Completion Dissection or Observation for Sentinel-Node Metastasis in Melanoma

Abstract

BACKGROUND Sentinel-lymph-node biopsy is associated with increased melanoma-specific survival (i.e., survival until death from melanoma) among patients with node-positive intermediate-thickness melanomas (1.2 to 3.5 mm). The value of completion lymph-node dissection for patients with sentinel-node metastases is not clear. METHODS In an international trial, we randomly assigned patients with sentinel-node metastases detected by means of standard pathological assessment or a multimarker molecular assay to immediate completion lymph-node dissection (dissection group) or nodal observation with ultrasonography (observation group). The primary end point was melanoma-specific survival. Secondary end points included disease-free survival and the cumulative rate of nonsentinel-node metastasis. RESULTS Immediate completion lymph-node dissection was not associated with increased melanoma-specific survival among 1934 patients with data that could be evaluated in an intention-to-treat analysis or among 1755 patients in the per-protocol analysis. In the per-protocol analysis, the mean (±SE) 3-year rate of melanoma-specific survival was similar in the dissection group and the observation group (86±1.3% and 86±1.2%, respectively; P=0.42 by the log-rank test) at a median follow-up of 43 months. The rate of disease-free survival was slightly higher in the dissection group than in the observation group (68±1.7% and 63±1.7%, respectively; P=0.05 by the log-rank test) at 3 years, based on an increased rate of disease control in the regional nodes at 3 years (92±1.0% vs. 77±1.5%; P<0.001 by the log-rank test); these results must be interpreted with caution. Nonsentinel-node metastases, identified in 11.5% of the patients in the dissection group, were a strong, independent prognostic factor for recurrence (hazard ratio, 1.78; P=0.005). Lymphedema was observed in 24.1% of the patients in the dissection group and in 6.3% of those in the observation group. CONCLUSIONS Immediate completion lymph-node dissection increased the rate of regional disease control and provided prognostic information but did not increase melanoma-specific survival among patients with melanoma and sentinel-node metastases. (Funded by the National Cancer Institute and others; MSLT-II ClinicalTrials.gov number, NCT00297895.)

How Much We Follow Guidelines in Surgery of Melanoma: It's Time to Reflect!

“…As reported above, all these findings stress the importance of follow guidelines, also in thin lesions 9 . In conclusion, in melanoma, sub-optimal compliance with appropriate guidelines result in poorer outcomes and increased morbidity and mortality.…”

“…8 Besides, the authors found that sentinel lymph-node biopsy (SNLB) reporting was just 37% of the total sample eligible for screening, showing an important gap in the routine analysis of SNLB. Indeed, although it has been showed that an immediate complete lymphnode dissection does not increase melanoma-specific survival among patients with melanoma and sentinelnode metastases 9 , SLNB should be performed in order to provide prognostic information, optimizing clinical and instrumental follow-ups and improving regional disease control.…”

Melanoma Staging: American Joint Committee on Cancer (AJCC) 8th Edition and Beyond

“…21,22 It is worth noting that the 8th edition AJCC Cancer Staging Manual provides specific recommendations for documentation of the now common scenario when SLN biopsy identifies tumor-involved SLNs but CLND is not performed. 9 To distinguish patients who have had a CLND from those who have not, the ''(sn)'' suffix should be appended to the N category for those who did not undergo CLND-i.e., a patient with a single tumorinvolved SLN who does not undergo CLND is pN1a(sn).…”

Surgical Management of Melanoma

“…A positive SLNB is the best predictor of recurrence and survival in patients with clinically node negative cutaneous melanoma (19). Indications for performing SLNB is a balance between the likelihood of finding a positive SLN, the risk of the procedure, as well as the likely benefits that will accrue to the patient from the knowledge of their SLN status (14).…”