Nov 2023: I-Food and Drug Administration igunyaze i-HEPZATO KIT (i-melphalan ye-Injection/Hepatic Delivery System, i-Delcath Systems, Inc.) njengokwelashwa okuqondiswe esibindini ezigulini ezikhulile ezinemelanoma ye-uveal ezinama-metastases esibindi angaxazululeki athinta ngaphansi kuka-50% wesibindi futhi asikho isifo se-extrahepatic, noma isifo se-extrahepatic esilinganiselwe emaphashini, amathambo, ama-lymph nodes, noma izicubu ezingaphansi kwesikhumba futhi kungaba
Ocwaningweni lwe-FOCUS (NCT02678572), abantu abangu-91 abane-melanoma ye-uveal kanye ne-metastases yesibindi engakwazi ukususwa babambe iqhaza ocwaningweni lwengalo eyodwa, olunelebula evulekile ukuze babone ukuthi ukwelashwa kusebenza kanjani. Uma ingxenye eyingozi kakhulu ye-uveal melanoma ivela esibindini futhi isifo esingaphandle kwesibindi singelashwa ngokwelashwa ngemisebe noma ngokuhlinzwa, khona-ke isifo esithile esingaphandle kwesibindi singatholakala emaphashini, ama-lymph nodes, ithambo, noma ngaphansi kwesikhumba. . Izizathu ezibalulekile zokungafaneleki kwakuwukuba namametastase okungenani ku-50% we-parenchyma yesibindi, ukuba ne-Child-Pugh Class B noma Crrhosis, noma ukuba ne-hepatitis B noma C.
Izindlela eziyinhloko zokulinganisa ukuthi into ethile yasebenza kahle kangakanani kwakuyizinga lokuphendula lenhloso (ORR) kanye nobude besikhathi sokuphendula (DoR), okwanqunywa ikomidi lokubuyekeza elimaphakathi elinobulungisa lisebenzisa i-RECIST v1.1. I-DoR emaphakathi yayiyizinyanga eziyi-14 (95% CI: 8.3, 17.7), kanti i-ORR yayingu-36.3% (95% CI: 26.4, 47).
I-Melphalan (HEPZATO) ifakwa emthanjeni wesibindi njalo emavikini angu-6 kuya kwayi-8 ukuze kufakwe ubuningi obungu-6 kusetshenziswa i-Hepatic Delivery System (HDS), okuyingxenye yedivayisi. Ngokusekelwe esisindweni esifanele somzimba, umthamo ophakanyisiwe we-melphalan ngu-3 mg/kg, nomthamo omkhulu wama-220 mg ekwelashweni okukodwa.
Kunesexwayiso Esinebhokisi mayelana nemiphumela ebucayi yenqubo, efana nokopha, ukulimala kwesibindi, nezehlakalo ze-thromboembolic, entweni enqumayo ye-HEPZATO KIT. Isexwayiso Esinebhokisi mayelana ne-myelosuppression kanye namandla okutheleleka okubi kakhulu, ukopha, noma i-anemia eyizimpawu nazo zifakiwe ezintweni ezinqumayo.
Ngenxa yamandla emiphumela engathi sína yenqubo efana nezenzakalo ze-thromboembolic, ukulimala kwe-hepatocellular, nokopha, I-HEPZATO KIT ifinyeleleka kuphela ngohlelo olukhawulelwe olungena ngaphansi Kwesu Lokuhlola Ubungozi kanye Nokunciphisa I-HEPZATO KIT.
I-Thrombocytopenia, ukukhathala, i-anemia, isicanucanu, ubuhlungu bemisipha namathambo, i-leukopenia, ubuhlungu besisu, i-neutropenia, ukuhlanza, ukwanda kwe-alanine aminotransferase, isikhathi eside se-thromboplastin esicushwe isikhathi eside, ukwanda kwe-aspartate aminotransferase, ukwanda kwegazi le-alkaline phosphatase, kanye ne-dyspnea (20%). ukusabela okungekuhle noma okungajwayelekile elabhorethri.
I-HEPZATO kanye ne-HEPZATO KIT ivinjiwe ezigulini ezine-metastase esebenzayo ye-intracranial noma izilonda zobuchopho ezinomkhuba wokopha; ukwehluleka kwesibindi, i-portal hypertension, noma imithambo eyaziwayo engcupheni yokopha; ukuhlinzwa noma ukwelashwa kwesibindi emasontweni ama-4 adlule; I-coagulopathy engalungiseki, ukungakwazi ukubulawa ngokubulala izinzwa okuvamile, okuhlanganisa nezimo zenhliziyo ezisebenzayo ezihlanganisa, kodwa ezingagcini nje, ukungazinzi kwe-coronary syndromes (i-angina engazinzile noma eqinile noma i-myocardial infarction), ukuhluleka kwenhliziyo okuwohlokayo noma okusha kokuqala, i-arrhythmias ephawulekayo, noma isifo esinamandla se-valvular. ; umlando wokungezwani komzimba noma i-hypersensitivity eyaziwayo ku-melphalan; umlando wokungezwani komzimba nezinto ezithile noma i-hypersensitivity eyaziwayo engxenyeni noma impahla esetshenziswa ngaphakathi kwe-HEPZATO KIT kuhlanganise nomlando wokungezwani ne-latex yerabha yemvelo; umlando wokungezwani komzimba noma i-hypersensitivity ku-heparin noma ukuba khona kwe-heparin-induced thrombocytopenia (HIT); kanye nomlando wokungezwani okukhulu nokungezwani nomzimba ekuhlukeni kwe-iodine okungalawulwa ngokunikezwa kusengaphambili ngama-antihistamine nama-steroids.
