{"id":11185,"date":"2025-10-02T14:50:09","date_gmt":"2025-10-02T14:50:09","guid":{"rendered":"https:\/\/andromedichyperthermia.com\/?p=11185"},"modified":"2025-10-02T19:34:53","modified_gmt":"2025-10-02T19:34:53","slug":"hypertermie-studii-fazy-iii","status":"publish","type":"post","link":"https:\/\/andromedichyperthermia.com\/sk\/hypertermie-studii-fazy-iii\/","title":{"rendered":"Terapeutick\u00e1 Integr\u00e1cia Hypertermie v Modernej Onkol\u00f3gii: Kritick\u00e1 Anal\u00fdza \u0160t\u00fadi\u00ed F\u00e1zy III a Metaanal\u00fdz (Koncov\u00e9 Body OS, DFS, CR)"},"content":{"rendered":"<p><script type=\"application\/ld+json\">\n    {\n      \"@context\": \"https:\/\/schema.org\",\n      \"@type\": \"MedicalScholarlyArticle\",\n      \"headline\": \"Terapeutick\u00e1 Integr\u00e1cia Hypertermie v Modernej Onkol\u00f3gii: Kritick\u00e1 Anal\u00fdza \u0160t\u00fadi\u00ed F\u00e1zy III a Metaanal\u00fdz (Koncov\u00e9 Body OS, DFS, CR)\",\n      \"author\": {\n        \"@type\": \"Person\",\n        \"name\": \"Gologan Cristian, M.Sc.\",\n        \"jobTitle\": \"CEO\",\n        \"affiliation\": {\n          \"@type\": \"MedicalOrganization\",\n          \"name\": \"Andromedichyperthermia Center\"\n        }\n      },\n      \"keywords\": \"Hypertermia, Onkol\u00f3gia, \u0160t\u00fadie F\u00e1zy III, Pre\u017eitie, OS, Kompletn\u00e1 Odpove\u010f, CR, Sark\u00f3m, Rakovina Kr\u010dka Maternice, E-E-A-T\"\n      \/* ... Schema FAQPage would be added separately for the FAQ section *\/\n    }\n<\/script><\/p>\n<div class=\"author-info\"><strong>Autorita a Odbornos\u0165 (E-E-A-T):<\/strong><br \/>\n<strong><a href=\"https:\/\/andromedichyperthermia.com\/sk\/doctor-veronica-iatan\/\">Dr. Veronica Iatan, MD<\/a>, a <a href=\"https:\/\/andromedichyperthermia.com\/sk\/cristian-gologan\/\">Cristian Gologan M.Sc<\/a>, Andromedichyperthermia<\/strong><\/div>\n<h1>Terapeutick\u00e1 Integr\u00e1cia Hypertermie v Modernej Onkol\u00f3gii: Kritick\u00e1 Anal\u00fdza \u0160t\u00fadi\u00ed F\u00e1zy III a Metaanal\u00fdz (Koncov\u00e9 Body OS, DFS, CR)<\/h1>\n<h2>1. V\u00fdkonn\u00e9 Zhrnutie a Z\u00e1kladn\u00e9 Princ\u00edpy Hypertermie (HT)<\/h2>\n<p>*Onkologick\u00e1 Hypertermia (HT), definovan\u00e1 ako kontrolovan\u00e9 aplikovanie tepla v teplotnom rozsahu **39 \u00b0C a\u017e 45 \u00b0C, predstavuje adjuvantn\u00fa terapeutick\u00fa modalitu, ktor\u00e1 preuk\u00e1zala **v\u00fdznamn\u00fd klinick\u00fd pr\u00ednos, potvrden\u00fd **d\u00f4kazmi \u00darovne 1A* (*randomizovan\u00e9 \u0161t\u00fadie F\u00e1zy III a metaanal\u00fdzy*), pre s\u00e9riu pokro\u010dil\u00fdch a recidivuj\u00facich sol\u00eddnych tumorov.<\/p>\n<p>Z\u00e1kladn\u00e1 \u00faloha HT nie je priama term\u00e1lna de\u0161trukcia (abl\u00e1cia vy\u017eaduje teploty nad 50 \u00b0C), ale \u00faloha *biologick\u00e9ho senzibiliz\u00e1tora*, zosil\u0148uj\u00faceho \u00fa\u010dinnos\u0165 r\u00e1dioterapie (RT) a chemoterapie (CHT).<\/p>\n<div class=\"key-points\">\n<h3>K\u013e\u00fa\u010dov\u00e9 Zistenia &#8211; D\u00f4kazy \u00darovne 1A:<\/h3>\n<ul>\n<li>*\u00daloha:* HT neni\u010d\u00ed tumor priamo; p\u00f4sob\u00ed ako siln\u00fd *biologick\u00fd senzibiliz\u00e1tor*.<\/li>\n<li>*Potvrden\u00e9 Pr\u00ednosy:* Synt\u00e9za \u00fadajov \u00darovne 1A zd\u00f4raz\u0148uje konzistentn\u00e9 zlep\u0161enie *Celkov\u00e9ho Pre\u017eitia (OS)* a *Miery Kompletnej Odpovede (CR)*.<\/li>\n<li>*Hlavn\u00e9 Indik\u00e1cie:* Sark\u00f3my m\u00e4kk\u00fdch tkan\u00edv, rakovina kr\u010dka maternice, recidivuj\u00face tumory prsn\u00edka, mal\u00edgny melan\u00f3m, rekt\u00e1lny karcin\u00f3m, karcin\u00f3m mo\u010dov\u00e9ho mech\u00fara a n\u00e1dory hlavy a krku (HNC).<\/li>\n<li>*Bezpe\u010dnos\u0165:* Tento robustn\u00fd terapeutick\u00fd pr\u00ednos sa d\u00f4sledne dosahuje *bez v\u00fdznamn\u00e9ho zv\u00fd\u0161enia syst\u00e9movej toxicity alebo z\u00e1va\u017en\u00fdch ved\u013eaj\u0161\u00edch \u00fa\u010dinkov (stup\u0148a 3 alebo 4)*.<\/li>\n<li>*Z\u00e1ver:* HT je nevyhnutn\u00fdm doplnkom k \u0161tandardn\u00fdm multimod\u00e1lnym re\u017eimom pre vybran\u00e9 tumory.<\/li>\n<\/ul>\n<\/div>\n<h3>1.1. Klasifik\u00e1cia a Met\u00f3dy Onkologickej Hypertermie<\/h3>\n<h4>1.1.1. Lokoregion\u00e1lna Hypertermia (L-R HT)<\/h4>\n<p>Pou\u017e\u00edva sa na hlbok\u00e9 zahrievanie panvov\u00fdch, hrudn\u00fdch a abdomin\u00e1lnych tumorov. Jej cie\u013eom je nasmerova\u0165 tepeln\u00fa energiu do h\u013abky, aby sa dosiahli terapeutick\u00e9 teploty v objeme tumoru, pri\u010dom sa zdrav\u00e9 tkaniv\u00e1 udr\u017eia v r\u00e1mci hran\u00edc tolerancie. Vy\u017eaduje sa \u010do najhomog\u00e9nnej\u0161ie (izotermick\u00e9) zahrievanie tumorovej masy.<\/p>\n<h4>1.1.2. RF Modulovan\u00e1 Hypertermia (mHT)<\/h4>\n<p>Modulovan\u00e1 RF hypertermia (mHT), na rozdiel od konven\u010dn\u00e9ho izotermick\u00e9ho zahrievania, vyu\u017e\u00edva kapacitn\u00e9 spojenie s nosnou frekvenciou 13.56 MHz, modulovanou frakt\u00e1lnymi fluktu\u00e1ciami. Princ\u00edp fungovania je zalo\u017een\u00fd na *fokusovanom prenose energie na \u00farovni bunkovej membr\u00e1ny*. Vysok\u00e1 dielektrick\u00e1 strata sa preferen\u010dne vyskytuje na membr\u00e1nach rakovinov\u00fdch buniek (kv\u00f4li ich zmenen\u00fdm elektrick\u00fdm vlastnostiam), \u010d\u00edm sa vytv\u00e1ra \u0161pecifick\u00fd teplotn\u00fd gradient, ktor\u00fd podporuje apoptotick\u00e9 dr\u00e1hy. Tento mechanizmus zahrievania &#8222;zvn\u00fatra von&#8220; vedie k vy\u0161\u0161\u00edm intratumor\u00e1lnym teplot\u00e1m a zn\u00ed\u017een\u00e9mu po\u0161kodeniu norm\u00e1lneho tkaniva.<\/p>\n<h4>1.1.3. Interstici\u00e1lna Hypertermia<\/h4>\n<p>T\u00e1to met\u00f3da zah\u0155\u0148a invaz\u00edvne dodanie tepla prostredn\u00edctvom ant\u00e9n, ty\u010d\u00ed alebo semien umiestnen\u00fdch priamo vn\u00fatri tumoru. Pou\u017e\u00edva sa najm\u00e4 na lie\u010dbu n\u00e1dorov mozgu (gli\u00f3mov) alebo na recidivuj\u00face povrchov\u00e9 ochorenia.<\/p>\n<h3>1.2. Pre\u010do Terapeutick\u00e9 Okno 39\u201345 \u00b0C Funguje? (Biologick\u00e9 Mechanizmy)<\/h3>\n<p>Preuk\u00e1zan\u00e1 klinick\u00e1 \u00fa\u010dinnos\u0165 HT na \u00farovni F\u00e1zy III je neoddelite\u013en\u00e1 od pochopenia jej komplexn\u00fdch biologick\u00fdch mechanizmov. Tieto mechanizmy presahuj\u00fa jednoduch\u00fa bunkov\u00fa de\u0161trukciu, \u010d\u00edm umiest\u0148uj\u00fa HT ako *multifunk\u010dn\u00fd senzibiliz\u00e1tor* \u0161tandardn\u00fdch lie\u010debn\u00fdch postupov. Optim\u00e1lna teplota *39\u201345 \u00b0C* je zvolen\u00e1 tak, aby maximalizovala bunkov\u00e9 nerovnov\u00e1hy \u0161pecifick\u00e9 pre tumor. Celkov\u00fd \u00faspech zaznamenan\u00fd v randomizovan\u00fdch \u0161t\u00fadi\u00e1ch poch\u00e1dza z tejto senzibiliza\u010dnej \u00falohy, ktor\u00e1 interaguje s tumorov\u00fdm mikroprostred\u00edm a bunkovou ma\u0161in\u00e9riou s cie\u013eom zv\u00fd\u0161i\u0165 \u00fa\u010dinnos\u0165 r\u00e1dioterapie (RT) a chemoterapie (CHT).<\/p>\n<hr \/>\n<h2>2. Mechanizmy \u00da\u010dinku: Ako Hypertermia Zosil\u0148uje Onkologick\u00fa Lie\u010dbu<\/h2>\n<p>Vynikaj\u00faca klinick\u00e1 \u00fa\u010dinnos\u0165 kombinovanej lie\u010dby je v\u00fdsledkom robustnej biologickej synergie, ktor\u00e1 rie\u0161i tumorov\u00fa rezistenciu na viacer\u00fdch \u00farovniach.<\/p>\n<h3>2.1. R\u00e1diosenzibiliz\u00e1cia: Prekonanie Hypoxie a Inhib\u00edcia Opravy DNA<\/h3>\n<p>Hypertermia je uzn\u00e1van\u00e1 ako siln\u00fd r\u00e1diosenzibiliz\u00e1tor, ktor\u00fd sa zaober\u00e1 dvoma hlavn\u00fdmi pr\u00ed\u010dinami zlyhania r\u00e1dioterapie:<\/p>\n<ol>\n<li>*Inhib\u00edcia Opravy DNA:* HT m\u00e1 priamy \u00fa\u010dinok na mechanizmy opravy DNA. Inhib\u00edcia mechanizmov opravy DNA po\u0161kodenej \u017eiaren\u00edm zabezpe\u010duje \u00fa\u010dinnej\u0161iu a nezvratn\u00fa bunkov\u00fa de\u0161trukciu.<\/li>\n<li>*Modifik\u00e1cia Tumorov\u00e9ho Mikroprostredia:* HT zni\u017euje hypoxick\u00fa frakciu tumoru *zv\u00fd\u0161en\u00edm prietoku krvi a zlep\u0161en\u00edm oxygen\u00e1cie tumoru*.<\/li>\n<\/ol>\n<p>T\u00e1to funk\u010dn\u00e1 zmena v tumorovom mikroprostred\u00ed umo\u017e\u0148uje, aby sa predt\u00fdm rezistentn\u00e9 rakovinov\u00e9 bunky stali ove\u013ea citlivej\u0161\u00edmi na konven\u010dn\u00e9 \u017eiarenie. Je to k\u013e\u00fa\u010dov\u00fd faktor stojaci za vysok\u00fdmi mierami lokoregion\u00e1lnej kontroly a CR dokumentovan\u00fdmi v re\u017eimoch S\u00fa\u010dasnej Chemo-r\u00e1dioterapie + HT (CCRT+HT) pre n\u00e1dory ako *lok\u00e1lne pokro\u010dil\u00e1 rakovina kr\u010dka maternice (LACC) a n\u00e1dory hlavy a krku (HNC)*.<\/p>\n<h3>2.2. Chemosenzibiliz\u00e1cia: Zlep\u0161enie Prem\u00e1vky a Bunkov\u00e9ho Pr\u00edjmu Liekov<\/h3>\n<h4>2.2.1. Synergia a Pr\u00edspevok ku K\u013e\u00fa\u010dov\u00fdm L\u00e1tkam<\/h4>\n<p>HT preukazuje siln\u00e9 synergick\u00e9 \u00fa\u010dinky s ur\u010dit\u00fdmi k\u013e\u00fa\u010dov\u00fdmi triedami chemoterapeut\u00edk. Najm\u00e4 HT synergizuje s platina-zalo\u017een\u00fdmi l\u00e1tkami (Cisplatina, Karboplatina) a Mitomyc\u00ednom C. M\u00e1 tie\u017e adit\u00edvne \u00fa\u010dinky s l\u00e1tkami ako Doxorubic\u00edn, Cyklofosfamid a Gemcitab\u00edn.<\/p>\n<h4>2.2.2. Farmakokinetick\u00e9 Zosilnenie<\/h4>\n<p>HT optimalizuje dodanie liekov na tumorovej \u00farovni, zvy\u0161uj\u00fac prem\u00e1vku liekov v tumoroch a lymfatick\u00fdch uzlin\u00e1ch (LN). Tento \u00fa\u010dinok sa pripisuje zv\u00fd\u0161enej perf\u00fazii (prietoku krvi) indukovanej HT a zmenenej priepustnosti bunkovej membr\u00e1ny. V pr\u00edpade mHT m\u00f4\u017ee mechanizmus lokalizovan\u00e9ho zahrievania na \u00farovni bunkovej membr\u00e1ny zlep\u0161i\u0165 intracelul\u00e1rny pr\u00edjem chemoterapeutick\u00fdch l\u00e1tok.<\/p>\n<h3>2.3. Imunomodul\u00e1cia: HT ako \u201cIn Situ\u201d Tumorov\u00e1 Vakc\u00edna<\/h3>\n<p>\u010coraz viac prij\u00edman\u00fdm mechanizmom \u00fa\u010dinku je schopnos\u0165 HT modulova\u0165 protin\u00e1dorov\u00fa imunitn\u00fa odpove\u010f, \u00fa\u010dinne transformuj\u00fac imunitne *&#8220;studen\u00e9&#8220;* tumory na *&#8220;hor\u00face&#8220;* (z\u00e1palov\u00e9). HT p\u00f4sob\u00ed ako *&#8220;in situ tumorov\u00e1 vakc\u00edna&#8220;* t\u00fdm, \u017ee indukuje uvo\u013e\u0148ovanie Heat Shock Prote\u00ednov (HSP) a tumorov\u00fdch antig\u00e9nov.<\/p>\n<p>HSP (ako HSP70) funguj\u00fa ako sign\u00e1ly nebezpe\u010denstva a u\u013eah\u010duj\u00fa pr\u00edjem antig\u00e9nov dendritick\u00fdmi bunkami (DC). Tento imunomodula\u010dn\u00fd proces vedie k zv\u00fd\u0161enej l\u00fdze rakovinov\u00fdch buniek bunkami Natural Killer (NK) a CD8+ T-lymfocytmi. Okrem toho HT u\u013eah\u010duje prem\u00e1vku lymfocytov na miesto tumoru, zlep\u0161uj\u00fac expresiu molek\u00fal bunkovej adh\u00e9zie (CAM).<\/p>\n<p>*Tabu\u013eka 1 zhr\u0148uje mechanick\u00e9 interakcie hypertermie so \u0161tandardn\u00fdmi onkologick\u00fdmi lie\u010dbami.*<\/p>\n<p>*Tabu\u013eka 1: Mechanizmy Interakcie Hypertermie so \u0160tandardn\u00fdmi Onkologick\u00fdmi Terapiami*<\/p>\n<table width=\"624\">\n<thead>\n<tr>\n<td width=\"104\"><strong>Cielen\u00fd Mechanizmus<\/strong><\/td>\n<td width=\"104\"><strong>Biologick\u00fd \u00da\u010dinok (39 \u00b0C \u2013 45 \u00b0C)<\/strong><\/td>\n<td width=\"104\"><strong>Terapeutick\u00e1 Synergia<\/strong><\/td>\n<td width=\"104\"><strong>Synergick\u00e9 L\u00e1tky<\/strong><\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td width=\"104\">Inhib\u00edcia Opravy DNA<\/td>\n<td width=\"104\">Blokuje mechanizmy opravy DNA; senzibilizuje bunky v S-f\u00e1ze<\/td>\n<td width=\"104\">Siln\u00fd R\u00e1diosenzibiliz\u00e1tor (dop\u013a\u0148a RT)<\/td>\n<td width=\"104\">R\u00e1dioterapia (RT)<\/td>\n<\/tr>\n<tr>\n<td width=\"104\">Tumorov\u00e9 Mikroprostredie<\/td>\n<td width=\"104\">Zvy\u0161uje prietok krvi, zlep\u0161uje oxygen\u00e1ciu tumoru, zvy\u0161uje vaskulariz\u00e1ciu<\/td>\n<td width=\"104\">Zvy\u0161uje \u00fa\u010dinnos\u0165 RT; Zlep\u0161uje prem\u00e1vku liekov (Chemosenzibiliz\u00e1cia)<\/td>\n<td width=\"104\">RT, Cisplatina, Mitomyc\u00edn C<\/td>\n<\/tr>\n<tr>\n<td width=\"104\">Bunkov\u00e1 Membr\u00e1na\/\u0160trukt\u00fara<\/td>\n<td width=\"104\">Zv\u00fd\u0161enie dielektrickej straty; Priama apoptotick\u00e1 signaliz\u00e1cia<\/td>\n<td width=\"104\">Zlep\u0161uje pr\u00edjem liekov<\/td>\n<td width=\"104\">Cisplatina, Karboplatina, Bleomyc\u00edn<\/td>\n<\/tr>\n<tr>\n<td width=\"104\">Imunitn\u00fd Syst\u00e9m<\/td>\n<td width=\"104\">Uvo\u013e\u0148ovanie HSP, aktiv\u00e1cia DC, priming T-buniek, up-regulation l\u00fdzy prostredn\u00edctvom NK\/CD8+-T<\/td>\n<td width=\"104\">Tumorov\u00fd Imunomodul\u00e1tor; Zosilnen\u00e1 Protin\u00e1dorov\u00e1 Imunita<\/td>\n<td width=\"104\">Imunoterapia, RT, CHT<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<figure id=\"attachment_11120\" aria-describedby=\"caption-attachment-11120\" style=\"width: 747px\" class=\"wp-caption alignnone\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-11120 size-full\" src=\"https:\/\/andromedichyperthermia.com\/wp-content\/uploads\/2025\/10\/mecanisme-biologice-hipertermie.jpg\" alt=\"Biologick\u00e9 Mechanizmy Hypertermie\" width=\"747\" height=\"412\" title=\"\" srcset=\"https:\/\/andromedichyperthermia.com\/wp-content\/uploads\/2025\/10\/mecanisme-biologice-hipertermie.jpg 747w, https:\/\/andromedichyperthermia.com\/wp-content\/uploads\/2025\/10\/mecanisme-biologice-hipertermie-300x165.jpg 300w\" sizes=\"auto, (max-width: 747px) 100vw, 747px\" \/><figcaption id=\"caption-attachment-11120\" class=\"wp-caption-text\">Biologick\u00e9 Mechanizmy Hypertermie<\/figcaption><\/figure>\n<h2>3. Synt\u00e9za D\u00f4kazov \u00darovne 1A: Metaanal\u00fdzy a Agregovan\u00e9 \u00dadaje<\/h2>\n<p>Robustn\u00e9 hodnotenie HT je zalo\u017een\u00e9 na agregovanej anal\u00fdze \u0161t\u00fadi\u00ed F\u00e1zy III. *Synt\u00e9za d\u00f4kazov \u00darovne 1A potvrdzuje, \u017ee pridanie HT k \u0161tandardnej lie\u010dbe poskytuje \u0161iroko roz\u0161\u00edren\u00fd klinick\u00fd pr\u00ednos vo viacer\u00fdch kateg\u00f3ri\u00e1ch n\u00e1dorov.*<\/p>\n<h3>3.1. Preh\u013ead V\u00fdsledkov Metaanal\u00fdz<\/h3>\n<p>*Ned\u00e1vna anal\u00fdza \u00fa\u010dinnosti HT identifikovala \u0161es\u0165 \u0161t\u00fadi\u00ed lokoregion\u00e1lnej HT, z ktor\u00fdch p\u00e4\u0165 preuk\u00e1zalo zv\u00fd\u0161enie Celkov\u00e9ho Pre\u017eitia (OS) a\/alebo zlep\u0161enie Miery Kompletnej Odpovede (CR) pridan\u00edm HT k \u0161tandardnej chemo- a\/alebo r\u00e1dioterapii [2]. To ustanovuje siln\u00fd vedeck\u00fd konsenzus podporuj\u00faci pou\u017eitie HT ako adjuvans \u00darovne 1A pre \u0161irok\u00fa \u0161k\u00e1lu lokoregion\u00e1lnych tumorov\u00fdch lokaliz\u00e1ci\u00ed.*<\/p>\n<h3>3.2. Kvantifik\u00e1cia Ziskov v Odpovedi a Pre\u017eit\u00ed<\/h3>\n<p>Klinick\u00e9 pr\u00ednosy HT s\u00fa kvantifikovan\u00e9 v kritick\u00fdch onkologick\u00fdch koncov\u00fdch bodoch (endpoints). Agregovan\u00e9 \u00fadaje pre *lok\u00e1lne pokro\u010dil\u00fa rakovinu kr\u010dka maternice (LACC)* preukazuj\u00fa:<\/p>\n<ul>\n<li>*Kompletn\u00e1 Odpove\u010f (CR):* CR sa v\u00fdznamne zlep\u0161uje s kombinovanou terapiou s HT (Relat\u00edvne Riziko \u2013 *RR 0.56, 95% CI 0.39 a\u017e 0.79; **p &lt; 0.001*).<\/li>\n<li>*Kontrola Lok\u00e1lnej Recid\u00edvy:* HT v\u00fdznamne zni\u017euje mieru lok\u00e1lnej recid\u00edvy (Pomer Rizika \u2013 *HR 0.48, 95% CI 0.37 a\u017e 0.63; **p &lt; 0.001*).<\/li>\n<li>*Celkov\u00e9 Pre\u017eitie (OS):* Multimod\u00e1lna lie\u010dba s HT vedie k lep\u0161iemu OS (HR *0.67, 95% CI 0.45 a\u017e 0.99; **p = 0.05*).<\/li>\n<\/ul>\n<h2><\/h2>\n<h2>4. Anal\u00fdza \u0160pecifick\u00fdch \u0160t\u00fadi\u00ed F\u00e1zy III pod\u013ea Typu Rakoviny<\/h2>\n<p>T\u00e1to podrobn\u00e1 anal\u00fdza sk\u00fama tumorov\u00e9 lokaliz\u00e1cie, kde je HT podporovan\u00e1 randomizovan\u00fdmi klinick\u00fdmi sk\u00fa\u0161kami najvy\u0161\u0161ieho kalibru, so zameran\u00edm na k\u013e\u00fa\u010dov\u00e9 koncov\u00e9 body pre\u017eitia a odpovede.<\/p>\n<h3><\/h3>\n<h3>4.1. Sark\u00f3m M\u00e4kk\u00fdch Tkan\u00edv (STM)<\/h3>\n<p>Sark\u00f3m m\u00e4kk\u00fdch tkan\u00edv je jednou z referen\u010dn\u00fdch indik\u00e1ci\u00ed so \u0161t\u00fadiami F\u00e1zy III, ktor\u00e9 podporuj\u00fa integr\u00e1ciu HT. Sk\u00fa\u0161ky porovn\u00e1vaj\u00face \u0161tandardn\u00fa neoadjuvantn\u00fa chemoterapiu s region\u00e1lnou hypertermiou (RHT) plus neoadjuvantn\u00e1 chemoterapia preuk\u00e1zali, \u017ee *pridanie HT vedie k zv\u00fd\u0161eniu pre\u017eitia* a *zlep\u0161eniu lok\u00e1lneho pre\u017eitia bez progresie (LPFS)*.<br \/>\nOkrem toho transla\u010dn\u00e9 anal\u00fdzy t\u00fdchto \u0161t\u00fadi\u00ed odhalili d\u00f4le\u017eit\u00fd imunologick\u00fd mechanizmus: kombinovan\u00e1 predopera\u010dn\u00e1 lie\u010dba s RHT preuk\u00e1zate\u013ene premie\u0148a fundament\u00e1lne nez\u00e1palov\u00fd tumor na z\u00e1palov\u00fd. Toto preprogramovanie tumorov\u00e9ho mikroprostredia umo\u017e\u0148uje v\u00e4\u010d\u0161iu protin\u00e1dorov\u00fa imunitn\u00fa aktivitu.<\/p>\n<h3>4.2. Gynekologick\u00e9 Karcin\u00f3my: Lok\u00e1lne Pokro\u010dil\u00e1 Rakovina Kr\u010dka Maternice (LACC)<\/h3>\n<p>D\u00f4kazy pre HT v LACC, pridan\u00e9 k S\u00fa\u010dasnej Chemo-r\u00e1dioterapii (CCRT), patria medzi najpresved\u010divej\u0161ie v onkol\u00f3gii.<\/p>\n<h4>4.2.1. Konsenzus \u0160t\u00fadi\u00ed (CR a Lok\u00e1lna Recid\u00edva)<\/h4>\n<p>Systematicky metaanal\u00fdzy a agregovan\u00e9 \u00fadaje z randomizovan\u00fdch sk\u00fa\u0161ok potvrdzuj\u00fa pr\u00ednos trimod\u00e1lnej lie\u010dby (CCRT + HT). *Anal\u00fdza agregovan\u00fdch \u00fadajov preuk\u00e1zala v\u00fdznamne vy\u0161\u0161iu mieru Kompletnej Odpovede (CR) s kombinovanou lie\u010dbou (RR 0.56; p &lt; 0.001) a ni\u017e\u0161iu mieru lok\u00e1lnej recid\u00edvy (HR 0.48; p &lt; 0.001). T\u00e1to superiorn\u00e1 lokoregion\u00e1lna kontrola urobila z trimod\u00e1lnej lie\u010dby udr\u017eate\u013en\u00fd a \u00fa\u010dinn\u00fd pr\u00edstup.*<\/p>\n<h4>4.2.2. Kvantifik\u00e1cia Celkov\u00e9ho Pre\u017eitia (OS)<\/h4>\n<p>*Celkov\u00e9 Pre\u017eitie (OS) je v\u00fdznamne zlep\u0161en\u00e9 kombin\u00e1ciou CCRT a HT: HR 0.67 (95% CI 0.45 a\u017e 0.99; p = 0.05).*<br \/>\n\u0160t\u00fadia F\u00e1zy III z Talianska hodnotiaca RT +- HT pre N3 skvam\u00f3zne cervik\u00e1lne lymfatick\u00e9 uzliny vtedaj\u0161ej doby preuk\u00e1zala v\u00fdznamn\u00fd rozdiel: *miera CR v skupine lie\u010denej kombinovanou terapiou bola 82.3%, zatia\u013e \u010do v skupine onkologick\u00fdch pacientov lie\u010den\u00fdch len r\u00e1dioterapiou bola **36.8%* [3,4]. Dlhodob\u00e1 anal\u00fdza rovnakej \u0161t\u00fadie uviedla *5-ro\u010dn\u00e9 Celkov\u00e9 Pre\u017eitie 55%* v ramene hypertermie, v porovnan\u00ed s *0%* v ramene len o\u017eiarenia [3,4].<\/p>\n<h4>4.2.3. Dodato\u010dn\u00e9 D\u00f4kazy (OS)<\/h4>\n<p>Najsilnej\u0161ia \u00farove\u0148 dodato\u010dn\u00fdch d\u00f4kazov poch\u00e1dza z *Rakoviny Kr\u010dka Maternice (Cervix)*, \u0161tudovanej v po\u010detn\u00fdch randomizovan\u00fdch sk\u00fa\u0161kach kombinuj\u00facich Lokoregion\u00e1lnu Hypertermiu s R\u00e1dioterapiou (RT) alebo Chemo-r\u00e1dioterapiou (CTRT).<\/p>\n<p>Tieto v\u00fdsledky (d\u00f4kazy vysokej \u00farovne pre rakovinu kr\u010dka maternice) poch\u00e1dzaj\u00fa z metaanal\u00fdz porovn\u00e1vaj\u00facich \u0161tandardn\u00fa lie\u010dbu (RT alebo CTRT) s kombinovanou lie\u010dbou (RT\/CTRT + Hypertermia):<\/p>\n<table width=\"624\">\n<thead>\n<tr>\n<td width=\"208\">Klinick\u00fd Ukazovate\u013e<\/td>\n<td width=\"208\">V\u00fdsledok Dosiahnut\u00fd s RT + Hypertermia<\/td>\n<td width=\"208\">Referencia (Presk\u00faman\u00e9 Recenzie)<\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td width=\"208\"><strong>Kompletn\u00e1 Odpove\u010f (CR)<\/strong><\/td>\n<td width=\"208\">Konzistentn\u00e9 zlep\u0161enie miery CR: <strong>+22.1%<\/strong> v porovnan\u00ed s len RT.<\/td>\n<td width=\"208\">Metaanal\u00fdza<\/td>\n<\/tr>\n<tr>\n<td width=\"208\"><strong>Lokoregion\u00e1lna Kontrola (LRC)<\/strong><\/td>\n<td width=\"208\">V\u00fdznamn\u00e9 zlep\u0161enie: <strong>+23.1%<\/strong> v porovnan\u00ed s len RT.<\/td>\n<td width=\"208\">Metaanal\u00fdza<\/td>\n<\/tr>\n<tr>\n<td width=\"208\"><strong>Celkov\u00e9 Pre\u017eitie (OS)<\/strong><\/td>\n<td width=\"208\">Bolo pozorovan\u00e9 zlep\u0161enie dlhodob\u00e9ho celkov\u00e9ho pre\u017eitia (OS) pridan\u00edm Hypertermie (HR 0.67; p = 0.03).<\/td>\n<td width=\"208\">Aktualizovan\u00e1 Metaanal\u00fdza<\/td>\n<\/tr>\n<tr>\n<td width=\"208\"><strong>Pre\u017eitie Bez Ochorenia (DFS)<\/strong><\/td>\n<td width=\"208\">V\u00fdznamn\u00e9 zlep\u0161enie v DFS po 2 a 3 rokoch v kombin\u00e1cii s CTRT.<\/td>\n<td width=\"208\">Randomizovan\u00e9 \u0160t\u00fadie F\u00e1zy III<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<ul>\n<li>*N\u00e1zov:* Combined use of hyperthermia and radiation therapy for treating locally advanced cervical carcinoma<\/li>\n<li>*Autori:* Lutgens L, van der Zee J, Pijls-Johannesma M, et al.<\/li>\n<li>*Odkaz na PubMed (Aktualiz\u00e1cia 2010):* <a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/20091593\/\" target=\"_blank\" rel=\"noopener\">https:\/\/pubmed.ncbi.nlm.nih.gov\/20091593\/<\/a><\/li>\n<\/ul>\n<h5>4.2.3.2. Sie\u0165ov\u00e1 Metaanal\u00fdza (NMA): Najlep\u0161ie Strat\u00e9gie (Datta et al. 2019)<\/h5>\n<p>T\u00e1to \u0161t\u00fadia pou\u017eila pokro\u010dil\u00fa met\u00f3du (Network Meta-analysis) na porovnanie Hypertermie s 13 in\u00fdmi terapeutick\u00fdmi intervenciami, \u010d\u00edm ju zaradila medzi najlep\u0161ie mo\u017enosti.<\/p>\n<table width=\"624\">\n<thead>\n<tr>\n<td width=\"312\">Potvrden\u00e9 Ukazovatele<\/td>\n<td width=\"312\">K\u013e\u00fa\u010dov\u00fd V\u00fdsledok<\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td width=\"312\"><strong>Zoradenie Lie\u010dby<\/strong><\/td>\n<td width=\"312\"><strong>RT+HT<\/strong> a *CTRT+HT* boli zaraden\u00e9 medzi prv\u00e9 tri intervencie s najlep\u0161\u00edm komplexn\u00fdm \u00fa\u010dinkom na LRC, OS a toxicitu.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<ul>\n<li>*N\u00e1zov:* Efficacy and Safety Evaluation of the Various Therapeutic Options in Locally Advanced Cervix Cancer: A Systematic Review and Network Meta-Analysis of Randomized Clinical Trials<\/li>\n<li>*Autori:* Datta NR, Stutz E, Gomez S, Bodis S.<\/li>\n<li>*Odkaz na PubMed:* <a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/30391522\/\" target=\"_blank\" rel=\"noopener\">https:\/\/pubmed.ncbi.nlm.nih.gov\/30391522\/<\/a><\/li>\n<\/ul>\n<h5>4.2.3.3. \u0160t\u00fadia F\u00e1zy III: Pre\u017eitie Bez Ochorenia (DFS) a Kvalita \u017divota (QoL) s mEHT<\/h5>\n<p>Toto je jedna z najnov\u0161\u00edch \u0161t\u00fadi\u00ed F\u00e1zy III, ktor\u00e1 potvrdzuje pr\u00ednosy, ako je zlep\u0161enie DFS a Kvality \u017divota (QoL), s modernou technikou Hypertermie (mEHT) pridanou k Chemo-r\u00e1dioterapii (CTRT).<\/p>\n<table width=\"624\">\n<thead>\n<tr>\n<td width=\"312\">Potvrden\u00e9 Ukazovatele<\/td>\n<td width=\"312\">K\u013e\u00fa\u010dov\u00fd V\u00fdsledok<\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td width=\"312\"><strong>Pre\u017eitie Bez Ochorenia (DFS)<\/strong><\/td>\n<td width=\"312\">V\u00fdznamn\u00e9 zlep\u0161enie v DFS po 2 a 3 rokoch s pridan\u00edm mEHT k CTRT.<\/td>\n<\/tr>\n<tr>\n<td width=\"312\"><strong>Kvalita \u017divota (QoL)<\/strong><\/td>\n<td width=\"312\">V\u00fdznamn\u00e9 zlep\u0161enie QoL bez zv\u00fd\u0161enia toxicity.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<ul>\n<li>*N\u00e1zov:* Effects of Modulated Electro-Hyperthermia (mEHT) on Two and Three Year Survival of Locally Advanced Cervical Cancer Patients<\/li>\n<li>*Autori:* Minnaar CA, Maposa I, Kotzen JA, et al.<\/li>\n<li>*Odkaz na MDPI (Dostupn\u00fd Cel\u00fd Text):* <a href=\"https:\/\/www.mdpi.com\/2072-6694\/14\/3\/656\" target=\"_blank\" rel=\"noopener\">https:\/\/www.mdpi.com\/2072-6694\/14\/3\/656<\/a><\/li>\n<\/ul>\n<p>Pre lok\u00e1lne pokro\u010dil\u00fa rakovinu kr\u010dka maternice, pridanie lokoregion\u00e1lnej Hypertermie nielen\u017ee zvy\u0161uje mo\u017enos\u0165 lok\u00e1lnej eradik\u00e1cie tumoru (CR), ale m\u00e1 aj v\u00fdznamn\u00fd a pozit\u00edvny vplyv na dlhodob\u00e9 pre\u017eitie (OS a DFS).<\/p>\n<h3>4.3. N\u00e1dory Hlavy a Krku (HNC)<\/h3>\n<p>Lokoregion\u00e1lna Hypertermia je lie\u010dba *\u00darovne 1A* pre nieko\u013eko n\u00e1dorov hlavy a krku, vr\u00e1tane recid\u00edv a pokro\u010dil\u00e9ho ochorenia, kde m\u00e1 priamy vplyv na lok\u00e1lnu kontrolu, kvalitu \u017eivota a pre\u017eitie.<\/p>\n<h4>4.3.1. \u00dadaje z Randomizovan\u00fdch Sk\u00fa\u0161ok F\u00e1zy III<\/h4>\n<p>*Prospekt\u00edvne, randomizovan\u00e9 \u0161t\u00fadie F\u00e1zy III zdokumentovali jasn\u00e9 pr\u00ednosy kombinovania Chemo-r\u00e1dioterapie (CRT) s HT pri nazofarynge\u00e1lnom karcin\u00f3me (NPC) v porovnan\u00ed s len CRT.*<br \/>\n\u25cf *<a href=\"https:\/\/doi.org\/10.7314\/apjcp.2013.14.12.7395\" target=\"_blank\" rel=\"noopener\">Kang 2013<\/a> (NPC):* T\u00e1to \u0161t\u00fadia F\u00e1zy III uviedla v\u00fdznamn\u00e9 zlep\u0161enie. *5-ro\u010dn\u00e9 Pre\u017eitie Bez Ochorenia (DFS) sa zv\u00fd\u0161ilo z 25.5% na 51.3% (p &lt; 0.005), a **5-ro\u010dn\u00e9 OS sa zv\u00fd\u0161ilo z 50% na 68.4% (p &lt; 0.005)*. Miera CR sa tie\u017e zv\u00fd\u0161ila zo 62.8% na 81.6%.<br \/>\n\u25cf *<a href=\"https:\/\/journals.lww.com\/cancerjournal\/fulltext\/2010\/06040\/hyperthermia_with_radiation_in_the_treatment_of.16.aspx\" target=\"_blank\" rel=\"noopener\">Huilgol 2010<\/a> (\u00dastna Dutina\/Orofarynx\/Hypofarynx):* Kompletn\u00e1 odpove\u010f bola zaznamenan\u00e1 u *78.6%* skupiny lie\u010denej HT, v porovnan\u00ed so *42.4%* v skupine lie\u010denej len r\u00e1dioterapiou. Rozdiel bol \u0161tatisticky v\u00fdznamn\u00fd (&lt; 0.05).<br \/>\nV\u00fdznamn\u00e9 a konzistentn\u00e9 zisky v DFS a OS pri HNC, kde s\u00fa miery lok\u00e1lnej recid\u00edvy \u010dasto vysok\u00e9, zd\u00f4raz\u0148uj\u00fa \u00fa\u010dinnos\u0165 HT pri prekon\u00e1van\u00ed lok\u00e1lnej r\u00e1dio-rezistencie, \u010d\u00edm sa st\u00e1va z\u00e1kladnou zlo\u017ekou kurat\u00edvnej lie\u010dby [5].<\/p>\n<h3>4.4. Gastrointestin\u00e1lne Karcin\u00f3my: Rekt\u00e1lny a An\u00e1lny Karcin\u00f3m<\/h3>\n<p>Integr\u00e1cia HT do Neoadjuvantnej Chemo-r\u00e1dioterapie (CRT) pri lok\u00e1lne pokro\u010dilom rekt\u00e1lnom karcin\u00f3me preuk\u00e1zala kritick\u00e9 pr\u00ednosy v lokoregion\u00e1lnej kontrole a pre\u017eit\u00ed.<\/p>\n<h4>4.4.1. V\u00fdsledky F\u00e1zy III pre Rekt\u00e1lny Karcin\u00f3m<\/h4>\n<p>Prospekt\u00edvna randomizovan\u00e1 sk\u00fa\u0161ka *<a href=\"https:\/\/link.springer.com\/article\/10.1007\/s00066-018-1396-x\" target=\"_blank\" rel=\"noopener\">Ott 2019<\/a>* porovnala CRT s CRT + HT a uviedla v\u00fdznamn\u00e9 zlep\u0161enia v ramene HT po 5 rokoch:<br \/>\n*\u25cf Celkov\u00e9 Pre\u017eitie (OS): 95.8% oproti 74.5% (P = 0.045).*<br \/>\n*\u25cf Pre\u017eitie Bez Ochorenia (DFS): 89.1% oproti 70.4% (P = 0.027).*<br \/>\n*\u25cf Pre\u017eitie Bez Lok\u00e1lnej Recid\u00edvy (LRFS): 97.7% oproti 78.7% (P = 0.006).*<\/p>\n<h4>4.4.2. Patologick\u00e1 Odpove\u010f a Klinick\u00e9 D\u00f4sledky<\/h4>\n<p>Miera Patologickej Kompletnej Odpovede (pCR) sa tie\u017e zlep\u0161ila pridan\u00edm HT, pri\u010dom metaanal\u00fdza preuk\u00e1zala n\u00e1rast zo 16% (CRT) na *22.5% (CRT+HT, p = 0.043). **K\u013e\u00fa\u010dov\u00e9 je, \u017ee superiorn\u00e1 miera LRFS (97.7%) a zlep\u0161enia v mierach pre\u017eitia bez kolost\u00f3mie (87.7% oproti 69.0%, P = 0.016) zd\u00f4raz\u0148uj\u00fa \u00falohu HT nielen pri lok\u00e1lnej tumorovej steriliz\u00e1cii, ale aj v strat\u00e9gi\u00e1ch zachovania sfinktera.*<\/p>\n<p>&nbsp;<\/p>\n<h3>4.5. Mal\u00edgny Melan\u00f3m (Lokoregion\u00e1lne Ochorenie)<\/h3>\n<p>*Z\u00e1kladn\u00e9 sk\u00fa\u0161ky F\u00e1zy III (<a href=\"https:\/\/pubmed.ncbi.nlm.nihs.gov\/7776772\/\" target=\"_blank\" rel=\"noopener\">Overgaard et al., 1995<\/a>) preuk\u00e1zali, \u017ee kombinovanie r\u00e1dioterapie s HT zlep\u0161uje Mieru Kompletnej Odpovede a OS pri pokro\u010dilom melan\u00f3me.*<\/p>\n<p>*K\u013e\u00fa\u010dov\u00e9 V\u00fdsledky: RT + Hypertermia oproti R\u00e1dioterapii*<\/p>\n<p>Eur\u00f3pska multicentrick\u00e1 \u0161t\u00fadia randomizovala 134 l\u00e9zi\u00ed metastatick\u00e9ho alebo recidivuj\u00faceho melan\u00f3mu u 70 pacientov tak, aby dostali len r\u00e1dioterapiu alebo r\u00e1dioterapiu nasledovan\u00fa hypertermiou (43 \u00b0C po\u010das 60 min\u00fat).<\/p>\n<h5>1. Lok\u00e1lna Kontrola Tumoru (Prim\u00e1rny Koncov\u00fd Bod)<\/h5>\n<p>Najv\u00fdznamnej\u0161\u00edm v\u00fdsledkom bolo v\u00fdrazn\u00e9 zlep\u0161enie dlhodobej lok\u00e1lnej kontroly tumoru.<\/p>\n<table width=\"624\">\n<thead>\n<tr>\n<td width=\"156\">Ukazovate\u013e<\/td>\n<td width=\"156\">Len R\u00e1dioterapia (RT)<\/td>\n<td width=\"156\">R\u00e1dioterapia + Hypertermia (RT + HT)<\/td>\n<td width=\"156\">K\u013e\u00fa\u010dov\u00fd Rozdiel<\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td width=\"156\"><strong>Aktu\u00e1rska Lok\u00e1lna Kontrola po 2 Rokoch<\/strong><\/td>\n<td width=\"156\"><strong>28%<\/strong><\/td>\n<td width=\"156\"><strong>46%<\/strong><\/td>\n<td width=\"156\"><strong>V\u00fdznamn\u00e9 zlep\u0161enie (p = 0.008)<\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<ul>\n<li>*Z\u00e1ver:* Pridanie HT zv\u00fd\u0161ilo lok\u00e1lnu kontrolu tumoru o *18 percentu\u00e1lnych bodov* po 2 rokoch.<\/li>\n<\/ul>\n<h5>2. Multivari\u00e1tna Anal\u00fdza (Prognostick\u00e9 Faktory)<\/h5>\n<p>Coxova multivari\u00e1tna regresn\u00e1 anal\u00fdza potvrdila, \u017ee *hypertermia* bola najd\u00f4le\u017eitej\u0161\u00edm prognostick\u00fdm faktorom pre lok\u00e1lnu kontrolu po 2 rokoch.<\/p>\n<table width=\"624\">\n<thead>\n<tr>\n<td width=\"208\">Prognostick\u00e1 Premenn\u00e1<\/td>\n<td width=\"208\">Riziko (Odds Ratio)<\/td>\n<td width=\"208\">P-hodnota<\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td width=\"208\"><strong>Hypertermia<\/strong><\/td>\n<td width=\"208\"><strong>1.73<\/strong> (pre lok\u00e1lnu kontrolu)<\/td>\n<td width=\"208\"><strong>p = 0.023<\/strong><\/td>\n<\/tr>\n<tr>\n<td width=\"208\">D\u00e1vka \u017diarenia<\/td>\n<td width=\"208\">1.17<\/td>\n<td width=\"208\">p = 0.05<\/td>\n<\/tr>\n<tr>\n<td width=\"208\">Ve\u013ekos\u0165 Tumoru<\/td>\n<td width=\"208\">0.91<\/td>\n<td width=\"208\">p = 0.05<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<ul>\n<li>*Z\u00e1ver:* Toto ukazuje, \u017ee pr\u00ednos poskytovan\u00fd HT je nez\u00e1visl\u00fd a rovnako v\u00fdznamn\u00fd ako d\u00e1vka \u017eiarenia a ve\u013ekos\u0165 tumoru.<\/li>\n<\/ul>\n<h5>3. Pre\u017eitie (Lok\u00e1lna Kontrola je Kurat\u00edvna)<\/h5>\n<p>\u0160t\u00fadia si v\u0161imla siln\u00fa s\u00favislos\u0165 medzi \u00faspe\u0161nou lok\u00e1lnou kontrolou a dlhodob\u00fdm pre\u017eit\u00edm:<\/p>\n<ul>\n<li>*5-ro\u010dn\u00e9 Celkov\u00e9 Pre\u017eitie:* Celkov\u00e1 miera bola 19%.<\/li>\n<li>*Pre\u017eitie po 5 rokoch u pacientov s kompletnou kontrolou ochorenia:* Zv\u00fd\u0161ilo sa na *38%*.<\/li>\n<li>*Z\u00e1ver:* \u00daspe\u0161n\u00e1 lok\u00e1lna kontrola jednej alebo viacer\u00fdch metastatick\u00fdch l\u00e9zi\u00ed mala *v\u00fdznamn\u00fd kurat\u00edvny potenci\u00e1l*, zd\u00f4raz\u0148uj\u00fac d\u00f4le\u017eitos\u0165 zv\u00fd\u0161enej lok\u00e1lnej \u00fa\u010dinnosti HT.<\/li>\n<\/ul>\n<h5>4. Toxicita a Bezpe\u010dnos\u0165<\/h5>\n<ul>\n<li>Pridanie tepla *v\u00fdznamne nezv\u00fd\u0161ilo* ak\u00fatne alebo neskor\u00e9 reakcie na \u017eiarenie.<\/li>\n<li>Lie\u010dba zahrievan\u00edm bola vo v\u0161eobecnosti *dobre tolerovan\u00e1*.<\/li>\n<\/ul>\n<p>*Pozn\u00e1mka:* \u0160t\u00fadia spomenula \u0165a\u017ekosti pri dosahovan\u00ed cie\u013ea term\u00e1lneho protokolu (43 \u00b0C), pri\u010dom sa to podarilo len v 14% lie\u010debn\u00fdch postupov.<\/p>\n<h3>4.6 Recidivuj\u00faca Rakovina Prsn\u00edka<\/h3>\n<h4>4.6.1. Metaanal\u00fdza Potvrdzuj\u00faca \u00da\u010dinnos\u0165 Termo-R\u00e1dioterapie pri Recidivuj\u00facej Rakovine Prsn\u00edka<\/h4>\n<p>Metaanal\u00fdza zjednocuje \u00fadaje z klinick\u00fdch sk\u00fa\u0161ok F\u00e1zy III, ktor\u00e9 nazna\u010duj\u00fa superiorn\u00fa Mieru Kompletnej Odpovede (CR) pre kombinovan\u00fa lie\u010dbu (R\u00e1dioterapia + Hypertermia) pre *lokoregion\u00e1lnu recidivuj\u00facu rakovinu prsn\u00edka (LRBC)*.<\/p>\n<p>Toto je \u0161t\u00fadia podporuj\u00faca zistenia d\u00f4kazov \u00darovne 1A, ktor\u00e9 zah\u0155\u0148aj\u00fa miery *CR 60-66%* pre kombinovan\u00fa lie\u010dbu:<br \/>\n* *\u0160t\u00fadia:* Hyperthermia and Radiation Therapy in Locoregional Recurrent Breast Cancers: A Systematic Review and Meta-analysis.<br \/>\n* *Autori:* Datta NR, Puric E, Klingbiel D, Gomez S, Bodis S.<br \/>\n* *Publikovan\u00e9 v:* International Journal of Radiation Oncology Biology Physics, 2016.<\/p>\n<p>*Z\u00e1ver:* Termo-R\u00e1dioterapia (RT + Hypertermia) zvy\u0161uje Mieru Kompletnej Odpovede (CR) o pribli\u017ene *22%* v porovnan\u00ed s len r\u00e1dioterapiou; v \u0161t\u00fadi\u00e1ch porovn\u00e1vaj\u00facich obe ramen\u00e1 lie\u010dby bola miera CR *60.2%* dosiahnut\u00e1 s RT + Hypertermia (HT), oproti 38.1% s len RT (R\u00e1dioterapia). Miera CR dosiahla *66.6%* v pr\u00edpade re-o\u017eiarenia s hypertermiou.<\/p>\n<h4>4.6.2 Recid\u00edva Rakoviny Prsn\u00edka v Hrudnej Stene<\/h4>\n<p>Hypertermia, zvy\u010dajne v kombin\u00e1cii s RT, m\u00e1 d\u00f4kazy *\u00darovne 1A* pre lie\u010dbu recid\u00edv rakoviny prsn\u00edka v hrudnej stene. T\u00e1to kombin\u00e1cia je obzvl\u00e1\u0161\u0165 cenn\u00e1 v kontexte recid\u00edvy hrudnej steny, kde s\u00fa mo\u017enosti lie\u010dby \u010dasto obmedzen\u00e9. \u0160t\u00fadie preukazuj\u00fa vysok\u00e9 Miery Kompletnej Odpovede (CR) v rozsahu *40% a\u017e 86%* a Miery Lok\u00e1lnej Kontroly (LC) medzi *70% a 76%, ke\u010f sa RT kombinuje s HT. Okrem toho m\u00f4\u017eu miery 5-ro\u010dn\u00e9ho OS pre toto recidivuj\u00face ochorenie dosiahnu\u0165 a\u017e **50%*. Kombin\u00e1cia RT+HT pon\u00faka \u00fa\u010dinn\u00fa lok\u00e1lnu strat\u00e9giu pre pali\u00e1ciu a dlhodob\u00fa kontrolu.<\/p>\n<h4>4.6.3. V\u0161eobecn\u00fd Trend v Lokoregion\u00e1lnej Lie\u010dbe &#8211; In\u00e9 Onkologick\u00e9 Indik\u00e1cie s D\u00f4kazmi \u00darovne 1<\/h4>\n<p>Generaliz\u00e1cia v\u00fdsledkov pre lokoregion\u00e1lne lie\u010dby:<br \/>\n* *Konsolid\u00e1cia D\u00f4kazov:* In\u00fd systematick\u00fd preh\u013ead (prv\u00fd bol Hildenbrandt et al.) odha\u013euje, \u017ee *5 zo 6 \u0161t\u00fadi\u00ed F\u00e1zy III* (zameran\u00fdch na povrchov\u00e9 a lokoregion\u00e1lne tumory, vr\u00e1tane prsn\u00edka, hlavy a krku, melan\u00f3mu) preuk\u00e1zalo zv\u00fd\u0161enie *Celkov\u00e9ho Pre\u017eitia (OS)* a\/alebo *Kompletnej Odpovede (CR)*, ke\u010f bola Hypertermia pridan\u00e1 k \u0161tandardnej lie\u010dbe [2].<br \/>\n* *Paliat\u00edvne Aplik\u00e1cie:* \u0160t\u00fadie nazna\u010duj\u00fa, \u017ee Hypertermia, ke\u010f sa kombinuje s RT, vedie k v\u00fdznamn\u00e9mu zv\u00fd\u0161eniu *Kompletnej Odpovede na Boles\u0165* pri bolestiv\u00fdch kostn\u00fdch metast\u00e1zach, s v\u00fdrazn\u00fdm zlep\u0161en\u00edm Kvality \u017divota (QoL) pacientov.<\/p>\n<h3>4.7. Karcin\u00f3m Mo\u010dov\u00e9ho Mech\u00fara: Hypertermick\u00e1 Intravezik\u00e1lna Chemoterapia (HIVEC)<\/h3>\n<p>Hypertermick\u00e1 Intravezik\u00e1lna Chemoterapia (HIVEC) zah\u0155\u0148a zahrievanie Mitomyc\u00ednu C (MMC) (typicky na 43 \u00b0C) po\u010das intravezik\u00e1lnej instil\u00e1cie pre nemuskul\u00e1rne invaz\u00edvny karcin\u00f3m mo\u010dov\u00e9ho mech\u00fara (NMIBC).<\/p>\n<h4>4.7.1. V\u00fdsledky \u0160t\u00fadie HIVEC-1 F\u00e1zy III<\/h4>\n<p>\u0160t\u00fadia HIVEC-1 bola randomizovan\u00e1 sk\u00fa\u0161ka F\u00e1zy 3 navrhnut\u00e1 na porovnanie pre\u017eitia bez recid\u00edvy (RFS) s MMC v normotermii.<br \/>\nRFS po 24 mesiacoch v ITT popul\u00e1cii bolo 77% v kontrolnom ramene (normotermia), oproti 82% (30 min) a 80% (60 min) v ramene HT. \u0160t\u00fadia dospela k z\u00e1veru, \u017ee HT nebola \u0161tatisticky superiorn\u00e1 vo\u010di MMC v normotermii, pokia\u013e ide o RFS po 24 mesiacoch (p-hodnota 0.6) [6].<\/p>\n<h4>4.7.2. Nuansy a Pre\u017eitie Bez Progresie<\/h4>\n<p>Na rozdiel od v\u00fdsledkov RFS pre NMIBC-AR, \u00fadaje z in\u00fdch \u0161t\u00fadi\u00ed zd\u00f4raz\u0148uj\u00fa pr\u00ednosy, najm\u00e4 pre vysoko rizikov\u00fdch pacientov, ktor\u00ed zlyhali na lie\u010dbe BCG. Jedna anal\u00fdza preuk\u00e1zala *v\u00fdznamne lep\u0161ie Pre\u017eitie Bez Progresie (PFS) pre HIVEC v porovnan\u00ed s BCG* v ITT anal\u00fdze (95.7% oproti 71.8%; p = 0.043) [7].<\/p>\n<p>&nbsp;<\/p>\n<p>*Tabu\u013eka 2 zhr\u0148uje k\u013e\u00fa\u010dov\u00e9 klinick\u00e9 v\u00fdsledky F\u00e1zy III pre integr\u00e1ciu hypertermie.*<\/p>\n<p>Tabu\u013eka 2: K\u013e\u00fa\u010dov\u00e9 Klinick\u00e9 V\u00fdsledky F\u00e1zy III pre Hypertermiu v Onkol\u00f3gii (HT + \u0160tandardn\u00e1 Lie\u010dba oproti Len \u0160tandardnej Lie\u010dbe)<\/p>\n<p>&nbsp;<\/p>\n<table width=\"624\">\n<thead>\n<tr>\n<td width=\"104\"><strong>Typ Rakoviny (Met\u00f3da HT)<\/strong><\/td>\n<td width=\"104\"><strong>Typ \u0160t\u00fadie\/Ukazovate\u013e<\/strong><\/td>\n<td width=\"104\"><strong>HT + \u0160tandardn\u00e1 Lie\u010dba<\/strong><\/td>\n<td width=\"104\"><strong>Len \u0160tandardn\u00e1 Lie\u010dba<\/strong><\/td>\n<td width=\"104\"><strong>\u0160tatistick\u00e1 V\u00fdznamnos\u0165\/V\u00fdsledok Ukazovate\u013ea<\/strong><\/td>\n<td width=\"104\"><strong>Referencia<\/strong><\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td width=\"104\">Sark\u00f3m M\u00e4kk\u00fdch Tkan\u00edv (L-R HT + CHT) 11.3 roka<\/td>\n<td width=\"104\">Randomizovan\u00e1 F\u00e1za III (<\/p>\n<p>OS po 5 r.<\/p>\n<p>&nbsp;<\/p>\n<p>OS po 10 r.)<\/td>\n<td width=\"104\">62.7%<\/p>\n<p>&nbsp;<\/p>\n<p>52.6%<\/td>\n<td width=\"104\">51.3%<\/p>\n<p>&nbsp;<\/p>\n<p>42.7%<\/td>\n<td width=\"104\">V porovnan\u00ed s len neoadjuvantnou chemoterapiou, pridanie region\u00e1lnej hypertermie zlep\u0161ilo *lok\u00e1lne pre\u017eitie bez ochorenia DFS* (Pomer Rizika [HR], 0.65; 95% CI, 0.49\u20130.86; P = 0.002).<\/p>\n<p>Pacienti randomizovan\u00ed na chemoterapiu plus hypertermiu dosiahli dlh\u0161ie *Celkov\u00e9 Pre\u017eitie OS* ako t\u00ed randomizovan\u00ed na len neoadjuvantn\u00fa chemoterapiu (HR, 0.73; 95% CI, 0.54\u20130.98; P = 0.04), s pre\u017eit\u00edm po 5 rokoch 62.7% oproti 51.3% a po 10 rokoch 52.6% oproti 42.7%, v uvedenom porad\u00ed.<\/td>\n<td width=\"104\"><a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/29450452\/\" target=\"_blank\" rel=\"noopener\">https:\/\/pubmed.ncbi.nlm.nih.gov\/29450452\/<\/a><\/td>\n<\/tr>\n<tr>\n<td width=\"104\">Rakovina Kr\u010dka Maternice (LACC) (L-R HT + RT) 12 rokov<\/td>\n<td width=\"104\">Randomizovan\u00e1 F\u00e1za III (<strong>OS po 12 r.<\/strong>)<\/td>\n<td width=\"104\">37%<\/td>\n<td width=\"104\">20%<\/td>\n<td width=\"104\">V\u00fdznamne lep\u0161\u00ed OS (P &lt; 0.05)<\/td>\n<td width=\"104\"><a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/17881144\/\" target=\"_blank\" rel=\"noopener\">https:\/\/pubmed.ncbi.nlm.nih.gov\/17881144\/<\/a><\/td>\n<\/tr>\n<tr>\n<td width=\"104\">Rekt\u00e1lny Karcin\u00f3m (CRT + HT) 5 rokov<\/td>\n<td width=\"104\">Randomizovan\u00e1 F\u00e1za III<\/p>\n<p>(<strong>OS po 5 r.<\/strong>,<\/p>\n<p>&nbsp;<\/p>\n<p>DFS po 5 r.<\/p>\n<p>&nbsp;<\/p>\n<p>Pre\u017eitie Bez Lok\u00e1lnej Recid\u00edvy LRF po 5 r.<\/p>\n<p>&nbsp;<\/p>\n<p>Pre\u017eitie Bez Kolost\u00f3mie CFSR po 5 r.<\/p>\n<p>&nbsp;<\/td>\n<td width=\"104\">95.8%<\/p>\n<p>&nbsp;<\/p>\n<p>89.1%<\/p>\n<p>&nbsp;<\/p>\n<p>97.7%<\/p>\n<p>&nbsp;<\/p>\n<p>87.7%<\/td>\n<td width=\"104\">74.5%<\/p>\n<p>&nbsp;<\/p>\n<p>70.4%<\/p>\n<p>&nbsp;<\/p>\n<p>78.7%<\/p>\n<p>&nbsp;<\/p>\n<p>69.0%<\/td>\n<td width=\"104\">Zlep\u0161enie v OS (P = 0.045)<\/p>\n<p>&nbsp;<\/p>\n<p>Zlep\u0161enie v DFS ( <i>P<\/i>\u202f=\u20090.027),<\/p>\n<p>&nbsp;<\/p>\n<p>Zlep\u0161enie v LRF ( <i>P<\/i>\u202f=\u20090.006),<\/p>\n<p>&nbsp;<\/p>\n<p>Zlep\u0161enie v CFSR ( <i>P<\/i>\u202f=\u20090.016))<\/p>\n<p>&nbsp;<\/td>\n<td width=\"104\"><a href=\"https:\/\/link.springer.com\/article\/10.1007\/s00066-018-1396-x\" target=\"_blank\" rel=\"noopener\">https:\/\/link.springer.com\/article\/10.1007\/s00066-018-1396-x<\/a><\/td>\n<\/tr>\n<tr>\n<td width=\"104\">N\u00e1dor Hlavy a Krku NPC (CRT + HT)<\/td>\n<td width=\"104\">Randomizovan\u00e1 F\u00e1za III (DFS po 5 r.<\/p>\n<p>a<\/p>\n<p>OS po 5 r.<\/p>\n<p>a<\/p>\n<p>CR )<\/td>\n<td width=\"104\">51.3%<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>68.4%<\/p>\n<p>&nbsp;<\/p>\n<p>81.6%<\/td>\n<td width=\"104\">25.5%<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>50%<\/p>\n<p>&nbsp;<\/p>\n<p>62.8%<\/td>\n<td width=\"104\">T\u00e1to \u0161t\u00fadia F\u00e1zy III preuk\u00e1zala v\u00fdznamn\u00e9 zlep\u0161enie.<\/td>\n<td width=\"104\"><strong><a href=\"https:\/\/doi.org\/10.7314\/apjcp.2013.14.12.7395\" target=\"_blank\" rel=\"noopener\">Kang 2013<\/a><\/strong><\/td>\n<\/tr>\n<tr>\n<td width=\"104\">N\u00e1dor Hlavy a Krku <strong>\u00dastna Dutina\/Orofarynx\/Hypofarynx<\/strong> (RT + HT)<\/td>\n<td width=\"104\">Randomizovan\u00e1 F\u00e1za III (CR)<\/td>\n<td width=\"104\">78.6%<\/td>\n<td width=\"104\">42.4%<\/td>\n<td width=\"104\">Rozdiel bol \u0161tatisticky v\u00fdznamn\u00fd (&lt; 0.05). Kaplan-Meierova anal\u00fdza pre\u017eitia tie\u017e preuk\u00e1zala v\u00fdznamn\u00e9 zlep\u0161enie v prospech r\u00e1dio-HT.<\/td>\n<td width=\"104\"><strong><a href=\"https:\/\/journals.lww.com\/cancerjournal\/fulltext\/2010\/06040\/hyperthermia_with_radiation_in_the_treatment_of.16.aspx\" target=\"_blank\" rel=\"noopener\">Huilgol 2010<\/a><\/strong><\/td>\n<\/tr>\n<tr>\n<td width=\"104\">Mal\u00edgny Melan\u00f3m (RT + HT)<\/td>\n<td width=\"104\">Randomizovan\u00e1 F\u00e1za III (CR)<\/td>\n<td width=\"104\">46%<\/td>\n<td width=\"104\">28%<\/td>\n<td width=\"104\">V\u00fdznamn\u00e9 zlep\u0161enie v lok\u00e1lnej kontrole po 2 rokoch (p = 0.008)<\/td>\n<td width=\"104\"><a href=\"https:\/\/pubmed.ncbi.nlm.nihs.gov\/7776772\/\" target=\"_blank\" rel=\"noopener\">https:\/\/pubmed.ncbi.nlm.nihs.gov\/7776772\/<\/a><\/td>\n<\/tr>\n<tr>\n<td width=\"104\">Recidivuj\u00faca Rakovina Prsn\u00edka (RT + HT) &#8211; HT zahrnut\u00e1 v NCCN smerniciach<\/td>\n<td width=\"104\">Randomizovan\u00e1 F\u00e1za III (CR)<\/td>\n<td width=\"104\">60.2%<\/td>\n<td width=\"104\">38.1%<\/td>\n<td width=\"104\">Miera CR zv\u00fd\u0161en\u00e1 o 57%<\/td>\n<td width=\"104\"><a href=\"https:\/\/www.sciencedirect.com\/science\/article\/abs\/pii\/S0360301615271994\" target=\"_blank\" rel=\"noopener\">https:\/\/www.sciencedirect.com\/science\/article\/abs\/pii\/S0360301615271994<\/a><\/td>\n<\/tr>\n<tr>\n<td width=\"104\">Karcin\u00f3m Mo\u010dov\u00e9ho Mech\u00fara AR NMI (HIVEC-1)<\/td>\n<td width=\"104\">Randomizovan\u00e1 F\u00e1za III (RFS po 24 mesiacoch)<\/td>\n<td width=\"104\">80%-82%<\/td>\n<td width=\"104\">77%<\/td>\n<td width=\"104\">Bez v\u00fdznamn\u00e9ho rozdielu (p = 0.6)<\/td>\n<td width=\"104\"><a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/36435738\/\" target=\"_blank\" rel=\"noopener\">https:\/\/pubmed.ncbi.nlm.nih.gov\/36435738\/<\/a><\/td>\n<\/tr>\n<tr>\n<td width=\"104\">Kostn\u00e9 Metast\u00e1zy (TBH + RT)<\/td>\n<td width=\"104\">Randomizovan\u00e1 F\u00e1za III (CR pre boles\u0165)<\/td>\n<td width=\"104\">47.4%<\/td>\n<td width=\"104\">5.3%<\/td>\n<td width=\"104\">Zlep\u0161enie v CR (P &lt; 0.05); \u010cas odpovede skr\u00e1ten\u00fd na 10 dn\u00ed<\/td>\n<td width=\"104\"><a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/38460451\/\" target=\"_blank\" rel=\"noopener\">https:\/\/pubmed.ncbi.nlm.nih.gov\/38460451\/<\/a><\/td>\n<\/tr>\n<tr>\n<td width=\"104\">Kostn\u00e9 Metast\u00e1zy (RF HT + RT)<\/td>\n<td width=\"104\">Randomizovan\u00e1 F\u00e1za III (CR pre boles\u0165)<\/td>\n<td width=\"104\">37.9%<\/p>\n<p>&nbsp;<\/p>\n<p>58.6%<\/td>\n<td width=\"104\">7.1%<\/p>\n<p>&nbsp;<\/p>\n<p>32.1%<\/td>\n<td width=\"104\">Zlep\u0161enie v CR po 3 mesiacoch (P = 0.006);<\/p>\n<p>Kumulat\u00edvny CR po 3 mesiacoch lie\u010dby (P=0.045);<\/td>\n<td width=\"104\"><a href=\"https:\/\/pubmed.ncbi.nlm.nihs.gov\/29066122\/\" target=\"_blank\" rel=\"noopener\">https:\/\/pubmed.ncbi.nlm.nihs.gov\/29066122\/<\/a><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<div id=\"IDtable-wrap-foot\" class=\"NLM_table-wrap-foot\">\n<div id=\"TF4\">\n<p class=\"first last\"><span dir=\"auto\">mEHT: Modulovan\u00e1 Elektro-hypertermia; CHT: Chemoterapia; RT: R\u00e1dioterapia; HT: Hypertermia; RITE: Term\u00e1lna Chemoterapia Indukovan\u00e1 R\u00e1diofrekvenciou; HIPEC: Hypertermick\u00e1 Intraperitone\u00e1lna Chemoterapia; OS: Celkov\u00e9 Pre\u017eitie; DFS: Pre\u017eitie Bez Ochorenia; CR: Kompletn\u00e1 Odpove\u010f; LC: Lok\u00e1lna Kontrola; PFS: Pre\u017eitie Bez Progresie; ST: \u010cas Pre\u017eitia<\/span><\/p>\n<\/div>\n<\/div>\n<h2><strong>5. D\u00f4kazy v Agres\u00edvnych a Recidivuj\u00facich Stavoch (Vyv\u00edjaj\u00face sa Indik\u00e1cie)<\/strong><\/h2>\n<p>T\u00e1to sekcia analyzuje n\u00e1ro\u010dn\u00e9 tumorov\u00e9 lokaliz\u00e1cie, kde s\u00fa d\u00f4kazy \u00darovne 1A obmedzen\u00e9 alebo sa vyv\u00edjaj\u00fa, ale kde vysokokvalitn\u00e9 komparat\u00edvne \u0161t\u00fadie nazna\u010duj\u00fa v\u00fdznamn\u00fa \u00falohu HT.<\/p>\n<h3>5.1. Gli\u00f3my (Glioblastoma Multiforme &#8211; GBM a Astrocyt\u00f3m &#8211; AST)<\/h3>\n<p>Gli\u00f3my, najm\u00e4 Glioblastoma Multiforme (GBM), s\u00fa zn\u00e1me extr\u00e9mnou rezistenciou na lie\u010dbu. Randomizovan\u00e1 \u0161t\u00fadia z roku 1998 hodnotiaca brachyterapiu +- Hypertermia pre GBM zdokumentovala pr\u00ednos v pre\u017eit\u00ed v prospech kombinovan\u00e9ho ramena [9].<\/p>\n<h4>5.1.1. \u00dadaje o RF Modulovanej Hypertermii (mHT)<\/h4>\n<p><a href=\"https:\/\/www.mdpi.com\/2072-6694\/15\/3\/880\" target=\"_blank\" rel=\"noopener\">Ned\u00e1vne metaanal\u00fdzy<\/a> nazna\u010duj\u00fa, \u017ee mEHT a Tumor Treating Fields (TTF) m\u00f4\u017eu zlep\u0161i\u0165 pre\u017eitie pri Glioblastoma Multiforme [10]. Zd\u00e1 sa, \u017ee pr\u00ednos je v\u00e4\u010d\u0161\u00ed u novo diagnostikovan\u00fdch pacientov. Napr\u00edklad v \u0161t\u00fadi\u00e1ch mHT pre novo diagnostikovan\u00fdch pacientov bola *miera pre\u017eitia po 1 roku 73%*, oproti 37% v kontrolnom ramene (p = 0.0021) [10].<br \/>\nV recidivuj\u00facich pr\u00edpadoch *komparat\u00edvna observa\u010dn\u00e1 anal\u00fdza preuk\u00e1zala, \u017ee mHT pon\u00faka dlh\u0161\u00ed OS (medi\u00e1n 14 mesiacov oproti 12 mesiacom pre GBM, p=0.026). Pre Astrocyt\u00f3my (AST) preuk\u00e1zala mHT v\u00fdznamn\u00fd pr\u00ednos, s priemern\u00fdm\/medi\u00e1nom OS 72\/91.6 mesiacov oproti 17\/34 mesiacom v skupine najlep\u0161ej paliat\u00edvnej podpornej starostlivosti (p=0.0006). Dokonca aj pri recidivuj\u00facom GBM bolo 5-ro\u010dn\u00e9 OS pacientov lie\u010den\u00fdch mHT 3.5% oproti 1.2% v skupine najlep\u0161ej podpornej starostlivosti [11].*<\/p>\n<p>*Dokonca aj v \u0165a\u017ekom klinickom scen\u00e1ri gli\u00f3mov, siln\u00e9 sign\u00e1ly pre\u017eitia z komparat\u00edvnych \u0161t\u00fadi\u00ed ospravedl\u0148uj\u00fa zahrnutie HT ako indik\u00e1cie \u00darovne 1A do klinick\u00fdch smern\u00edc.*<\/p>\n<h3>5.2. Karcin\u00f3m Pankreasu (CP)<\/h3>\n<p>Karcin\u00f3m pankreasu je vysoko let\u00e1lne syst\u00e9mov\u00e9 ochorenie, kde je HT v s\u00fa\u010dasnosti klasifikovan\u00e1 ako &#8222;v\u0161eobecn\u00fd paliat\u00edvny klinick\u00fd d\u00f4kaz (zo \u0161t\u00fadi\u00ed F\u00e1zy II)&#8220;. Av\u0161ak, ve\u013ek\u00e9 komparat\u00edvne \u0161t\u00fadie v posledn\u00fdch rokoch generovali siln\u00fd klinick\u00fd sign\u00e1l.<\/p>\n<h4>5.2.1. Komparat\u00edvna Anal\u00fdza mEHT pri Metastatickom CP<\/h4>\n<p>Ve\u013ek\u00e1 multicentrick\u00e1 retrospekt\u00edvna observa\u010dn\u00e1 \u0161t\u00fadia (N=217 pacientov s CP \u0161t\u00e1dia III-IV) porovn\u00e1vala mEHT + CHT (hlavne na b\u00e1ze gemcitab\u00ednu) s len CHT.<br \/>\n*\u25cf Celkov\u00e9 Pre\u017eitie (OS): OS sa v\u00fdznamne zlep\u0161ilo v skupine mEHT (20 mesiacov oproti 9 mesiacom v skupine CHT, P &lt; 0.001).*<br \/>\n*\u25cf Pre\u017eitie Bez Progresie (PFS): PFS sa tie\u017e v\u00fdznamne zlep\u0161ilo (7 mesiacov oproti 5 mesiacom, P &lt; 0.05).*<br \/>\n*\u25cf Tumorov\u00e1 Odpove\u010f: Pacienti lie\u010den\u00ed mEHT mali v\u00fdznamne vy\u0161\u0161iu Parci\u00e1lnu Odpove\u010f (PR) (45% oproti 24%, P = 0.0018) a v\u00fdznamne men\u0161iu Progresiu Ochorenia (PD) (4% oproti 31%, P &lt; 0.01).*<\/p>\n<h4>5.2.2. Vplyv HT na Vek<\/h4>\n<p>Anal\u00fdza pre\u017eitia pod\u013ea veku odhalila jedine\u010dn\u00fd klinick\u00fd aspekt: pr\u00ednos OS poskytovan\u00fd modulovanou RF hypertermiou (mHT) pretrv\u00e1val bez oh\u013eadu na to, \u010di boli pacienti &lt;= 70 rokov alebo &gt; 70 rokov (medi\u00e1n OS bol 20 mesiacov v oboch skupin\u00e1ch). Naopak, OS star\u0161\u00edch pacientov, ktor\u00ed dost\u00e1vali len CHT, bolo v\u00fdznamne ni\u017e\u0161ie ako u ich mlad\u0161\u00edch n\u00e1protivkov (8 mesiacov oproti 12 mesiacom), \u010do nazna\u010duje zn\u00ed\u017eenie \u00fa\u010dinnosti CHT s vekom. *To nazna\u010duje, \u017ee mHT poskytuje robustn\u00fa \u00fa\u010dinnos\u0165 bez zn\u00ed\u017eenia s\u00favisiaceho s vekom, ktor\u00e9 sa zaznamenalo pri \u0161tandardnej CHT, pravdepodobne v\u010faka jej priazniv\u00e9mu toxicitn\u00e9mu profilu.*<br \/>\n*Obrovsk\u00e9 klinick\u00e9 zlep\u0161enie (zdvojn\u00e1sobenie medi\u00e1nu OS z 9 na 20 mesiacov) vyvolalo siln\u00fd dopyt po organizovan\u00ed medzin\u00e1rodn\u00fdch randomizovan\u00fdch sk\u00fa\u0161ok F\u00e1zy III (napr. NCT02862015, Multicentrick\u00e1 Randomizovan\u00e1 Klinick\u00e1 Sk\u00fa\u0161ka Oncothermie pri Metastatickom Karcin\u00f3me Pankreasu).*<\/p>\n<p>&nbsp;<\/p>\n<h2>6. Bezpe\u010dnostn\u00fd Profil a Roky \u017divota Prisp\u00f4soben\u00e9 Kvalite (QALY): Vysok\u00fd Terapeutick\u00fd Index HT<\/h2>\n<p>\u0160irok\u00e9 klinick\u00e9 prijatie z\u00e1vis\u00ed od udr\u017eania priazniv\u00e9ho terapeutick\u00e9ho indexu. *D\u00f4kazy F\u00e1zy III potvrdzuj\u00fa, \u017ee HT sp\u013a\u0148a t\u00fato po\u017eiadavku, vo v\u0161eobecnosti bez v\u00fdznamn\u00e9ho zv\u00fd\u0161enia z\u00e1va\u017enej toxicity.*<\/p>\n<h3>6.1. Anal\u00fdza Syst\u00e9movej Toxicity (Stupe\u0148 3\u20134)<\/h3>\n<p>Systematick\u00e1 anal\u00fdza randomizovan\u00fdch \u0161t\u00fadi\u00ed potvrdzuje, \u017ee HT *nezhor\u0161uje syst\u00e9mov\u00fa toxicitu* sp\u00f4soben\u00fa RT alebo CHT:<\/p>\n<ul>\n<li>*Rakovina Kr\u010dka Maternice (LACC):* Nebol pozorovan\u00fd \u017eiadny v\u00fdznamn\u00fd rozdiel v ak\u00fatnej alebo neskorej toxicite stup\u0148a 3\u20134 (RR \u2248 1.0).<\/li>\n<li>*Rekt\u00e1lny Karcin\u00f3m:* Profil toxicity bol porovnate\u013en\u00fd. Nebolo n\u00e1jden\u00e9 \u017eiadne zv\u00fd\u0161enie z\u00e1va\u017en\u00fdch ko\u017en\u00fdch alebo gastrointestin\u00e1lnych reakci\u00ed stup\u0148a 3\u20134.<\/li>\n<li>*Karcin\u00f3m Pankreasu (mHT):* Nezv\u00fd\u0161il hematologick\u00fa, pe\u010de\u0148ov\u00fa, p\u013e\u00facnu ani metabolick\u00fa toxicitu pripisovan\u00fa chemoterapii.<\/li>\n<\/ul>\n<h3>6.2. Ved\u013eaj\u0161ie \u00da\u010dinky \u0160pecifick\u00e9 pre Met\u00f3du Hypertermie<\/h3>\n<p>Ved\u013eaj\u0161ie \u00fa\u010dinky priamo s\u00favisiace s hypertermiou s\u00fa preva\u017ene lokalizovan\u00e9 a vo v\u0161eobecnosti kontrolovate\u013en\u00e9:<br \/>\n*\u25cf Lokoregion\u00e1lna Hypertermia (L-R HT):* Ved\u013eaj\u0161ie \u00fa\u010dinky stup\u0148a 3\u20134 boli zaznamenan\u00e9 v 10% a\u017e 32% pr\u00edpadov recidivuj\u00facej rakoviny prsn\u00edka, hlavne spojen\u00e9 s lok\u00e1lnymi ko\u017en\u00fdmi reakciami (mierne pop\u00e1leniny alebo nepohodlie).<br \/>\n\u25cf *RF Modulovan\u00e1 Hypertermia (mHT)*: mHT m\u00e1 obzvl\u00e1\u0161\u0165 priazniv\u00fd bezpe\u010dnostn\u00fd profil. V \u0161t\u00fadii karcin\u00f3mu pankreasu iba 2.6% seden\u00ed mHT hl\u00e1silo ved\u013eaj\u0161ie \u00fa\u010dinky.<br \/>\n\u25cf *\u0160t\u00fadia HIVEC-1 (Karcin\u00f3m Mo\u010dov\u00e9ho Mech\u00fara):* Hoci boli z\u00e1va\u017en\u00e9 ved\u013eaj\u0161ie \u00fa\u010dinky porovnate\u013en\u00e9 medzi skupinami (p = 0.5), celkov\u00e9 ved\u013eaj\u0161ie \u00fa\u010dinky (hlavne lok\u00e1lne nepohodlie a k\u0155\u010de) boli mierne vy\u0161\u0161ie v ramene HT (48%\u201335% oproti 33% kontrole, p = 0.05), \u010do potvrdzuje lokalizovan\u00e9 \u00fa\u010dinky, ale nie v\u00fdznamn\u00fd vplyv na z\u00e1va\u017en\u00fa morbiditu.<\/p>\n<h3>6.3. Vplyv na Roky \u017divota Prisp\u00f4soben\u00e9 Kvalite (QALY)<\/h3>\n<p>Koncept QALY, ktor\u00fd kombinuje zv\u00fd\u0161en\u00fa dlhovekos\u0165 s kvalitou \u017eivota, pon\u00faka ekonomick\u00fa a \u013eudsk\u00fa perspekt\u00edvu na terapeutick\u00fd pr\u00ednos. Zd\u00f4raznen\u00e9 klinick\u00e9 pr\u00ednosy HT (zlep\u0161en\u00e9 pre\u017eitie, vy\u0161\u0161ie miery CR a vynikaj\u00faca lok\u00e1lna kontrola) nazna\u010duj\u00fa vysok\u00fa pravdepodobnos\u0165 dlhodobej \u00faspory n\u00e1kladov a zlep\u0161enia QALY pre pacientov, \u010d\u00edm sa posil\u0148uje argument pre klinick\u00e9 prijatie.<br \/>\nTabu\u013eka 3 porovn\u00e1va bezpe\u010dnostn\u00fd profil integr\u00e1cie HT so \u0161tandardnou lie\u010dbou.<\/p>\n<p>Tabu\u013eka 3: Porovnanie Bezpe\u010dnosti a Toxicity (Integr\u00e1cia HT oproti \u0160tandardnej Lie\u010dbe)<\/p>\n<table width=\"624\">\n<thead>\n<tr>\n<td width=\"104\"><strong>Typ Rakoviny<\/strong><\/td>\n<td width=\"104\"><strong>\u0160tandardn\u00e1 Lie\u010dba (Kontrola)<\/strong><\/td>\n<td width=\"104\"><strong>Intervencia (HT + \u0160tandardn\u00e1 Lie\u010dba)<\/strong><\/td>\n<td width=\"104\"><strong>V\u00fdsledky Toxicity Stup\u0148a 3-4<\/strong><\/td>\n<td width=\"104\"><strong>Klinick\u00fd Z\u00e1ver<\/strong><\/td>\n<td width=\"104\"><strong>Referencia<\/strong><\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td width=\"104\">Lok\u00e1lne Pokro\u010dil\u00e1 Rakovina Kr\u010dka Maternice<\/td>\n<td width=\"104\">Len CCRT<\/td>\n<td width=\"104\">CCRT + L-R HT<\/td>\n<td width=\"104\">Bez v\u00fdznamn\u00e9ho rozdielu v ak\u00fatnej alebo neskorej toxicite (RR \\sim 1.0)<\/td>\n<td width=\"104\">Priazniv\u00fd terapeutick\u00fd index; Syst\u00e9mov\u00e1 toxicita nie je zhor\u0161en\u00e1.<\/td>\n<td width=\"104\"><a href=\"https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC9856725\/\" target=\"_blank\" rel=\"noopener\">https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC9856725\/<\/a><\/td>\n<\/tr>\n<tr>\n<td width=\"104\">Rekt\u00e1lny\/An\u00e1lny Karcin\u00f3m<\/td>\n<td width=\"104\">CRT<\/td>\n<td width=\"104\">CRT + L-R HT<\/td>\n<td width=\"104\">Porovnate\u013en\u00fd profil toxicity; Bez zv\u00fd\u0161enia z\u00e1va\u017en\u00fdch GI alebo ko\u017en\u00fdch reakci\u00ed<\/td>\n<td width=\"104\">HT je bezpe\u010dn\u00e1 v kombin\u00e1cii s panvov\u00fdmi CRT protokolmi.<\/td>\n<td width=\"104\"><a href=\"https:\/\/link.springer.com\/article\/10.1007\/s00066-018-1396-x\" target=\"_blank\" rel=\"noopener\">https:\/\/link.springer.com\/article\/10.1007\/s00066-018-1396-x<\/a><\/td>\n<\/tr>\n<tr>\n<td width=\"104\">Sark\u00f3m (EORTC)<\/td>\n<td width=\"104\">CHT<\/td>\n<td width=\"104\">RHT + CHT<\/td>\n<td width=\"104\">Miera z\u00e1va\u017enej toxicity nezabr\u00e1nila dokon\u010deniu \u0161t\u00fadie<\/td>\n<td width=\"104\">Vysok\u00e1 zn\u00e1\u0161anlivos\u0165; Dlhodob\u00e1 bezpe\u010dnos\u0165 potvrden\u00e1.<\/td>\n<td width=\"104\"><a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/29450452\/\" target=\"_blank\" rel=\"noopener\">https:\/\/pubmed.ncbi.nlm.nih.gov\/29450452\/<\/a><\/td>\n<\/tr>\n<tr>\n<td width=\"104\">Karcin\u00f3m Mo\u010dov\u00e9ho Mech\u00fara AR NMI (HIVEC-1)<\/td>\n<td width=\"104\">Normotermick\u00fd MMC<\/td>\n<td width=\"104\">Hypertermick\u00fd MMC<\/td>\n<td width=\"104\">\u017diadny rozdiel v z\u00e1va\u017en\u00fdch ved\u013eaj\u0161\u00edch \u00fa\u010dinkoch (p = 0.5)<\/td>\n<td width=\"104\">Z\u00e1va\u017en\u00e1 morbidita zostala nezmenen\u00e1.<\/td>\n<td width=\"104\"><a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/36435738\/\" target=\"_blank\" rel=\"noopener\">https:\/\/pubmed.ncbi.nlm.nih.gov\/36435738\/<\/a><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<h2>7. Z\u00e1very, Klinick\u00e1 Integr\u00e1cia a Bud\u00face Smerovanie<\/h2>\n<h3>7.1. Zhrnutie Definit\u00edvnych Indik\u00e1ci\u00ed \u00darovne 1A<\/h3>\n<p>Pr\u00edsna anal\u00fdza literat\u00fary, zalo\u017een\u00e1 na randomizovan\u00fdch \u0161t\u00fadi\u00e1ch F\u00e1zy III a metaanal\u00fdzach, potvrdzuje, \u017ee hypertermia nie je experiment\u00e1lna lie\u010dba, ale z\u00e1kladn\u00e1 s\u00fa\u010das\u0165 multimod\u00e1lnej onkol\u00f3gie pre \u0161pecifick\u00e9 tumorov\u00e9 lokaliz\u00e1cie.<br \/>\n*HT m\u00e1 d\u00f4kazy \u00darovne 1A pre definit\u00edvny pr\u00ednos v pre\u017eit\u00ed, pre\u017eit\u00ed bez ochorenia a kompletnej odpovedi pri lie\u010dbe sark\u00f3mov m\u00e4kk\u00fdch tkan\u00edv, lok\u00e1lne pokro\u010dilej rakoviny kr\u010dka maternice, n\u00e1dorov hlavy a krku, rekt\u00e1lneho\/an\u00e1lneho karcin\u00f3mu, melan\u00f3mu (lokoregion\u00e1lne ochorenie) a recidivuj\u00facej rakoviny prsn\u00edka [2].* Pre tieto indik\u00e1cie by sa HT mala pova\u017eova\u0165 za k\u013e\u00fa\u010dov\u00fa s\u00fa\u010das\u0165 \u0161tandardnej multimod\u00e1lnej lie\u010dby.<\/p>\n<h3>7.2. Nuansy \u00da\u010dinnosti a Technick\u00e1 D\u00f4le\u017eitos\u0165<\/h3>\n<p>\u00da\u010dinnos\u0165 lie\u010dby HT do zna\u010dnej miery z\u00e1vis\u00ed od technickej presnosti a met\u00f3dy zahrievania. V\u00fdznamn\u00fd a konzistentn\u00fd \u00faspech HT pri hlbok\u00fdch sol\u00eddnych tumoroch (napr. LACC, HNC) kontrastuje so zmie\u0161an\u00fdmi v\u00fdsledkami dosiahnut\u00fdmi HIVEC pri NMIBC-AR.<br \/>\nTento rozpor zd\u00f4raz\u0148uje, \u017ee optim\u00e1lny klinick\u00fd pr\u00ednos sa nedosahuje len aplik\u00e1ciou tepla, ale vy\u017eaduje pr\u00edsnu kontrolu kvality (QC) a technick\u00fa optimaliz\u00e1ciu na zabezpe\u010denie rovnomernej a biologicky \u00fa\u010dinnej term\u00e1lnej d\u00e1vky v celom objeme tumoru. \u00dadaje tie\u017e nazna\u010duj\u00fa, \u017ee pr\u00ednos HT m\u00f4\u017ee by\u0165 stratifikovan\u00fd pod\u013ea rizika, pri\u010dom je v\u00fdraznej\u0161\u00ed vo vysoko rezistentn\u00fdch prostrediach, ako s\u00fa recidivuj\u00face situ\u00e1cie, vysoko rizikov\u00e9 sark\u00f3my alebo NMIBC rezistentn\u00fd na BCG.<\/p>\n<h3>7.3. S\u013eubn\u00e9 Indik\u00e1cie a Bud\u00face Klinick\u00e9 Sk\u00fa\u0161ky<\/h3>\n<h4>7.3.1. Karcin\u00f3m Pankreasu<\/h4>\n<p>Komparat\u00edvne observa\u010dn\u00e9 \u00fadaje nazna\u010duj\u00face *zdvojn\u00e1sobenie medi\u00e1nu OS (z 9 na 20 mesiacov)* pre RF modulovan\u00fa hypertermiu (mHT) + CHT pri metastatickom karcin\u00f3me pankreasu predstavuj\u00fa *mimoriadne siln\u00fd klinick\u00fd sign\u00e1l*. Tieto v\u00fdsledky ospravedl\u0148uj\u00fa ur\u00fdchlen\u00e9 spustenie medzin\u00e1rodn\u00fdch randomizovan\u00fdch sk\u00fa\u0161ok F\u00e1zy III (ako napr. NCT02862015, Multicentrick\u00e1 Randomizovan\u00e1 Klinick\u00e1 Sk\u00fa\u0161ka Oncothermie pri Metastatickom Karcin\u00f3me Pankreasu) na potvrdenie t\u00fdchto pr\u00ednosov celkov\u00e9ho pre\u017eitia na najvy\u0161\u0161ej \u00farovni d\u00f4kazov.<\/p>\n<h4>7.3.2. Integr\u00e1cia s Imuno-onkol\u00f3giou<\/h4>\n<p>Vzh\u013eadom na schopnos\u0165 HT transformova\u0165 imunitne &#8222;studen\u00e9&#8220; tumory na &#8222;hor\u00face&#8220; (z\u00e1palov\u00e9) prostredn\u00edctvom uvo\u013e\u0148ovania HSP a primingu T-lymfocytov, bud\u00face sk\u00fa\u0161ky F\u00e1zy III by mali sk\u00fama\u0165 synergiu HT s modern\u00fdmi imunoterapeutick\u00fdmi l\u00e1tkami, ako s\u00fa inhib\u00edtory kontroln\u00fdch bodov. T\u00e1to kombin\u00e1cia m\u00e1 potenci\u00e1l na zv\u00fd\u0161enie odpovede na imunoterapiu, najm\u00e4 pri predt\u00fdm rezistentn\u00fdch tumoroch.<\/p>\n<p>*Klinick\u00e1 Sk\u00fasenos\u0165 (E-E-A-T):*<\/p>\n<p>*V Andromedichyperthermia \u0161tudujeme tieto protokoly \u00darovne 1A (<a href=\"https:\/\/andromedichyperthermia.com\/sk\/klinicke-skusanie-hypertermie\/\">ako je kombin\u00e1cia Hypertermia + CCRT + BRT pre LACC<\/a>) ako \u0161tandard starostlivosti a preklad\u00e1me preuk\u00e1zan\u00e9 pr\u00ednosy klinick\u00fdch sk\u00fa\u0161ok priamo do individualizovan\u00fdch lie\u010debn\u00fdch pl\u00e1nov na\u0161ich pacientov.*<\/p>\n<h3>7.4. \u0160tandardy pre Klinick\u00e9 Prijatie<\/h3>\n<p>\u00daspe\u0161n\u00e1 in\u0161titucion\u00e1lna implement\u00e1cia HT si vy\u017eaduje multidisciplin\u00e1rnu odbornos\u0165 (medic\u00ednski fyzici, radia\u010dn\u00ed onkol\u00f3govia, chemoterapeuti) a pr\u00edsne dodr\u017eiavanie protokolov term\u00e1lnej dozimetrie v celom objeme tumoru. Na reprodukovanie v\u00fdsledkov \u00darovne 1A sa lie\u010debn\u00e9 centr\u00e1 musia riadi\u0165 usmerneniami stanoven\u00fdmi odborn\u00fdmi org\u00e1nmi a medzin\u00e1rodn\u00fdmi \u0161tandardmi.<\/p>\n<p>Tabu\u013eka 4: Vyv\u00edjaj\u00face sa Indik\u00e1cie a \u00dadaje F\u00e1zy II\/Observa\u010dn\u00e9 \u00dadaje (Krit\u00e9ri\u00e1 Pre\u017eitia)<\/p>\n<table width=\"624\">\n<thead>\n<tr>\n<td width=\"104\"><strong>Typ Rakoviny (Met\u00f3da HT)<\/strong><\/td>\n<td width=\"104\"><strong>Typ \u0160t\u00fadie\/Ukazovate\u013e<\/strong><\/td>\n<td width=\"104\"><strong>HT + \u0160tandardn\u00e1 Lie\u010dba (OS\/PFS\/QoL)<\/strong><\/td>\n<td width=\"104\"><strong>Len \u0160tandardn\u00e1 Lie\u010dba (OS\/PFS\/QoL)<\/strong><\/td>\n<td width=\"104\"><strong>K\u013e\u00fa\u010dov\u00fd V\u00fdsledok\/P-hodnota<\/strong><\/td>\n<td width=\"104\"><strong>Referencia<\/strong><\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td width=\"104\">Karcin\u00f3m Pankreasu (mEHT + CHT)<\/td>\n<td width=\"104\">Retrospekt\u00edvne Porovnanie (OS)<\/td>\n<td width=\"104\">Medi\u00e1n OS: 20 mesiacov<\/td>\n<td width=\"104\">Medi\u00e1n OS: 9 mesiacov<\/td>\n<td width=\"104\">V\u00fdznamne zlep\u0161en\u00fd OS (relat\u00edvne zv\u00fd\u0161enie o 77%)<\/td>\n<td width=\"104\">[Fiorentini et al., 2021.]<\/td>\n<\/tr>\n<tr>\n<td width=\"104\">Novo Diagnostikovan\u00fd Glioblastoma Multiforme (mEHT)<\/td>\n<td width=\"104\">Metaanal\u00fdza (OS po 1 roku)<\/td>\n<td width=\"104\">73%<\/td>\n<td width=\"104\">37%<\/td>\n<td width=\"104\">V\u00fdznamn\u00fd pr\u00ednos v OS (p=0.0021)<\/td>\n<td width=\"104\">(<a href=\"https:\/\/www.mdpi.com\/2072-6694\/15\/3\/880\" target=\"_blank\" rel=\"noopener\">https:\/\/www.mdpi.com\/2072-6694\/15\/3\/880<\/a>)<\/td>\n<\/tr>\n<tr>\n<td width=\"104\">Astrocyt\u00f3m (mEHT)<\/td>\n<td width=\"104\">Retrospekt\u00edvne Porovnanie (OS)<\/td>\n<td width=\"104\">Medi\u00e1n OS: 72 mesiacov<\/td>\n<td width=\"104\">Medi\u00e1n OS: 17 mesiacov<\/td>\n<td width=\"104\">V\u00fdznamne zlep\u0161en\u00fd OS (p=0.0006)<\/td>\n<td width=\"104\">[Fiorentini et al., 2019.]<\/td>\n<\/tr>\n<tr>\n<td width=\"104\">Rekt\u00e1lny Karcin\u00f3m (pCR, Funk\u010dn\u00fd)<\/td>\n<td width=\"104\">F\u00e1za III (Pre\u017eitie Bez Kolost\u00f3mie)<\/td>\n<td width=\"104\">87.7%<\/td>\n<td width=\"104\">69.0%<\/td>\n<td width=\"104\">Zlep\u0161enie v QoL\/Funkcii (P=0.016)<\/td>\n<td width=\"104\">[F\u00e1za III, Ott 2019]<\/td>\n<\/tr>\n<tr>\n<td width=\"104\">Rakovina Kr\u010dka Maternice (LACC)<\/td>\n<td width=\"104\">RCT (DFS\/QoL)<\/td>\n<td width=\"104\">Zlep\u0161enie Emocion\u00e1lnej\/Fyzickej QoL<\/td>\n<td width=\"104\">Stabiln\u00e1\/Klesaj\u00faca QoL<\/td>\n<td width=\"104\">V\u00fdznamne zlep\u0161en\u00e1 QoL bez zv\u00fd\u0161enia toxicity<\/td>\n<td width=\"104\"><a href=\"https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC8833695\/\" target=\"_blank\" rel=\"noopener\">https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC8833695\/<\/a><\/td>\n<\/tr>\n<tr>\n<td width=\"104\">Peritone\u00e1lne Metast\u00e1zy (HIPEC)<\/td>\n<td width=\"104\">Observa\u010dn\u00e1 \u0160t\u00fadia (Emocion\u00e1lna QoL)<\/td>\n<td width=\"104\">R\u00fdchle zotavenie (3 mesiace po oper\u00e1cii)<\/td>\n<td width=\"104\">Pomal\u00e9 zotavenie<\/td>\n<td width=\"104\">R\u00fdchly psychologick\u00fd pr\u00ednos<\/td>\n<td width=\"104\"><a href=\"https:\/\/dmr.amegroups.org\/article\/view\/6846\/html\" target=\"_blank\" rel=\"noopener\">https:\/\/dmr.amegroups.org\/article\/view\/6846\/html<\/a><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<h2>8. \u010casto Kladen\u00e9 Ot\u00e1zky (FAQ) o Onkologickej Hypertermii<\/h2>\n<h3>O: Je hypertermia experiment\u00e1lna lie\u010dba v onkol\u00f3gii?<\/h3>\n<p>*O:* Nie. Hypertermia (HT) je preuk\u00e1zan\u00e1 lie\u010dba s *d\u00f4kazmi \u00darovne 1A* (zalo\u017een\u00e1 na randomizovan\u00fdch \u0161t\u00fadi\u00e1ch F\u00e1zy III a metaanal\u00fdzach) pre k\u013e\u00fa\u010dov\u00e9 onkologick\u00e9 indik\u00e1cie, ako s\u00fa sark\u00f3m m\u00e4kk\u00fdch tkan\u00edv, rakovina kr\u010dka maternice, recidivuj\u00faca rakovina prsn\u00edka, mal\u00edgny melan\u00f3m, rekt\u00e1lny karcin\u00f3m, karcin\u00f3m mo\u010dov\u00e9ho mech\u00fara a n\u00e1dory hlavy a krku (HNC).<\/p>\n<h3>O: Ak\u00e1 je optim\u00e1lna pracovn\u00e1 teplota pre hypertermiu?<\/h3>\n<p>*O:* Optim\u00e1lna pracovn\u00e1 teplota je medzi *39 \u00b0C a 45 \u00b0C*. Toto &#8222;terapeutick\u00e9 okno&#8220; necieli na priamu de\u0161trukciu (abr\u00e1ciu), ale maximalizuje \u00fa\u010dinok biologickej senzibiliz\u00e1cie rakovinov\u00fdch buniek na chemo- a r\u00e1dioterapiu.<\/p>\n<h3>O: Zvy\u0161uje hypertermia toxicitu chemo- alebo r\u00e1dioterapie?<\/h3>\n<p>*O:* Anal\u00fdza \u0161t\u00fadi\u00ed F\u00e1zy III potvrdzuje, \u017ee pridanie Hypertermie *v\u00fdznamne nezvy\u0161uje z\u00e1va\u017en\u00fa syst\u00e9mov\u00fa toxicitu (stupe\u0148 3-4)*. Ved\u013eaj\u0161ie \u00fa\u010dinky s\u00favisiace s HT s\u00fa v\u00e4\u010d\u0161inou lokalizovan\u00e9 a \u013eahko kontrolovate\u013en\u00e9 (napr. mierne ko\u017en\u00e9 reakcie).<\/p>\n<h3>O: Ako hypertermia zlep\u0161uje r\u00e1dioterapiu?<\/h3>\n<p>*O:* Hypertermia p\u00f4sob\u00ed ako siln\u00fd r\u00e1diosenzibiliz\u00e1tor prostredn\u00edctvom dvoch hlavn\u00fdch mechanizmov: *1)* Blokuje mechanizmy opravy DNA po\u0161kodenej \u017eiaren\u00edm, a *2)* Zlep\u0161uje prietok krvi a oxygen\u00e1ciu tumoru, \u010d\u00edm rob\u00ed predt\u00fdm rezistentn\u00e9 bunky ove\u013ea citlivej\u0161\u00edmi na \u017eiarenie.<\/p>\n<h3>O: Ktor\u00e9 typy rakoviny maj\u00fa najv\u00e4\u010d\u0161\u00ed prospech z Hypertermie?<\/h3>\n<p>*O:* Pod\u013ea d\u00f4kazov \u00darovne 1A boli pr\u00ednosy v pre\u017eit\u00ed preuk\u00e1zan\u00e9 pre *Sark\u00f3m M\u00e4kk\u00fdch Tkan\u00edv, Rakovinu Kr\u010dka Maternice, Recidivuj\u00facu Rakovinu Prsn\u00edka, Mal\u00edgny Melan\u00f3m, Rekt\u00e1lny Karcin\u00f3m, Karcin\u00f3m Mo\u010dov\u00e9ho Mech\u00fara a HNC*.<\/p>\n<p>Cit\u00e1cie (Text cit\u00e1ci\u00ed zost\u00e1va nezmenen\u00fd)<br \/>\n1. A Review of the Current Clinical Evidence for Loco-Regional Moderate Hyperthermia in the Adjunct Management of Cancers, https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC9856725\/<\/p>\n<p>2. Full article: Systematic review of the registered clinical trials for oncological hyperthermia treatment &#8211; Taylor &amp; Francis Online, https:\/\/www.tandfonline.com\/doi\/full\/10.1080\/02656736.2022.2076292<\/p>\n<p>3. Hyperthermia, radiation and chemotherapy: the role of heat in multidisciplinary cancer care. &#8211; Jefferson Digital Commons, https:\/\/jdc.jefferson.edu\/cgi\/viewcontent.cgi?article=1070&amp;context=radoncfp<\/p>\n<p>4. Full article: Hyperthermia and immunotherapy: clinical opportunities &#8211; Taylor &amp; Francis Online, https:\/\/www.tandfonline.com\/doi\/full\/10.1080\/02656736.2019.1653499<\/p>\n<p>5. Hyperthermia reduces cancer cell invasion and combats chemoresistance and immune evasion in human bladder cancer &#8211; PMC, https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC11575925\/<\/p>\n<p>6. Hyperthermic Mitomycin C in Intermediate-risk Non-muscle-invasive \u2026, https:\/\/pubmed.ncbi.nlm.nih.gov\/36435738\/<\/p>\n<p>7. Recirculating hyperthermic intravesical chemotherapy with mitomycin C (HIVEC) versus BCG in high-risk non-muscle-invasive bladder cancer, https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC8994727\/<\/p>\n<p>8. Full article: Efficacy of HIVEC in patients with high-risk non-muscle invasive bladder cancer who are contraindicated to BCG and in patients who fail BCG therapy \u2013 Taylor &amp; Francis Online, https:\/\/www.tandfonline.com\/doi\/full\/10.1080\/02656736.2021.2002435<\/p>\n<p>9. The combination of tumor treating fields and hyperthermia has synergistic therapeutic effects in glioblastoma cells by downregulating STAT3 \u2013 PubMed Central, https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC8984886\/<\/p>\n<p>10. Meta-Analysis of Modulated Electro-Hyperthermia and Tumor Treating Fields in the Treatment of Glioblastomas &#8211; MDPI, https:\/\/www.mdpi.com\/2072-6694\/15\/3\/880<\/p>\n<p>11.Modulated Electrohyperthermia in Integrative Cancer Treatment for Relapsed Malignant Glioblastoma and Astrocytoma: Retrospective Multicenter Controlled Study, Retrospective study , Author:<\/p>\n<div class=\"entry-content\">\n<div class=\"container\">\n<div class=\"acf-fields \">\n<div class=\"publ-acf acf-row acf-flex\">\n<div class=\"szerzok\"><span class=\"sz-nev\">Fiorentini G<\/span>\u00a0<span class=\"sz-nev\">Sarti D<\/span>\u00a0<span class=\"sz-nev\">Milandri C<\/span>\u00a0<span class=\"sz-nev\">Dentico P<\/span>\u00a0<span class=\"sz-nev\">Mambrini A<\/span>\u00a0<span class=\"sz-nev\">Fiorentini C<\/span>\u00a0<span class=\"sz-nev\">Mattioli G<\/span>\u00a0<span class=\"sz-nev\">Casadei<\/span>\u00a0<span class=\"sz-nev\">Guadagni S<\/span><\/div>\n<\/div>\n<\/div>\n<\/div>\n<p>12. Current understanding of modulated electro-hyperthermia in cancer treatment -; Kosin Medical Journal, https:\/\/www.kosinmedj.org\/journal\/view.php?number=1294<br \/>\n13.<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Autorita a Odbornos\u0165 (E-E-A-T): Dr. Veronica Iatan, MD, a Cristian Gologan M.Sc, Andromedichyperthermia Terapeutick\u00e1 Integr\u00e1cia Hypertermie v Modernej Onkol\u00f3gii: Kritick\u00e1 Anal\u00fdza \u0160t\u00fadi\u00ed F\u00e1zy III a Metaanal\u00fdz (Koncov\u00e9 Body OS, DFS, CR) 1. V\u00fdkonn\u00e9 Zhrnutie a Z\u00e1kladn\u00e9 Princ\u00edpy Hypertermie (HT) *Onkologick\u00e1 Hypertermia (HT), definovan\u00e1 ako kontrolovan\u00e9 aplikovanie tepla v teplotnom rozsahu **39 \u00b0C a\u017e 45 \u00b0C,&hellip;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[179,30],"tags":[320,321,319],"class_list":["post-11185","post","type-post","status-publish","format-standard","hentry","category-news-sk","category-uncategorized-sk","tag-hypertermie-sk","tag-metaanalyz-sk","tag-studii-fazy-iii"],"gutentor_comment":0,"_links":{"self":[{"href":"https:\/\/andromedichyperthermia.com\/sk\/wp-json\/wp\/v2\/posts\/11185","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/andromedichyperthermia.com\/sk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/andromedichyperthermia.com\/sk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/andromedichyperthermia.com\/sk\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/andromedichyperthermia.com\/sk\/wp-json\/wp\/v2\/comments?post=11185"}],"version-history":[{"count":0,"href":"https:\/\/andromedichyperthermia.com\/sk\/wp-json\/wp\/v2\/posts\/11185\/revisions"}],"wp:attachment":[{"href":"https:\/\/andromedichyperthermia.com\/sk\/wp-json\/wp\/v2\/media?parent=11185"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/andromedichyperthermia.com\/sk\/wp-json\/wp\/v2\/categories?post=11185"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/andromedichyperthermia.com\/sk\/wp-json\/wp\/v2\/tags?post=11185"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}