{"id":11182,"date":"2025-10-02T14:50:09","date_gmt":"2025-10-02T14:50:09","guid":{"rendered":"https:\/\/andromedichyperthermia.com\/?p=11182"},"modified":"2025-10-02T19:35:43","modified_gmt":"2025-10-02T19:35:43","slug":"hypertermie-studii-faze-iii","status":"publish","type":"post","link":"https:\/\/andromedichyperthermia.com\/cs\/hypertermie-studii-faze-iii\/","title":{"rendered":"Terapeutick\u00e1 Integrace Hypertermie v Modern\u00ed Onkologii: Kritick\u00e1 Anal\u00fdza Studi\u00ed F\u00e1ze 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 Integrace Hypertermie v Modern\u00ed Onkologii: Kritick\u00e1 Anal\u00fdza Studi\u00ed F\u00e1ze 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\": \"Hypertermie, Onkologie, Studie F\u00e1ze III, P\u0159e\u017eit\u00ed, OS, Kompletn\u00ed Odpov\u011b\u010f, CR, Sarkom, Rakovina D\u011blo\u017en\u00edho \u010c\u00edpku, 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 Odbornost (E-E-A-T):<\/strong><br \/>\n<strong><a href=\"https:\/\/andromedichyperthermia.com\/cs\/doctor-veronica-iatan\/\">Dr. Veronica Iatan, MD<\/a>, a <a href=\"https:\/\/andromedichyperthermia.com\/cs\/cristian-gologan\/\">Cristian Gologan M.Sc<\/a>, Andromedichyperthermia<\/strong><\/div>\n<h1>Terapeutick\u00e1 Integrace Hypertermie v Modern\u00ed Onkologii: Kritick\u00e1 Anal\u00fdza Studi\u00ed F\u00e1ze III a Metaanal\u00fdz (Koncov\u00e9 Body OS, DFS, CR)<\/h1>\n<h2>1. Shrnut\u00ed a Z\u00e1kladn\u00ed Principy Hypertermie (HT)<\/h2>\n<p>*Onkologick\u00e1 Hypertermie (HT), definovan\u00e1 jako kontrolovan\u00e9 aplikov\u00e1n\u00ed tepla v teplotn\u00edm rozmez\u00ed od **39\u00b0C do 45\u00b0C, p\u0159edstavuje dopl\u0148kovou terapeutickou modalitu, kter\u00e1 prok\u00e1zala **v\u00fdznamn\u00fd klinick\u00fd p\u0159\u00ednos, potvrzen\u00fd **d\u016fkazy \u00darovn\u011b 1A* (*randomizovan\u00e9 studie F\u00e1ze III a metaanal\u00fdzy*), pro \u0159adu pokro\u010dil\u00fdch a rekurentn\u00edch solidn\u00edch n\u00e1dor\u016f.<\/p>\n<p>Z\u00e1kladn\u00ed role HT nespo\u010d\u00edv\u00e1 v p\u0159\u00edm\u00e9m termick\u00e9m ni\u010den\u00ed (ablace vy\u017eaduje teploty nad 50\u00b0C), ale v p\u016fsoben\u00ed jako *biologick\u00fd senzibiliz\u00e1tor*, kter\u00fd zesiluje \u00fa\u010dinnost radioterapie (RT) a chemoterapie (KT).<\/p>\n<div class=\"key-points\">\n<h3>Kl\u00ed\u010dov\u00e1 Zji\u0161t\u011bn\u00ed &#8211; D\u016fkazy \u00darovn\u011b 1A:<\/h3>\n<ul>\n<li>*Role:* HT ni\u010d\u00ed n\u00e1dor p\u0159\u00edmo; p\u016fsob\u00ed jako siln\u00fd *biologick\u00fd senzibiliz\u00e1tor*.<\/li>\n<li>*Potvrzen\u00e9 V\u00fdhody:* Synt\u00e9za dat \u00darovn\u011b 1A nazna\u010duje konzistentn\u00ed zlep\u0161en\u00ed *Celkov\u00e9ho P\u0159e\u017eit\u00ed (OS)* a *M\u00edry Kompletn\u00ed Odpov\u011bdi (CR)*.<\/li>\n<li>*Hlavn\u00ed Indikace:* Sarkomy m\u011bkk\u00fdch tk\u00e1n\u00ed, rakovina d\u011blo\u017en\u00edho \u010d\u00edpku, rekurentn\u00ed n\u00e1dory prsu, malign\u00ed melanom, karcinom rekta, karcinom mo\u010dov\u00e9ho m\u011bch\u00fd\u0159e a n\u00e1dory hlavy a krku (HNC).<\/li>\n<li>*Bezpe\u010dnost:* Tento robustn\u00ed terapeutick\u00fd p\u0159\u00ednos je d\u016fsledn\u011b dosahov\u00e1n *bez v\u00fdznamn\u00e9ho zv\u00fd\u0161en\u00ed syst\u00e9mov\u00e9 toxicity nebo z\u00e1va\u017en\u00fdch vedlej\u0161\u00edch \u00fa\u010dink\u016f (stupe\u0148 3 nebo 4)*.<\/li>\n<li>*Z\u00e1v\u011br:* HT je nezbytn\u00fdm dopl\u0148kem standardn\u00edch multimod\u00e1ln\u00edch re\u017eim\u016f pro vybran\u00e9 n\u00e1dory.<\/li>\n<\/ul>\n<\/div>\n<h3>1.1. Klasifikace a Metody Onkologick\u00e9 Hypertermie<\/h3>\n<h4>1.1.1. Lokoregion\u00e1ln\u00ed Hypertermie (L-R HT)<\/h4>\n<p>Pou\u017e\u00edv\u00e1 se pro hlubok\u00e9 zah\u0159\u00edv\u00e1n\u00ed p\u00e1nevn\u00edch, hrudn\u00edch a b\u0159i\u0161n\u00edch n\u00e1dor\u016f. Jej\u00edm c\u00edlem je sm\u011brovat tepelnou energii do hloubky, aby se dos\u00e1hlo terapeutick\u00fdch teplot v n\u00e1dorov\u00e9m objemu, a z\u00e1rove\u0148 udr\u017eet zdrav\u00e9 tk\u00e1n\u011b v r\u00e1mci toleran\u010dn\u00edch limit\u016f. Hled\u00e1 se co nejhomogenn\u011bj\u0161\u00ed (izotermick\u00e9) zah\u0159\u00edv\u00e1n\u00ed n\u00e1dorov\u00e9 masy.<\/p>\n<h4>1.1.2. Modulovan\u00e1 Radiofrekven\u010dn\u00ed Hypertermie (mHT)<\/h4>\n<p>Modulovan\u00e1 RF hypertermie (mHT), na rozd\u00edl od konven\u010dn\u00edho izotermick\u00e9ho oh\u0159evu, vyu\u017e\u00edv\u00e1 kapacitn\u00ed vazbu s nosnou frekvenc\u00ed 13.56 MHz, modulovanou frakt\u00e1ln\u00edmi \u010dasov\u00fdmi fluktuacemi. Princip fungov\u00e1n\u00ed je zalo\u017een na *c\u00edlen\u00e9m p\u0159enosu energie na \u00farovni bun\u011b\u010dn\u00e9 membr\u00e1ny*. Vysok\u00e9 dielektrick\u00e9 ztr\u00e1ty se vyskytuj\u00ed p\u0159ednostn\u011b v membr\u00e1n\u00e1ch n\u00e1dorov\u00fdch bun\u011bk (kv\u016fli jejich zm\u011bn\u011bn\u00fdm elektrick\u00fdm vlastnostem), \u010d\u00edm\u017e se vytv\u00e1\u0159\u00ed specifick\u00fd teplotn\u00ed gradient, kter\u00fd spou\u0161t\u00ed cesty apopt\u00f3zy. Tento mechanismus oh\u0159evu \u201ezevnit\u0159 ven\u201c vede k vy\u0161\u0161\u00edm intratumor\u00e1ln\u00edm teplot\u00e1m a sn\u00ed\u017een\u00e9mu po\u0161kozen\u00ed norm\u00e1ln\u00ed tk\u00e1n\u011b.<\/p>\n<h4>1.1.3. Interstici\u00e1ln\u00ed Hypertermie<\/h4>\n<p>Tato metoda zahrnuje invazivn\u00ed dod\u00e1v\u00e1n\u00ed tepla pomoc\u00ed ant\u00e9n, ty\u010d\u00ed nebo sem\u00ednek um\u00edst\u011bn\u00fdch p\u0159\u00edmo uvnit\u0159 n\u00e1doru. Pou\u017e\u00edv\u00e1 se zejm\u00e9na k l\u00e9\u010db\u011b n\u00e1dor\u016f mozku (gliomy) nebo rekurentn\u00edch povrchov\u00fdch onemocn\u011bn\u00ed.<\/p>\n<h3>1.2. Pro\u010d Terapeutick\u00e9 Okno 39\u201345 \u00b0C Funguje? (Biologick\u00e9 Mechanismy)<\/h3>\n<p>Prok\u00e1zan\u00e1 klinick\u00e1 \u00fa\u010dinnost HT na \u00darovni F\u00e1ze III je neodd\u011bliteln\u00e1 od pochopen\u00ed jej\u00edch slo\u017eit\u00fdch biologick\u00fdch mechanism\u016f. Tyto mechanismy p\u0159esahuj\u00ed jednoduchou bun\u011b\u010dnou destrukci, \u010d\u00edm\u017e se HT umis\u0165uje jako *multifunk\u010dn\u00ed senzibiliz\u00e1tor* standardn\u00edch l\u00e9\u010deb. Optim\u00e1ln\u00ed teplota *39\u201345 \u00b0C* je zvolena tak, aby maximalizovala n\u00e1dorov\u011b specifick\u00e9 bun\u011b\u010dn\u00e9 nerovnov\u00e1hy. Celkov\u00fd \u00fasp\u011bch zaznamenan\u00fd v randomizovan\u00fdch studi\u00edch pramen\u00ed z t\u00e9to senzibilizuj\u00edc\u00ed role, kter\u00e1 interaguje s n\u00e1dorov\u00fdm mikroprost\u0159ed\u00edm a bun\u011b\u010dn\u00fdm apar\u00e1tem za \u00fa\u010delem zv\u00fd\u0161en\u00ed \u00fa\u010dinnosti radioterapie (RT) a chemoterapie (KT).<\/p>\n<hr \/>\n<h2>2. Mechanismy \u00da\u010dinku: Jak Hypertermie Zesiluje Onkologickou L\u00e9\u010dbu<\/h2>\n<p>Vynikaj\u00edc\u00ed klinick\u00e1 \u00fa\u010dinnost kombinovan\u00e9 l\u00e9\u010dby je v\u00fdsledkem siln\u00e9 biologick\u00e9 synergie, kter\u00e1 \u0159e\u0161\u00ed n\u00e1dorovou rezistenci na n\u011bkolika \u00farovn\u00edch.<\/p>\n<h3>2.1. Radiosenzibilizace: P\u0159ekon\u00e1n\u00ed Hypoxie a Inhibice Opravy DNA<\/h3>\n<p>Hypertermie je uzn\u00e1v\u00e1na jako siln\u00fd radiosenzibiliz\u00e1tor, kter\u00fd \u0159e\u0161\u00ed dv\u011b hlavn\u00ed p\u0159\u00ed\u010diny selh\u00e1n\u00ed radioterapie:<\/p>\n<ol>\n<li>*Inhibice Opravy DNA:* HT m\u00e1 p\u0159\u00edm\u00fd vliv na mechanismy opravy DNA. Inhibice mechanism\u016f opravy DNA po\u0161kozen\u00e9 z\u00e1\u0159en\u00edm zaji\u0161\u0165uje \u00fa\u010dinn\u011bj\u0161\u00ed a nevratnou bun\u011b\u010dnou smrt.<\/li>\n<li>*Modifikace N\u00e1dorov\u00e9ho Mikroprost\u0159ed\u00ed:* HT sni\u017euje hypoxickou frakci n\u00e1doru *zv\u00fd\u0161en\u00edm pr\u016ftoku krve a zlep\u0161en\u00edm oxygenace n\u00e1doru*.<\/li>\n<\/ol>\n<p>Tato funk\u010dn\u00ed zm\u011bna v n\u00e1dorov\u00e9m mikroprost\u0159ed\u00ed umo\u017e\u0148uje, aby n\u00e1dorov\u00e9 bu\u0148ky, kter\u00e9 byly d\u0159\u00edve rezistentn\u00ed, staly se mnohem citliv\u011bj\u0161\u00edmi na konven\u010dn\u00ed z\u00e1\u0159en\u00ed. To je kl\u00ed\u010dov\u00fd faktor stoj\u00edc\u00ed za vysok\u00fdmi m\u00edrami lokoregion\u00e1ln\u00ed kontroly a CR dokumentovan\u00fdmi v re\u017eimech Sou\u010dasn\u00e1 Chemoradioterapie + HT (CCRT+HT) pro n\u00e1dory jako je *lok\u00e1ln\u011b pokro\u010dil\u00fd karcinom d\u011blo\u017en\u00edho \u010d\u00edpku (LACC) a n\u00e1dory hlavy a krku (HNC)*.<\/p>\n<h3>2.2. Chemosenzitivita: Zlep\u0161en\u00ed Prometu L\u00e9k\u016f a Bun\u011b\u010dn\u00e9ho P\u0159\u00edjmu<\/h3>\n<h4>2.2.1. Synergie a P\u0159\u00edsp\u011bvek ke Kl\u00ed\u010dov\u00fdm L\u00e1tk\u00e1m<\/h4>\n<p>HT vykazuje siln\u00e9 synergick\u00e9 \u00fa\u010dinky s ur\u010dit\u00fdmi kl\u00ed\u010dov\u00fdmi t\u0159\u00eddami chemoterapeutik. Zejm\u00e9na HT synergicky p\u016fsob\u00ed s l\u00e1tkami na b\u00e1zi platiny (Cisplatina, Karboplatina) a Mitomycinem C. M\u00e1 tak\u00e9 aditivn\u00ed \u00fa\u010dinky s l\u00e1tkami jako Doxorubicin, Cyklofosfamid a Gemcitabin.<\/p>\n<h4>2.2.2. Farmakokinetick\u00e9 Zes\u00edlen\u00ed<\/h4>\n<p>HT optimalizuje dod\u00e1v\u00e1n\u00ed l\u00e9k\u016f na \u00farovni n\u00e1doru, zvy\u0161uje promet l\u00e9k\u016f v n\u00e1dorech a lymfatick\u00fdch uzlin\u00e1ch (LN). Tento \u00fa\u010dinek je p\u0159ipisov\u00e1n zv\u00fd\u0161en\u00e9 perfuzi (pr\u016ftoku krve) indukovan\u00e9 HT a zm\u011bn\u011bn\u00e9 propustnosti bun\u011b\u010dn\u00e9 membr\u00e1ny. V p\u0159\u00edpad\u011b mHT m\u016f\u017ee mechanismus lokalizovan\u00e9ho zah\u0159\u00edv\u00e1n\u00ed na \u00farovni bun\u011b\u010dn\u00e9 membr\u00e1ny zlep\u0161it intracelul\u00e1rn\u00ed p\u0159\u00edjem chemoterapeutick\u00fdch l\u00e1tek.<\/p>\n<h3>2.3. Imunomodulace: HT jako &#8222;In Situ&#8220; N\u00e1dorov\u00e1 Vakc\u00edna<\/h3>\n<p>St\u00e1le v\u00edce p\u0159ij\u00edman\u00fdm mechanismem \u00fa\u010dinku je schopnost HT modulovat protin\u00e1dorovou imunitn\u00ed odpov\u011b\u010f, efektivn\u011b transformovat imunologicky *&#8220;chladn\u00e9&#8220;* n\u00e1dory na *&#8220;hork\u00e9&#8220;* (zan\u00edcen\u00e9) n\u00e1dory. HT p\u016fsob\u00ed jako *&#8220;in situ n\u00e1dorov\u00e1 vakc\u00edna&#8220;* indukov\u00e1n\u00edm uvol\u0148ov\u00e1n\u00ed Protein\u016f Teplotn\u00edho \u0160oku (HSP) a n\u00e1dorov\u00fdch antigen\u016f.<\/p>\n<p>HSP (jako HSP70) p\u016fsob\u00ed jako sign\u00e1ly nebezpe\u010d\u00ed a usnad\u0148uj\u00ed p\u0159\u00edjem antigen\u016f dendritick\u00fdmi bu\u0148kami (DC). Tento imunomodula\u010dn\u00ed proces vede ke zv\u00fd\u0161en\u00e9 l\u00fdze n\u00e1dorov\u00fdch bun\u011bk ze strany Natural Killer (NK) bun\u011bk a CD8+ T lymfocyt\u016f. D\u00e1le HT usnad\u0148uje promet lymfocyt\u016f do m\u00edsta n\u00e1doru, zlep\u0161uje expresi molekul bun\u011b\u010dn\u00e9 adheze (CAM).<\/p>\n<p>*Tabulka 1 shrnuje mechanick\u00e9 interakce hypertermie se standardn\u00edmi onkologick\u00fdmi l\u00e9\u010dbami.*<\/p>\n<p>*Tabulka 1: Mechanismy Interakce Hypertermie se Standardn\u00edmi Onkologick\u00fdmi Terapiemi*<\/p>\n<table width=\"624\">\n<thead>\n<tr>\n<td width=\"104\"><strong>C\u00edlen\u00fd Mechanismus<\/strong><\/td>\n<td width=\"104\"><strong>Biologick\u00fd \u00da\u010dinek (39 \u00b0C \u2013 45 \u00b0C)<\/strong><\/td>\n<td width=\"104\"><strong>Terapeutick\u00e1 Synergie<\/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\">Inhibice Opravy DNA<\/td>\n<td width=\"104\">Blokuje mechanismy opravy DNA; senzibilizuje bu\u0148ky v S f\u00e1zi<\/td>\n<td width=\"104\">Siln\u00fd Radiosenzibiliz\u00e1tor (dopl\u0148uje RT)<\/td>\n<td width=\"104\">Radioterapie (RT)<\/td>\n<\/tr>\n<tr>\n<td width=\"104\">N\u00e1dorov\u00e9 Mikroprost\u0159ed\u00ed<\/td>\n<td width=\"104\">Zvy\u0161uje pr\u016ftok krve, zlep\u0161uje oxygenaci n\u00e1doru, zvy\u0161uje vaskularizaci<\/td>\n<td width=\"104\">Zvy\u0161uje \u00fa\u010dinnost RT; Zlep\u0161uje promet l\u00e9k\u016f (Chemosenzitivita)<\/td>\n<td width=\"104\">RT, Cisplatina, Mitomycin C<\/td>\n<\/tr>\n<tr>\n<td width=\"104\">Bun\u011b\u010dn\u00e1 Membr\u00e1na\/Struktura<\/td>\n<td width=\"104\">Zv\u00fd\u0161en\u00ed dielektrick\u00fdch ztr\u00e1t; P\u0159\u00edm\u00e1 apoptotick\u00e1 signalizace<\/td>\n<td width=\"104\">Zlep\u0161uje p\u0159\u00edjem l\u00e9k\u016f<\/td>\n<td width=\"104\">Cisplatina, Karboplatina, Bleomycin<\/td>\n<\/tr>\n<tr>\n<td width=\"104\">Imunitn\u00ed Syst\u00e9m<\/td>\n<td width=\"104\">Uvol\u0148ov\u00e1n\u00ed HSP, aktivace DC, priming T bun\u011bk, up-regulace l\u00fdzy ze strany NK\/CD8+-T<\/td>\n<td width=\"104\">N\u00e1dorov\u00fd Imunomodul\u00e1tor; Zes\u00edlen\u00e1 Protin\u00e1dorov\u00e1 Imunita<\/td>\n<td width=\"104\">Imunoterapie, RT, KT<\/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 Mechanismy 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 Mechanismy Hypertermie<\/figcaption><\/figure>\n<h2>3. Synt\u00e9za D\u016fkaz\u016f \u00darovn\u011b 1A: Metaanal\u00fdzy a Agregovan\u00e1 Data<\/h2>\n<p>Robustn\u00ed hodnocen\u00ed HT je zalo\u017eeno na agregovan\u00e9 anal\u00fdze studi\u00ed F\u00e1ze III. *Synt\u00e9za d\u016fkaz\u016f \u00darovn\u011b 1A potvrzuje, \u017ee p\u0159id\u00e1n\u00ed HT ke standardn\u00ed l\u00e9\u010db\u011b poskytuje \u0161iroce roz\u0161\u00ed\u0159en\u00fd klinick\u00fd p\u0159\u00ednos v r\u00e1mci n\u011bkolika kategori\u00ed n\u00e1dor\u016f.*<\/p>\n<h3>3.1. P\u0159ehled V\u00fdsledk\u016f Metaanal\u00fdzy<\/h3>\n<p>*Ned\u00e1vn\u00e1 anal\u00fdza \u00fa\u010dinnosti HT identifikovala \u0161est studi\u00ed lokoregion\u00e1ln\u00ed HT, z nich\u017e p\u011bt prok\u00e1zalo zv\u00fd\u0161en\u00ed Celkov\u00e9ho P\u0159e\u017eit\u00ed (OS) a\/nebo zlep\u0161en\u00ed M\u00edry Kompletn\u00ed Odpov\u011bdi (CR) p\u0159id\u00e1n\u00edm HT ke standardn\u00ed chemo- a\/nebo radioterapii [2]. To vytv\u00e1\u0159\u00ed siln\u00fd v\u011bdeck\u00fd konsenzus podporuj\u00edc\u00ed pou\u017eit\u00ed HT jako adjuvans \u00darovn\u011b 1A pro \u0161irokou \u0161k\u00e1lu lokoregion\u00e1ln\u00edch n\u00e1dorov\u00fdch m\u00edst.*<\/p>\n<h3>3.2. Kvantifikace Zisk\u016f v Odpov\u011bdi a P\u0159e\u017eit\u00ed<\/h3>\n<p>Klinick\u00e9 v\u00fdhody HT jsou kvantifikov\u00e1ny v kritick\u00fdch onkologick\u00fdch koncov\u00fdch bodech. Agregovan\u00e1 data pro *lok\u00e1ln\u011b pokro\u010dil\u00fd karcinom d\u011blo\u017en\u00edho \u010d\u00edpku (LACC)* ukazuj\u00ed:<\/p>\n<ul>\n<li>*Kompletn\u00ed Odpov\u011b\u010f (CR):* CR se v\u00fdznamn\u011b zlep\u0161uje s kombinovanou terapi\u00ed s HT (Relativn\u00ed Riziko \u2013 *RR 0.56, 95% CI 0.39 a\u017e 0.79; **p &lt; 0.001*).<\/li>\n<li>*Kontrola Lok\u00e1ln\u00ed Rekurence:* HT v\u00fdznamn\u011b sni\u017euje m\u00edru lok\u00e1ln\u00ed rekurence (Pom\u011br Rizik \u2013 *HR 0.48, 95% CI 0.37 a\u017e 0.63; **p &lt; 0.001*).<\/li>\n<li>*Celkov\u00e9 P\u0159e\u017eit\u00ed (OS):* Multimod\u00e1ln\u00ed l\u00e9\u010dba s HT vede k lep\u0161\u00edmu 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 Specifick\u00fdch Studi\u00ed F\u00e1ze III podle Typu Rakoviny<\/h2>\n<p>Tato podrobn\u00e1 anal\u00fdza zkoum\u00e1 n\u00e1dorov\u00e1 m\u00edsta, kde je HT podpo\u0159ena randomizovan\u00fdmi klinick\u00fdmi studiemi nejvy\u0161\u0161\u00edho kalibru, se zam\u011b\u0159en\u00edm na kl\u00ed\u010dov\u00e9 v\u00fdsledky p\u0159e\u017eit\u00ed a odpov\u011bdi.<\/p>\n<h3><\/h3>\n<h3>4.1. Sarkom M\u011bkk\u00fdch Tk\u00e1n\u00ed (STM)<\/h3>\n<p>Sarkom m\u011bkk\u00fdch tk\u00e1n\u00ed je jednou z referen\u010dn\u00edch indikac\u00ed se studiemi F\u00e1ze III podporuj\u00edc\u00edmi integraci HT. Studie porovn\u00e1vaj\u00edc\u00ed standardn\u00ed neoadjuvantn\u00ed chemoterapii s region\u00e1ln\u00ed hypertermi\u00ed (RHT) plus neoadjuvantn\u00ed chemoterapie prok\u00e1zaly, \u017ee *p\u0159id\u00e1n\u00ed HT vede ke zv\u00fd\u0161en\u00ed p\u0159e\u017eit\u00ed* a *zlep\u0161en\u00ed lok\u00e1ln\u00edho p\u0159e\u017eit\u00ed bez progrese (LPFS)*.<br \/>\nNav\u00edc transla\u010dn\u00ed anal\u00fdza t\u011bchto studi\u00ed odhalila d\u016fle\u017eit\u00fd imunitn\u00ed mechanismus: Kombinovan\u00e1 p\u0159edopera\u010dn\u00ed l\u00e9\u010dba s RHT prok\u00e1zala, \u017ee transformuje n\u00e1dor, kter\u00fd je v podstat\u011b nez\u00e1n\u011btliv\u00fd, na z\u00e1n\u011btliv\u00fd n\u00e1dor. Tato p\u0159eprogramov\u00e1n\u00ed n\u00e1dorov\u00e9ho mikroprost\u0159ed\u00ed umo\u017e\u0148uje zes\u00edlenou protin\u00e1dorovou imunitn\u00ed aktivitu.<\/p>\n<h3>4.2. Gynekologick\u00e9 Karcinomy: Lok\u00e1ln\u011b Pokro\u010dil\u00fd Karcinom D\u011blo\u017en\u00edho \u010c\u00edpku (LACC)<\/h3>\n<p>D\u016fkazy pro HT u LACC, p\u0159idan\u00e9 k Sou\u010dasn\u00e9 Chemoradioterapii (CCRT), pat\u0159\u00ed mezi nejp\u0159esv\u011bd\u010div\u011bj\u0161\u00ed v onkologii.<\/p>\n<h4>4.2.1. Konsenzus Studi\u00ed (CR a Lok\u00e1ln\u00ed Rekurence)<\/h4>\n<p>Systematicky metaanal\u00fdzy a agregovan\u00e1 data z randomizovan\u00fdch studi\u00ed potvrzuj\u00ed p\u0159\u00ednos trimod\u00e1ln\u00ed l\u00e9\u010dby (CCRT + HT). *Anal\u00fdza agregovan\u00fdch dat uk\u00e1zala v\u00fdznamn\u011b vy\u0161\u0161\u00ed m\u00edru Kompletn\u00ed Odpov\u011bdi (CR) s kombinovanou l\u00e9\u010dbou (RR 0.56; p &lt; 0.001) a ni\u017e\u0161\u00ed m\u00edru lok\u00e1ln\u00ed rekurence (HR 0.48; p &lt; 0.001). Tato vynikaj\u00edc\u00ed lokoregion\u00e1ln\u00ed kontrola u\u010dinila trimod\u00e1ln\u00ed l\u00e9\u010dbu \u017eivotaschopn\u00fdm a \u00fa\u010dinn\u00fdm p\u0159\u00edstupem.*<\/p>\n<h4>4.2.2. Kvantifikace Celkov\u00e9ho P\u0159e\u017eit\u00ed (OS)<\/h4>\n<p>*Celkov\u00e9 P\u0159e\u017eit\u00ed (OS) je v\u00fdznamn\u011b zlep\u0161eno kombinac\u00ed CCRT a HT: HR 0.67 (95% CI 0.45 a\u017e 0.99; p = 0.05).*<br \/>\nJedna studie F\u00e1ze III z It\u00e1lie hodnot\u00edc\u00ed RT +- HT pro cervik\u00e1ln\u00ed N3 skvam\u00f3zn\u00ed lymfatick\u00e9 uzliny z t\u00e9 doby uk\u00e1zala mimo\u0159\u00e1dn\u00fd rozd\u00edl: *m\u00edra CR ve skupin\u011b l\u00e9\u010den\u00e9 kombinovanou terapi\u00ed byla 82.3%, zat\u00edmco ve skupin\u011b onkologick\u00fdch pacient\u016f l\u00e9\u010den\u00fdch pouze radioterapi\u00ed byla **36.8%* [3,4]. Dlouhodob\u00e1 anal\u00fdza t\u00e9\u017ee studie uv\u00e1d\u011bla *5let\u00e9 Celkov\u00e9 P\u0159e\u017eit\u00ed 55%* v rameni hypertermie, ve srovn\u00e1n\u00ed s *0%* v rameni pouze z\u00e1\u0159en\u00ed [3,4].<\/p>\n<h4>4.2.3. Dopl\u0148kov\u00e9 D\u016fkazy (OS)<\/h4>\n<p>Nejsiln\u011bj\u0161\u00ed dopl\u0148kov\u00e1 \u00farove\u0148 d\u016fkaz\u016f poch\u00e1z\u00ed z *Rakoviny D\u011blo\u017en\u00edho \u010c\u00edpku (Cervix)*, studovan\u00e9 v \u010detn\u00fdch randomizovan\u00fdch studi\u00edch, kter\u00e9 kombinovaly lokoregion\u00e1ln\u00ed Hypertermii s Radioterapi\u00ed (RT) nebo Chemoradioterapi\u00ed (CTRT).<\/p>\n<p>Tyto v\u00fdsledky (d\u016fkaz vysok\u00e9 \u00farovn\u011b pro rakovinu d\u011blo\u017en\u00edho \u010d\u00edpku) jsou z\u00edsk\u00e1ny z metaanal\u00fdz porovn\u00e1vaj\u00edc\u00edch standardn\u00ed l\u00e9\u010dbu (RT nebo CTRT) s kombinovanou l\u00e9\u010dbou (RT\/CTRT + Hypertermie):<\/p>\n<table width=\"624\">\n<thead>\n<tr>\n<td width=\"208\">Klinick\u00fd Ukazatel<\/td>\n<td width=\"208\">V\u00fdsledek Z\u00edskan\u00fd s RT + Hypertermie<\/td>\n<td width=\"208\">Reference (P\u0159e\u010dten\u00e9 Recenze)<\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td width=\"208\"><strong>Kompletn\u00ed Odpov\u011b\u010f (CR)<\/strong><\/td>\n<td width=\"208\">Konzistentn\u00ed zlep\u0161en\u00ed m\u00edry CR: <strong>+22.1%<\/strong> ve srovn\u00e1n\u00ed s pouze RT.<\/td>\n<td width=\"208\">Metaanal\u00fdza<\/td>\n<\/tr>\n<tr>\n<td width=\"208\"><strong>Lokoregion\u00e1ln\u00ed Kontrola (LRC)<\/strong><\/td>\n<td width=\"208\">V\u00fdznamn\u00e9 zlep\u0161en\u00ed: <strong>+23.1%<\/strong> ve srovn\u00e1n\u00ed s pouze RT.<\/td>\n<td width=\"208\">Metaanal\u00fdza<\/td>\n<\/tr>\n<tr>\n<td width=\"208\"><strong>Celkov\u00e9 P\u0159e\u017eit\u00ed (OS)<\/strong><\/td>\n<td width=\"208\">Bylo zaznamen\u00e1no zlep\u0161en\u00ed dlouhodob\u00e9ho celkov\u00e9ho p\u0159e\u017eit\u00ed (OS) s p\u0159id\u00e1n\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>P\u0159e\u017eit\u00ed Bez Nemoci (DFS)<\/strong><\/td>\n<td width=\"208\">V\u00fdznamn\u00e9 zlep\u0161en\u00ed DFS po 2 a 3 letech v kombinaci s CTRT.<\/td>\n<td width=\"208\">Randomizovan\u00e9 Studie F\u00e1ze III<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<ul>\n<li>*N\u00e1zev:* Combined use of hyperthermia and radiation therapy for treating locally advanced cervical carcinoma (Kombinovan\u00e9 pou\u017eit\u00ed hypertermie a radioterapie k l\u00e9\u010db\u011b lok\u00e1ln\u011b pokro\u010dil\u00e9ho karcinomu d\u011blo\u017en\u00edho \u010d\u00edpku)<\/li>\n<li>*Auto\u0159i:* Lutgens L, van der Zee J, Pijls-Johannesma M, et al.<\/li>\n<li>*Odkaz na PubMed (Aktualizace 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. S\u00ed\u0165ov\u00e1 Metaanal\u00fdza (NMA): Nejlep\u0161\u00ed Strategie (Datta et al. 2019.)<\/h5>\n<p>Tato studie pou\u017eila pokro\u010dilou metodu (Network Meta-analysis) k porovn\u00e1n\u00ed Hypertermie s 13 dal\u0161\u00edmi terapeutick\u00fdmi intervencemi, \u010d\u00edm\u017e ji za\u0159adila mezi nejlep\u0161\u00ed mo\u017enosti.<\/p>\n<table width=\"624\">\n<thead>\n<tr>\n<td width=\"312\">Potvrzen\u00e9 Ukazatele<\/td>\n<td width=\"312\">Kl\u00ed\u010dov\u00fd V\u00fdsledek<\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td width=\"312\"><strong>\u0158azen\u00ed L\u00e9\u010deb<\/strong><\/td>\n<td width=\"312\"><strong>RT+HT<\/strong> a *CTRT+HT* byly za\u0159azeny mezi t\u0159i nejlep\u0161\u00ed intervence s nejlep\u0161\u00edm celkov\u00fdm \u00fa\u010dinkem na LRC, OS a toxicitu.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<ul>\n<li>*N\u00e1zev:* 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 (Hodnocen\u00ed \u00da\u010dinnosti a Bezpe\u010dnosti R\u016fzn\u00fdch Terapeutick\u00fdch Mo\u017enost\u00ed u Lok\u00e1ln\u011b Pokro\u010dil\u00e9ho Karcinomu D\u011blo\u017en\u00edho \u010c\u00edpku: Systematick\u00fd P\u0159ehled a S\u00ed\u0165ov\u00e1 Metaanal\u00fdza Randomizovan\u00fdch Klinick\u00fdch Studi\u00ed)<\/li>\n<li>*Auto\u0159i:* 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. Studie F\u00e1ze III: P\u0159e\u017eit\u00ed Bez Nemoci (DFS) a Kvalita \u017divota (QoL) s mEHT<\/h5>\n<p>Toto je jedna z nejnov\u011bj\u0161\u00edch studi\u00ed F\u00e1ze III, kter\u00e1 potvrzuje v\u00fdhody, jako je zlep\u0161en\u00ed DFS a Kvality \u017divota (QoL), s modern\u00ed technikou Hypertermie (mEHT) p\u0159idanou k Chemoradioterapii (CTRT).<\/p>\n<table width=\"624\">\n<thead>\n<tr>\n<td width=\"312\">Potvrzen\u00e9 Ukazatele<\/td>\n<td width=\"312\">Kl\u00ed\u010dov\u00fd V\u00fdsledek<\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td width=\"312\"><strong>P\u0159e\u017eit\u00ed Bez Nemoci (DFS)<\/strong><\/td>\n<td width=\"312\">V\u00fdznamn\u00e9 zlep\u0161en\u00ed DFS po 2 a 3 letech s p\u0159id\u00e1n\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\u0161en\u00ed QoL bez zv\u00fd\u0161en\u00ed toxicity.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<ul>\n<li>*N\u00e1zev:* Effects of Modulated Electro-Hyperthermia (mEHT) on Two and Three Year Survival of Locally Advanced Cervical Cancer Patients (\u00da\u010dinky Modulovan\u00e9 Elektrohypertermie (mEHT) na Dvoulet\u00e9 a T\u0159\u00edlet\u00e9 P\u0159e\u017eit\u00ed Pacientek s Lok\u00e1ln\u011b Pokro\u010dil\u00fdm Karcinomem D\u011blo\u017en\u00edho \u010c\u00edpku)<\/li>\n<li>*Auto\u0159i:* Minnaar CA, Maposa I, Kotzen JA, et al.<\/li>\n<li>*Odkaz na MDPI (K dispozici 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>Pro lok\u00e1ln\u011b pokro\u010dil\u00fd karcinom d\u011blo\u017en\u00edho \u010d\u00edpku p\u0159id\u00e1n\u00ed lokoregion\u00e1ln\u00ed Hypertermie nejen zvy\u0161uje mo\u017enost lok\u00e1ln\u00ed eradikace n\u00e1doru (CR), ale m\u00e1 tak\u00e9 v\u00fdznamn\u00fd a pozitivn\u00ed vliv na dlouhodob\u00e9 p\u0159e\u017eit\u00ed (OS a DFS).<\/p>\n<h3>4.3. Karcinomy Hlavy a Krku (HNC)<\/h3>\n<p>Lokoregion\u00e1ln\u00ed Hypertermie je l\u00e9\u010dba *\u00darovn\u011b 1A* pro \u0159adu n\u00e1dor\u016f hlavy a krku, v\u010detn\u011b rekurenc\u00ed a pokro\u010dil\u00e9ho onemocn\u011bn\u00ed, kde m\u00e1 p\u0159\u00edm\u00fd dopad na lok\u00e1ln\u00ed kontrolu, kvalitu \u017eivota a p\u0159e\u017eit\u00ed.<\/p>\n<h4>4.3.1. Data z Randomizovan\u00fdch Studi\u00ed F\u00e1ze III<\/h4>\n<p>*Prospektivn\u00ed, randomizovan\u00e9 studie F\u00e1ze III dokumentovaly jasn\u00e9 v\u00fdhody kombinace Chemoradioterapie (CRT) s HT u karcinomu nosohltanu (NPC) ve srovn\u00e1n\u00ed s pouze CRT.*<br \/>\n\u25cf *<a href=\"https:\/\/doi.org\/10.7314\/apjcp.2013.14.12.7395\" target=\"_blank\" rel=\"noopener\">Kang 2013<\/a> (NPC):* Tato studie F\u00e1ze III zaznamenala v\u00fdznamn\u00e9 zlep\u0161en\u00ed. *P\u0159e\u017eit\u00ed Bez Nemoci (DFS) po 5 letech se zv\u00fd\u0161ilo z 25.5% na 51.3% (p &lt; 0.005)* a *OS po 5 letech se zv\u00fd\u0161ilo z 50% na 68.4% (p &lt; 0.005)*. M\u00edra CR se tak\u00e9 zv\u00fd\u0161ila z 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> (Or\u00e1ln\u00ed Dutina\/Orofarynx\/Hypofarynx):* Kompletn\u00ed odpov\u011b\u010f byla zaznamen\u00e1na u *78.6%* skupiny l\u00e9\u010den\u00e9 HT, ve srovn\u00e1n\u00ed s *42.4%* skupiny l\u00e9\u010den\u00e9 pouze radioterapi\u00ed. Rozd\u00edl byl statisticky v\u00fdznamn\u00fd (&lt; 0.05).<br \/>\nV\u00fdznamn\u00e9 a konzistentn\u00ed zisky v DFS a OS u HNC, kde jsou m\u00edry lok\u00e1ln\u00ed rekurence \u010dasto vysok\u00e9, zd\u016fraz\u0148uj\u00ed \u00fa\u010dinnost HT p\u0159i p\u0159ekon\u00e1v\u00e1n\u00ed lok\u00e1ln\u00ed radio-rezistence, \u010d\u00edm\u017e se st\u00e1v\u00e1 z\u00e1kladn\u00ed sou\u010d\u00e1st\u00ed l\u00e9\u010dby s kurativn\u00edm z\u00e1m\u011brem [5].<\/p>\n<h3>4.4. Gastrointestin\u00e1ln\u00ed Karcinomy: Rekt\u00e1ln\u00ed a An\u00e1ln\u00ed Karcinom<\/h3>\n<p>Integrace HT do Neoadjuvantn\u00ed Chemoradioterapie (CRT) u lok\u00e1ln\u011b pokro\u010dil\u00e9ho rekt\u00e1ln\u00edho karcinomu prok\u00e1zala kritick\u00e9 v\u00fdhody v lokoregion\u00e1ln\u00ed kontrole a p\u0159e\u017eit\u00ed.<\/p>\n<h4>4.4.1. V\u00fdsledky F\u00e1ze III pro Rekt\u00e1ln\u00ed Karcinom<\/h4>\n<p>Prospektivn\u00ed randomizovan\u00e1 studie *<a href=\"https:\/\/link.springer.com\/article\/10.1007\/s00066-018-1396-x\" target=\"_blank\" rel=\"noopener\">Ott 2019<\/a>* porovn\u00e1vala CRT s CRT + HT a zaznamenala v\u00fdznamn\u00e1 zlep\u0161en\u00ed v rameni HT po 5 letech:<br \/>\n*\u25cf Celkov\u00e9 P\u0159e\u017eit\u00ed (OS): 95.8% oproti 74.5% (P = 0.045).*<br \/>\n*\u25cf P\u0159e\u017eit\u00ed Bez Nemoci (DFS): 89.1% oproti 70.4% (P = 0.027).*<br \/>\n*\u25cf Lok\u00e1ln\u00ed P\u0159e\u017eit\u00ed Bez Rekurence (LRFS): 97.7% oproti 78.7% (P = 0.006).*<\/p>\n<h4>4.4.2. Patologick\u00e1 Odpov\u011b\u010f a Klinick\u00e9 Implikace<\/h4>\n<p>M\u00edra Patologick\u00e9 Kompletn\u00ed Odpov\u011bdi (pCR) se tak\u00e9 zlep\u0161ila s p\u0159id\u00e1n\u00edm HT, p\u0159i\u010dem\u017e metaanal\u00fdza uk\u00e1zala n\u00e1r\u016fst z 16% (CRT) na *22.5% (CRT+HT, p = 0.043). **Kl\u00ed\u010dov\u011b, vynikaj\u00edc\u00ed m\u00edra LRFS (97.7%) a zlep\u0161en\u00ed v m\u00edr\u00e1ch p\u0159e\u017eit\u00ed bez kolostomie (87.7% oproti 69.0%, P = 0.016) zd\u016fraz\u0148uj\u00ed roli HT nejen v lok\u00e1ln\u00ed sterilizaci n\u00e1doru, ale tak\u00e9 ve strategi\u00edch zachov\u00e1n\u00ed sv\u011bra\u010de.*<\/p>\n<p>&nbsp;<\/p>\n<h3>4.5. Malign\u00ed Melanom (Lokoregion\u00e1ln\u00ed Onemocn\u011bn\u00ed)<\/h3>\n<p>*Z\u00e1kladn\u00ed studie F\u00e1ze III (<a href=\"https:\/\/pubmed.ncbi.nlm.nihs.gov\/7776772\/\" target=\"_blank\" rel=\"noopener\">Overgaard et al., 1995<\/a>) prok\u00e1zaly, \u017ee kombinace radioterapie s HT zlep\u0161uje M\u00edru Kompletn\u00ed Odpov\u011bdi a OS u pokro\u010dil\u00e9ho melanomu.*<\/p>\n<p>*Kl\u00ed\u010dov\u00e9 V\u00fdsledky: RT + Hypertermie oproti Radioterapii*<\/p>\n<p>Evropsk\u00e1 multicentrick\u00e1 randomizovan\u00e1 studie randomizovala 134 l\u00e9z\u00ed metastatick\u00e9ho nebo rekurentn\u00edho melanomu u 70 pacient\u016f, aby obdr\u017eeli bu\u010f pouze radioterapii, nebo radioterapii n\u00e1sledovanou hypertermi\u00ed (43\u00b0C po dobu 60 minut).<\/p>\n<h5>1. Lok\u00e1ln\u00ed Kontrola N\u00e1doru (Prim\u00e1rn\u00ed Koncov\u00fd Bod)<\/h5>\n<p>Nejv\u00fdznamn\u011bj\u0161\u00edm v\u00fdsledkem bylo v\u00fdznamn\u00e9 zlep\u0161en\u00ed dlouhodob\u00e9 lok\u00e1ln\u00ed kontroly n\u00e1doru.<\/p>\n<table width=\"624\">\n<thead>\n<tr>\n<td width=\"156\">Ukazatel<\/td>\n<td width=\"156\">Pouze Radioterapie (RT)<\/td>\n<td width=\"156\">Radioterapie + Hypertermie (RT + HT)<\/td>\n<td width=\"156\">Kl\u00ed\u010dov\u00fd Rozd\u00edl<\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td width=\"156\"><strong>Aktu\u00e1\u0159sk\u00e1 Lok\u00e1ln\u00ed Kontrola po 2 Letech<\/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\u0161en\u00ed (p = 0.008)<\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<ul>\n<li>*Z\u00e1v\u011br:* P\u0159id\u00e1n\u00ed HT zv\u00fd\u0161ilo lok\u00e1ln\u00ed kontrolu n\u00e1doru o *18 procentn\u00edch bod\u016f* po 2 letech.<\/li>\n<\/ul>\n<h5>2. Multivariantn\u00ed Anal\u00fdza (Prognostick\u00e9 Faktory)<\/h5>\n<p>Coxova multivariantn\u00ed regresn\u00ed anal\u00fdza potvrdila, \u017ee *hypertermie* byla nejd\u016fle\u017eit\u011bj\u0161\u00edm prognostick\u00fdm faktorem pro lok\u00e1ln\u00ed kontrolu po 2 letech.<\/p>\n<table width=\"624\">\n<thead>\n<tr>\n<td width=\"208\">Prognostick\u00e1 Prom\u011bnn\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>Hypertermie<\/strong><\/td>\n<td width=\"208\"><strong>1.73<\/strong> (pro lok\u00e1ln\u00ed kontrolu)<\/td>\n<td width=\"208\"><strong>p = 0.023<\/strong><\/td>\n<\/tr>\n<tr>\n<td width=\"208\">D\u00e1vka Z\u00e1\u0159en\u00ed<\/td>\n<td width=\"208\">1.17<\/td>\n<td width=\"208\">p = 0.05<\/td>\n<\/tr>\n<tr>\n<td width=\"208\">Velikost N\u00e1doru<\/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\u00e1v\u011br:* To ukazuje, \u017ee p\u0159\u00ednos poskytovan\u00fd HT je nez\u00e1visl\u00fd a stejn\u011b v\u00fdznamn\u00fd jako pou\u017eit\u00e1 d\u00e1vka z\u00e1\u0159en\u00ed a velikost n\u00e1doru.<\/li>\n<\/ul>\n<h5>3. P\u0159e\u017eit\u00ed (Lok\u00e1ln\u00ed Kontrola je Kurativn\u00ed)<\/h5>\n<p>Studie zaznamenala silnou korelaci mezi \u00fasp\u011b\u0161nou lok\u00e1ln\u00ed kontrolou a dlouhodob\u00fdm p\u0159e\u017eit\u00edm:<\/p>\n<ul>\n<li>*5let\u00e9 Celkov\u00e9 P\u0159e\u017eit\u00ed:* Celkov\u00e1 m\u00edra byla 19%.<\/li>\n<li>*5let\u00e9 P\u0159e\u017eit\u00ed u Pacient\u016f s Kompletn\u00ed Kontrolou Nemoci:* Zv\u00fd\u0161ilo se na *38%*.<\/li>\n<li>*Z\u00e1v\u011br:* \u00dasp\u011b\u0161n\u00e1 lok\u00e1ln\u00ed kontrola jedn\u00e9 nebo v\u00edce metastatick\u00fdch l\u00e9z\u00ed m\u011bla *v\u00fdznamn\u00fd kurativn\u00ed potenci\u00e1l*, zd\u016fraz\u0148uj\u00edc\u00ed d\u016fle\u017eitost zv\u00fd\u0161en\u00e9 lok\u00e1ln\u00ed \u00fa\u010dinnosti HT.<\/li>\n<\/ul>\n<h5>4. Toxicita a Bezpe\u010dnost<\/h5>\n<ul>\n<li>P\u0159id\u00e1n\u00ed tepla *v\u00fdznamn\u011b nezv\u00fd\u0161ilo* akutn\u00ed nebo pozdn\u00ed reakce na z\u00e1\u0159en\u00ed.<\/li>\n<li>L\u00e9\u010dba oh\u0159evem byla obecn\u011b *dob\u0159e tolerov\u00e1na*.<\/li>\n<\/ul>\n<p>*Pozn\u00e1mka:* Studie zm\u00ednila pot\u00ed\u017ee s dosa\u017een\u00edm tepeln\u00e9ho protokolu (43\u00b0C), poda\u0159ilo se to pouze ve 14% l\u00e9\u010den\u00ed.<\/p>\n<h3>4.6 Rekurentn\u00ed Rakovina Prsu<\/h3>\n<h4>4.6.1. Metaanal\u00fdza Potvrzuj\u00edc\u00ed \u00da\u010dinnost Termoradioterapie u Rekurentn\u00edho Rakoviny Prsu<\/h4>\n<p>Metaanal\u00fdza konsoliduje data z klinick\u00fdch studi\u00ed F\u00e1ze III, kter\u00e1 ukazuj\u00ed na vy\u0161\u0161\u00ed M\u00edru Kompletn\u00ed Odpov\u011bdi (CR) pro kombinovanou l\u00e9\u010dbu (Radioterapie + Hypertermie) u *lokoregion\u00e1ln\u011b rekurentn\u00ed rakoviny prsu (LRBC)*.<\/p>\n<p>Toto je studie, kter\u00e1 podporuje v\u00fdsledky d\u016fkaz\u016f \u00darovn\u011b 1A, kter\u00e9 zahrnuj\u00ed m\u00edry *CR 60-66%* pro kombinovanou l\u00e9\u010dbu:<br \/>\n* *Studie:* Hyperthermia and Radiation Therapy in Locoregional Recurrent Breast Cancers: A Systematic Review and Meta-analysis. (Hypertermie a Radioterapie u Lokoregion\u00e1ln\u011b Rekurentn\u00edch Karcinom\u016f Prsu: Systematick\u00fd P\u0159ehled a Metaanal\u00fdza)<br \/>\n* *Auto\u0159i:* Datta NR, Puric E, Klingbiel D, Gomez S, Bodis S.<br \/>\n* *Publikov\u00e1no v:* International Journal of Radiation Oncology Biology Physics, 2016.<\/p>\n<p>*Z\u00e1v\u011br:* Termoradioterapie (RT + Hypertermie) zvy\u0161uje M\u00edru Kompletn\u00ed Odpov\u011bdi (CR) o p\u0159ibli\u017en\u011b *22%* ve srovn\u00e1n\u00ed s pouze radioterapi\u00ed; ve studi\u00edch porovn\u00e1vaj\u00edc\u00edch dv\u011b ramena l\u00e9\u010dby bylo dosa\u017eeno m\u00edry CR *60.2%* s RT + Hypertermi\u00ed (HT), oproti 38.1% s pouze RT (Radioterapie). M\u00edra CR dos\u00e1hla *66.6%* v p\u0159\u00edpad\u011b re-oz\u00e1\u0159en\u00ed s hypertermi\u00ed.<\/p>\n<h4>4.6.2 Torak\u00e1ln\u00ed Rekurence Rakoviny Prsu<\/h4>\n<p>Hypertermie, obvykle v kombinaci s RT, m\u00e1 d\u016fkazy *\u00darovn\u011b 1A* pro l\u00e9\u010dbu torak\u00e1ln\u00ed rekurence rakoviny prsu. Tato kombinace je zvl\u00e1\u0161t\u011b cenn\u00e1 v kontextu rekurence hrudn\u00ed st\u011bny, kde jsou mo\u017enosti l\u00e9\u010dby \u010dasto omezen\u00e9. Studie ukazuj\u00ed vysok\u00e9 M\u00edry Kompletn\u00ed Odpov\u011bdi (CR) v rozmez\u00ed *40% a\u017e 86%* a M\u00edry Lok\u00e1ln\u00ed Kontroly (LC) mezi *70% a 76%, kdy\u017e je RT kombinov\u00e1na s HT. Nav\u00edc m\u00edry OS po 5 letech pro toto rekurentn\u00ed onemocn\u011bn\u00ed mohou dos\u00e1hnout a\u017e **50%*. Kombinace RT+HT nab\u00edz\u00ed \u00fa\u010dinnou lok\u00e1ln\u00ed strategii pro paliaci a dlouhodobou kontrolu.<\/p>\n<h4>4.6.3. Obecn\u00fd Trend v Lokoregion\u00e1ln\u00ed L\u00e9\u010db\u011b &#8211; Jin\u00e9 Onkologick\u00e9 Indikace s D\u016fkazy \u00darovn\u011b 1<\/h4>\n<p>Generalizace v\u00fdsledk\u016f pro lokoregion\u00e1ln\u00ed l\u00e9\u010dby:<br \/>\n* *Konsolidace D\u016fkaz\u016f:* Druh\u00e1 systematick\u00e1 revize (prvn\u00ed byla Hildenbrandt et al.) odhaluje, \u017ee *5 ze 6 studi\u00ed F\u00e1ze III* (zam\u011b\u0159en\u00fdch na povrchov\u00e9 a lokoregion\u00e1ln\u00ed n\u00e1dory, v\u010detn\u011b prsu, hlavy a krku, melanomu) prok\u00e1zalo zv\u00fd\u0161en\u00ed *Celkov\u00e9ho P\u0159e\u017eit\u00ed (OS)* a\/nebo *Kompletn\u00ed Odpov\u011bdi (CR)*, kdy\u017e byla Hypertermie p\u0159id\u00e1na ke standardn\u00ed l\u00e9\u010db\u011b [2].<br \/>\n* *Paliativn\u00ed Aplikace:* Studie ukazuj\u00ed, \u017ee Hypertermie, v kombinaci s RT, vede k v\u00fdznamn\u00e9mu zv\u00fd\u0161en\u00ed *Kompletn\u00ed Odpov\u011bdi na Bolest* u bolestiv\u00fdch kostn\u00edch metast\u00e1z, s v\u00fdznamn\u00fdm zlep\u0161en\u00edm Kvality \u017divota (QoL) pacient\u016f.<\/p>\n<h3>4.7. Rakovina Mo\u010dov\u00e9ho M\u011bch\u00fd\u0159e: Hypertermick\u00e1 Intravesik\u00e1ln\u00ed Chemoterapie (HIVEC)<\/h3>\n<p>Hypertermick\u00e1 Intravesik\u00e1ln\u00ed Chemoterapie (HIVEC) zahrnuje zah\u0159\u00edv\u00e1n\u00ed Mitomycinu C (MMC) (obvykle na 43\u00b0C) b\u011bhem intravesik\u00e1ln\u00ed instilace pro nemuskul\u00e1rn\u011b-invazivn\u00ed rakovinu mo\u010dov\u00e9ho m\u011bch\u00fd\u0159e (NMIBC).<\/p>\n<h4>4.7.1. V\u00fdsledky Studie HIVEC-1 F\u00e1ze III<\/h4>\n<p>Studie HIVEC-1 byla randomizovan\u00e1 studie F\u00e1ze 3 navr\u017een\u00e1 k porovn\u00e1n\u00ed p\u0159e\u017eit\u00ed bez rekurence (RFS) s MMC v normotermii.<br \/>\nRFS po 24 m\u011bs\u00edc\u00edch v ITT populaci bylo 77% v kontroln\u00edm rameni (normotermie), oproti 82% (30 min) a 80% (60 min) v rameni HT. Studie dosp\u011bla k z\u00e1v\u011bru, \u017ee HT nebyla statisticky lep\u0161\u00ed ne\u017e MMC v normotermii, pokud jde o RFS po 24 m\u011bs\u00edc\u00edch (p-hodnota 0.6) [6].<\/p>\n<h4>4.7.2. Nuance a P\u0159e\u017eit\u00ed Bez Progrese<\/h4>\n<p>Na rozd\u00edl od v\u00fdsledk\u016f RFS pro NMIBC-AR data z jin\u00fdch studi\u00ed zd\u016fraz\u0148uj\u00ed v\u00fdhody, zejm\u00e9na pro vysoce rizikov\u00e9 pacienty, kte\u0159\u00ed zme\u0161kali BCG terapii. Anal\u00fdza uk\u00e1zala *v\u00fdznamn\u011b lep\u0161\u00ed P\u0159e\u017eit\u00ed Bez Progrese (PFS) pro HIVEC ve srovn\u00e1n\u00ed s BCG* v ITT anal\u00fdze (95.7% oproti 71.8%; p = 0.043) [7].<\/p>\n<p>&nbsp;<\/p>\n<p>*Tabulka 2 shrnuje kl\u00ed\u010dov\u00e9 klinick\u00e9 v\u00fdsledky F\u00e1ze III pro integraci hypertermie.*<\/p>\n<p>Tabulka 2: Kl\u00ed\u010dov\u00e9 Klinick\u00e9 V\u00fdsledky F\u00e1ze III pro Hypertermii v Onkologii (HT + Standardn\u00ed L\u00e9\u010dba oproti Pouze Standardn\u00ed L\u00e9\u010dba)<\/p>\n<p>&nbsp;<\/p>\n<table width=\"624\">\n<thead>\n<tr>\n<td width=\"104\"><strong>Typ Rakoviny (Metoda HT)<\/strong><\/td>\n<td width=\"104\"><strong>Typ Studie\/Ukazatel<\/strong><\/td>\n<td width=\"104\"><strong>HT + Standardn\u00ed L\u00e9\u010dba<\/strong><\/td>\n<td width=\"104\"><strong>Pouze Standardn\u00ed L\u00e9\u010dba<\/strong><\/td>\n<td width=\"104\"><strong>Statistick\u00e1 V\u00fdznamnost\/V\u00fdsledek Ukazatele<\/strong><\/td>\n<td width=\"104\"><strong>Reference<\/strong><\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td width=\"104\">Sarkom M\u011bkk\u00fdch Tk\u00e1n\u00ed (L-R HT + KT) 11.3 let<\/td>\n<td width=\"104\">Randomizovan\u00e1 F\u00e1ze III (<\/p>\n<p>OS po 5 letech<\/p>\n<p>&nbsp;<\/p>\n<p>OS po 10 letech)<\/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\">Ve srovn\u00e1n\u00ed s pouze neoadjuvantn\u00ed chemoterapi\u00ed zlep\u0161ilo p\u0159id\u00e1n\u00ed region\u00e1ln\u00ed hypertermie *lok\u00e1ln\u00ed p\u0159e\u017eit\u00ed bez nemoci DFS* (Pom\u011br Rizik [HR], 0.65; 95% CI, 0.49\u20130.86; P = 0.002).<\/p>\n<p>Pacienti randomizovan\u00ed na chemoterapii plus hypertermii dos\u00e1hli del\u0161\u00edho *Celkov\u00e9ho P\u0159e\u017eit\u00ed OS* ne\u017e ti randomizovan\u00ed na pouze neoadjuvantn\u00ed chemoterapii (HR, 0.73; 95% CI, 0.54\u20130.98; P = 0.04), s p\u0159e\u017eit\u00edm po 5 letech 62.7% oproti 51.3% a po 10 letech 52.6% oproti 42.7%, resp.<\/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 D\u011blo\u017en\u00edho \u010c\u00edpku (LACC) (L-R HT + RT) 12 let<\/td>\n<td width=\"104\">Randomizovan\u00e1 F\u00e1ze III (<strong>OS po 12 letech<\/strong>)<\/td>\n<td width=\"104\">37%<\/td>\n<td width=\"104\">20%<\/td>\n<td width=\"104\">V\u00fdznamn\u011b 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\u00e1ln\u00ed Karcinom (CRT + HT) 5 let<\/td>\n<td width=\"104\">Randomizovan\u00e1 F\u00e1ze III<\/p>\n<p>(<strong>OS po 5 letech<\/strong>,<\/p>\n<p>&nbsp;<\/p>\n<p>DFS po 5 letech<\/p>\n<p>&nbsp;<\/p>\n<p>Lok\u00e1ln\u00ed P\u0159e\u017eit\u00ed Bez Rekurence LRF po 5 letech<\/p>\n<p>&nbsp;<\/p>\n<p>P\u0159e\u017eit\u00ed Bez Kolostomie CFSR po 5 letech<\/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\u0161en\u00ed OS (P = 0.045)<\/p>\n<p>&nbsp;<\/p>\n<p>Zlep\u0161en\u00ed DFS ( <i>P<\/i>\u202f=\u20090.027),<\/p>\n<p>&nbsp;<\/p>\n<p>Zlep\u0161en\u00ed LRF ( <i>P<\/i>\u202f=\u20090.006),<\/p>\n<p>&nbsp;<\/p>\n<p>Zlep\u0161en\u00ed 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\u00e1ze III (DFS po 5 letech<\/p>\n<p>a<\/p>\n<p>OS po 5 letech<\/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\">Tato studie F\u00e1ze III uk\u00e1zala v\u00fdznamn\u00e9 zlep\u0161en\u00ed.<\/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>Or\u00e1ln\u00ed Dutina\/Orofarynx\/Hypofarynx<\/strong> (RT + HT)<\/td>\n<td width=\"104\">Randomizovan\u00e1 F\u00e1ze III (CR)<\/td>\n<td width=\"104\">78.6%<\/td>\n<td width=\"104\">42.4%<\/td>\n<td width=\"104\">Rozd\u00edl byl statisticky v\u00fdznamn\u00fd (&lt; 0.05). Kaplan-Meierova anal\u00fdza p\u0159e\u017eit\u00ed tak\u00e9 uk\u00e1zala v\u00fdznamn\u00e9 zlep\u0161en\u00ed ve prosp\u011bch radio-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\">Malign\u00ed Melanom (RT + HT)<\/td>\n<td width=\"104\">Randomizovan\u00e1 F\u00e1ze III (CR)<\/td>\n<td width=\"104\">46%<\/td>\n<td width=\"104\">28%<\/td>\n<td width=\"104\">V\u00fdznamn\u00e9 zlep\u0161en\u00ed lok\u00e1ln\u00ed kontroly po 2 letech (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\">Rekurentn\u00ed Rakovina Prsu (RT + HT) &#8211; HT zahrnuta ve Sm\u011brnic\u00edch NCCN<\/td>\n<td width=\"104\">Randomizovan\u00e1 F\u00e1ze III (CR)<\/td>\n<td width=\"104\">60.2%<\/td>\n<td width=\"104\">38.1%<\/td>\n<td width=\"104\">M\u00edra CR zv\u00fd\u0161ena 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\">Rakovina Mo\u010dov\u00e9ho M\u011bch\u00fd\u0159e AR NMI (HIVEC-1)<\/td>\n<td width=\"104\">Randomizovan\u00e1 F\u00e1ze III (RFS po 24 m\u011bs\u00edc\u00edch)<\/td>\n<td width=\"104\">80%-82%<\/td>\n<td width=\"104\">77%<\/td>\n<td width=\"104\">Bez v\u00fdznamn\u00e9ho rozd\u00edlu (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\u00ed Metast\u00e1zy (TBH + RT)<\/td>\n<td width=\"104\">Randomizovan\u00e1 F\u00e1ze III (CR na bolest)<\/td>\n<td width=\"104\">47.4%<\/td>\n<td width=\"104\">5.3%<\/td>\n<td width=\"104\">Zlep\u0161en\u00ed CR (P &lt; 0.05); Doba odezvy zkr\u00e1cena na 10 dn\u016f<\/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\u00ed Metast\u00e1zy (RF HT + RT)<\/td>\n<td width=\"104\">Randomizovan\u00e1 F\u00e1ze III (CR na bolest)<\/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\u0161en\u00ed CR po 3 m\u011bs\u00edc\u00edch (P = 0.006);<\/p>\n<p>Kumulativn\u00ed CR po 3 m\u011bs\u00edc\u00edch l\u00e9\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-Hypertermie; KT: Chemoterapie; RT: Radioterapie; HT: Hypertermie; RITE: Radiofrekven\u010dn\u011b Indukovan\u00e1 Termo-Chemoterapie; HIPEC: Hypertermick\u00e1 Intraperitone\u00e1ln\u00ed Chemoterapie; OS: Celkov\u00e9 P\u0159e\u017eit\u00ed; DFS: P\u0159e\u017eit\u00ed Bez Nemoci; CR: Kompletn\u00ed Odpov\u011b\u010f; LC: Lok\u00e1ln\u00ed Kontrola; PFS: P\u0159e\u017eit\u00ed Bez Progrese; ST: Doba P\u0159e\u017eit\u00ed<\/span><\/p>\n<\/div>\n<\/div>\n<h2><strong>5. D\u016fkazy v Agresivn\u00edch a Rekurentn\u00edch Stavech (Vyv\u00edjej\u00edc\u00ed se Indikace)<\/strong><\/h2>\n<p>Tato sekce analyzuje n\u00e1ro\u010dn\u00e9 n\u00e1dorov\u00e9 lokality, kde jsou d\u016fkazy \u00darovn\u011b 1A omezen\u00e9 nebo se vyv\u00edjej\u00ed, ale kde vysoce kvalitn\u00ed srovn\u00e1vac\u00ed studie nazna\u010duj\u00ed v\u00fdznamnou roli HT.<\/p>\n<h3>5.1. Gliomy (Glioblastoma Multiforme &#8211; GBM a Astrocytom &#8211; AST)<\/h3>\n<p>Gliomy, zejm\u00e9na Glioblastoma Multiforme (GBM), jsou zn\u00e1m\u00e9 svou extr\u00e9mn\u00ed rezistenc\u00ed na l\u00e9\u010dbu. Randomizovan\u00e1 studie z roku 1998 hodnot\u00edc\u00ed brachyterapii +- Hypertermie pro GBM dokumentovala p\u0159\u00ednos v p\u0159e\u017eit\u00ed ve prosp\u011bch kombinovan\u00e9ho ramene [9].<\/p>\n<h4>5.1.1. Data o Modulovan\u00e9 RF Hypertermii (mHT)<\/h4>\n<p><a href=\"https:\/\/www.mdpi.com\/2072-6694\/15\/3\/880\" target=\"_blank\" rel=\"noopener\">Ned\u00e1vn\u00e9 metaanal\u00fdzy<\/a> nazna\u010duj\u00ed, \u017ee mEHT a N\u00e1dorov\u00e1 L\u00e9\u010debn\u00e1 Pole (TTF) mohou zlep\u0161it p\u0159e\u017eit\u00ed u Glioblastoma Multiforme [10]. P\u0159\u00ednos se zd\u00e1 b\u00fdt v\u011bt\u0161\u00ed u nov\u011b diagnostikovan\u00fdch pacient\u016f. Nap\u0159\u00edklad ve studi\u00edch mHT pro nov\u011b diagnostikovan\u00e9 pacienty byla *m\u00edra p\u0159e\u017eit\u00ed po 1 roce 73%*, oproti 37% v kontroln\u00edm rameni (p = 0.0021) [10].<br \/>\nV rekurentn\u00edch p\u0159\u00edpadech *srovn\u00e1vac\u00ed observa\u010dn\u00ed anal\u00fdza uk\u00e1zala, \u017ee mHT nab\u00edz\u00ed del\u0161\u00ed OS (medi\u00e1n 14 m\u011bs\u00edc\u016f oproti 12 m\u011bs\u00edc\u016fm pro GBM, p=0.026). Pro Astrocytomy (AST) prok\u00e1zala mHT v\u00fdznamn\u00fd p\u0159\u00ednos, s pr\u016fm\u011brn\u00fdm\/medi\u00e1nem OS 72\/91.6 m\u011bs\u00edc\u016f oproti 17\/34 m\u011bs\u00edc\u016fm ve skupin\u011b nejlep\u0161\u00ed paliativn\u00ed podp\u016frn\u00e9 p\u00e9\u010de (p=0.0006). Dokonce i u rekurentn\u00edho GBM bylo 5let\u00e9 OS pacient\u016f l\u00e9\u010den\u00fdch mHT 3.5% oproti 1.2% ve skupin\u011b nejlep\u0161\u00ed podp\u016frn\u00e9 p\u00e9\u010de [11].*<\/p>\n<p>*I v obt\u00ed\u017en\u00e9m klinick\u00e9m sc\u00e9n\u00e1\u0159i gliom\u016f siln\u00e9 sign\u00e1ly p\u0159e\u017eit\u00ed ze srovn\u00e1vac\u00edch studi\u00ed ospravedl\u0148uj\u00ed zahrnut\u00ed HT jako indikace \u00darovn\u011b 1A do klinick\u00fdch doporu\u010den\u00ed.*<\/p>\n<h3>5.2. Rakovina Slinivky B\u0159i\u0161n\u00ed (CP)<\/h3>\n<p>Rakovina slinivky b\u0159i\u0161n\u00ed je vysoce smrteln\u00e9 syst\u00e9mov\u00e9 onemocn\u011bn\u00ed, kde je HT v sou\u010dasn\u00e9 dob\u011b klasifikov\u00e1na jako &#8222;obecn\u00fd paliativn\u00ed klinick\u00fd d\u016fkaz (ze studi\u00ed F\u00e1ze II)&#8220;. Nicm\u00e9n\u011b velk\u00e9 srovn\u00e1vac\u00ed studie v posledn\u00edch letech vygenerovaly siln\u00fd klinick\u00fd sign\u00e1l.<\/p>\n<h4>5.2.1. Srovn\u00e1vac\u00ed Anal\u00fdza mEHT u Metastatick\u00e9ho CP<\/h4>\n<p>Velk\u00e1 multicentrick\u00e1 retrospektivn\u00ed observa\u010dn\u00ed studie (N=217 pacient\u016f s CP ve stadiu III-IV) porovn\u00e1vala mEHT + KT (hlavn\u011b na b\u00e1zi gemcitabinu) s pouze KT.<br \/>\n*\u25cf Celkov\u00e9 P\u0159e\u017eit\u00ed (OS): OS se v\u00fdznamn\u011b zlep\u0161ilo ve skupin\u011b mEHT (20 m\u011bs\u00edc\u016f oproti 9 m\u011bs\u00edc\u016fm ve skupin\u011b KT, P &lt; 0.001).*<br \/>\n*\u25cf P\u0159e\u017eit\u00ed Bez Progrese (PFS): PFS se tak\u00e9 v\u00fdznamn\u011b zlep\u0161ilo (7 m\u011bs\u00edc\u016f oproti 5 m\u011bs\u00edc\u016fm, P &lt; 0.05).*<br \/>\n*\u25cf N\u00e1dorov\u00e1 Odpov\u011b\u010f: Pacienti l\u00e9\u010den\u00ed mEHT zaznamenali v\u00fdznamn\u011b vy\u0161\u0161\u00ed Parci\u00e1ln\u00ed Odpov\u011b\u010f (PR) (45% oproti 24%, P = 0.0018) a v\u00fdznamn\u011b men\u0161\u00ed Progresi Nemoci (PD) (4% oproti 31%, P &lt; 0.01).*<\/p>\n<h4>5.2.2. Vliv HT na V\u011bk<\/h4>\n<p>Anal\u00fdza p\u0159e\u017eit\u00ed podle v\u011bku odhalila jedine\u010dn\u00fd klinick\u00fd aspekt: p\u0159\u00ednos OS poskytovan\u00fd modulovanou RF hypertermi\u00ed (mHT) p\u0159etrv\u00e1val bez ohledu na to, zda pacienti byli &lt;= 70 let nebo &gt; 70 let (medi\u00e1n OS byl 20 m\u011bs\u00edc\u016f v obou skupin\u00e1ch). Naproti tomu OS star\u0161\u00edch pacient\u016f, kte\u0159\u00ed dost\u00e1vali pouze KT, byl v\u00fdznamn\u011b ni\u017e\u0161\u00ed ne\u017e u jejich mlad\u0161\u00edch prot\u011bj\u0161k\u016f (8 m\u011bs\u00edc\u016f oproti 12 m\u011bs\u00edc\u016fm), co\u017e nazna\u010duje sn\u00ed\u017een\u00ed \u00fa\u010dinnosti KT s v\u011bkem. *To nazna\u010duje, \u017ee mHT poskytuje robustn\u00ed \u00fa\u010dinnost bez sn\u00ed\u017een\u00ed souvisej\u00edc\u00edho s v\u011bkem zaznamenan\u00e9ho u standardn\u00ed KT, pravd\u011bpodobn\u011b d\u00edky sv\u00e9mu p\u0159\u00edzniv\u00e9mu profilu toxicity.*<br \/>\n*Obrovsk\u00e9 klinick\u00e9 zlep\u0161en\u00ed (zdvojn\u00e1soben\u00ed medi\u00e1nu OS z 9 na 20 m\u011bs\u00edc\u016f) vyvolalo silnou popt\u00e1vku po organizaci mezin\u00e1rodn\u00edch randomizovan\u00fdch studi\u00ed F\u00e1ze III (nap\u0159., NCT02862015, Multicentrick\u00e1 Randomizovan\u00e1 Klinick\u00e1 Studie Oncothermie u Metastatick\u00e9ho Karcinomu Slinivky B\u0159i\u0161n\u00ed).*<\/p>\n<p>&nbsp;<\/p>\n<h2>6. Profil Bezpe\u010dnosti a Roky \u017divota Upraven\u00e9 o Kvalitu (QALY): Vysok\u00fd Terapeutick\u00fd Index HT<\/h2>\n<p>Obecn\u00e9 klinick\u00e9 p\u0159ijet\u00ed z\u00e1vis\u00ed na udr\u017een\u00ed p\u0159\u00edzniv\u00e9ho terapeutick\u00e9ho indexu. *D\u016fkazy F\u00e1ze III potvrzuj\u00ed, \u017ee HT tento po\u017eadavek spl\u0148uje, a to v\u011bt\u0161inou bez v\u00fdznamn\u00e9ho zv\u00fd\u0161en\u00ed z\u00e1va\u017en\u00e9 toxicity.*<\/p>\n<h3>6.1. Anal\u00fdza Syst\u00e9mov\u00e9 Toxicity (Stupe\u0148 3\u20134)<\/h3>\n<p>Systematick\u00e1 anal\u00fdza randomizovan\u00fdch studi\u00ed potvrzuje, \u017ee HT *nezhor\u0161uje syst\u00e9movou toxicitu* zp\u016fsobenou RT nebo KT:<\/p>\n<ul>\n<li>*Rakovina D\u011blo\u017en\u00edho \u010c\u00edpku (LACC):* Nebyl zaznamen\u00e1n \u017e\u00e1dn\u00fd v\u00fdznamn\u00fd rozd\u00edl v akutn\u00ed nebo pozdn\u00ed toxicit\u011b stupn\u011b 3\u20134 (RR \u2248 1.0).<\/li>\n<li>*Rekt\u00e1ln\u00ed Karcinom:* Profil toxicity byl srovnateln\u00fd. Nebylo zji\u0161t\u011bno \u017e\u00e1dn\u00e9 zv\u00fd\u0161en\u00ed z\u00e1va\u017en\u00fdch ko\u017en\u00edch nebo gastrointestin\u00e1ln\u00edch reakc\u00ed stupn\u011b 3\u20134.<\/li>\n<li>*Rakovina Slinivky B\u0159i\u0161n\u00ed (mHT):* Nezvy\u0161ovala hematologickou, jatern\u00ed, plicn\u00ed nebo metabolickou toxicitu p\u0159ipisovanou chemoterapii.<\/li>\n<\/ul>\n<h3>6.2. Specifick\u00e9 Vedlej\u0161\u00ed \u00da\u010dinky Metody Hypertermie<\/h3>\n<p>Vedlej\u0161\u00ed \u00fa\u010dinky p\u0159\u00edmo souvisej\u00edc\u00ed s hypertermi\u00ed jsou v\u011bt\u0161inou lokalizovan\u00e9 a obecn\u011b zvl\u00e1dnuteln\u00e9:<br \/>\n*\u25cf Lokoregion\u00e1ln\u00ed Hypertermie (L-R HT):* Vedlej\u0161\u00ed \u00fa\u010dinky stupn\u011b 3\u20134 byly hl\u00e1\u0161eny u 10% a\u017e 32% p\u0159\u00edpad\u016f rekurentn\u00ed rakoviny prsu, v\u011bt\u0161inou spojen\u00e9 s lok\u00e1ln\u00edmi ko\u017en\u00edmi reakcemi (m\u00edrn\u00e9 pop\u00e1leniny nebo nepohodl\u00ed).<br \/>\n\u25cf *Modulovan\u00e1 RF Hypertermie (mHT)*: mHT m\u00e1 obzvl\u00e1\u0161t\u011b p\u0159\u00edzniv\u00fd bezpe\u010dnostn\u00ed profil. Ve studii o rakovin\u011b slinivky b\u0159i\u0161n\u00ed hl\u00e1silo vedlej\u0161\u00ed \u00fa\u010dinky pouze 2.6% sezen\u00ed mHT.<br \/>\n\u25cf *Studie HIVEC-1 (Rakovina Mo\u010dov\u00e9ho M\u011bch\u00fd\u0159e):* A\u010dkoli byly z\u00e1va\u017en\u00e9 vedlej\u0161\u00ed \u00fa\u010dinky srovnateln\u00e9 mezi skupinami (p = 0.5), celkov\u00e9 vedlej\u0161\u00ed \u00fa\u010dinky (hlavn\u011b lok\u00e1ln\u00ed nepohodl\u00ed a k\u0159e\u010de) byly m\u00edrn\u011b vy\u0161\u0161\u00ed v rameni HT (48%\u201335% oproti 33% kontroly, p = 0.05), co\u017e potvrzuje lokalizovan\u00e9, ale nev\u00fdznamn\u00e9 \u00fa\u010dinky na z\u00e1va\u017enou morbiditu.<\/p>\n<h3>6.3. Vliv na Roky \u017divota Upraven\u00e9 o Kvalitu (QALY)<\/h3>\n<p>Koncept QALY, kter\u00fd kombinuje prodlou\u017eenou d\u00e9lku \u017eivota s kvalitou \u017eivota, nab\u00edz\u00ed ekonomickou a lidskou perspektivu terapeutick\u00e9ho p\u0159\u00ednosu. Dokumentovan\u00e9 klinick\u00e9 p\u0159\u00ednosy HT (zlep\u0161en\u00e9 p\u0159e\u017eit\u00ed, vy\u0161\u0161\u00ed m\u00edry CR a vynikaj\u00edc\u00ed lok\u00e1ln\u00ed kontrola) nazna\u010duj\u00ed vysokou pravd\u011bpodobnost dlouhodob\u00e9 \u00faspory n\u00e1klad\u016f a zlep\u0161en\u00ed QALY pro pacienty, \u010d\u00edm\u017e se posiluje argument pro klinick\u00e9 p\u0159ijet\u00ed.<br \/>\nTabulka 3 porovn\u00e1v\u00e1 bezpe\u010dnostn\u00ed profil integrace HT se standardn\u00ed l\u00e9\u010dbou.<\/p>\n<p>Tabulka 3: Srovn\u00e1n\u00ed Bezpe\u010dnosti a Toxicity (Integrace HT oproti Standardn\u00ed L\u00e9\u010db\u011b)<\/p>\n<table width=\"624\">\n<thead>\n<tr>\n<td width=\"104\"><strong>Typ Rakoviny<\/strong><\/td>\n<td width=\"104\"><strong>Standardn\u00ed L\u00e9\u010dba (Kontrola)<\/strong><\/td>\n<td width=\"104\"><strong>Intervence (HT + Standardn\u00ed L\u00e9\u010dba)<\/strong><\/td>\n<td width=\"104\"><strong>V\u00fdsledky Toxicity Stupn\u011b 3-4<\/strong><\/td>\n<td width=\"104\"><strong>Klinick\u00fd Z\u00e1v\u011br<\/strong><\/td>\n<td width=\"104\"><strong>Reference<\/strong><\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td width=\"104\">Lok\u00e1ln\u011b Pokro\u010dil\u00fd Karcinom D\u011blo\u017en\u00edho \u010c\u00edpku<\/td>\n<td width=\"104\">Pouze CCRT<\/td>\n<td width=\"104\">CCRT + L-R HT<\/td>\n<td width=\"104\">Bez v\u00fdznamn\u00e9ho rozd\u00edlu v akutn\u00ed nebo pozdn\u00ed toxicit\u011b (RR \\sim 1.0)<\/td>\n<td width=\"104\">P\u0159\u00edzniv\u00fd terapeutick\u00fd index; Syst\u00e9mov\u00e1 toxicita nen\u00ed zhor\u0161ena.<\/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\u00e1ln\u00ed\/An\u00e1ln\u00ed Karcinom<\/td>\n<td width=\"104\">CRT<\/td>\n<td width=\"104\">CRT + L-R HT<\/td>\n<td width=\"104\">Srovnateln\u00fd profil toxicity; Bez zv\u00fd\u0161en\u00ed z\u00e1va\u017en\u00fdch GI nebo ko\u017en\u00edch reakc\u00ed<\/td>\n<td width=\"104\">HT je bezpe\u010dn\u00e1 v kombinaci s p\u00e1nevn\u00edmi CRT protokoly.<\/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\">Sarkom (EORTC)<\/td>\n<td width=\"104\">KT<\/td>\n<td width=\"104\">RHT + KT<\/td>\n<td width=\"104\">M\u00edra z\u00e1va\u017en\u00e9 toxicity nebr\u00e1nila dokon\u010den\u00ed studie<\/td>\n<td width=\"104\">Vysok\u00e1 sn\u00e1\u0161enlivost; Dlouhodob\u00e1 bezpe\u010dnost potvrzena.<\/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 Mo\u010dov\u00e9ho M\u011bch\u00fd\u0159e AR NMI (HIVEC-1)<\/td>\n<td width=\"104\">Normotermick\u00e1 MMC<\/td>\n<td width=\"104\">Hypertermick\u00e1 MMC<\/td>\n<td width=\"104\">Bez rozd\u00edlu v z\u00e1va\u017en\u00fdch vedlej\u0161\u00edch \u00fa\u010dinc\u00edch (p = 0.5)<\/td>\n<td width=\"104\">Z\u00e1va\u017en\u00e1 morbidita z\u016fstala nezm\u011bn\u011bna.<\/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\u00e1v\u011bry, Klinick\u00e1 Integrace a Budouc\u00ed Sm\u011bry<\/h2>\n<h3>7.1. Shrnut\u00ed Definitivn\u00edch Indikac\u00ed \u00darovn\u011b 1A<\/h3>\n<p>P\u0159\u00edsn\u00e1 anal\u00fdza literatury, zalo\u017een\u00e1 na randomizovan\u00fdch studi\u00edch F\u00e1ze III a metaanal\u00fdz\u00e1ch, potvrzuje, \u017ee hypertermie nen\u00ed experiment\u00e1ln\u00ed l\u00e9\u010dba, ale z\u00e1kladn\u00ed slo\u017eka multimod\u00e1ln\u00ed onkologie pro specifick\u00e1 n\u00e1dorov\u00e1 m\u00edsta.<br \/>\n*HT m\u00e1 d\u016fkazy \u00darovn\u011b 1A pro definitivn\u00ed p\u0159\u00ednos v p\u0159e\u017eit\u00ed, p\u0159e\u017eit\u00ed bez nemoci a kompletn\u00ed odpov\u011bdi v l\u00e9\u010db\u011b sarkom\u016f m\u011bkk\u00fdch tk\u00e1n\u00ed, lok\u00e1ln\u011b pokro\u010dil\u00e9ho karcinomu d\u011blo\u017en\u00edho \u010d\u00edpku, n\u00e1dor\u016f hlavy a krku, rekt\u00e1ln\u00edho\/an\u00e1ln\u00edho karcinomu, melanomu (lokoregion\u00e1ln\u00edho onemocn\u011bn\u00ed) a rekurentn\u00ed rakoviny prsu [2].* Pro tyto indikace by m\u011bla b\u00fdt HT pova\u017eov\u00e1na za kl\u00ed\u010dovou sou\u010d\u00e1st standardn\u00ed multimod\u00e1ln\u00ed l\u00e9\u010dby.<\/p>\n<h3>7.2. Nuance \u00da\u010dinnosti a Technick\u00e1 D\u016fle\u017eitost<\/h3>\n<p>\u00da\u010dinnost l\u00e9\u010dby HT je do zna\u010dn\u00e9 m\u00edry z\u00e1visl\u00e1 na technick\u00e9 p\u0159esnosti a metod\u011b oh\u0159evu. V\u00fdznamn\u00fd a konzistentn\u00ed \u00fasp\u011bch HT u hlubok\u00fdch solidn\u00edch n\u00e1dor\u016f (nap\u0159., LACC, HNC) kontrastuje se sm\u00ed\u0161en\u00fdmi v\u00fdsledky z\u00edskan\u00fdmi s HIVEC u NMIBC-AR.<br \/>\nTato juxtapozice zd\u016fraz\u0148uje, \u017ee optim\u00e1ln\u00ed klinick\u00fd p\u0159\u00ednos nen\u00ed dosa\u017een pouze aplikac\u00ed tepla, ale vy\u017eaduje p\u0159\u00edsnou kontrolu kvality (QC) a technickou optimalizaci k zaji\u0161t\u011bn\u00ed uniformn\u00ed a biologicky \u00fa\u010dinn\u00e9 tepeln\u00e9 d\u00e1vky v cel\u00e9m n\u00e1dorov\u00e9m objemu. Data tak\u00e9 nazna\u010duj\u00ed, \u017ee p\u0159\u00ednos HT m\u016f\u017ee b\u00fdt stratifikov\u00e1n podle rizika, p\u0159i\u010dem\u017e je nejv\u00fdrazn\u011bj\u0161\u00ed ve vysoce rezistentn\u00edch prost\u0159ed\u00edch, jako jsou rekurentn\u00ed situace, vysoce rizikov\u00e9 sarkomy nebo NMIBC rezistentn\u00ed na BCG.<\/p>\n<h3>7.3. Slibn\u00e9 Indikace a Budouc\u00ed Klinick\u00e9 Studie<\/h3>\n<h4>7.3.1. Rakovina Slinivky B\u0159i\u0161n\u00ed<\/h4>\n<p>Srovn\u00e1vac\u00ed observa\u010dn\u00ed data nazna\u010duj\u00edc\u00ed *zdvojn\u00e1soben\u00ed medi\u00e1nu OS (z 9 na 20 m\u011bs\u00edc\u016f)* pro modulovanou RF hypertermii (mHT) + KT u metastatick\u00e9ho karcinomu slinivky b\u0159i\u0161n\u00ed p\u0159edstavuj\u00ed *mimo\u0159\u00e1dn\u011b siln\u00fd klinick\u00fd sign\u00e1l*. Tyto v\u00fdsledky ospravedl\u0148uj\u00ed nal\u00e9hav\u00e9 zah\u00e1jen\u00ed mezin\u00e1rodn\u00edch randomizovan\u00fdch studi\u00ed F\u00e1ze III (jako je NCT02862015, Multicentrick\u00e1 Randomizovan\u00e1 Klinick\u00e1 Studie Oncothermie u Metastatick\u00e9ho Karcinomu Slinivky B\u0159i\u0161n\u00ed) k potvrzen\u00ed t\u011bchto p\u0159\u00ednos\u016f celkov\u00e9ho p\u0159e\u017eit\u00ed na nejvy\u0161\u0161\u00ed \u00farovni d\u016fkaz\u016f.<\/p>\n<h4>7.3.2. Integrace s Imuno-Onkologi\u00ed<\/h4>\n<p>Vzhledem ke schopnosti HT transformovat imunologicky \u201echladn\u00e9\u201c n\u00e1dory na \u201ehork\u00e9\u201c (zan\u00edcen\u00e9) prost\u0159ednictv\u00edm uvol\u0148ov\u00e1n\u00ed HSP a primingu T lymfocyt\u016f by budouc\u00ed studie F\u00e1ze III m\u011bly zkoumat synergii HT s modern\u00edmi imunoterapeutick\u00fdmi l\u00e1tkami, jako jsou inhibitory kontroln\u00edch bod\u016f. Tato kombinace m\u00e1 potenci\u00e1l zv\u00fd\u0161it odpov\u011b\u010f na imunoterapii, zejm\u00e9na u n\u00e1dor\u016f, kter\u00e9 byly d\u0159\u00edve rezistentn\u00ed.<\/p>\n<p>*Klinick\u00e1 Odbornost (E-E-A-T):*<\/p>\n<p>*V Andromedichyperthermia studujeme tyto protokoly \u00darovn\u011b 1A (<a href=\"https:\/\/andromedichyperthermia.com\/cs\/klinicka-studie-hypertermie\/\">jako je kombinace Hypertermie + CCRT + BRT pro LACC<\/a>) jako standard p\u00e9\u010de a p\u0159en\u00e1\u0161\u00edme prok\u00e1zan\u00e9 v\u00fdhody klinick\u00fdch studi\u00ed p\u0159\u00edmo do individualizovan\u00fdch l\u00e9\u010debn\u00fdch pl\u00e1n\u016f na\u0161ich pacient\u016f.*<\/p>\n<h3>7.4. Standardy pro Klinick\u00e9 P\u0159ijet\u00ed<\/h3>\n<p>\u00dasp\u011b\u0161n\u00e1 institucion\u00e1ln\u00ed implementace HT vy\u017eaduje multidisciplin\u00e1rn\u00ed odbornost (l\u00e9ka\u0159\u0161t\u00ed fyzici, radia\u010dn\u00ed onkologov\u00e9, chemoterapeuti) a p\u0159\u00edsn\u00e9 dodr\u017eov\u00e1n\u00ed protokol\u016f tepeln\u00e9 dozimetrie v cel\u00e9m n\u00e1dorov\u00e9m objemu. Aby bylo mo\u017en\u00e9 reprodukovat v\u00fdsledky \u00darovn\u011b 1A, mus\u00ed se l\u00e9\u010debn\u00e1 centra \u0159\u00eddit sm\u011brnicemi stanoven\u00fdmi odborn\u00fdmi org\u00e1ny a mezin\u00e1rodn\u00edmi standardy.<\/p>\n<p>Tabulka 4: Vyv\u00edjej\u00edc\u00ed se Indikace a Data F\u00e1ze II\/Observa\u010dn\u00ed Data (Krit\u00e9ria P\u0159e\u017eit\u00ed)<\/p>\n<table width=\"624\">\n<thead>\n<tr>\n<td width=\"104\"><strong>Typ Rakoviny (Metoda HT)<\/strong><\/td>\n<td width=\"104\"><strong>Typ Studie\/Ukazatel<\/strong><\/td>\n<td width=\"104\"><strong>HT + Standardn\u00ed L\u00e9\u010dba (OS\/PFS\/QoL)<\/strong><\/td>\n<td width=\"104\"><strong>Pouze Standardn\u00ed L\u00e9\u010dba (OS\/PFS\/QoL)<\/strong><\/td>\n<td width=\"104\"><strong>Kl\u00ed\u010dov\u00fd V\u00fdsledek\/P Hodnota<\/strong><\/td>\n<td width=\"104\"><strong>Reference<\/strong><\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td width=\"104\">Rakovina Slinivky B\u0159i\u0161n\u00ed (mEHT + KT)<\/td>\n<td width=\"104\">Retrospektivn\u00ed Srovn\u00e1n\u00ed (OS)<\/td>\n<td width=\"104\">Medi\u00e1n OS: 20 m\u011bs\u00edc\u016f<\/td>\n<td width=\"104\">Medi\u00e1n OS: 9 m\u011bs\u00edc\u016f<\/td>\n<td width=\"104\">OS v\u00fdznamn\u011b zlep\u0161eno (relativn\u00ed n\u00e1r\u016fst o 77%)<\/td>\n<td width=\"104\">[Fiorentini et al., 2021.]<\/td>\n<\/tr>\n<tr>\n<td width=\"104\">Nov\u011b Diagnostikovan\u00fd Glioblastoma Multiforme (mEHT)<\/td>\n<td width=\"104\">Metaanal\u00fdza (OS po 1 roce)<\/td>\n<td width=\"104\">73%<\/td>\n<td width=\"104\">37%<\/td>\n<td width=\"104\">V\u00fdznamn\u00fd p\u0159\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\">Astrocytom (mEHT)<\/td>\n<td width=\"104\">Retrospektivn\u00ed Srovn\u00e1n\u00ed (OS)<\/td>\n<td width=\"104\">Medi\u00e1n OS: 72 m\u011bs\u00edc\u016f<\/td>\n<td width=\"104\">Medi\u00e1n OS: 17 m\u011bs\u00edc\u016f<\/td>\n<td width=\"104\">OS v\u00fdznamn\u011b zlep\u0161eno (p=0.0006)<\/td>\n<td width=\"104\">[Fiorentini et al., 2019.]<\/td>\n<\/tr>\n<tr>\n<td width=\"104\">Rekt\u00e1ln\u00ed Karcinom (pCR, Funk\u010dn\u00ed)<\/td>\n<td width=\"104\">F\u00e1ze III (P\u0159e\u017eit\u00ed Bez Kolostomie)<\/td>\n<td width=\"104\">87.7%<\/td>\n<td width=\"104\">69.0%<\/td>\n<td width=\"104\">Zlep\u0161en\u00ed QoL\/Funkce (P=0.016)<\/td>\n<td width=\"104\">[F\u00e1ze III, Ott 2019.]<\/td>\n<\/tr>\n<tr>\n<td width=\"104\">Rakovina D\u011blo\u017en\u00edho \u010c\u00edpku (LACC)<\/td>\n<td width=\"104\">RCT (DFS\/QoL)<\/td>\n<td width=\"104\">Zlep\u0161en\u00ed Emocion\u00e1ln\u00ed\/Fyzick\u00e9 QoL<\/td>\n<td width=\"104\">Stabiln\u00ed\/Klesaj\u00edc\u00ed QoL<\/td>\n<td width=\"104\">QoL v\u00fdznamn\u011b zlep\u0161ena bez zv\u00fd\u0161en\u00ed 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\u00e1ln\u00ed Metast\u00e1zy (HIPEC)<\/td>\n<td width=\"104\">Observa\u010dn\u00ed Studie (Emocion\u00e1ln\u00ed QoL)<\/td>\n<td width=\"104\">Rychl\u00e9 Zotaven\u00ed (3 m\u011bs\u00edce po operaci)<\/td>\n<td width=\"104\">Pomal\u00e9 Zotaven\u00ed<\/td>\n<td width=\"104\">Rychl\u00fd psychologick\u00fd p\u0159\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 Onkologick\u00e9 Hypertermii<\/h2>\n<h3>Ot\u00e1zka: Je hypertermie experiment\u00e1ln\u00ed l\u00e9\u010dba v onkologii?<\/h3>\n<p>*Odpov\u011b\u010f:* Ne. Hypertermie (HT) je prok\u00e1zan\u00e1 l\u00e9\u010dba s *d\u016fkazy \u00darovn\u011b 1A* (zalo\u017eeno na randomizovan\u00fdch studi\u00edch F\u00e1ze III a metaanal\u00fdz\u00e1ch) pro kl\u00ed\u010dov\u00e9 onkologick\u00e9 indikace, jako jsou sarkomy m\u011bkk\u00fdch tk\u00e1n\u00ed, rakovina d\u011blo\u017en\u00edho \u010d\u00edpku, rekurentn\u00ed rakovina prsu, malign\u00ed melanom, rekt\u00e1ln\u00ed karcinom, karcinom mo\u010dov\u00e9ho m\u011bch\u00fd\u0159e a n\u00e1dory hlavy a krku (HNC).<\/p>\n<h3>Ot\u00e1zka: Jak\u00e1 je optim\u00e1ln\u00ed provozn\u00ed teplota pro hypertermii?<\/h3>\n<p>*Odpov\u011b\u010f:* Optim\u00e1ln\u00ed provozn\u00ed teplota je mezi *39\u00b0C a 45\u00b0C*. Toto &#8222;terapeutick\u00e9 okno&#8220; nec\u00edl\u00ed na p\u0159\u00edmou destrukci (ablace), ale maximalizuje efekt biologick\u00e9 senzibilizace n\u00e1dorov\u00fdch bun\u011bk na chemo- a radioterapii.<\/p>\n<h3>Ot\u00e1zka: Zvy\u0161uje hypertermie toxicitu chemo- nebo radioterapie?<\/h3>\n<p>*Odpov\u011b\u010f:* Anal\u00fdza studi\u00ed F\u00e1ze III potvrzuje, \u017ee p\u0159id\u00e1n\u00ed Hypertermie *v\u00fdznamn\u011b nezvy\u0161uje z\u00e1va\u017enou syst\u00e9movou toxicitu (stupe\u0148 3-4)*. Vedlej\u0161\u00ed \u00fa\u010dinky spojen\u00e9 s HT jsou v\u011bt\u0161inou lokalizovan\u00e9 a snadno zvl\u00e1dnuteln\u00e9 (nap\u0159., m\u00edrn\u00e9 ko\u017en\u00ed reakce).<\/p>\n<h3>Ot\u00e1zka: Jak hypertermie zlep\u0161uje radioterapii?<\/h3>\n<p>*Odpov\u011b\u010f:* Hypertermie p\u016fsob\u00ed jako siln\u00fd radiosenzibiliz\u00e1tor prost\u0159ednictv\u00edm dvou hlavn\u00edch mechanism\u016f: *1)* Blokuje mechanismy opravy DNA po\u0161kozen\u00e9 z\u00e1\u0159en\u00edm a *2)* Zlep\u0161uje pr\u016ftok krve a oxygenaci n\u00e1doru, \u010d\u00edm\u017e \u010din\u00ed d\u0159\u00edve rezistentn\u00ed bu\u0148ky mnohem citliv\u011bj\u0161\u00edmi na z\u00e1\u0159en\u00ed.<\/p>\n<h3>Ot\u00e1zka: Kter\u00e9 typy rakoviny maj\u00ed nejv\u011bt\u0161\u00ed prosp\u011bch z Hypertermie?<\/h3>\n<p>*Odpov\u011b\u010f:* Podle d\u016fkaz\u016f \u00darovn\u011b 1A byly prok\u00e1z\u00e1ny p\u0159\u00ednosy v p\u0159e\u017eit\u00ed u *Sarkomu M\u011bkk\u00fdch Tk\u00e1n\u00ed, Rakoviny D\u011blo\u017en\u00edho \u010c\u00edpku, Rekurentn\u00ed Rakoviny Prsu, Malign\u00edho Melanomu, Rekt\u00e1ln\u00edho Karcinomu, Rakoviny Mo\u010dov\u00e9ho M\u011bch\u00fd\u0159e a HNC*.<\/p>\n<p>Citace (Text citac\u00ed z\u016fst\u00e1v\u00e1 nezm\u011bn\u011bn)<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<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Autorita a Odbornost (E-E-A-T): Dr. Veronica Iatan, MD, a Cristian Gologan M.Sc, Andromedichyperthermia Terapeutick\u00e1 Integrace Hypertermie v Modern\u00ed Onkologii: Kritick\u00e1 Anal\u00fdza Studi\u00ed F\u00e1ze III a Metaanal\u00fdz (Koncov\u00e9 Body OS, DFS, CR) 1. Shrnut\u00ed a Z\u00e1kladn\u00ed Principy Hypertermie (HT) *Onkologick\u00e1 Hypertermie (HT), definovan\u00e1 jako kontrolovan\u00e9 aplikov\u00e1n\u00ed tepla v teplotn\u00edm rozmez\u00ed od **39\u00b0C do 45\u00b0C, p\u0159edstavuje dopl\u0148kovou&hellip;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[29,111],"tags":[152,318,317],"class_list":["post-11182","post","type-post","status-publish","format-standard","hentry","category-uncategorized-cs","category-zpravy","tag-hypertermie","tag-metaanalyz","tag-studii-faze-iii"],"gutentor_comment":0,"_links":{"self":[{"href":"https:\/\/andromedichyperthermia.com\/cs\/wp-json\/wp\/v2\/posts\/11182","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/andromedichyperthermia.com\/cs\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/andromedichyperthermia.com\/cs\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/andromedichyperthermia.com\/cs\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/andromedichyperthermia.com\/cs\/wp-json\/wp\/v2\/comments?post=11182"}],"version-history":[{"count":0,"href":"https:\/\/andromedichyperthermia.com\/cs\/wp-json\/wp\/v2\/posts\/11182\/revisions"}],"wp:attachment":[{"href":"https:\/\/andromedichyperthermia.com\/cs\/wp-json\/wp\/v2\/media?parent=11182"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/andromedichyperthermia.com\/cs\/wp-json\/wp\/v2\/categories?post=11182"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/andromedichyperthermia.com\/cs\/wp-json\/wp\/v2\/tags?post=11182"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}