Ukugunyazwa kusheshise ukugunyazwa kwe-pembrolizumab (Keytruda, Merck) yokwelashwa kweziguli ezine-hepatocellular carcinoma (HCC) ezazithole ngaphambilini i-sorafenib (Nexavar, Bayer). I-Keytruda iphinde igunyazwe ngokuhlanganiswa ne-carboplatin ne-paclitaxel noma i-nab-paclitaxel yokwelashwa komugqa wokuqala we-metastatic squamous non-small cell lung cancer.
I-FDA isuselwe kumiphumela yokuhlola engalo eyodwa, ilebula evuliwe engu-KEYNOTE-224. Ukuhlolwa kwakuhlanganisa iziguli ze-104 (iminyaka ephakathi, iminyaka engu-68; 83% abesilisa; 81% abamhlophe; 14% base-Asia) abane-HCC ababhekana nokuqhubekela phambili kwesifo noma ngokumelene nokungabekezelelani. Isimo sokusebenza kwe-ECOG sazo zonke iziguli sasingu-0 (61%) noma u-1 (39%), okwakuwukukhubazeka kokusebenza kwesibindi kwe-Child-Pugh grade A. Ngaphezu kwalokho, ama-21% ayene-seropositive yegciwane le-hepatitis B, ama-25% ayene-seropositive yegciwane le-hepatitis C, kanti amaphesenti angu-9 ayene-seropositive. Amaphesenti angu-64 eziguli anesifo se-extrahepatic, i-17% ine-vascular invasion, kanti i-9% inakho kokubili. Iziguli zithole i-pembrolizumab 200 mg njalo emavikini angu-3 izinyanga ezingu-24, noma kuze kube yilapho isifo siqhubeka noma ubuthi obungamukeleki. Izinga lokuphendula lenjongo kanye nobude besikhathi sokuphendula kusetshenziswe njengemiphumela eyinhloko yokusebenza ngempumelelo. Isikhathi sokuchayeka esimaphakathi se-pembrolizumab sasiyizinyanga ezi-4.2. I-ORR ebikwe ngabacwaningi yayingu-17% (95% CI, 11-26), kuhlanganise nesilinganiso sokuphendula esiphelele esingu-1% kanye nesilinganiso sokuphendula esiyingxenye esingu-16%. Ezigulini eziyi-18 ezithole impendulo, eziyi-16 (89%) zisasebenza okungenani izinyanga eziyi-6, kanti eziyi-10 (56%) zisasebenza okungenani izinyanga eziyi-12.
The adverse effects of Pembrolizumab-treated HCC patients appeared to be similar to those observed in other studies of melanoma or NSCLC, but the incidence of ascites increased (grade 3/4, 8%) and immune-mediated hepatitis (2.9%). Grade 3 or 4 laboratory abnormalities that occurred more frequently in the KEYNOTE-224 trial included elevated alanine aminotransferase (20%), elevated aspartate aminotransferase (9%) and hyperbilirubinemia (10 %).
Ukugunyazwa kuka-Keytruda kunikeza inketho yokwelapha entsha ezigulini ezine-hepatocellular carcinoma ezithole ukwelashwa kwe-sorafenib.
