{"id":1864,"date":"2023-06-05T17:28:00","date_gmt":"2023-06-05T15:28:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1864"},"modified":"2024-03-30T17:32:26","modified_gmt":"2024-03-30T16:32:26","slug":"30a-liecivo-olaparib-lynparza-na-udrziavaciu-liecbu-rekurentneho-na-platinu-odpovedajuceho-karcinomu-vajecnikov-alebo-karcinomu-fallopiovej-trubice-alebo-peritonealneho-karcinomu-s-pritomnostou","status":"publish","type":"post","link":"https:\/\/www.niho.sk\/en\/30a-liecivo-olaparib-lynparza-na-udrziavaciu-liecbu-rekurentneho-na-platinu-odpovedajuceho-karcinomu-vajecnikov-alebo-karcinomu-fallopiovej-trubice-alebo-peritonealneho-karcinomu-s-pritomnostou\/","title":{"rendered":"30A: Lie\u010divo olaparib (Lynparza) na udr\u017eiavaciu lie\u010dbu rekurentn\u00e9ho, na platinu odpovedaj\u00faceho karcin\u00f3mu vaje\u010dn\u00edkov (alebo karcin\u00f3mu Fallopiovej trubice alebo peritone\u00e1lneho karcin\u00f3mu) s pr\u00edtomnos\u0165ou BRCA-mut\u00e1cie"},"content":{"rendered":"\n<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>Epiteli\u00e1lny (alebo epitelov\u00fd) karcin\u00f3m je najroz\u0161\u00edrenej\u0161\u00edm histologick\u00fdm typom karcin\u00f3mu ov\u00e1ri\u00ed, Fallopiovej trubice a prim\u00e1rneho peritone\u00e1lneho karcin\u00f3mu, pri\u010dom subtyp \u201ehigh-grade\u201c ser\u00f3zny karcin\u00f3m (HGSC) m\u00e1 najhor\u0161iu progn\u00f3zu spomedzi v\u0161etk\u00fdch subtypov. Aj ke\u010f v\u00fdznamn\u00e1 \u010das\u0165 pacientok odpoved\u00e1 na prvo-l\u00edniov\u00fa chemoterapiu, u 55-75% z nich nastane do 2 rokov rekurencia ochorenia. Riziko rekurencie ochorenia nepriaznivo vpl\u00fdva na psychick\u00fd stav pacientok a s\u0165a\u017euje pl\u00e1novanie aktiv\u00edt, ktor\u00e9 by mohli ma\u0165 pozit\u00edvny vplyv na kvalitu ich \u017eivota. Okrem toho, \u010d\u00edm maj\u00fa pacientky viac absolvovan\u00fdch chemoterapi\u00ed na b\u00e1ze platiny, t\u00fdm maj\u00fa v\u00e4\u010d\u0161ie riziko vytvorenia rezistencie na lie\u010dbu platinou. Udr\u017eiavacia lie\u010dba by mala vies\u0165 k oddialeniu rekurencie a t\u00fdm pred\u013a\u017eeniu \u010dasu medzi chemoterapiami. Aktu\u00e1lne nie je na Slovensku v udr\u017eiavacej lie\u010dbe HGSC kategorizovan\u00e9 \u017eiadne lie\u010divo, hraden\u00e1 lie\u010dba tak nezodpoved\u00e1 najnov\u0161\u00edm medzin\u00e1rodn\u00fdm postupom.<\/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>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).&nbsp;<\/p>\n\n\n\n<p>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:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>odpovede na lie\u010dbu chemoterapiou obsahuj\u00facou platinu, alebo&nbsp;<\/li>\n\n\n\n<li>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<p>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<p>Liek Lynparza bol registrovan\u00fd Eur\u00f3pskou liekovou agent\u00farou v decembri 2014.<\/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>Klinick\u00fd odborn\u00edk sa vyjadril, \u017ee na Slovensku s\u00fa\u010dasn\u00e1 lie\u010dba HGSOC nie je v s\u00falade s najnov\u0161\u00edmi medzin\u00e1rodn\u00fdmi odpor\u00fa\u010daniami, ke\u010f\u017ee na toto ochorenie nie je kategorizovan\u00fd \u017eiadny liek. Uviedol, \u017ee nepr\u00edtomnos\u0165 udr\u017eiavacej lie\u010dby u pacientov vedie k zhor\u0161eniu priebehu ochorenia, kvality \u017eivota a skracuje pre\u017e\u00edvanie pacientok. U lek\u00e1rov pracuj\u00facich s pacientmi s ochoren\u00edm m\u00f4\u017ee nekategorizovanie lieku Lynparza podpori\u0165 frustr\u00e1ciu zo zaost\u00e1vania za najlep\u0161\u00edm \u0161tandardom.<\/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 olaparib (Lynparza) na udr\u017eiavaciu lie\u010dbu rekurentn\u00e9ho, na platinu odpovedaj\u00faceho karcin\u00f3mu vaje\u010dn\u00edkov (alebo karcin\u00f3mu Fallopiovej trubice alebo peritone\u00e1lneho karcin\u00f3mu) s pr\u00edtomnos\u0165ou BRCA-mut\u00e1cie.<\/p>\n\n\n\n<p class=\"has-custom-highlight-background-color has-background\">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.<\/p>\n\n\n\n<p>Odpor\u00fa\u010dame zv\u00e1\u017ei\u0165 \u00fapravu indika\u010dn\u00e9ho obmedzenia pridan\u00edm nasleduj\u00facej vety:&nbsp;<\/p>\n\n\n\n<p>Podmienkou hradenej lie\u010dby je dobr\u00fd v\u00fdkonnostn\u00fd stav pacienta charakterizovan\u00fd na ECOG \u0161k\u00e1le (Eastern Cooperative Oncology Group performance status) ako sk\u00f3re 0-1.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>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&#8230;<\/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":[97,96],"class_list":["post-1864","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-lynparza","tag-olaparib"],"_links":{"self":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1864","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=1864"}],"version-history":[{"count":0,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1864\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media\/1865"}],"wp:attachment":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1864"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1864"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1864"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}