Melanoma Treatment (PDQ®): Treatment - Health Professional Information [NCI] - Stage II Melanoma Treatment
With the use of a vital blue dye and a radiopharmaceutical agent injected at the site of the primary tumor, the first lymph node in the lymphatic basin that drains the lesion can be identified, removed, and examined microscopically. Multiple studies have demonstrated the diagnostic accuracy of SLNB, with false-negative rates of 0% to 2%.[3,8,9,10,11,12] If metastatic melanoma is detected, a complete regional lymphadenectomy can be performed in a second procedure.
No published data on the clinical significance of micrometastatic melanoma in regional lymph nodes are available from prospective trials. Some evidence suggests that for patients with tumors of intermediate thickness and occult metastasis, survival is better among patients who undergo immediate regional lymphadenectomy than it is among those who delay lymphadenectomy until the clinical appearance of nodal metastasis. This finding should be viewed with caution because it arose from a post hoc subset analysis of data from a randomized trial.
Evidence (regional lymphadenectomy):
- The International Multicenter Selective Lymphadenectomy Trial (MSLT-1 [JWCI-MORD-MSLT-1193]) included 1,269 patients with intermediate-thickness (defined as 1.2 mm-3.5 mm in this study) primary melanomas.[Level of evidence: 1iiB]
- There was no melanoma-specific survival advantage (primary endpoint) for patients randomly assigned to undergo wide excision plus SLNB, followed by immediate complete lymphadenectomy for node positivity versus nodal observation and delayed lymphadenectomy for subsequent nodal recurrence at a median of 59.8 months.
- This trial was not designed to detect a difference in the impact of lymphadenectomy in patients with microscopic lymph node involvement.
- Three other prospective randomized trials have failed to show a survival benefit for prophylactic regional LNDs.[15,16,17]
High-dose interferon alpha-2b was approved in 1995 for the adjuvant treatment of patients with melanoma who have undergone a complete surgical resection but are considered to be at a high risk of relapse. Evidence was based on a significantly improved relapse-free survival (RFS) and marginally improved overall survival (OS) that were seen in EST-1684.
Subsequent large, randomized trials have not been able to reproduce a benefit in OS. Ongoing trials are testing therapies that have demonstrated improved OS in patients with stage IV disease.