Pembrolizumab ine chemotherapy inotenderwa neUSFDA kune biliary turakiti cancer

Pembrolizumab ine chemotherapy inotenderwa neUSFDA kune biliary turakiti cancer

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Musi wa31 Gumiguru, 2023, Food and Drug Administration yakabvumidza pembrolizumab (Keytruda, Merck) kuti ishandiswe negemcitabine uye cisplatin kurapa biliary tract carcinoma (BTC) iyo yapararira kana kuti yafambira mberi munharaunda asi isingabviswe.

Kubudirira kwakaongororwa mune chidzidzo chakanzi KEYNOTE-966 (NCT04003636), iyo yaive yakawanda, yakasarudzika, yakapetwa-mapofu, placebo-inodzorwa muyedzo unosanganisira 1069 varwere vane munharaunda yepamusoro isingagadzirike kana metastatic BTC yakanga isati yambopfuura systemic kurapwa kwehurwere hwepamusoro. . Varwere vakapihwa zvisina tsarukano kuti vagamuchire pembrolizumab pamwe chete negemcitabine uye cisplatin mavhiki matatu ega ega, kana placebo pamwe negemcitabine uye cisplatin pachirongwa chimwe chete. Kurapa kwakaramba kuchienderera mberi kusvikira zvisingagoneki nemigumisiro yakaipa kana kukura kwechirwere. Cisplatin yakapihwa kusvika ku3 cycles, nepo gemcitabine yakaenderera mberi zvichienderana nekutonga kwachiremba. Kutungamirirwa kwePembrolizumab kana placebo kwaichengetedzwa kusvika pakukura kwehurwere, huturu husingashiviriri, kana nguva yakareba yemakore maviri.

Mhedzisiro yekutanga yekubudirira yaive kupona kwese (OS). Pembrolizumab yakasanganiswa nekemotherapy yakaratidza kuwedzera kukuru kwehupenyu hwese huchienzaniswa ne placebo yakasanganiswa nekemotherapy, ine ngozi ye0.83 (95% CI: 0.72, 0.95); divi rimwe p-kukosha=0.0034. Kupona kwepakati pese (OS) yaive mwedzi gumi nemaviri ne12.7% yekuvimba nguva (CI) ye95 kusvika 11.5 muboka rimwe, uye 13.6 mwedzi ine 10.9% CI ye95 kusvika 9.9 mune rimwe boka.

Kuvhiringidzwa kwepembrolizumab nekuda kwezviitiko zvakashata zvakaitika mu55% ​​yevarwere. Yakaderera neutrophil count, yakaderera platelet count, anemia, yakaderera chena masero eropa, fivha, kuneta, cholangitis, yakakwira ALT uye AST, uye kuvharika kwebiliary ndiwo mamwe emhedzisiro kana matambudziko erabhu aiitika kakawanda (≥2%) zvekuti kurapwa kwaifanira kumiswa.

Chiyero chinokurudzirwa chepembrolizumab ndeye 200 mg mavhiki matatu ega ega kana 3 mg masvondo matanhatu ega ega kusvika kufambira mberi kwechirwere kana huturu husingagoneki. Ipa pembrolizumab pamberi pechemotherapy kana zvese zvikapihwa pazuva rimwe chete.

Wona ruzivo rwakazara rwekurayira Keytruda.

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