{"id":1947,"date":"2023-12-22T17:02:00","date_gmt":"2023-12-22T16:02:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1947"},"modified":"2024-04-10T17:04:22","modified_gmt":"2024-04-10T15:04:22","slug":"51-liecivo-pembrolizumab-keytruda-na-liecbu-dospelych-pacientov-s-metastatickym-kolorektalnym-karcinomom","status":"publish","type":"post","link":"https:\/\/niho.sk\/en\/51-liecivo-pembrolizumab-keytruda-na-liecbu-dospelych-pacientov-s-metastatickym-kolorektalnym-karcinomom\/","title":{"rendered":"51: Lie\u010divo pembrolizumab (Keytruda) na lie\u010dbu dospel\u00fdch pacientov s metastatick\u00fdm kolorekt\u00e1lnym karcin\u00f3mom"},"content":{"rendered":"
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  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

    Kolorekt\u00e1lny karcin\u00f3m (CRC), zhubn\u00fd n\u00e1dor hrub\u00e9ho \u010dreva a kone\u010dn\u00edka, je jedno z naj\u010dastej\u0161\u00edch n\u00e1dorov\u00fdch ochoren\u00ed v ekonomicky rozvinut\u00fdch krajin\u00e1ch. Celosvetovo bol v roku 2020 CRC tret\u00edm naj\u010dastej\u0161ie diagnostikov\u00fdm typom rakoviny a prv\u00fdm v Eur\u00f3pe, pri\u010dom v po\u010dte \u00famrt\u00ed patril karcin\u00f3m p\u013e\u00fac celosvetovo na 2. miesto. CRC je \u010dastej\u0161\u00ed u mu\u017eov ako u \u017eien. CRC s MSI-H, alebo s dMMR je genetick\u00fd podtyp CRC s agres\u00edvnej\u0161\u00edm priebehom. Pr\u00edznaky CRC sa prejavia v\u00e4\u010d\u0161inou a\u017e v pokro\u010dilom \u0161t\u00e1diu. Typicky sa vyskytuje bru\u0161n\u00fd diskomfort, pocity plnosti a nedokonal\u00e9ho vypr\u00e1zdnenia, plynatos\u0165, z\u00e1pcha, hna\u010dka, vy\u010derpanos\u0165, krv v stolici a \u010fal\u0161ie. Straty krvi m\u00f4\u017eu vies\u0165 k nedostatku \u017eeleza a\/alebo an\u00e9mii a ved\u00fa k sympt\u00f3mom vy\u010derpania, du\u0161nosti a bledej farbe ko\u017ee. Pr\u00edtomnos\u0165 a mno\u017estvo sympt\u00f3mov m\u00e1 signifikantn\u00fd vplyv na kvalitu \u017eivota pacientov. Pod\u013ea ASCO (z angl. American Society of Clinical Oncology) predstavuje 5-ro\u010dn\u00e1 relat\u00edvna miera pre\u017eitia pri metastatickom \u0161t\u00e1diu CRC 14 %.<\/p>\n\n\n\n

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

      Keytruda obsahuje lie\u010divo pembrolizumab, ktor\u00fd je monoklon\u00e1lna protil\u00e1tka. KEYTRUDA \u00fa\u010dinkuje tak, \u017ee pom\u00e1ha v\u00e1\u0161mu imunitn\u00e9mu syst\u00e9mu bojova\u0165 proti rakovine.<\/p>\n\n\n\n

      Keytruda bol registrovan\u00fd v Eur\u00f3pskej \u00fanii pre hodnoten\u00fa indik\u00e1ciu v j\u00fali 2015.<\/p>\n\n\n\n

        \n
      1. Ako sa na hodnoten\u00e9 lie\u010divo pozeraj\u00fa odborn\u00edci?\u00a0<\/strong><\/li>\n<\/ol>\n\n\n\n

        Na z\u00e1klade vyjadren\u00ed odborn\u00edkov maj\u00fa pacienti na Slovensku obmedzen\u00e9 mo\u017enosti lie\u010dby pod\u013ea najnov\u0161\u00edch medzin\u00e1rodn\u00fdch postupov. Odborn\u00edci pova\u017euj\u00fa za d\u00f4le\u017eit\u00e9 ma\u0165 mo\u017enos\u0165 pou\u017e\u00edva\u0165 v\u0161etky najnov\u0161ie lie\u010debn\u00e9 re\u017eimy u\u017e v prvej l\u00ednii lie\u010dby MM.<\/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 (Merck Sharp & Dohme B.V. (NLD)) podal \u017eiados\u0165 o zaradenie lie\u010diva pembrolizumab (Keytruda) na lie\u010dbu dospel\u00fdch pacientov s metastatick\u00fdm kolorekt\u00e1lnym karcin\u00f3mom.<\/p>\n\n\n\n

          NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o roz\u0161\u00edrenie indika\u010dn\u00e9ho obmedzenia lieku Keytruda o indik\u00e1ciu metastatick\u00fd kolorekt\u00e1lny karcin\u00f3m v prvej l\u00ednii lie\u010dby pri po\u017eadovanej \u00fahrade vo v\u00fd\u0161ke 2 878 eur za balenie.<\/p>\n\n\n\n

          V\u00fdsledok je spojen\u00fd s vysokou mierou neistoty a je optimistick\u00fd najm\u00e4 z d\u00f4vodu modelovania pr\u00ednosu lieku vo\u010di mixu kompar\u00e1torov, ktor\u00e9ho \u00fa\u010dinnos\u0165 je ve\u013emi pravdepodobne podhodnoten\u00e1. Z tohto d\u00f4vodu odpor\u00fa\u010dame po\u017eadova\u0165 adekv\u00e1tnu z\u013eavu na kompenzovanie pr\u00edtomnej neistoty.<\/p>\n\n\n\n

          Z\u00e1rove\u0148 NIHO odpor\u00fa\u010da doplnenie indika\u010dn\u00e9ho obmedzenia o dobr\u00fd v\u00fdkonnostn\u00fd stav pacienta.<\/p>","protected":false},"excerpt":{"rendered":"

          NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o roz\u0161\u00edrenie indika\u010dn\u00e9ho obmedzenia lieku Keytruda o indik\u00e1ciu metastatick\u00fd kolorekt\u00e1lny karcin\u00f3m…<\/p>","protected":false},"author":3,"featured_media":1857,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[92,93],"class_list":["post-1947","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-keytruda","tag-pembrolizumab"],"_links":{"self":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1947","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/comments?post=1947"}],"version-history":[{"count":0,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1947\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media\/1857"}],"wp:attachment":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1947"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1947"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1947"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}