Completion dissection or observation for sentinel-node metastasis in melanoma Journal Article
| Authors: | Faries, B.; Thompson, J. F.; Cochran, A. J.; Andtbacka, R. H.; Mozzillo, N.; Zager, J. S.; Jahkola, T.; Bowles, T. L.; Testori, A.; Beitsch, P. D.; Hoekstra, H. J.; Moncrieff, M.; Ingvar, C.; Wouters, M. W. J. M.; Sabel, M. S.; Levine, E. A.; Agnese, D.; Henderson, M.; Dummer, R.; Rossi, C. R.; Neves, R. I.; Trocha, S. D.; Wright, F.; Byrd, D. R.; Matter, M.; Hsueh, E.; MacKenzie-Ross, A.; Johnson, D. B.; Terheyden, P.; Berger, A. C.; Huston, T. L.; Wayne, J. D.; Smithers, B. M.; Neuman, H. B.; Schneebaum, S.; Gershenwald, J. E.; Ariyan, C. E.; Desai, D. C.; Jacobs, L.; McMasters, K. M.; Gesierich, A.; Hersey, P.; Bines, S. D.; Kane, J. M.; Barth, R. J.; McKinnon, G.; Farma, J. M.; Schultz, E.; Vidal-Sicart, S.; Hoefer, R. A.; Lewis, J. M.; Scheri, R.; Kelley, M. C.; Nieweg, O. E.; Noyes, R. D.; Hoon, D. S. B.; Wang, H. J.; Elashoff, D. A.; Elashoff, R. M. |
| Article Title: | 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 intermediatethickness 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 melanomaspecific survival among 1934 patients with data that could be evaluated in an intention-Totreat 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 logrank 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. © 2017 Massachusetts Medical Society. |
| Keywords: | adult; controlled study; human tissue; aged; survival rate; major clinical study; histopathology; cancer recurrence; disease free survival; lymph node dissection; melanoma; randomized controlled trial; lymphedema; cancer specific survival; multicenter study; echography; cancer control; clinical observation; molecular diagnosis; cancer prognosis; sentinel lymph node metastasis; human; male; female; priority journal; article |
| Journal Title: | New England Journal of Medicine |
| Volume: | 376 |
| Issue: | 23 |
| ISSN: | 0028-4793 |
| Publisher: | Massachusetts Medical Society |
| Date Published: | 2017-06-08 |
| Start Page: | 2211 |
| End Page: | 2222 |
| Language: | English |
| DOI: | 10.1056/NEJMoa1613210 |
| PUBMED: | 28591523 |
| PROVIDER: | scopus |
| PMCID: | PMC5548388 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 3 July 2017 -- Source: Scopus |
