Mvumo yakakurumidza kubvumirwa pembrolizumab (Keytruda, Merck) yekurapa varwere vane hepatocellular carcinoma (HCC) avo vakambogamuchira sorafenib (Nexavar, Bayer). Keytruda inotenderwa zvakare musanganiswa ne carboplatin uye paclitaxel kana nab-paclitaxel yekutanga-mutsara kurapwa kwe metastatic squamous isiri diki cell kenza yemapapu.
FDA yakavakirwa pane imwechete-ruoko, yakavhurika label KEYNOTE-224 bvunzo mhinduro. Muedzo wacho waisanganisira varwere ve104 (makore epakati, makore 68; 83% varume; 81% vatsvene; 14% vokuAsia) vane HCC vakawana kufambira mberi kwechirwere kana kupesana neKusagadzikana. Mamiriro eECOG evarwere vese aive 0 (61%) kana 1 (39%), yaive yeChild-Pugh giredhi A yekushaya chiropa. Mukuwedzera, 21% vaiva seropositive yehutachiona hweH hepatitis B, 25% vaiva seropositive yehutachiona hweH hepatitis C, uye 9% vaiva seropositive. 64% yevarwere vane extrahepatic chirwere, 17% vane vascular invasion, uye 9% vane zvose. Varwere vakagamuchira pembrolizumab 200 mg mavhiki ega e3 kwemwedzi ye24, kana kusvika pakukura kwechirwere kana chepfu isingagamuchirwi. Chinangwa chemhinduro uye nguva yekupindura zvakashandiswa semhedzisiro huru yekubudirira. Iyo yepakati yekuratidzwa nguva yepembrolizumab yaive mwedzi 4.2. IORR yakashumwa nevatsvakurudzi yaiva 17% (95% CI, 11-26), kusanganisira 1% yakakwana yekupindura chiyero uye 16% chikamu chekupindura. Pakati pevarwere ve18 vakawana mhinduro, 16 (89%) vakanga vachiri kushanda kwemwedzi mitanhatu, uye 6 (10%) vakanga vachiri kushanda kweinenge mwedzi ye56.
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 %).
Mvumo yeKeytruda inopa nzira itsva yekurapa kune varwere vane hepatocellular carcinoma vakagamuchira sorafenib kurapwa.