{"id":2316,"date":"2014-09-09T10:33:58","date_gmt":"2014-09-09T15:33:58","guid":{"rendered":"http:\/\/blogviejo.sld.cu\/inorbib\/?p=2316"},"modified":"2016-03-01T17:40:04","modified_gmt":"2016-03-01T17:40:04","slug":"la-incidencia-de-metastasis-del-sistema-nervioso-central-en-pacientes-con-cancer-de-mama-metastasico-her2-positivo-tratadas-con-pertuzumab-trastuzumab-y-docetaxel-resultados-de-la-fase-iii-aleatoriz","status":"publish","type":"post","link":"https:\/\/blogs.sld.cu\/inorbib\/2014\/09\/09\/la-incidencia-de-metastasis-del-sistema-nervioso-central-en-pacientes-con-cancer-de-mama-metastasico-her2-positivo-tratadas-con-pertuzumab-trastuzumab-y-docetaxel-resultados-de-la-fase-iii-aleatoriz\/","title":{"rendered":"La incidencia de met\u00e1stasis del sistema nervioso central en pacientes con c\u00e1ncer de mama metast\u00e1sico HER2-positivo tratadas con pertuzumab, trastuzumab y docetaxel: resultados de la fase III aleatorizado CLEOPATRA estudio"},"content":{"rendered":"<p><!--[if gte mso 9]&gt;     &lt;![endif]--><\/p>\n<p><!--[if gte mso 9]&gt;  Normal 0   21   false false false  ES-CR X-NONE X-NONE                           &lt;![endif]--><!--[if gte mso 9]&gt;                                                                                                                                            &lt;![endif]--><!--[if gte mso 10]&gt; &lt;! \/* Style Definitions *\/ table.MsoNormalTable {mso-style-name:&quot;Tabla normal&quot;; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-priority:99; mso-style-qformat:yes; mso-style-parent:&quot;&quot;; mso-padding-alt:0cm 5.4pt 0cm 5.4pt; mso-para-margin-top:0cm; mso-para-margin-right:0cm; mso-para-margin-bottom:10.0pt; mso-para-margin-left:0cm; line-height:115%; mso-pagination:widow-orphan; font-size:11.0pt; font-family:&quot;Calibri&quot;,&quot;sans-serif&quot;; mso-ascii-font-family:Calibri; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:&quot;Times New Roman&quot;; mso-fareast-theme-font:minor-fareast; mso-hansi-font-family:Calibri; mso-hansi-theme-font:minor-latin;} --> <!--[endif] --><\/p>\n<p class=\"MsoNormal\"><span class=\"hps\"><span lang=\"ES\"> <\/span><\/span><span lang=\"ES\"> <\/span>L<span lang=\"ES\"><span class=\"hps\">os resultados del<\/span> <span class=\"hps\">ensayo de fase<\/span> <span class=\"hps\">III<\/span> <span class=\"hps\">CLEOPATRA<\/span> <span class=\"hps\">en<\/span> <span class=\"hps\">el receptor del factor<\/span> <span class=\"hps\">de crecimiento epid\u00e9rmico humano<\/span> <span class=\"hps\">de primera l\u00ednea<\/span> <span class=\"hps\">2 positivo<\/span><span> <\/span><span class=\"hps\">c\u00e1ncer de mama<\/span> <span class=\"hps\">metast\u00e1sico<\/span> <span class=\"hps\">demostr\u00f3<\/span> <span class=\"hps\">mejoras significativas en la<\/span> <span class=\"hps\">libre de progresi\u00f3n<\/span> <span class=\"hps\">y la supervivencia global<\/span> <span class=\"hps\">con<\/span> <span class=\"hps\">pertuzumab<\/span>, <span class=\"hps\">trastuzumab<\/span> <span class=\"hps\">y<\/span> <span class=\"hps\">docetaxel<\/span> <span class=\"hps\">m\u00e1s<\/span> <span class=\"hps\">placebo<\/span>, <span class=\"hps\">trastuzumab<\/span> <span class=\"hps\">y<\/span> <span class=\"hps\">docetaxel<\/span>. <span class=\"hps\">Llevamos a cabo<\/span> <span class=\"hps\">an\u00e1lisis exploratorios<\/span> <span class=\"hps\">de<\/span> <span class=\"hps\">la<\/span> <span class=\"hps\">incidencia<\/span> <span class=\"hps\">y el tiempo para<\/span> <span class=\"hps\">el desarrollo<\/span> <span class=\"hps\">del<\/span> <span class=\"hps\">sistema nervioso<\/span> <span class=\"hps\">(<\/span>CNS) <span class=\"hps\">met\u00e1stasis<\/span> <span class=\"hps\">centrales<\/span> <span class=\"hps\">en pacientes<\/span> <span class=\"hps\">de<\/span> <span class=\"hps\">CLEOPATRA<\/span>.<\/span><\/p>\n<p class=\"MsoNormal\"><span class=\"hps\"><span lang=\"ES\">Los pacientes recibieron<\/span><\/span><span lang=\"ES\"> <span class=\"hps\">pertuzumab<\/span> <span class=\"hps\">\/ placebo<\/span>: <span class=\"hps\">840<\/span> <span class=\"hps\">mg<\/span> <span class=\"hps\">en<\/span> <span class=\"hps\">el ciclo 1<\/span>, a continuaci\u00f3n, <span class=\"hps\">420<\/span> <span class=\"hps\">mg<\/span>; <span class=\"hps\">trastuzumab<\/span>: <span class=\"hps\">8<\/span> <span class=\"hps\">mg \/<\/span> <span class=\"hps\">kg<\/span> <span class=\"hps\">en el ciclo 1<\/span>, a continuaci\u00f3n, <span class=\"hps\">6<\/span> <span class=\"hps\">mg \/<\/span> <span class=\"hps\">kg<\/span>; <span class=\"hps\">docetaxel<\/span>: <span class=\"hps\">inicia a<\/span> <span class=\"hps\">75<\/span> <span class=\"hps\">mg<\/span> <span class=\"hps\">\/<\/span> <span class=\"hps\">m2<\/span>. <span class=\"hps\">F\u00e1rmacos del estudio<\/span> <span class=\"hps\">se administraron<\/span> <span class=\"hps\">por v\u00eda intravenosa<\/span> <span class=\"hps\">cada 3 semanas.<\/span> <span class=\"hps\">El<\/span> <span class=\"hps\">rango logar\u00edtmico<\/span><br \/>\n<span class=\"hps\">prueba<\/span> <span class=\"hps\">se utiliz\u00f3<\/span> <span class=\"hps\">para las comparaciones entre<\/span> <span class=\"hps\">el brazo<\/span> <span class=\"hps\">de<\/span> <span class=\"hps\">momento de<\/span> <span class=\"hps\">met\u00e1stasis en el SNC<\/span> <span class=\"hps\">como el primer<\/span> <span class=\"hps\">lugar de la<\/span> <span class=\"hps\">progresi\u00f3n de la enfermedad<\/span> <span class=\"hps\">y<\/span> <span class=\"hps\">la supervivencia global<\/span> <span class=\"hps\">en pacientes con<\/span> <span class=\"hps\">met\u00e1stasis al SNC<\/span> <span class=\"hps\">como el primer<\/span> <span class=\"hps\">lugar de la<\/span> <span class=\"hps\">progresi\u00f3n de la enfermedad<\/span>. &lt;span <!--more-->class=&#8221;hps&#8221;&gt;El<\/span> <span class=\"hps\">enfoque de<\/span> <span class=\"hps\">Kaplan<\/span><span class=\"atn\">&#8211;<\/span>Meier <span class=\"hps\">fue<\/span> <span class=\"hps\">utilizado<\/span> <span class=\"hps\">para estimar el tiempo<\/span> <span class=\"hps\">medio hasta la<\/span> <span class=\"hps\">met\u00e1stasis en el SNC<\/span> <span class=\"hps\">como<\/span> <span class=\"hps\">primer sitio<\/span> <span class=\"hps\">de<\/span> <span class=\"hps\">progresi\u00f3n de la enfermedad<\/span> <span class=\"hps\">y la supervivencia<\/span> <span class=\"hps\">global media<\/span>.<\/span><\/p>\n<p class=\"MsoNormal\"><span class=\"hps\"><span lang=\"ES\">La incidencia de<\/span><\/span><span lang=\"ES\"> <span class=\"hps\">met\u00e1stasis<\/span> <span class=\"hps\">del SNC<\/span> <span class=\"hps\">como el primer<\/span> <span class=\"hps\">lugar de la<\/span> <span class=\"hps\">progresi\u00f3n de la enfermedad<\/span> <span class=\"hps\">fue similar<\/span> <span class=\"hps\">entre los brazos<\/span>; <span class=\"hps\">brazo de placebo<\/span>:<br \/>\n<span class=\"hps\">51<\/span> <span class=\"hps\">de<\/span> <span class=\"hps\">406<\/span> <span class=\"hps\">(<\/span>12,6%), el brazo <span class=\"hps\">pertuzumab<\/span>: <span class=\"hps\">55<\/span> <span class=\"hps\">de<\/span> <span class=\"hps\">402<\/span> <span class=\"hps\">(<\/span>13,7%). <span class=\"hps\">El tiempo medio para<\/span> <span class=\"hps\">el desarrollo<\/span> <span class=\"hps\">de<\/span> <span class=\"hps\">met\u00e1stasis<\/span> <span class=\"hps\">del SNC<\/span> <span class=\"hps\">como<\/span> <span class=\"hps\">primer sitio<\/span> <span class=\"hps\">de<\/span><span> <\/span><span class=\"hps\">progresi\u00f3n de la enfermedad<\/span> <span class=\"hps\">fue de 11,9<\/span> <span class=\"hps\">meses en el grupo<\/span> <span class=\"hps\">placebo<\/span> <span class=\"hps\">y 15,0<\/span> <span class=\"hps\">meses en el grupo<\/span> <span class=\"hps\">pertuzumab<\/span>; <span class=\"hps\">raz\u00f3n de riesgo<\/span> <span class=\"hps\">(HR<\/span>) = <span class=\"hps\">0,58<\/span>, <span class=\"hps\">intervalo de confianza del<\/span> <span class=\"hps\">95<\/span>% <span class=\"hps\">(IC<\/span>),39-,85, <span class=\"hps\">P<\/span> <span class=\"hps\">=<\/span> <span class=\"hps\">0,0049<\/span>. <span class=\"hps\">La supervivencia global<\/span> <span class=\"hps\">en los pacientes<\/span> <span class=\"hps\">que desarrollaron<\/span> <span class=\"hps\">met\u00e1stasis en el SNC met\u00e1stasis<\/span> <span class=\"hps\">como el primer<\/span> <span class=\"hps\">sitio de la<\/span> <span class=\"hps\">progresi\u00f3n de la enfermedad<\/span> <span class=\"hps\">mostr\u00f3<\/span> <span class=\"hps\">una tendencia a favor<\/span> <span class=\"hps\">de<\/span> <span class=\"hps\">pertuzumab<\/span>, <span class=\"hps\">trastuzumab<\/span> <span class=\"hps\">y<\/span> <span class=\"hps\">docetaxel<\/span>; <span class=\"hps\">HR<\/span> <span class=\"hps\">=<\/span> <span class=\"hps\">0,66;<\/span><br \/>\n<span class=\"hps\">IC del<\/span> <span class=\"hps\">95%:<\/span> <span class=\"hps\">0,39 a 1,11<\/span>. <span class=\"hps\">Mediana de supervivencia global<\/span> <span class=\"hps\">fue de 26,3<\/span> <span class=\"hps\">frente a<\/span> <span class=\"hps\">34,4 meses<\/span> <span class=\"hps\">en<\/span> <span class=\"hps\">los<\/span> <span class=\"hps\">brazos de placebo<\/span> <span class=\"hps\">y<\/span> <span class=\"hps\">pertuzumab<\/span>, <span class=\"hps\">respectivamente<\/span>.<span class=\"hps\"> Comparaci\u00f3n<\/span> <span class=\"hps\">Tratamiento<\/span> <span class=\"hps\">de<\/span> <span class=\"hps\">las curvas de supervivencia<\/span> <span class=\"hps\">no fue estad\u00edsticamente<\/span> <span class=\"hps\">significativo para<\/span> <span class=\"hps\">la prueba de log<\/span>-rank <span class=\"hps\">(<\/span>p = <span class=\"hps\">0.1139<\/span>), <span class=\"hps\">pero<\/span><br \/>\n<span class=\"hps\">significativo para<\/span> <span class=\"hps\">la prueba de Wilcoxon<\/span> <span class=\"hps\">(p =<\/span> <span class=\"hps\">0,0449<\/span>).<br \/>\n<span class=\"hps\">Conclusiones<\/span>: <span class=\"hps\">Si bien<\/span> <span class=\"hps\">la incidencia de<\/span> <span class=\"hps\">met\u00e1stasis en el SNC<\/span> <span class=\"hps\">fue similar<\/span> <span class=\"hps\">entre los brazos<\/span>, <span class=\"hps\">nuestros<\/span> <span class=\"hps\">resultados sugieren que el<\/span> <span class=\"hps\">pertuzumab<\/span>, <span class=\"hps\">trastuzumab<\/span> <span class=\"hps\">y<\/span> <span class=\"hps\">docetaxel<\/span><span> <\/span><span class=\"hps\">retrasa la<\/span> <span class=\"hps\">aparici\u00f3n de la<\/span> <span class=\"hps\">enfermedad del SNC<\/span> <span class=\"hps\">en comparaci\u00f3n<\/span> <span class=\"hps\">con el placebo<\/span>, el trastuzumab, <span class=\"hps\">y<\/span> <span class=\"hps\">doceta en con el tratamiento<\/span> <span class=\"hps\">de<\/span> <span class=\"hps\">las curvas de supervivencia<\/span> <span class=\"hps\">no fue estad\u00edsticamente<\/span> <span class=\"hps\">significativo para<\/span> <span class=\"hps\">la prueba de log<\/span>-rank <span class=\"hps\">(<\/span>p = <span class=\"hps\">0.1139<\/span>), <span class=\"hps\">pero<\/span> <span class=\"hps\">significativo para<\/span> <span class=\"hps\">la prueba de Wilcoxon<\/span> <span class=\"hps\">(p =<\/span> <span class=\"hps\">0,0449<\/span>).<br \/>\n<span class=\"hps\"><span> <\/span><\/span><\/span><\/p>\n<p class=\"MsoNormal\"><span class=\"hps\"><span lang=\"ES\">Si bien<\/span><\/span><span lang=\"ES\"> <span class=\"hps\">la incidencia de<\/span> <span class=\"hps\">met\u00e1stasis en el SNC<\/span> <span class=\"hps\">fue similar<\/span> <span class=\"hps\">entre los brazos<\/span>, <span class=\"hps\">nuestros<\/span> <span class=\"hps\">resultados sugieren que el<\/span> <span class=\"hps\">pertuzumab<\/span>, <span class=\"hps\">trastuzumab<\/span> <span class=\"hps\">y<\/span> <span class=\"hps\">docetaxel<\/span> <span class=\"hps\">retrasa la<\/span> <span class=\"hps\">aparici\u00f3n de la<\/span> <span class=\"hps\">enfermedad del SNC<\/span> <span class=\"hps\">en comparaci\u00f3n<\/span> <span class=\"hps\">con el placebo<\/span>, el trastuzumab, <span class=\"hps\">y<\/span> <span class=\"hps\">doceta<\/span><\/span><\/p>\n<p class=\"MsoNormal\"><span>Tomado de: Annals of Oncology <\/span><span>25: 1116<\/span><span>\u2013<\/span><span>1121, 2014<\/span><\/p>\n<p><!--more--><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Los resultados del ensayo de fase III CLEOPATRA en el receptor del factor de crecimiento epid\u00e9rmico humano de primera l\u00ednea 2 positivo c\u00e1ncer de mama metast\u00e1sico demostr\u00f3 mejoras significativas en la libre de progresi\u00f3n y la supervivencia global con pertuzumab, trastuzumab y docetaxel m\u00e1s placebo, trastuzumab y docetaxel. Llevamos a cabo an\u00e1lisis exploratorios de la [&hellip;]<\/p>\n","protected":false},"author":176,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[8],"tags":[],"_links":{"self":[{"href":"https:\/\/blogs.sld.cu\/inorbib\/wp-json\/wp\/v2\/posts\/2316"}],"collection":[{"href":"https:\/\/blogs.sld.cu\/inorbib\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.sld.cu\/inorbib\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.sld.cu\/inorbib\/wp-json\/wp\/v2\/users\/176"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.sld.cu\/inorbib\/wp-json\/wp\/v2\/comments?post=2316"}],"version-history":[{"count":1,"href":"https:\/\/blogs.sld.cu\/inorbib\/wp-json\/wp\/v2\/posts\/2316\/revisions"}],"predecessor-version":[{"id":3029,"href":"https:\/\/blogs.sld.cu\/inorbib\/wp-json\/wp\/v2\/posts\/2316\/revisions\/3029"}],"wp:attachment":[{"href":"https:\/\/blogs.sld.cu\/inorbib\/wp-json\/wp\/v2\/media?parent=2316"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.sld.cu\/inorbib\/wp-json\/wp\/v2\/categories?post=2316"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.sld.cu\/inorbib\/wp-json\/wp\/v2\/tags?post=2316"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}