NgoJanuwari 14, 2019, i-cabozantinib (CABOMETYX, Exelixis, Inc.) yamukelwa yi Ukuphathwa Kwezokudla Nezidakamizwa ezigulini ezine-hepatocellular carcinoma (HCC) ezike zelashwa ngaphambilini nge-sorafenib.
Ukuvunyelwa kwakususelwa ocwaningweni olwenziwe ngokungahleliwe (2: 1) CELESTIAL (NCT01908426), blind-blind, placebo-controlled, multicenter Study in iziguli ze-HCC ezazithole i-sorafenib phambilini futhi zalimala nesibindi ku-Child Pugh Class A. Iziguli zazingenzelwanga ukuthola kungaba i-cabozantinib 60 mg kanye nsuku zonke ngomlomo (n = 470) noma i-placebo (n = 237) ngaphambi kokubi kwesifo noma ubuthi obungafanele.
Isilinganiso esiyinhloko sokusebenza ngempumelelo kwakuwukusinda okuphelele (OS); Izinyathelo ezengeziwe zemiphumela kwakuyi-progression-free survival (PFS) kanye nezinga lokuphendula eliphelele (ORR), njengoba lihlolwe abaphenyi ngokwe-RECIST 1.1 ngayinye. I-Median OS yayiyizinyanga ezingu-10.2 (95% CI: 9.1,12.0) ezigulini ezithola i-cabozantinib nezinyanga ezingu-8 (95% CI: 6.8, 9.4) kulabo abathola i-placebo (HR 0.76; 95% CI: 0.63, 0.92; p=0.0049). . I-Median PFS yayiyizinyanga ezingu-5.2 (4.0, 5.5) nezinyanga ezingu-1.9 (1.9, 1.9), ezingalweni ze-cabozantinib ne-placebo, ngokulandelana (HR 0.44; 95% CI: 0.36, 0.52; p<0.001). I-ORR yayingu-4% (95% CI: 2.3, 6.0) engalweni ye-cabozantinib kanye no-0.4% (95% CI: 0.0, 2.3) engalweni ye-placebo.
Uhudo, ukukhathala, ukuncipha kwesifiso sokudla, i-erythrodysesthesia ye-palmar-plantar, isicanucanu, umfutho wegazi ophakeme, nokuhlanza yizimo ezimbi ezivame kakhulu cishe kumaphesenti angama-25 eziguli ezathola i-cabozantinib ezivivinyweni zomtholampilo ukuze kuncishiswe imvamisa.
Umthamo onconywayo we-cabozantinib ungama-60 mg ngomlomo, okungenani ihora eli-1 ngaphambi noma amahora amabili ngemuva kokudla, kanye ngosuku.
FDA unikeze lesi sicelo ukuqokwa kwezintandane. Ochwepheshe bezempilo kufanele babike yonke imicimbi emibi kakhulu okusolwa ukuthi ihlotshaniswa nokusetshenziswa kwanoma imuphi umuthi nedivayisi kwabakwa-FDA Uhlelo Lokubika lweMedWatch noma ngokushayela u-1-800-FDA-1088.
