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UPDATES: NCCN Guidelines® and NCCN Compendium®
NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) and the NCCN Drugs and Biologics Compendium (NCCN Compendium®) for Melanoma. These NCCN Guidelines® are currently available as Version 1.2014.
- Primary Treatment
- For Stage IA patients (0.76-1.0 mm thick, no ulceration, mitotic rate < 1 per mm2), the primary treatment recommendation changed to "Wide excision (category 1) with sentinel biopsy (category 2B)." Previously "sentinel node biopsy" was category 2A. (ME-2)
- For Stage III in-transit patients, the following local therapy options were revised: (ME-5) These same changes were made on ME-8 for recurrence.
- IL-2 was added to the list of intralesional treatments.
- Topical imiquimod was clarified as being recommended for "superficial" dermal lesions.
- Adjuvant Treatment
- For patients with Stage III (clinically positive node[s]), the recommendation "Consider RT to nodal basin if multiple nodes involved or macroscopic extranodal extension" changed to "Consider RT to nodal basin in selected patients, based on location, size and number of involved nodes, and/or macroscopic extranodal extension (category 2B)." (ME-4). This change was also made for the adjuvant treatment of patients with nodal recurrence (ME-9)
- Footnote "l" 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 associated with improved DFS, but its impact on overall survival is unclear shown to improve disease free survival (DFS) (category 1); its impact on overall survival remains unclear (category 2B)." (ME-5)
- Footnote "o" was revised: "It is important to consider the potential risks and benefits when considering adjuvant RT. Adjuvant nodal basin RT is associated with reduced lymph node field recurrence but has no impact on relapse-free or overall survival, and its benefits must be weighed against the increased probability of long term skin and regional toxicities and potential reduced quality of life. See Principles of Radiation Therapy (ME-D)."
- Footnote "t" was revised: Initial clinical recurrence should be confirmed pathologically whenever possible if clinically indicated. Obtain tissue for genetic analysis…" (ME-6)
- Follow-up (ME-7)
- Footnote "r": The second bullet under "Common Follow-up Recommendations was For All Patients" was revised: "Educate patient in monthly regular self skin exam and monthly lymph node self exam for Stage IA - IV NED."
- Treatment of Metastatic Disease (ME-10)
- After "Limited (Resectable)," two new pathways were added for "No evidence of disease" and "Residual disease."
- Principles of Surgical Margins for Wide Excision of Primary Melanoma (ME-B)
- The recommended clinical margin for In situ changed from "0.5 cm" to "0.5-1.0 cm."
- Principles of Complete Lymph Node Dissection (ME-C)
- A new bullet was added, "For primary melanomas of the head and neck with clinically or microscopically positive lymph nodes in the parotid gland, a parotidectomy and appropriate neck dissection of the draining nodal basins is recommended."
- Principles of Radiation Therapy for Melanoma (ME-D)
- This section was revised extensively.
- Systemic Therapy Options for Advanced or Metastatic Melanoma
- Preferred Regimens
- Dabrafenib was added as a category 1 recommendation.
- Other Active Regimens: The following agents were added
- Trametinib (category 1)
- Albumin-bound paclitaxel
- Footnote 3 was revised, "Vemurafenib, dabrafenib, and trametinib are recommended only for patients with V600 mutation of the BRAF gene documented by an FDA-approved or Clinical Laboratory Improvement Amendments (CLIA)-approved facility."
- Footnote 4 was revised, "Vemurafenib and dabrafenib have the potential for significant dermatologic complications including cutaneous squamous cell carcinoma and extreme photosensitivity...."
- Footnote 5 is new to the algorithm: "Dabrafenib administration can be associated with significant febrile toxicity."
- Footnote 8 is new to the algorithm: "The principle 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."
For the complete updated versions of the NCCN Guidelines®, the NCCN Drugs & Biologics Compendium (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.com.
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