{"id":1949,"date":"2023-12-22T17:04:00","date_gmt":"2023-12-22T16:04:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1949"},"modified":"2024-04-10T17:09:38","modified_gmt":"2024-04-10T15:09:38","slug":"52-liecivo-sacituzumab-govitekan-trodelvy-na-liecbu-dospelych-pacientov-s-pokrocilym-trojito-negativnym-karcinomom-prsnika-ktori-podstupili-dve-alebo-viac-systemovych-terapii","status":"publish","type":"post","link":"https:\/\/niho.sk\/en\/52-liecivo-sacituzumab-govitekan-trodelvy-na-liecbu-dospelych-pacientov-s-pokrocilym-trojito-negativnym-karcinomom-prsnika-ktori-podstupili-dve-alebo-viac-systemovych-terapii\/","title":{"rendered":"52: Lie\u010divo sacituzumab govitekan (Trodelvy) na lie\u010dbu dospel\u00fdch pacientov s pokro\u010dil\u00fdm trojito negat\u00edvnym karcin\u00f3mom prsn\u00edka, ktor\u00ed podst\u00fapili dve alebo viac syst\u00e9mov\u00fdch terapi\u00ed"},"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

    Trojito negat\u00edvny karcin\u00f3m prsn\u00edka (z angl. triple-negative breast cancer, TNBC) je agres\u00edvny podtyp karcin\u00f3mu prsn\u00edka, pri\u010dom v metastatickom \u0161t\u00e1diu m\u00e1va ve\u013emi zl\u00fa progn\u00f3zu, r\u00fdchlo progreduje a pacientky maj\u00fa kr\u00e1tke pre\u017e\u00edvanie. \u00damrtnos\u0165 pacientov s TNBC do 3 mesiacov po recid\u00edve je a\u017e 75 %. Lie\u010dba sacituzumab govitekanom (SG) je v predmetnej indik\u00e1cii na z\u00e1klade odpor\u00fa\u010dan\u00ed a be\u017enej klinickej praxe v zahrani\u010d\u00ed pova\u017eovan\u00e1 za \u0161tandardn\u00fa. Ochorenie vytv\u00e1ra ve\u013ek\u00fa z\u00e1\u0165a\u017e na pacientov po fyzickej aj psychickej str\u00e1nke, skracuje ich o\u010dak\u00e1van\u00e9 pre\u017e\u00edvanie a m\u00e1 tie\u017e \u010dasto v\u00fdrazn\u00fd dopad na bl\u00edzkych pacienta, ke\u010f\u017ee vznik\u00e1 potreba pom\u00e1ha\u0165 so starostlivos\u0165ou o pacienta a jeho dom\u00e1cnos\u0165. <\/p>\n\n\n\n

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

      Sacituzumab je humanizovan\u00e1 monoklon\u00e1lna protil\u00e1tka. Biochemickou reakciou v tele m\u00e1 liek Trodelvy za cie\u013e po\u0161kodenie DNA rakovinov\u00fdch buniek, ktor\u00e9 m\u00e1 vies\u0165 k ich smrti.<\/p>\n\n\n\n

      Lie\u010dba je hraden\u00e1 do progresie ochorenia alebo netolerovate\u013enej toxicity, pod\u013ea toho \u010do nastane sk\u00f4r, a podlieha predch\u00e1dzaj\u00facemu s\u00fahlasu zdravotnej pois\u0165ovne.<\/p>\n\n\n\n

      Trodelvy bol registrovan\u00fd v Eur\u00f3pskej \u00fanii pre hodnoten\u00fa indik\u00e1ciu v okt\u00f3bri 2019.<\/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

        Pacientky o\u010dak\u00e1vaj\u00fa \u00fa\u010dinnej\u0161iu lie\u010dbu v porovnan\u00ed so \u0161tandardnou chemoterapiou. Hradenie Trodelvy by mohlo zlep\u0161i\u0165 lie\u010debn\u00e9 mo\u017enosti pacientok, pre ktor\u00e9 je moment\u00e1lne jedinou lie\u010debnou mo\u017enos\u0165ou chemoterapia.<\/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 (Gilead Sciences Ireland UC) podal \u017eiados\u0165 o zaradenie lie\u010diva sacituzumab govitekan (Trodelvy) na lie\u010dbu dospel\u00fdch pacientov s pokro\u010dil\u00fdm trojito negat\u00edvnym karcin\u00f3mom prsn\u00edka, ktor\u00ed podst\u00fapili dve alebo viac syst\u00e9mov\u00fdch terapi\u00ed.<\/p>\n\n\n\n

          NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Trodelvy v predmetnej indik\u00e1ci\u00ed, pokia\u013e dr\u017eite\u013e registr\u00e1cie uprav\u00ed po\u017eadovan\u00fa v\u00fd\u0161ku \u00fahrady tak, aby sp\u013a\u0148ala krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti.<\/p>\n\n\n\n

          V\u00fdsledok hodnotenia n\u00e1kladovej efekt\u00edvnosti je aj pri pri n\u00e1kladovo efekt\u00edvnej \u00fahrade spojen\u00fd s vysokou mierou neistoty, \u017ee v klinickej praxi nebud\u00fa splnen\u00e9 krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti. NIHO preto odpor\u00fa\u010da po\u017eadova\u0165 od dr\u017eite\u013ea registr\u00e1cie adekv\u00e1tnu dodato\u010dn\u00fa z\u013eavu, ktor\u00e1 zn\u00ed\u017ei t\u00fato neistotu.<\/p>","protected":false},"excerpt":{"rendered":"

          NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Trodelvy v predmetnej indik\u00e1ci\u00ed, pokia\u013e…<\/p>","protected":false},"author":3,"featured_media":1950,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[135,134],"class_list":["post-1949","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-sacituzumab-govitekan","tag-trodelvy"],"_links":{"self":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1949","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=1949"}],"version-history":[{"count":0,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1949\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media\/1950"}],"wp:attachment":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1949"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1949"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1949"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}