{"id":2308,"date":"2023-01-04T17:04:00","date_gmt":"2023-01-04T16:04:00","guid":{"rendered":"https:\/\/niho.sk\/?p=2308"},"modified":"2024-12-04T17:37:56","modified_gmt":"2024-12-04T16:37:56","slug":"13b-liecivo-ribociklib-kisqali-v-kombinacii-s-fulvestrantom-v-prvej-linii-liecby-pokrocileho-hr-her2-karcinomu-prsnika-so-skorym-nastupom-relapsu-alebo-progresie-ochorenia-od-ukoncenia-neo","status":"publish","type":"post","link":"https:\/\/niho.sk\/en\/13b-liecivo-ribociklib-kisqali-v-kombinacii-s-fulvestrantom-v-prvej-linii-liecby-pokrocileho-hr-her2-karcinomu-prsnika-so-skorym-nastupom-relapsu-alebo-progresie-ochorenia-od-ukoncenia-neo\/","title":{"rendered":"13B: Lie\u010divo ribociklib (Kisqali) v kombin\u00e1cii s fulvestrantom v prvej l\u00ednii lie\u010dby pokro\u010dil\u00e9ho HR+\/HER2- karcin\u00f3mu prsn\u00edka so skory\u0301m n\u00e1stupom relapsu alebo progresie ochorenia od ukon\u010denia (neo)adjuvantnej endokrinnej terapie"},"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

    Karcin\u00f3m prsn\u00edka (BC) je celosvetovo naj\u010dastej\u0161\u00edm n\u00e1dorov\u00fdm ochoren\u00edm u \u017eien a aj naj\u010dastej\u0161ou pr\u00ed\u010dinou \u00famrtia \u017eien v s\u00favislosti s onkologick\u00fdm ochoren\u00edm. Pokro\u010dil\u00fd karcin\u00f3m prsn\u00edka sa pova\u017euje za nevylie\u010dite\u013en\u00fd, pacientky s\u00fa lie\u010den\u00e9 nekurat\u00edvnou lie\u010dbou. N\u00e1stup ochorenia je sp\u00e1jan\u00fd s v\u00fdrazne zhor\u0161enou kvalitou \u017eivota vo v\u0161etk\u00fdch aspektoch a vytv\u00e1ra psychick\u00fa z\u00e1\u0165a\u017e nielen na pacientky, ale aj bl\u00edzkych, ktor\u00ed sa sna\u017eia ich podporova\u0165 a pom\u00e1ha\u0165 im.<\/p>\n\n\n\n

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

      Ribociklib, zn\u00e1my ako Kisqali, je selekt\u00edvny inhib\u00edtor cykl\u00edn-dependentn\u00fdch kin\u00e1z 4 a 6 (CDK4\/6). Tieto kin\u00e1zy s\u00fa zodpovedn\u00e9 za regul\u00e1ciu bunkov\u00e9ho cyklu, a ich inhib\u00edcia zabra\u0148uje n\u00e1dorov\u00fdm bunk\u00e1m vstupova\u0165 do \u010fal\u0161\u00edch f\u00e1z rastu, \u010d\u00edm sa spoma\u013euje ich delenie a prolifer\u00e1cia.<\/p>\n\n\n\n

      V kombin\u00e1cii s fulvestrantom, ktor\u00fd sa pod\u00e1va intramuskul\u00e1rne, sl\u00fa\u017ei Ribociklib na lie\u010dbu hormon\u00e1lne receptor pozit\u00edvnych (HR+) a HER2 negat\u00edvnych (HER2-) typov karcin\u00f3mu prsn\u00edka\u200b. <\/p>\n\n\n\n

      Ribociklib bol registrovan\u00fd Eur\u00f3pskou liekovou agent\u00farou (EMA) v roku 2017\u200b.<\/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

        Odborn\u00edci vn\u00edmaj\u00fa pridan\u00fa hodnotu Ribociklibu v kombin\u00e1cii s fulvestrantom najm\u00e4 v pred\u013a\u017een\u00ed doby pre\u017e\u00edvania bez progresie ochorenia (PFS) u pacientiek. Klinick\u00e9 \u0161t\u00fadie (napr. MONALEESA-3) nazna\u010dili v\u00fdznamn\u00e9 zlep\u0161enie PFS a mierne zlep\u0161enie celkov\u00e9ho pre\u017e\u00edvania (OS). Av\u0161ak, v\u00fdsledky nie s\u00fa v\u017edy \u0161tatisticky signifikantn\u00e9 a subpopul\u00e1cia relevantn\u00e1 pre hodnotenie je mal\u00e1, \u010do prin\u00e1\u0161a neistoty do interpret\u00e1cie v\u00fdsledkov. Niektor\u00e9 pacientky vykazuj\u00fa zv\u00fd\u0161en\u00fa toxicitu lie\u010dby\u200b.<\/p>\n\n\n\n

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

          NIHO sa zaoberalo hodnoten\u00edm klinick\u00e9ho pr\u00ednosu Ribociklibu, jeho n\u00e1kladovej efekt\u00edvnosti a mo\u017en\u00e9ho dopadu na verejn\u00e9 zdravotn\u00e9 poistenie. Dr\u017eite\u013eom registr\u00e1cie je spolo\u010dnos\u0165 Novartis, ktor\u00e1 podala \u017eiados\u0165 o kategoriz\u00e1ciu lieku Kisqali v kombin\u00e1cii s fulvestrantom pre pacientky v \u0161pecifickej indik\u00e1cii\u200b.<\/p>\n\n\n\n

          Odpor\u00fa\u010danie NIHO: NIHO odpor\u00fa\u010da nevyhovie\u0165 \u017eiadosti o kategoriz\u00e1ciu lieku v hodnotenej indik\u00e1cii. Hlavn\u00fdmi d\u00f4vodmi s\u00fa:
          – Nemo\u017enos\u0165 preuk\u00e1za\u0165 n\u00e1kladov\u00fa efekt\u00edvnos\u0165 v r\u00e1mci predlo\u017eenej ceny\u200b.
          – Nedostatok aktu\u00e1lnych d\u00e1t zapracovan\u00fdch do farmakoekonomick\u00e9ho modelu.
          – V\u00fdznamn\u00e1 neistota spojen\u00e1 s malou subpopul\u00e1ciou a ne\u00fapln\u00fdmi \u00fadajmi z klinick\u00fdch \u0161t\u00fadi\u00ed.<\/p>","protected":false},"excerpt":{"rendered":"

          Karcin\u00f3m prsn\u00edka (BC) je celosvetovo naj\u010dastej\u0161\u00edm n\u00e1dorov\u00fdm ochoren\u00edm u \u017eien a aj naj\u010dastej\u0161ou pr\u00ed\u010dinou \u00famrtia \u017eien v s\u00favislosti s onkologick\u00fdm ochoren\u00edm. Pokro\u010dil\u00fd karcin\u00f3m prsn\u00edka sa pova\u017euje za nevylie\u010dite\u013en\u00fd, pacientky s\u00fa lie\u010den\u00e9 nekurat\u00edvnou lie\u010dbou. N\u00e1stup ochorenia je sp\u00e1jan\u00fd s v\u00fdrazne zhor\u0161enou kvalitou \u017eivota vo v\u0161etk\u00fdch aspektoch a vytv\u00e1ra psychick\u00fa z\u00e1\u0165a\u017e nielen na pacientky, ale aj bl\u00edzkych, […]<\/p>\n","protected":false},"author":3,"featured_media":2292,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[142,143],"class_list":["post-2308","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-kisqali","tag-ribociklib"],"_links":{"self":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/2308","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=2308"}],"version-history":[{"count":0,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/2308\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media\/2292"}],"wp:attachment":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media?parent=2308"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/categories?post=2308"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/tags?post=2308"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}