{"id":1867,"date":"2023-06-05T17:32:00","date_gmt":"2023-06-05T15:32:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1867"},"modified":"2024-03-30T17:33:56","modified_gmt":"2024-03-30T16:33:56","slug":"30b-liecivo-olaparib-lynparza-v-monoterapii-na-adjuvantnu-liecbu-dospelych-pacientov-s-vysokorizikovym-vcasnym-trojnasobne-negativnym-karcinomom-prsnika-s-germinativnymi-mutaciami-brca1-2","status":"publish","type":"post","link":"https:\/\/niho.sk\/en\/30b-liecivo-olaparib-lynparza-v-monoterapii-na-adjuvantnu-liecbu-dospelych-pacientov-s-vysokorizikovym-vcasnym-trojnasobne-negativnym-karcinomom-prsnika-s-germinativnymi-mutaciami-brca1-2\/","title":{"rendered":"30B: Lie\u010divo olaparib (Lynparza) v monoterapii na adjuvantn\u00fa lie\u010dbu dospel\u00fdch pacientov s vysokorizikov\u00fdm v\u010dasn\u00fdm trojn\u00e1sobne negat\u00edvnym karcin\u00f3mom prsn\u00edka s germinat\u00edvnymi mut\u00e1ciami BRCA1\/2"},"content":{"rendered":"\n
    \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

    Trojn\u00e1sobne negat\u00edvny karcin\u00f3m prsn\u00edka (\u010falej len TNBC, z angl. triple-negative breast cancer) s germinat\u00edvnymi BRCA mut\u00e1ciami (\u010falej len gBRCAm) je ochorenie, ktor\u00e9 vytv\u00e1ra ve\u013ek\u00fa z\u00e1\u0165a\u017e na pacientov po fyzickej aj psychickej str\u00e1nke a skracuje ich o\u010dak\u00e1van\u00e9 pre\u017e\u00edvanie. Ochorenie m\u00e1 \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. Aktu\u00e1lne hraden\u00e1 lie\u010dba pre pacientov s TNBC s gBRCAm plne nezodpoved\u00e1 najnov\u0161\u00edm medzin\u00e1rodn\u00fdm postupom.<\/p>\n\n\n\n

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

      Lynparza obsahuje lie\u010divo olaparib. Olaparib je typ lieku proti rakovine naz\u00fdvan\u00fd inhib\u00edtor PARP (inhib\u00edtor poly[adenoz\u00edndifosf\u00e1t-rib\u00f3zo]polymer\u00e1zy). <\/p>\n\n\n\n

      Inhib\u00edtory PARP m\u00f4\u017eu ni\u010di\u0165 rakovinov\u00e9 bunky, ktor\u00e9 nie s\u00fa schopn\u00e9 \u00fa\u010dinne opravova\u0165 po\u0161kodenie DNA. Tieto osobitn\u00e9 rakovinov\u00e9 bunky mo\u017eno rozpozna\u0165 pod\u013ea: <\/p>\n\n\n\n

        \n
      • odpovede na lie\u010dbu chemoterapiou obsahuj\u00facou platinu, alebo <\/li>\n\n\n\n
      • stanovenia chybn\u00fdch g\u00e9nov zodpovedn\u00fdch za opravu DNA, ako napr\u00edklad g\u00e9ny BRCA (g\u00e9ny rakoviny prsn\u00edka, BReast CAncer).<\/li>\n<\/ul>\n\n\n\n

        Ke\u010f sa Lynparza pou\u017e\u00edva v kombin\u00e1cii s abirater\u00f3nom (inhib\u00edtorom androg\u00e9nov\u00fdch receptorov), t\u00e1to kombin\u00e1cia m\u00f4\u017ee pom\u00f4c\u0165 zv\u00fd\u0161i\u0165 protin\u00e1dorov\u00fd \u00fa\u010dinok v bunk\u00e1ch karcin\u00f3mu prostaty s chybn\u00fdmi g\u00e9nmi zodpovedn\u00fdmi za opravu DNA alebo bez nich (napr. g\u00e9ny BRCA).<\/p>\n\n\n\n

        Liek Lynparza bol registrovan\u00fd Eur\u00f3pskou liekovou agent\u00farou v decembri 2014.<\/p>\n\n\n\n

          \n
        1. Ako sa na axikabtag\u00e9n ciloleucel pozeraj\u00fa odborn\u00edci? <\/strong><\/li>\n<\/ol>\n\n\n\n

          Olaparib ako PARP inhib\u00edtor m\u00e1 svoje miesto v medzin\u00e1rodn\u00fdch \u0161tandardoch ESMO na z\u00e1klade svojho pr\u00ednosu a preto, podobne ako v in\u00fdch pr\u00edpadoch, jeho neuhr\u00e1dzanie na Slovensku prin\u00e1\u0161a zaost\u00e1vanie lie\u010dby na Slovensku v najvy\u0161\u0161om medzin\u00e1rodnom \u0161tandarde. Olaparib je jedn\u00fdm z PARP inhib\u00edtorov, ktor\u00e9 ako jedin\u00e9 predstavuj\u00fa cielen\u00fa lie\u010dbu pre pacientky s gBRCAm. Odborn\u00edci \u010delia na r\u00f4znych \u00farovniach probl\u00e9mom, kedy musia pre pacientov vybera\u0165 suboptim\u00e1lne rie\u0161enia a lie\u010dby. Tento fakt s\u00e1m osebe je frustruj\u00faci pre klinick\u00fdch odborn\u00edkov.<\/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 olaparib (Lynparza) v monoterapii na adjuvantn\u00fa lie\u010dbu dospel\u00fdch pacientov s vysokorizikov\u00fdm v\u010dasn\u00fdm trojn\u00e1sobne negat\u00edvnym karcin\u00f3mom prsn\u00edka s germinat\u00edvnymi mut\u00e1ciami BRCA1\/2.<\/p>\n\n\n\n

            NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Lynparza 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 a z\u00e1rove\u0148 bude upraven\u00e9 indika\u010dn\u00e9 obmedzenie pod\u013ea n\u00e1vrhu NIHO.<\/p>\n\n\n\n

            V\u00fdsledok hodnotenia n\u00e1kladovej efekt\u00edvnosti je aj pri uvedenej \u00fahrade spojen\u00fd s vysokou mierou neistoty, \u017ee v klinickej praxi nebud\u00fa splnen\u00e9 krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti. Preto NIHO odpor\u00fa\u010da po\u017eadova\u0165 od dr\u017eite\u013ea registr\u00e1cie adekv\u00e1tnu dodato\u010dn\u00fa z\u013eavu, ktorou by sa t\u00e1to neistota kompenzovala.<\/p>\n","protected":false},"excerpt":{"rendered":"

            NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Lynparza v predmetnej indik\u00e1ci\u00ed, 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":1865,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[96],"class_list":["post-1867","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-olaparib"],"_links":{"self":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1867","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=1867"}],"version-history":[{"count":0,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1867\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media\/1865"}],"wp:attachment":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1867"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1867"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1867"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}