Nov 2023: Chikafu neDrug Administration yakabvumidza HEPZATO KIT (melphalan yeInjection/Hepatic Delivery System, Delcath Systems, Inc.) semushonga unotungamirwa nechiropa kune varwere vakuru vane uveal melanoma vane isingagadziriswe hepatic metastases inokanganisa isingasviki 50% yechiropa uye. hapana chirwere cheextrahepatic, kana chirwere cheextrahepatic chinogumira kumapapu, bhonzo, lymph nodes, kana subcutaneous tishu uye inogona
Muchidzidzo cheFOCUS (NCT02678572), vanhu 91 vane uveal melanoma uye metastases yechiropa iyo yaisagona kubviswa vakatora chikamu mune imwe-ruoko, yakavhurika-label kuedza kuona kuti kurapwa kwakashanda sei. Kana chikamu chinotyisa cheveveal melanoma chakabva pachiropa uye chirwere chiri kunze kwechiropa chinogona kurapwa neradiation therapy kana kuvhiyiwa, ipapo chimwe chirwere kunze kwechiropa chinogona kuwanikwa mumapapu, lymph nodes, bone, kana pasi peganda. . Zvikonzero zvakakosha zvekusakodzera kwaive kuita metastases mune inokwana 50% yechiropa parenchyma, kuve neChild-Pugh Kirasi B kana C chirrhosis, kana kuve nehepatitis B kana C.
Nzira huru dzekuyera kuti chimwe chinhu chakashanda sei yaive yechinangwa chekupindura mwero (ORR) uye nguva yekupindura (DoR), iyo yakasarudzwa nedare repakati rekuongorora komiti uchishandisa RECIST v1.1. Iyo yepakati DoR yaive mwedzi gumi nemana (14% CI: 95, 8.3), uye ORR yaive 17.7% (36.3% CI: 95, 26.4).
Melphalan (HEPZATO) inopinzwa muropa retsinga mavhiki matanhatu kusvika masere ega ega kwekanopfuura katanhatu kupinza uchishandisa Hepatic Delivery System (HDS), chikamu chemudziyo. Zvichienderana nehuremu hwemuviri hwakakodzera, iyo melphalan dose yakakurudzirwa i6 mg/kg, ine huwandu hwepamusoro hwe8 mg mukurapa kumwe chete.
Pane Yambiro Yebhokisi maererano nemhedzisiro yakakomba, sekubuda ropa, kukuvara kwechiropa, uye zviitiko zvethromboembolic, muzvinyorwa zveHEPZATO KIT. Yambiro ine Bhokisi maererano ne myelosuppression uye mukana wekutapukira kwakanyanya, kubuda ropa, kana symptomatic anemia inosanganisirwa mune zvakarairwa.
Nekuda kwekugona kwezvakakomba peri-procedural mhedzisiro senge thromboembolic zviitiko, hepatocellular kukuvadzwa, uye kubuda ropa, HEPZATO KIT inongosvikika chete kuburikidza nechirongwa chinorambidzwa chinowira pasi peHEPZATO KIT Risk Evaluation uye Mitigation Strategy.
Thrombocytopenia, kuneta, kupererwa neropa, kuda kurutsa, marwadzo emusculoskeletal, leukopenia, marwadzo emudumbu, neutropenia, kurutsa, alanine aminotransferase yakawedzera, kwenguva yakareba activated partial thromboplastin nguva, yakawedzera aspartate aminotransferase, yakawedzera ropa alkaline phosphatase, uye dyspnea yakawanda (20%). maitiro asina kunaka kana kukanganisa murabhoritari.
HEPZATO uye HEPZATO KIT inopikiswa kune varwere vane inoshanda intracranial metastases kana maronda europi ane propensity yekubuda ropa; kukundikana kwechiropa, portal hypertension, kana misiyano inozivikanwa iri panjodzi yekubuda ropa; kuvhiyiwa kana kurapwa kwechiropa mumavhiki e4 apfuura; isina kurongeka coagulopathy, kusakwanisa kuita zvakachengeteka pasi peanesthesia, kusanganisira mamiriro emwoyo anoshanda anosanganisira, asi asina kuganhurirwa, asina kugadzikana coronary syndromes (isina kugadzikana kana yakanyanya angina kana myocardial infarction), kuwedzera kana kutsva-kutanga congestive moyo kusakundikana, yakakosha arrhythmias, kana chirwere chakakomba chevalvular. ; nhoroondo yeallergies kana inozivikanwa hypersensitivity kune melphalan; nhoroondo yeallergies kana inozivikanwa hypersensitivity kune chikamu kana chinhu chinoshandiswa mukati meHEPZATO KIT kusanganisira nhoroondo yekusawirirana kune zvakasikwa rabha latex; nhoroondo yekusagadzikana kana hypersensitivity kune heparin kana kuvapo kweheparin-induced thrombocytopenia (HIT); uye nhoroondo yezvakanyanya allergic reaction kune iodinated mutsauko usingadzorwi nepremedication ne antihistamines uye steroid.
