Nyamavhuvhu 2021: Nivolumab (Opdivo, Bristol-Myers Squibb Co.) yakagamuchirwa neKudya neDrug Administration kweAdjuvant kurapwa kwevarwere vane urothelial carcinoma (UC) avo vari panjodzi huru yekudzokororazve mushure mekunyanyisa resection.
Ino inguva yekutanga iyo FDA kubvumidza kurapwa kweAdjuvant kune avo vane njodzi huru UC varwere. Zvakawanikwa zvakare zvakatsigira danho rekushandura mvumo yekukurumidza nivolumab yekufambira mberi / metastatic UC kune mvumo yakajairwa.
Nivolumab akafundwa muCHECKMATE-274 (NCT02632409), iyo yakasarudzika, yakapofomara-bofu, inodzorwa-placebo-inodzorwa muvarwere vane UC yedundira kana yepamusoro urinary turakiti (renal pelvis kana ureter) vaive panjodzi huru yekudzokazve mukati memazuva zana nemakumi maviri e yakakura resection. Varwere vaiwanzopihwa (120: 1) kuti vagamuchire nivolumab 1 mg kana placebo nekupinza mukati memavhiki maviri ega ega kudzokorora kana kusagadzikana kwehuturu, ine yakanyanya kurapwa nguva yegore rimwe.
Muboka rechinangwa-ku-kurapa (ITT) uye muvarwere vane mapundu anoratidza PD-L1 isingasviki 1%, chinangwa chikuru chekubudirira chaive chekuferefeta-yakaongororwa chirwere-isina kupona (DFS). Nguva yekutanga kudzokorora (yemunzvimbo urothelial turakiti, yemo isiri-urothelial turakiti, kana kure metastatic) kana kufa kwakashandiswa kuona DFS. Pamusoro pezvinangwa zvose zvekutanga, kuwedzera kwenhamba kunokosha muDFS kwakashumwa kune vatori vechikamu pa nivolumab arm vs. placebo pane imwe nguva yakatsanangurwa yekuongorora. Mukuongorora kweITT, varwere vakawana nivolumab vaiva nepakati DFS yemwedzi ye20.8 (95 muzana CI: 16.5, 27.6) ichienzaniswa nemwedzi ye10.8 (95 muzana CI: 8.3, 13.9) muvarwere vakagamuchira placebo (HR 0.70; 95 muzana CI : 0.57, 0.86; p=0.0008). Varwere vakagamuchira nivolumab vaive nepakati DFS yekusawana (95 muzana yekuvimba nguva: 21.2, isingafungidzirwe) ichienzaniswa nemwedzi 8.4 (95 muzana yekuvimba nguva: 5.6, 21.2) kune avo vakawana placebo (HR 0.55; 95 muzana yekuvimba nguva: 0.39, 0.77; p=0.0005).
Iyo isina kusarudzika DFS hazard reshiyo fungidziro yaive 0.83 mukuwongorora kwekuongorora kwevarwere vane PD-L1-isina mamota (58 muzana) (95 muzana CI: 0.64, 1.08). Iine 33 muzana yevakafa muhuwandu hwese hwakasarudzika, OS data ichiri mudiki. Pakanga paine makumi matatu nenomwe vakafa muUUC subpopulation (37 mune nivolumab ruoko, 20 mune placebo ruoko).
Rashes, kuneta, manyoka, pruritus, musculoskeletal marwadzo, uye weti turakiti hutachiona ndiyo yakanyanya kuwanda mhedzisiro yakaonekwa mune vangangoita makumi maviri muzana yevatori vechikamu vakagamuchira nivolumab muCHECKMATE-20.
Nivolumab inorayirwa pachiyero che240 mg masvondo maviri ega ega kana 480 mg vhiki yega yega yekurapa kwekuwedzera kweUC.
Dheuteronomio: https://www.fda.gov/
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