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I-Cabozantinib ivunyelwe umdlavuza we-thyroid ohlukile

Yabelana ngalokhu okuthunyelwe

Okthoba 2021: Cabozantinib (Cabometyx, Exelixis, Inc.) igunyazwe yi-Food and Drug Administration kuziguli ezikhulile kanye nezingane ezineminyaka engu-12 ubudala nangaphezulu ezinomdlavuza wegilo wegilo osuthuthuke kakhulu noma we-metastatic (DTC) oqhubeke ngokulandela ukwelashwa okuhloswe ngaphambili kwe-VEGFR futhi ezingafanelekile noma eziphikisana ne-iodine ene-radioactive. .

 

I-COSMIC-311, okungahleliwe (2:1), okungaboni kabili, okulawulwa yi-placebo, ukuhlolwa komtholampilo kwe-multicenter (NCT03690388) ezigulini ezine-DTC ethuthukisiwe yasendaweni noma ye-metastatic ethuthuke ngemva kokwelashwa kwangaphambili okuhloswe kwe-VEGFR futhi yayingafanelekile noma iphikisana ne-radioactive. iodine, yayisetshenziselwa ukuhlola ukusebenza kahle. Iziguli zanikezwa i-cabozantinib 60 mg noma i-placebo noma ukunakekelwa okungcono kakhulu okusekela kuze kube yilapho isifo siqhubeka noma ubuthi obungamukeleki.

Izinyathelo ezibalulekile zomphumela wokuphumelela kwaba ukusinda-mahhala (i-PFS) kubantu benhloso yokwelapha kanye nezinga lokuphendula lilonke (ORR) ezigulini zokuqala eziyi-100 ezingahleliwe, zombili ezihlolwe ikomiti elizimele elizimele elibukeze i-radiological eliphuphuthekile lisebenzisa i-RECIST. 1.1 imibandela. Uma kuqhathaniswa ne-placebo, i-CABOMETYX inciphise kakhulu ingozi yokugula noma ukufa (p0.0001). I-PFS emaphakathi engalweni ye-cabozantinib yayiyizinyanga ezingu-11.0 (amaphesenti angu-95 CI: 7.4, 13.8), uma kuqhathaniswa nezinyanga ezingu-1.9 (amaphesenti angu-95 CI: 1.9, 3.7) engalweni ye-placebo. Emaqenjini e-cabozantinib kanye ne-placebo, ama-ORR ayengamaphesenti angu-18 (amaphesenti angu-95 CI: amaphesenti angu-10, amaphesenti angu-29) namaphesenti angu-0 (amaphesenti angu-95 CI: amaphesenti angu-0, amaphesenti angu-11), ngokulandelana.

Uhudo, i-palmar-plantar erythrodysesthesia (PPE), ukukhathala, umfutho wegazi ophakeme, kanye ne-stomatitis kwakuyimiphumela emibi kakhulu (amaphesenti angama-25). I-Hypocalcemia yafakwa njengenothi lokuxwayisa.

Kuze kube yilapho isifo siqhubeka noma ubuthi obungamukeleki, umthamo onconyiwe we-ejenti eyodwa ye-cabozantinib ngu-60 mg kanye ngosuku. Ezigulini zezingane (ezineminyaka engu-12 ubudala nangaphezulu ezine-BSA engaphansi kuka-1.2 m2), umthamo onconyiwe we-cabozantinib ngu-40 mg kanye ngosuku kuze kuqhubeke isifo noma ubuthi obungabekezeleleki.

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