Oggolaanshaha la dedejiyey oggolaanshaha pembrolizumab (Keytruda, Merck) ee daaweynta bukaannada qaba kansarka hepatocellular kansarka (HCC) kuwaas oo hore u helay sorafenib (Nexavar, Bayer). Keytruda ayaa sidoo kale la ansixiyay iyadoo lagu daray carboplatin iyo paclitaxel ama nab-paclitaxel ee daaweynta safka koowaad ee kansarka sambabada unugyada unugyada yaryar ee aan yarayn.
FDA waxay ku salaysan tahay hal gacan, summada furan ee KEYNOTE-224 natiijooyinka baaritaanka. Tijaabada waxaa ka mid ahaa 104 bukaan (da'da dhexe, 68 sano; 83% lab ah; 81% caddaan ah; 14% Aasiyaan) oo leh HCC kuwaas oo la kulmay horumarka cudurka ama ka soo horjeeda dulqaad la'aanta. Heerka waxqabadka ECOG ee dhammaan bukaannada ayaa ahaa 0 (61%) ama 1 (39%), taas oo ahayd heerka Ilmaha-Pugh ee shaqada beerka. Intaa waxaa dheer, 21% waxay ahaayeen seropositive fayraska cagaarshow B, 25% waxay ahaayeen seropositive fayraska cagaarshow C, iyo 9% waxay ahaayeen seropositive. 64% bukaanada ayaa qaba cudur ka baxsan cagaarshowga, 17% waxay qabaan duulaanka xididdada dhiigga, iyo 9% labaduba waxay qabaan. Bukaan-socodka ayaa helay pembrolizumab 200 mg 3 toddobaad kasta 24 bilood, ama ilaa uu cudurku ka sii socdo ama sunta aan la aqbali karin. Heerka jawaabta ujeeddada iyo muddada jawaabta ayaa loo adeegsaday natiijooyinka waxtarka ugu weyn. Waqtiga soo-gaadhista dhexdhexaadka ah ee pembrolizumab wuxuu ahaa 4.2 bilood. ORR-ga ay soo sheegeen cilmi-baarayaashu waxay ahaayeen 17% (95% CI, 11-26), oo ay ku jiraan 1% heerka jawaab celinta oo dhammaystiran iyo 16% heerka jawaabta qayb ahaan. 18 ka bukaan ee helay jawaabta, 16 (89%) ayaa wali wax ku ool ah ugu yaraan 6 bilood, iyo 10 (56%) ayaa wali waxtarkoodu ahaa ugu yaraan 12 bilood.
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 %).
Oggolaanshaha Keytruda waxay siisaa ikhtiyaar daawayn cusub bukaanada qaba kansarka hepatocellular ee helay daawaynta sorafenib.
