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Completion Dissection or Observation for Sentinel-Node Metastasis in Melanoma.
- Source :
-
The New England journal of medicine [N Engl J Med] 2017 Jun 08; Vol. 376 (23), pp. 2211-2222. - Publication Year :
- 2017
-
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.<br />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.<br />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.<br />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 .).
- Subjects :
- Adult
Aged
Disease-Free Survival
Female
Humans
Intention to Treat Analysis
Lymph Nodes diagnostic imaging
Lymph Nodes pathology
Lymphatic Metastasis diagnosis
Lymphedema etiology
Male
Melanoma mortality
Melanoma pathology
Melanoma surgery
Middle Aged
Neoplasm Staging methods
Postoperative Complications
Prognosis
Proportional Hazards Models
Sentinel Lymph Node pathology
Survival Analysis
Ultrasonography
Young Adult
Lymph Node Excision adverse effects
Melanoma secondary
Sentinel Lymph Node surgery
Sentinel Lymph Node Biopsy adverse effects
Watchful Waiting
Subjects
Details
- Language :
- English
- ISSN :
- 1533-4406
- Volume :
- 376
- Issue :
- 23
- Database :
- MEDLINE
- Journal :
- The New England journal of medicine
- Publication Type :
- Academic Journal
- Accession number :
- 28591523
- Full Text :
- https://doi.org/10.1056/NEJMoa1613210