Final trial report of sentinel-node biopsy versus nodal observation in melanoma

Morton, D. L., Thompson, J. F., Cochran, A. J., Mozzillo, N., Nieweg, O. E., Roses, D. F., Hoekstra, H. J., Karakousis, C. P., Puleo, C. A., Coventry, B. J., Kashani-Sabet, M., Smithers, B. M., Paul, E., Kraybill ,W. G., McKinnon, J. G., Wang, H.-J., Elashoff, R. and Faries, M. B. (2014) Final trial report of sentinel-node biopsy versus nodal observation in melanoma. New England Journal of Medicine, 370 7: 599-609. doi:10.1056/NEJMoa1310460

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Author Morton, D. L.
Thompson, J. F.
Cochran, A. J.
Mozzillo, N.
Nieweg, O. E.
Roses, D. F.
Hoekstra, H. J.
Karakousis, C. P.
Puleo, C. A.
Coventry, B. J.
Kashani-Sabet, M.
Smithers, B. M.
Paul, E.
Kraybill ,W. G.
McKinnon, J. G.
Wang, H.-J.
Elashoff, R.
Faries, M. B.
Title Final trial report of sentinel-node biopsy versus nodal observation in melanoma
Journal name New England Journal of Medicine   Check publisher's open access policy
ISSN 0028-4793
Publication date 2014-02-01
Year available 2014
Sub-type Article (original research)
DOI 10.1056/NEJMoa1310460
Open Access Status File (Publisher version)
Volume 370
Issue 7
Start page 599
End page 609
Total pages 11
Place of publication Boston, United States
Publisher Massachusetts Medical Society
Language eng
Abstract BackgroundSentinel-node biopsy, a minimally invasive procedure for regional melanoma staging, was evaluated in a phase 3 trial.
Formatted abstract
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.
Keyword Medicine, General & Internal
General & Internal Medicine
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Non HERDC
School of Medicine Publications
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Citation counts: TR Web of Science Citation Count  Cited 391 times in Thomson Reuters Web of Science Article | Citations
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