From the Guidelines
For patients with stage 3 melanoma who have received preparative immunotherapy with a complete response, adjuvant therapy with either nivolumab or pembrolizumab for 52 weeks is recommended to reduce the risk of recurrence, with dabrafenib plus trametinib being an alternative option for BRAF-mutant patients. The choice of adjuvant therapy should be based on the patient's BRAF mutation status, with nivolumab or pembrolizumab being the preferred options for BRAF wild-type patients 1. For BRAF-mutant patients, dabrafenib plus trametinib is a viable alternative, with the combination of dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) for 1 year being a recommended option 1. Key considerations in selecting adjuvant therapy include the patient's overall health, potential side effects, and the risk of recurrence. Regular monitoring for immune-related adverse events, such as thyroiditis, colitis, hepatitis, and pneumonitis, is essential during treatment with immunotherapy 1. The patient's response to adjuvant therapy should be closely monitored, with regular follow-up appointments, physical examinations, imaging studies, and laboratory tests to assess for any signs of recurrence or treatment-related toxicity. In general, the goal of adjuvant therapy is to improve recurrence-free survival and overall survival, while minimizing treatment-related side effects and maintaining quality of life. Some key points to consider when discussing adjuvant therapy options with patients include:
- The potential benefits and risks of each treatment option
- The patient's individual risk of recurrence and overall prognosis
- The potential side effects and toxicity associated with each treatment option
- The importance of regular follow-up and monitoring during and after treatment.
From the FDA Drug Label
1.2 Adjuvant Treatment of Melanoma OPDIVO is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma.
The recommended adjuvant therapy for stage 3 melanoma after complete response to preparative immunotherapy is nivolumab (OPDIVO), as a single agent, for adult and pediatric patients 12 years and older with completely resected Stage III melanoma 2.
- Key points:
- Indication: Adjuvant treatment of completely resected Stage III melanoma
- Patient population: Adult and pediatric patients 12 years and older
- Dosage: Not specified in the provided text, please refer to the full prescribing information for dosage recommendations.
From the Research
Adjuvant Therapy for Stage 3 Melanoma
The recommended adjuvant therapy for stage 3 melanoma after complete response to preparative immunotherapy includes:
- Immunotherapy with anti-programmed cell death protein 1 (PD-1) monotherapy, such as nivolumab or pembrolizumab 3
- Targeted therapy with BRAF/MEK inhibitors, such as dabrafenib and trametinib 3 Key considerations for adjuvant therapy include:
- Stage of melanoma: adjuvant treatment is recommended for patients with stage IIIB-IIID melanoma, and may be considered for patients with stage IIIA melanoma 3
- Presence of BRAF V600E mutation: patients with this mutation may benefit from targeted therapy with BRAF/MEK inhibitors 4
Efficacy of Adjuvant Therapies
Studies have shown that:
- Adjuvant immunotherapy with nivolumab or pembrolizumab can achieve 2-year and 3-year recurrence-free survival rates of approximately 72% and 65%, respectively 3
- Adjuvant targeted therapy with dabrafenib and trametinib can achieve 2-year and 3-year recurrence-free survival rates of approximately 68% and 60%, respectively 3
- Neo-adjuvant immunotherapy with combined ipilimumab and nivolumab can induce major pathologic response rates of up to 50-60% 5, 6
Management of Recurrences
In cases of recurrence, management strategies may include: