Noofambar 2023: Maamulka Cunnada iyo Dawooyinka ayaa ansixiyay HEPZATO KIT (melphalan for Injection/Hepatic Delivery System, Delcath Systems, Inc.) sida daawaynta beerka haga ee bukaanada qaangaarka ah ee qaba melanoma uveal kuwaas oo leh cagaarshow cagaarshow aan la daboolin oo saameeya wax ka yar 50% beerka iyo ma jiro cudur kabaxsan, ama cudur kabaxsan oo ku xaddidan sambabada, lafaha, qanjidhada, ama unugyada subcutaneous oo waxay noqon kartaa
Daraasadda FOCUS (NCT02678572), 91 qof oo qaba melanoma uveal melanoma iyo metastases beerka oo aan la saari karin ayaa ka qayb qaatay hal gacan, tijaabo sumad furan si loo arko sida ugu wanaagsan ee daaweyntu u shaqeyso. Haddii qaybta ugu khatarta badan ee melanoma ee uveal melanoma ay ka timaaddo beerka oo cudurka ka baxsan beerka lagu daweyn karo daaweynta shucaaca ama qaliinka, markaa cudur ka baxsan beerka ayaa laga heli karaa sambabada, qanjidhada qanjidhada, lafaha, ama maqaarka hoostiisa. . Sababaha muhiimka ah ee aan loogu qalmin ayaa ah inuu ku dhaco metastases ugu yaraan 50% parenchyma beerka, oo leh Child-Pugh Class B ama C cirrhosis, ama cagaarshow B ama C.
Siyaabaha ugu muhiimsan ee lagu cabbiro sida wanaagsan ee wax u shaqeeyeen waxay ahaayeen heerka jawaabta ujeeddada (ORR) iyo muddada jawaabta (DoR), kuwaas oo ay go'aamiyeen guddi dhexdhexaadin ah oo cadaalad ah oo isticmaalaya RECIST v1.1. Dhexdhexaadka DoR wuxuu ahaa 14 bilood (95% CI: 8.3, 17.7), ORR wuxuu ahaa 36.3% (95% CI: 26.4, 47).
Melphalan (HEPZATO) waxaa lagu shubaa halbowlaha beerka beerka 6 ilaa 8 asbuuc kasta ugu badnaan 6 faleebo iyadoo la isticmaalayo Nidaamka Bixinta Cagaarshowga (HDS), qayb ka mid ah qalabka. Iyada oo ku saleysan miisaanka jirka ee saxda ah, qiyaasta melphalan ee la soo jeediyay waa 3 mg/kg, oo leh qiyaasta ugu badan ee 220 mg hal daawaynta.
Waxaa jira Digniin Sanduuqan oo ku saabsan cawaaqib-xumo halis ah, sida dhiig-baxa, dhaawaca beerka, iyo dhacdooyinka thromboembolic, oo ku jira agabka qoraya qalabka HEPZATO. Digniin sanduuq ah oo ku saabsan myelosuppression iyo suurtagalnimada infekshannada halista ah, dhiig-baxa, ama dhiig-yaraanta calaamaduhu waxay sidoo kale ku jirtaa walxaha qorida.
Sababo la xiriira suurtagalnimada cawaaqibka habraacyada halista ah sida dhacdooyinka thromboembolic, dhaawaca hepatocellular, iyo dhiig-baxa, HEPZATO KIT waxaa lagu heli karaa oo keliya iyada oo loo marayo barnaamijka xaddidan ee hoos yimaada Qiimaynta Khatarta KIT ee HEPZATO iyo Xeeladda Yaraynta.
Thrombocytopenia, daal, dhiig-yaraan, lallabbo, xanuunka murqaha, leukopenia, calool xanuun, neutropenia, matag, korodhka alanine aminotransferase, thromboplastin qayb firfircoon oo dheeraad ah, kordhinta aminotransferase aspartate, fosfatase dhiig oo kordhay, iyo dyspnea ayaa ahaa kuwa ugu caansan (20%) falcelinta xun ama cilladaha shaybaarka.
HEPZATO iyo KIT-KA HEPZATO waa ka mamnuuc bukaanada qaba metastases-ka firfircoon ee intracranial ama nabarada maskaxda ee u nugul inay dhiig baxaan; beerka oo shaqadiisa gabay, hypertension portal, ama kala duwanaansho la og yahay oo halis ugu jira dhiigbax; qalliin ama daawaynta beerka ee 4 toddobaad ee la soo dhaafay; xinjirowga lidka ku ah aan la sixi karin, awood la'aanta in si badbaado leh loo maro suuxdinta guud, oo ay ku jiraan xaaladaha wadnaha ee firfircoon oo ay ku jiraan, laakiin aan ku xaddidnayn, cilladaha wadnaha ee aan degganayn (angina aan degganayn ama daran ama wadnaxanuun myocardial), ka sii dara ama bilawga cusub ee wadne-gabka wadnaha, arrhythmias weyn, ama cudur valvular daran ; taariikhda xasaasiyadda ama xasaasiyad la yaqaan ee melphalan; taariikhda xasaasiyadda ama dareenka kacsanaanta la og yahay ee qayb ama walxo lagu isticmaalo gudaha HEPZATO KIT oo ay ku jirto taariikhda xasaasiyadda cinjirka dabiiciga ah; taariikhda xasaasiyadda ama xasaasiyadda heparin ama joogitaanka heparin-induced thrombocytopenia (HIT); iyo taariikhda falcelinta xasaasiyadda daran ee ka soo horjeedda iodinated ee aan la xakameynin daawaynta hore ee antihistamines iyo steroids.
