{"id":36413,"date":"2014-06-20T21:42:49","date_gmt":"2014-06-21T02:12:49","guid":{"rendered":"http:\/\/piel-l.org\/blog\/?p=36413"},"modified":"2014-06-20T22:00:35","modified_gmt":"2014-06-21T02:30:35","slug":"caso-comentario-final-trial-report-of-sentinel-node-biopsy-versus-nodal-observation-in-melanoma","status":"publish","type":"post","link":"https:\/\/piel-l.org\/blog\/36413","title":{"rendered":"Caso comentario: Final Trial Report of Sentinel-Node Biopsy versus Nodal Observation in Melanoma"},"content":{"rendered":"<p><strong><em>The New England Journal of Medicine<\/em><\/strong><br \/>\n<em>D.L. Morton, J.F. Thompson, A.J. Cochran, N. Mozzillo, O.E. Nieweg, D.F. Roses, H.J. Hoekstra, C.P. Karakousis, C.A. Puleo, B.J. Coventry, M. Kashani-Sabet, B.M. Smithers, E. Paul, W.G. Kraybill, J.G. McKinnon, H.-J. Wang, R. Elashoff, and M.B. Faries, for the MSLT Group*<\/em><\/p>\n<p><!--more--><\/p>\n<p>ABSTRACT<\/p>\n<p><strong>Background<\/strong><\/p>\n<p>Sentinel-node biopsy, a minimally invasive procedure for regional melanoma staging, was evaluated in a phase 3 trial.<\/p>\n<p><strong>Methods<\/strong><\/p>\n<p>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).<\/p>\n<p><strong>Results<\/strong><\/p>\n<p>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 (\u00b1SE) 10-year disease-free survival rates were significantly im- proved 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\u00b11.8% vs. 64.7\u00b12.3%; hazard ratio for recurrence or metastasis, 0.76; P=0.01), and those with thick melanomas, defined as &gt;3.50 mm (50.7\u00b14.0% vs. 40.5\u00b14.7%; hazard ratio, 0.70; P=0.03). Among patients with intermediate-thickness melanomas, the 10-year mela- noma-specific survival rate was 62.1\u00b14.8% among those with metastasis versus 85.1\u00b11.5% for those without metastasis (hazard ratio for death from melanoma, 3.09; P&lt;0.001); among patients with thick melanomas, the respective rates were 48.0\u00b17.0% and 64.6\u00b14.9% (hazard ratio, 1.75; P=0.03). Biopsy-based management improved the 10-year rate of distant disease\u2013free 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.<\/p>\n<p><strong>Conclusions<\/strong><\/p>\n<p>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 manage- ment prolongs disease-free survival for all patients and prolongs distant disease\u2013free 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.)<\/p>\n<p>n engl j med 370;7 nejm.org february 13, 2014<\/p>\n<p><strong>N Engl J Med 2014;370:599-609.?DOI: 10.1056\/NEJMoa1310460?<\/strong><em>Copyright \u00a9 2014 Massachusetts Medical Society.<\/em><\/p>\n<p>&nbsp;<\/p>\n<blockquote><p><span style=\"font-size: 18pt;\"><strong>COMENTARIOS<\/strong><\/span><\/p>\n<p>Este ensayo cl\u00ednico prospectivo y aleatorizado iniciado por el Multicenter Selective Lymphadenectomy Trial (MSLT-I) en 1994 y cerrado en el 2002 es uno de los m\u00e1s interesantes \u00faltimamente aparecidos tanto por el n\u00famero de pacientes (2001 pacientes), como por el tiempo de seguimiento (10 a\u00f1os), con la finalidad de determinar la utilidad del estudio del ganglio centinela como predictor de metet\u00e1stasis regionales ocultas en pacientes con Melanoma (Breslow de espesor parcial 1,20-3,50mm y Breslow de espesor total &gt; 3,50mm) as\u00ed como demostrar el beneficio de la disecci\u00f3n ganglionar inmediata versus la disecci\u00f3n diferida, solo en el momento de la presencia cl\u00ednica de adenomegalias.<\/p>\n<p>El 60% (grupo de estudio) de los casos recibieron excisi\u00f3n amplia de la lesi\u00f3n m\u00e1s ganglio centinela, en caso de ser positivo se realiz\u00f3 disecci\u00f3n ganglionar inmediata; mientras que al resto del grupo (grupo observaci\u00f3n: 40%) solo ex\u00e9resis amplia con margen de 2-3 cm m\u00e1s observaci\u00f3n, en este grupo se realiz\u00f3 disecci\u00f3n ganglionar diferida solo al momento de aparici\u00f3n de met\u00e1stasis cl\u00ednicas regionales.<\/p>\n<p>La sobrevida global a 10 a\u00f1os tanto para el grupo Breslow de espesor parcial como en el Grupo Breslow de espesor total (con o sin met\u00e1stasis ganglionares) no hubo diferencias estad\u00edsticamente significativas. En lo que si hubo diferencias significativas fue en lo referente al periodo libre de enfermedad; en este sentido, en el grupo de estudio (biopsia + ganglio centinela) tuvo un periodo libre de enfermedad significativamente mayor que el grupo de observaci\u00f3n.\u00a0 Por otra parte, la ausencia o presencia de ganglios positivos durante el estudio del ganglio centinela estaba relacionada con una mejor o peor sobrevida respectivamente. Similarmente y mediante el an\u00e1lisis multivariado se demostr\u00f3 que el estatus del ganglio centinela es un fuerte predictor de recurrencia loco-regional y muerte por esta enfermedad.<\/p>\n<p>Para finalizar, este interesante ensayo cl\u00ednico demuestra que los pacientes con Melanoma Breslow &gt; de 1,20mm y sin ganglios desde el punto de vista cl\u00ednico, son los que se benefician del estudio del ganglio centinela ya que disminuye la recurrencia loco-regional, las met\u00e1stasis a distancia por tanto la muerte por melanoma y aumenta el periodo libre de enfermedad. Actualmente se encuentra en desarrollo la utilidad del ganglio centinela en pacientes con Melanoma Breslow &lt; 1,20mm.<\/p>\n<p><strong>Dr. Wilmar de Jes\u00fas Brice\u00f1o Rond\u00f3n<\/strong><br \/>\n<strong>Cirujano General \u2013 Cirujano Onc\u00f3logo<\/strong><br \/>\n<strong>Cl\u00ednica Nuestra Se\u00f1ora del Pilar CA<\/strong><br \/>\n<strong>Barinas, Edo Barinas, Venezuela<\/strong><\/p><\/blockquote>\n","protected":false},"excerpt":{"rendered":"<p>The New England Journal of Medicine D.L. Morton, J.F. Thompson, A.J. Cochran, N. Mozzillo, O.E. Nieweg, D.F. Roses, H.J. Hoekstra, C.P. Karakousis, C.A. Puleo, B.J. Coventry, M. Kashani-Sabet, B.M. Smithers, E. Paul, W.G. Kraybill, J.G. McKinnon, H.-J. Wang, R. Elashoff, and M.B. Faries, for the MSLT Group*<\/p>\n","protected":false},"author":93,"featured_media":36414,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[11,415],"tags":[],"class_list":["post-36413","post","type-post","status-publish","format-standard","has-post-thumbnail","","category-secciones-de-colaboradores","category-melanoma-al-dia"],"_links":{"self":[{"href":"https:\/\/piel-l.org\/blog\/wp-json\/wp\/v2\/posts\/36413","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/piel-l.org\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/piel-l.org\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/piel-l.org\/blog\/wp-json\/wp\/v2\/users\/93"}],"replies":[{"embeddable":true,"href":"https:\/\/piel-l.org\/blog\/wp-json\/wp\/v2\/comments?post=36413"}],"version-history":[{"count":0,"href":"https:\/\/piel-l.org\/blog\/wp-json\/wp\/v2\/posts\/36413\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/piel-l.org\/blog\/wp-json\/wp\/v2\/media\/36414"}],"wp:attachment":[{"href":"https:\/\/piel-l.org\/blog\/wp-json\/wp\/v2\/media?parent=36413"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/piel-l.org\/blog\/wp-json\/wp\/v2\/categories?post=36413"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/piel-l.org\/blog\/wp-json\/wp\/v2\/tags?post=36413"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}