{"id":1882,"date":"2023-06-22T17:49:00","date_gmt":"2023-06-22T15:49:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1882"},"modified":"2024-03-30T17:53:50","modified_gmt":"2024-03-30T16:53:50","slug":"35a-liecivo-osimertinib-tagrisso-ako-monoterapia-v-adjuvantnej-liecbe-pacientov-s-nsclc-s-mutaciami-egfr","status":"publish","type":"post","link":"https:\/\/www.niho.sk\/en\/35a-liecivo-osimertinib-tagrisso-ako-monoterapia-v-adjuvantnej-liecbe-pacientov-s-nsclc-s-mutaciami-egfr\/","title":{"rendered":"35A: Lie\u010divo osimertinib (Tagrisso) ako monoterapia v adjuvantnej lie\u010dbe pacientov s NSCLC s mut\u00e1ciami EGFR"},"content":{"rendered":"<ol class=\"wp-block-list\">\n<li><strong>Ak\u00e1 je z\u00e1\u0165a\u017e ochorenia pre pacienta? Ako z\u00e1sadn\u00e9 je ochorenie?<\/strong><\/li>\n<\/ol>\n\n\n\n<p>Karcin\u00f3m p\u013e\u00fac (KP) celosvetovo patr\u00ed k naj\u010dastej\u0161\u00edm n\u00e1dorov\u00fdm ochoreniam. P\u013e\u00facne zhubn\u00e9 n\u00e1dory zvy\u010dajne vznikaj\u00fa v bunk\u00e1ch, ktor\u00e9 lemuj\u00fa priedu\u0161ky a \u010dasti p\u013e\u00fac, ako s\u00fa priedu\u0161ni\u010dky alebo alveoly. V pr\u00edpade NSCLC ide o \u010dastej\u0161\u00ed typ rakoviny p\u013e\u00fac, ktor\u00fd zodpoved\u00e1 pribli\u017ene 80-85 % p\u013e\u00facnych karcin\u00f3mov. Najv\u00e4\u010d\u0161\u00edm rizikov\u00fdm faktorom KP je akt\u00edvne, ale aj pas\u00edvne faj\u010denie, vystavenie organizmu \u0161kodliv\u00fdm l\u00e1tkam ako rad\u00f3n, arz\u00e9n alebo azbest. V neposlednom rade m\u00f4\u017ee by\u0165 rizikov\u00fdm faktorom vzniku KP aj genetick\u00e1 predispoz\u00edcia. Medzi naj\u010dastej\u0161ie sympt\u00f3my KP patr\u00ed ka\u0161e\u013e, v neskor\u0161\u00edch f\u00e1zach m\u00f4\u017eu prib\u00fada\u0165 infekcie v oblasti hrudn\u00edka, chr\u010danie, vyka\u0161liavanie krvi, zachr\u00edpnutie \u010di strata hmotnosti. U \u013eud\u00ed s lokalizovan\u00fdm NSCLC je celkov\u00e1 5-ro\u010dn\u00e1 miera pre\u017eitia 63 %. S neskor\u0161\u00edm \u010dasom diagnostikovania ochorenia sa miera pre\u017eitia v\u00fdrazne zni\u017euje.<\/p>\n\n\n\n<ol class=\"wp-block-list\" start=\"2\">\n<li><strong>O ak\u00fd liek ide?<\/strong><\/li>\n<\/ol>\n\n\n\n<p>TAGRISSO obsahuje lie\u010divo osimertinib, ktor\u00fd patr\u00ed do skupiny liekov naz\u00fdvan\u00fdch inhib\u00edtory prote\u00ednkin\u00e1zy, ktor\u00e9 sa pou\u017e\u00edvaj\u00fa na lie\u010dbu rakoviny. TAGRISSO sa pou\u017e\u00edva na lie\u010dbu dospel\u00fdch s typom rakoviny p\u013e\u00fac naz\u00fdvanej \u201enemalobunkov\u00fd karcin\u00f3m p\u013e\u00fac\u201c. Ak sa vy\u0161etren\u00edm preuk\u00e1\u017ee, \u017ee va\u0161a rakovina vykazuje ur\u010dit\u00e9 zmeny (mut\u00e1cie) v g\u00e9ne naz\u00fdvanom \u201eEGFR\u201c (receptor epiderm\u00e1lneho rastov\u00e9ho faktora), je pravdepodobn\u00e9, \u017ee va\u0161a rakovina bude odpoveda\u0165 na lie\u010dbu TAGRISSOM. TAGRISSO v\u00e1m m\u00f4\u017eu predp\u00edsa\u0165:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>po \u00faplnom odstr\u00e1nen\u00ed v\u00e1\u0161ho n\u00e1doru ako lie\u010dbu po chirurgickom z\u00e1kroku (adjuvantn\u00e1 lie\u010dba); alebo&nbsp;<\/li>\n\n\n\n<li>ako prv\u00fd liek, ktor\u00fd budete dost\u00e1va\u0165 na lie\u010dbu va\u0161ej rakoviny, ktor\u00e1 sa roz\u0161\u00edrila do \u010fal\u0161\u00edch \u010dast\u00ed tela; alebo&nbsp;<\/li>\n\n\n\n<li>za ur\u010dit\u00fdch okolnost\u00ed, ak va\u0161a rakovina bola v minulosti lie\u010den\u00e1 in\u00fdmi liekmi obsahuj\u00facimi inhib\u00edtor prote\u00ednkin\u00e1zy.<\/li>\n<\/ul>\n\n\n\n<p>Liek TAGRISSO bol registrovan\u00fd Eur\u00f3pskou liekovou agent\u00farou v decembri 2015 a n\u00e1sledne roz\u0161\u00edren\u00fd o \u010fal\u0161ie indik\u00e1cie v roku 2018 a 2021.<\/p>\n\n\n\n<ol class=\"wp-block-list\" start=\"3\">\n<li><strong>Ako sa na hodnoten\u00e9 lie\u010divo pozeraj\u00fa odborn\u00edci?&nbsp;<\/strong><\/li>\n<\/ol>\n\n\n\n<p>Pod\u013ea odborn\u00edka je adjuvantn\u00e1 cielen\u00e1 lie\u010dba s osimertinibom pilierom \u00faspechu dosahovania kompletn\u00fdch remisi\u00ed u tak n\u00e1ro\u010dne lie\u010dite\u013en\u00e9ho ochorenia, ak\u00fdm je karcin\u00f3m p\u013e\u00fac. Nevyu\u017eitie mo\u017enosti implementovania lie\u010dby s osimertinibom odborn\u00edk pova\u017euje za trestuhodn\u00e9, nako\u013eko je celosvetov\u00e1 snaha o dosiahnutie lep\u0161\u00edch v\u00fdsledkov v lie\u010dbe tohto smrte\u013en\u00e9ho ochorenia. Rovnako je cie\u013eom ka\u017ed\u00e9ho klinick\u00e9ho onkol\u00f3ga na Slovensku prenies\u0165 do klinickej praxe lie\u010div\u00e1 zahrnut\u00e9 v ESMO (Eur\u00f3pska spolo\u010dnos\u0165 pre lek\u00e1rsku onkol\u00f3giu).<\/p>\n\n\n\n<ol class=\"wp-block-list\" start=\"4\">\n<li><strong>\u010co hodnotilo NIHO a ak\u00fd je v\u00fdsledok?<\/strong><\/li>\n<\/ol>\n\n\n\n<p>Dr\u017eite\u013e registr\u00e1cie (AstraZeneca AB (SWE)) podal \u017eiados\u0165 o zaradenie lie\u010diva osimertinib (Tagrisso) ako monoterapia v adjuvantnej lie\u010dbe pacientov s NSCLC s mut\u00e1ciami EGFR.<\/p>\n\n\n\n<p class=\"has-custom-highlight-background-color has-background\">NIHO odpor\u00fa\u010da nevyhovie\u0165 \u017eiadosti o kategorizovanie lieku Tagrisso v indik\u00e1cii adjuvantnej lie\u010dby u pacientov s nemalobunkov\u00fdm karcin\u00f3mom p\u013e\u00fac (NSCLC), pokia\u013e nebude dostato\u010dne adresovan\u00e1 neistota plyn\u00faca z farmako-ekonomick\u00e9ho modelovania, kde pr\u00ednos v celkovom pre\u017e\u00edvan\u00ed je postaven\u00fd na n\u00e1hradnom ukazovateli.<\/p>\n\n\n\n<p>NIHO taktie\u017e odpor\u00fa\u010da zv\u00e1\u017ei\u0165 doplnenie indika\u010dn\u00e9ho obmedzenia o v\u00fdkonnostn\u00fd stav pacienta.<\/p>","protected":false},"excerpt":{"rendered":"<p>NIHO odpor\u00fa\u010da nevyhovie\u0165 \u017eiadosti o kategorizovanie lieku Tagrisso v indik\u00e1cii adjuvantnej lie\u010dby u pacientov s nemalobunkov\u00fdm karcin\u00f3mom p\u013e\u00fac (NSCLC), pokia\u013e&#8230;<\/p>","protected":false},"author":3,"featured_media":1883,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[106,105],"class_list":["post-1882","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-osimertinib","tag-tagrisso"],"_links":{"self":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1882","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/comments?post=1882"}],"version-history":[{"count":0,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1882\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media\/1883"}],"wp:attachment":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1882"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1882"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1882"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}