{"id":1885,"date":"2023-06-22T17:54:00","date_gmt":"2023-06-22T15:54:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1885"},"modified":"2024-03-30T17:55:45","modified_gmt":"2024-03-30T16:55:45","slug":"35b-liecivo-osimertinib-tagrisso-na-liecbu-dospelych-pacientov-v-prvej-linii-s-lokalne-pokrocilym-alebo-metastatickym-nemalobunkovym-karcinomom-pluc-s-aktivujucimi-mutaciami","status":"publish","type":"post","link":"https:\/\/www.niho.sk\/en\/35b-liecivo-osimertinib-tagrisso-na-liecbu-dospelych-pacientov-v-prvej-linii-s-lokalne-pokrocilym-alebo-metastatickym-nemalobunkovym-karcinomom-pluc-s-aktivujucimi-mutaciami\/","title":{"rendered":"35B: Lie\u010divo osimertinib (Tagrisso) na lie\u010dbu dospely\u0301ch pacientov v prvej l\u00ednii s lok\u00e1lne pokro\u010dily\u0301m alebo metastaticky\u0301m nemalobunkovy\u0301m karcin\u00f3mom p\u013e\u00fac s aktivuj\u00facimi mut\u00e1ciami EGFR"},"content":{"rendered":"
    \n
  1. Ak\u00e1 je z\u00e1\u0165a\u017e ochorenia pre pacienta? Ako z\u00e1sadn\u00e9 je ochorenie?<\/strong><\/li>\n<\/ol>\n\n\n\n

    Rakovina p\u013e\u00fac je z\u00e1va\u017en\u00e9 mal\u00edgne ochorenie, ktor\u00e9mu sa pripisuje celosvetovo prv\u00e9 miesto v po\u010dte \u00famrt\u00ed na onkologick\u00e9 ochorenia. V\u00e4\u010d\u0161ina pacientov s rakovinou p\u013e\u00fac je diagnostikovan\u00e1 v lok\u00e1lne pokro\u010dilom, pr\u00edpadne a\u017e metastatickom \u0161t\u00e1diu ochorenia, \u010do m\u00e1 negat\u00edvny vplyv na progn\u00f3zu pacienta. Pribli\u017ene 80 % pacientov m\u00e1 nemalobunkov\u00fd histologick\u00fd typ ochorenia, pri\u010dom 19 % z nich m\u00e1 mut\u00e1ciu v receptore epiderm\u00e1lneho rastov\u00e9ho faktora. Pod\u013ea odpor\u00fa\u010dan\u00ed Eur\u00f3pskej spolo\u010dnosti pre lek\u00e1rsku onkol\u00f3giu (ESMO) predstavuje osimertinib lie\u010divo prvej vo\u013eby pre t\u00fato skupinu pacientov. Klinick\u00fd odborn\u00edk zd\u00f4raznil, \u017ee osimertinib preuk\u00e1zal aj aktivitu u pacientov s metast\u00e1zami v mozgu, \u010do je v\u00fdznamn\u00fd benefit pre t\u00fato skupinu pacientov.<\/p>\n\n\n\n

      \n
    1. O ak\u00fd liek ide?<\/strong><\/li>\n<\/ol>\n\n\n\n

      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: <\/p>\n\n\n\n

        \n
      • po \u00faplnom odstr\u00e1nen\u00ed v\u00e1\u0161ho n\u00e1doru ako lie\u010dbu po chirurgickom z\u00e1kroku (adjuvantn\u00e1 lie\u010dba); alebo <\/li>\n\n\n\n
      • 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 <\/li>\n\n\n\n
      • 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

        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

          \n
        1. Ako sa na hodnoten\u00e9 lie\u010divo pozeraj\u00fa odborn\u00edci? <\/strong><\/li>\n<\/ol>\n\n\n\n

          Pr\u00ednosy implementovania hodnoten\u00e9ho lie\u010diva zhrnul klinick\u00fd odborn\u00edk nasledovne: lep\u0161\u00ed profil toxicity ako doteraz pou\u017e\u00edvan\u00e9 lie\u010div\u00e1, dlhodobo dosiahnut\u00fd lep\u0161\u00ed v\u00fdkonnostn\u00fd stav pacientov, dlh\u0161ie pokra\u010dovanie v ambulantnej lie\u010dbe bez potreby hospitaliz\u00e1ci\u00ed a za\u0165a\u017eovania zdravotn\u00edckeho syst\u00e9mu, lep\u0161ie klinick\u00e9 v\u00fdsledky, efektivita lie\u010diva pri inici\u00e1lnom postihnut\u00ed mozgu metast\u00e1zami. Pre mlad\u00fdch pacientov (lie\u010dia sa v na\u0161om centre aj tridsa\u0165ro\u010dn\u00ed pacienti) je predmetn\u00e1 lie\u010dba z\u00e1rukou plnohodnotn\u00e9ho \u017eivota (v rodinnom \u017eivote, mo\u017enos\u0165 aj pokra\u010dovania v zamestnan\u00ed) a dlhodobej parci\u00e1lnej remisie.<\/p>\n\n\n\n

            \n
          1. \u010co hodnotilo NIHO a ak\u00fd je v\u00fdsledok?<\/strong><\/li>\n<\/ol>\n\n\n\n

            Dr\u017eite\u013e registr\u00e1cie (AstraZeneca AB (SWE)) podal \u017eiados\u0165 o zaradenie lie\u010diva osimertinib (Tagrisso) na lie\u010dbu dospel\u00fdch pacientov v prvej l\u00ednii s lok\u00e1lne pokro\u010dil\u00fdm alebo metastatick\u00fdm nemalobunkov\u00fdm karcin\u00f3mom p\u013e\u00fac s aktivuj\u00facimi mut\u00e1ciami EGFR.<\/p>\n\n\n\n

            NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Tagrisso v hodnotenej indik\u00e1cii, pokia\u013e dr\u017eite\u013e registr\u00e1cie uprav\u00ed po\u017eadovan\u00fa v\u00fd\u0161ku \u00fahrady tak, aby sp\u013a\u0148ala z\u00e1konn\u00e9 krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti.<\/p>\n\n\n\n

            Z\u00e1rove\u0148, aj pri uvedenej \u00fahrade je pr\u00edtomn\u00e1 stredn\u00e1 neistota, \u017ee krit\u00e9ria n\u00e1kladovej efekt\u00edvnosti nebud\u00fa v klinickej praxi splnen\u00e9. Odpor\u00fa\u010dame preto po\u017eadova\u0165 od dr\u017eite\u013ea registr\u00e1cie dodato\u010dn\u00fa adekv\u00e1tnu z\u013eavu, aby sa t\u00e1to neistota kompenzovala.<\/p>","protected":false},"excerpt":{"rendered":"

            NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Tagrisso v hodnotenej indik\u00e1cii, pokia\u013e dr\u017eite\u013e registr\u00e1cie uprav\u00ed po\u017eadovan\u00fa v\u00fd\u0161ku \u00fahrady tak, aby …<\/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-1885","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\/1885","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=1885"}],"version-history":[{"count":0,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1885\/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=1885"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1885"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1885"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}