Amincewa da haɓaka amincewar pembrolizumab (Keytruda, Merck) don kula da marasa lafiya da ciwon hanta (HCC) waɗanda a baya suka karɓi sorafenib (Nexavar, Bayer). Hakanan an yarda da Keytruda a hade tare da carboplatin da paclitaxel ko nab-paclitaxel don maganin layin farko na ciwon huhu na huhu na metastatic.
FDA ta dogara ne akan hannu ɗaya, buɗaɗɗen lakabin KEYNOTE-224 sakamakon gwajin. Gwajin ya haɗa da marasa lafiya 104 (shekarun matsakaici, shekaru 68; 83% maza; 81% fararen fata; 14% Asians) tare da HCC waɗanda suka sami ci gaba da cututtuka ko rashin haƙuri. Matsayin aikin ECOG na duk marasa lafiya shine 0 (61%) ko 1 (39%), wanda shine raunin aikin hanta na Child-Pugh. Bugu da kari, kashi 21% sun kasance masu saurin kamuwa da cutar hanta ta hepatitis B, kashi 25% sun kasance masu saurin kamuwa da cutar hanta ta C, kuma kashi 9% sun kasance masu saurin kamuwa da cutar hanta. 64% na marasa lafiya suna da cututtukan hanta, 17% suna da mamayewar jijiyoyin jini, kuma 9% suna da duka biyun. Marasa lafiya sun karɓi pembrolizumab 200 MG kowane mako 3 na tsawon watanni 24, ko har sai cutar ta ci gaba ko kuma rashin yarda da guba. An yi amfani da ƙimar amsa maƙasudi da tsawon lokacin amsa azaman babban sakamako mai inganci. Tsakanin bayyanar pembrolizumab shine watanni 4.2. ORR da aka ruwaito ta masu binciken shine 17% (95% CI, 11-26), gami da 1% cikakken ƙimar amsawa da ƙimar amsawa ta 16%. Daga cikin marasa lafiya 18 da suka sami amsa, 16 (89%) har yanzu suna da tasiri na akalla watanni 6, kuma 10 (56%) har yanzu suna da tasiri na akalla watanni 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 %).
Amincewar Keytruda yana ba da sabon zaɓin magani ga marasa lafiya da ciwon hanta da suka sami maganin sorafenib.
