Mbudzi 2021: Pembrolizumab (Keytruda, Merck) yakabatana nechemotherapy, ine kana isina bevacizumab, yakatenderwa neChikafu neDrug Administration kuvarwere vane chirwere chegomarara remuchibereko chinoramba chiripo, chinodzokororwa, kana metastatic vane mapundu anoratidza PD-L1 (CPS 1), sekutemerwa nebvunzo yakatenderwa neFDA.
Pembrolizumab yakapihwawo mvumo yenguva dzose sekurapa kumwe chete neFDA kune varwere vane kenza yakadzokororwa kana metastatic yemuromo wekervical vane chirwere chekukura kana mushure mechemotherapy uye vane mapundu anoratidza PD-L1 (CPS 1), sekusimbiswa neFDA-yakatenderwa muyedzo. FDA yakapa kukurumidza kubvumidzwa kune ichi chiratidzo munaChikumi 2018, pamwe neyeyedzo yemumwe, PD-L1 IHC 22C3 pharmDx (Dako North America Inc.).
Pembrolizumab with paclitaxel and cisplatin or paclitaxel and carboplatin, with or without bevacizumab, was studied in KEYNOTE-826 (NCT03635567), a multicenter, randomised, double-blind, placebo-controlled trial. The experiment involved 617 patients who had not been treated with chemotherapy and had chronic, recurring, or first-line metastatic chirwere chemuviri wechibereko. Patients were enrolled regardless of whether or whether they had PD-L1 expression. Pembrolizumab 200 mg with chemotherapy with or without bevacizumab or placebo plus chemotherapy with or without bevacizumab were randomly assigned (1:1) to one of two treatment groups. Pembrolizumab was given until disease progression, intolerable toxicity, or 24 months had passed from the start of the study.
Kupona kwese (OS) uye kufambira mberi-kusina kupona (PFS) ndiyo yaive yakakosha mhedzisiro matanho, ayo akaongororwa nemuongorori achishandisa RECIST v1.1, iyo yakagadziridzwa kuti itevere huwandu hwemaronda anovavarirwa gumi uye huwandu hwe10. panhengo. ORR uye kureba kwekuita kwakashandiswawo sekuwedzera mhedzisiro zviyero (DoR). Iyo yepakati OS muruwoko rwepembrolizumab haina kusvika (5 muzana CI: 95, NR) uye yaive mwedzi 19.8 (16.3 muzana CI: 95, 14.5) muruwoko rwe placebo (HR 19.4; 0.64 muzana CI: 95, 0.50; 0.81- sided p-value = 1) kune varwere vane mapundu anoratidza PD-L0.0001 (CPS 1, N = 1). Iyo yepakati PFS muruwoko rwepembrolizumab yaive mwedzi gumi. mativi p-ukoshi 548). Mune pembrolizumab uye placebo maoko, mhinduro yechinangwa yaive 10.4 muzana (95 muzana CI: 9.7, 12.3) uye 8.2 muzana (95 muzana CI: 6.3, 8.5), zvichiteerana, nepakati DoRs ye0.62 uye 95 mwedzi.
Pembrolizumab, chemotherapy, uye bevacizumab zvakabatanidzwa ne peripheral neuropathy, alopecia, anemia, kuneta/asthenia, kuda kurutsa, neutropenia, manyoka, hypertension, thrombocytopenia, kuvimbiswa, arthralgia, kurutsa, urinary tract infection, kuderera kwechirwere chetachiona, hypothyroidism, hypothyroidism, chirwere chekushaya ropa. 20 muzana yevarwere.
Pembrolizumab inopiwa pachiyero che 200 mg mavhiki matatu ega ega kana 3 mg mavhiki e400 kusvika kufambira mberi kwechirwere kana huturu husingagamuchirwi huchiitika, hunogona kusvika kumwedzi ye6.
