Final Trial Report of Sentinel-Node Biopsy versus Nodal Observation in Melanoma

By D. Morton, John F. Thompson, A. Cochran, N. Mozzillo, O. Nieweg, D. Roses, H. J. Hoekstra, C. Karakousis, C. Puleo, B. Coventry and 8 more. New England Journal of Medicine, 2014

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Background Sentinel-node biopsy, a minimally invasive procedure for regional melanoma staging, was evaluated in a phase 3 trial. Methods We evaluated outcomes in 2001 patients with primary cutaneous melanomas randomly assigned to undergo wide excision and nodal observation, with lymphadenectomy for nodal relapse (observation group), or wide excision and sentinel-node biopsy, with immediate lymphadenectomy for nodal metastases detected on biopsy (biopsy group). Results No significant treatment-related difference in the 10-year melanoma-specific survival rate was seen in the overall study population (20.8% with and 79.2% without nodal metastases). Mean (±SE) 10-year disease-free survival rates were significantly improved in the biopsy group, as compared with the observation group, among patients with intermediate-thickness melanomas, defined as 1.20 to 3.50 mm (71.3±1.8% vs. 64.7±2.3%; hazard ratio for recurrence or metastasis, 0.76; P = 0.01), and those with thick melanomas, defined as >3.50 mm (50.7±4.0% vs. 40.5±4.7%; hazard ratio, 0.70; P = 0.03). Among patients with intermediate-thickness melanomas, the 10-year melanoma-specific survival rate was 62.1±4.8% among those with metastasis versus 85.1±1.5% for those without metastasis (hazard ratio for death from melanoma, 3.09; P<0.001); among patients with thick melanomas, the respective rates were 48.0±7.0% and 64.6±4.9% (hazard ratio, 1.75; P = 0.03). Biopsy-based management improved the 10-year rate of distant disease–free survival (hazard ratio for distant metastasis, 0.62; P = 0.02) and the 10-year rate of melanoma-specific survival (hazard ratio for death from melanoma, 0.56; P = 0.006) for patients with intermediate-thickness melanomas and nodal metastases. Accelerated-failure-time latent-subgroup analysis was performed to account for the fact that nodal status was initially known only in the biopsy group, and a significant treatment benefit persisted. Conclusions Biopsy-based staging of intermediate-thickness or thick primary melanomas provides important prognostic information and identifies patients with nodal metastases who may benefit from immediate complete lymphadenectomy. Biopsy-based management prolongs disease-free survival for all patients and prolongs distant disease–free survival and melanoma-specific survival for patients with nodal metastases from intermediate-thickness melanomas. (Funded by the National Cancer Institute, National Institutes of Health, and the Australia and New Zealand Melanoma Trials Group; ClinicalTrials.gov number, NCT00275496.)

Subfields: Epidemiology, Molecular Biology, Oncology

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Citations in the corpus

Melanoma Staging: Evidence-Based Changes in the American Joint Committee on Cancer Eighth Edition Cancer Staging Manual (2017, background): “The frequency of SLN metastasis increases with increasing tumor thickness and other adverse clinicopathological prognostic factors.(2,5) Clinical imaging technologies have also advanced, having become more sophisticated and more widely available, facilitating the detection of distant metastatic dise”
Ferroptosis: mechanisms and links with diseases (2021, background): “Melanoma usually metastases to lymph nodes before forming distant metastases due to the low cell survival rate in the blood, which is one of the most important predictors of distant metastasis and death in patients with cutaneous melanomas.(181,182) It is recently shown that the lymphatic environmen”
Cutaneous melanoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up†. (2019, neutral): “In the Multicentre Selective Lympadenectomy Trial I (MSLT-I), there was no significant treatment-related difference between WLE/SN versus WLE/nodal observation in the 10year follow-up melanoma-specific survival rate in patients with intermediate-thickness melanomas and thick primary melanomas [27].”
Genomic Classification of Cutaneous Melanoma (2015, positive): “…and Ross, 2011), early surgical intervention for patients with microscopic regional lymph node metastases (i.e., positive SLNs) has recently been found useful for prognosis, may improve survival in a subgroup of such patients, and serves to guide the use of adjuvant therapy (Morton et al., 2014).”