What are the National Institute for Health and Care Excellence (NICE) guidelines for melanoma?

From the Guidelines

The NCCN guidelines for melanoma recommend neoadjuvant systemic therapies, including pembrolizumab monotherapy, as a preferred regimen for resectable stage III melanoma, based on prospective trial data 1.

Key Recommendations

• Neoadjuvant therapy is generally preferred over the previous standard approach of therapeutic lymph node dissection (TLND), followed by adjuvant systemic treatment, for patients with resectable stage III melanoma with clinically positive nodes or nodal recurrence 1.
• The recommended neoadjuvant regimens include pembrolizumab monotherapy, "flip dose" nivolumab, and ipilimumab, as well as other regimens such as nivolumab and relatlimab, and dabrafenib/trametinib for certain circumstances 1.
• Sentinel lymph node biopsy is a key prognostic factor in medical decision-making and patient outcomes, and is recommended for patients with stage IB-IIC melanoma and a Breslow thickness of more than 1mm 1.
• Wider excision is performed with peripheral surgical margins based on Breslow thickness, along with pathologic staging of the regional lymph nodes via sentinel lymph node biopsy 1.

Treatment Approaches

• Neoadjuvant therapy posits that administration of anti–PD-1 therapy before surgery could induce an immune response from a larger population of tumor-infiltrating T cells, leading to improved clinical outcomes 1.
• The clinical, pathologic, and radiographic response to the initial round of neoadjuvant immunotherapy could potentially guide postoperative adjuvant therapy selection, with duration and extent depending on the degree of pathologic response in the postneoadjuvant surgical specimen 1.
• Other potential advantages to neoadjuvant therapy include an earlier start of systemic therapy and elimination of unnecessary surgery, although counterbalanced against the potential drawbacks of delays in surgery and/or introduction of immune toxicity prior to surgery 1.

From the FDA Drug Label

The provided drug labels do not directly address the NICE guidelines for melanoma.

The FDA drug label does not answer the question.

From the Research

Melanoma NICE Guidelines

• The National Institute for Health and Care Excellence (NICE) guidelines for melanoma have been updated to reflect the latest advances in the management of the disease 2
• The guidelines recommend the use of pembrolizumab as a first-line treatment for patients with advanced BRAF V600-mutant melanoma, due to its association with longer overall survival compared to dabrafenib/trametinib 3
• Adjuvant pembrolizumab has been shown to improve recurrence-free survival in patients with high-risk resected melanoma, although it did not significantly improve overall survival 4

Surgical Management

• The guidelines recommend definitive wide local excision of primary cutaneous melanoma with margins of:
  • 5-10 mm for melanoma in situ
  • 1 cm for invasive melanoma (pT1) ≤ 1.0 mm thick
  • 1-2 cm for invasive melanoma (pT2) 1.01-2.00 mm thick
  • 1-2 cm for invasive melanoma (pT3) 2.01-4.00 mm thick
  • 2 cm for invasive melanoma (pT4) > 4.0 mm thick 5
• Sentinel lymph node biopsy should be discussed for melanomas ≥ 1 mm thickness (≥ 0.8 mm if other high-risk features) 5

Systemic Therapies

• Pembrolizumab and nivolumab are commonly used therapies for advanced melanoma, with no significant difference in overall survival between the two treatments 6
• The choice of therapy should be based on patient and provider preference, taking into account individual patient characteristics and needs 6