Bishii Janaayo 14, 2019, cabozantinib (CABOMETYX, Exelixis, Inc.) waxaa oggolaaday Maamulka Cuntada iyo Dawooyinka bukaanada qaba kansarka hepatocellular (HCC) ee hore loogu daaweeyay sorafenib.
Ansixinta waxay ku saleysneyd kala sooc (2: 1) CELESTIAL (NCT01908426), indhoole laba-indhoole ah, xakamaynta placebo, daraasado badan oo bukaan-socodka ah oo ka tirsan bukaanada HCC oo horey u helay sorafenib isla markaana qaba dhaawac beerka ee Class Pugh Class A. Bukaannada ayaa loo kala saaray inay helaan ama cabozantinib 60 mg hal mar maalintii afka (n = 470) ama placebo (n = 237) kahor intaanay kasii darin cudurka ama sunta aan habooneyn.
Qiyaasta waxtarka aasaasiga ah waxay ahayd badbaadada guud (OS); Tallaabooyinka natiijada dheeraadka ah waxay ahaayeen badbaadada-free-horumarka (PFS) iyo heerka jawaabta guud (ORR), sida ay qiimeeyeen baarayaashu RECIST 1.1. Dhexdhexaadinta OS waxay ahayd 10.2 bilood (95% CI: 9.1,12.0) bukaanada qaata cabozantinib iyo 8 bilood (95% CI: 6.8, 9.4) kuwa qaata placebo (HR 0.76; 95% CI: 0.63, 0.92; p=0.0049) . Dhexdhexaadinta PFS waxay ahayd 5.2 bilood (4.0, 5.5) iyo 1.9 bilood (1.9, 1.9), ee cabozantinib iyo placebo hubka, siday u kala horreeyaan (HR 0.44; 95% CI: 0.36, 0.52; p <0.001). ORR wuxuu ahaa 4% (95% CI: 2.3, 6.0) ee cududda cabozantinib iyo 0.4% (95% CI: 0.0, 2.3) ee cududda placebo.
Shuban, daal, rabitaanka cuntada oo yaraada, palmar-plantar erythrodysesthesia, lallabbo, hypertension, iyo matag ayaa ah falcelinta ugu badan ee xun ee ku saabsan 25 boqolkiiba bukaannada helay cabozantinib ee tijaabooyinka bukaan-socodka si loo yareeyo soo noqnoqoshada.
Qiyaasta lagu taliyey ee cabozantinib waa 60 mg afka ah, ugu yaraan 1 saac kahor ama 2 saacadood cuntada kadib, hal mar maalintii.
FDA ogolaaday codsigan magacaabista daawada agoonta. Xirfadlayaasha daryeelka caafimaadku waa inay u soo sheegaan dhammaan dhacdooyinka halista ah ee halista ah ee looga shakisan yahay inay la xiriiraan isticmaalka daawo kasta iyo qalab kasta FDA Nidaamka Warbixinta ee MedWatch ama adiga oo waca 1-800-FDA-1088.
