity. Regular dermatologic evaluation with referral to a dermatologist is recommended. Patients should also be carefully monitored for educated to report the development of other adverse reactions such as joint pain and swelling.”
      • Footnote 5: “Dabrafenib administration can be associated with significant febrile toxicity episodic and recurrent fevers that should be managed by discontinuation of dabrafenib and institution of anti-pyretics such as acetaminophen and/or NSAIDs. Dabrafenib is associated with keratoacanthoma/low grade squamous carcinomas and little if any significant photosensitivity. 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.”
      • Footnote 8: “The principal indication for the primary treatment of BRAF-mutated metastatic melanoma with trametinib is intolerance to BRAF inhibitors. Trametinib is not indicated for treatment of patients who have received prior BRAF inhibitor therapy. While it may have some clinical activity when used in combination with BRAF inhibitors, the clinical efficacy of combination therapy remains under investigation. Trametinib is not indicated for treatment of patients who have experienced progression of disease on prior BRAF inhibitor therapy. The principal indication for the primary treatment of BRAF-mutated melanoma with trametinib is intolerance to BRAF inhibitors.  While trametinib may have some clinical activity when used in combination with BRAF inhibitors, the efficacy of combination therapy remains under investigation.”

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