Agasti 2021: I-Tivozanib (Fotivda, AVEO Pharmaceuticals, Inc.), i-kinase inhibitor, ivunyelwe yi-FDA yeziguli ezindala ezine-renal cell carcinoma (RCC) esibuyele emuva noma esibuyele emuva ngemuva kokwelashwa kwesistimu okubili noma ngaphezulu.
I-TIVO-3 (NCT02627963), i-randomized (1:1), ilebula evulekile, isivivinyo se-multicenter se-tivozanib ngokumelene ne-sorafenib ezigulini ezine-RCC ethuthukisiwe ebuyele emuva noma ephikisayo eyayithole ukwelashwa okuhleliwe okubili noma okuthathu kwangaphambili, okuhlanganisa okungenani inhibitor eyodwa ye-VEGFR kinase. ngaphandle kwe-sorafenib noma i-tivozanib, yasetshenziselwa ukuhlola ukusebenza kahle. Iziguli zanikezwa i-tivozanib 1.34 mg ngomlomo kanye ngosuku izinsuku ezingu-21 ezilandelanayo njalo ezinsukwini ezingu-28 noma i-sorafenib 400 mg ngomlomo kabili ngosuku kuze kube yilapho isifo siqhubeka noma ubuthi obungabekezeleleki, noma yikuphi okufike kuqala.
Ukusinda kwe-Progression-free survival (PFS) kwakuyisilinganiso esiyinhloko somphumela wokusebenza ngempumelelo, esabuyekezwa yikomiti elizimele elizimele elibukeza i-radiological review. Ukusinda sekukonke (i-OS) nezinga lokuphendula okuhlosiwe bekuyizinjongo ezimbili ezisebenzayo (ORR).
I-PFS ephakathi engalweni ye-tivozanib (n = 175) bekuyizinyanga eziyi-5.6 (95% CI: 4.8, 7.3), uma kuqhathaniswa nezinyanga eziyi-3.9 (95% CI: 3.7, 5.6) engalweni ye-sorafenib (HR 0.73; 95% CI: 0.56, 0.95; p = 0.016). I-median OS yamaqembu e-tivozanib ne-sorafenib kwakuyizinyanga eziyi-16.4 (95% CI: 13.4, 21.9) nezinyanga eziyi-19.2 (95% CI: 14.9, 24.2), ngokulandelana (HR 0.97; 95% CI: 0.75, 1.24). I-ORR yengalo ye-tivozanib ibingamaphesenti ayi-18 (amaphesenti angama-95 we-CI: amaphesenti ayi-12, amaphesenti angama-24) kanti engalweni ye-sorafenib ibingamaphesenti ayi-8 (amaphesenti angama-95 we-CI: amaphesenti ama-4, amaphesenti ayi-13).
Ukukhathala, umfutho wegazi ophakeme, isifo sohudo, ukuncipha kokudla, isicanucanu, i-dysphonia, i-hypothyroidism, ukukhwehlela, ne-stomatitis kwakuyimiphumela emibi kakhulu (20%). Ukwehla kwe-sodium, ukwanda kwe-lipase, kanye nokwehla kwe-phosphate kwakuyizinto ebezijwayelekile kakhulu ebangeni lesi-3 noma le-4 elebhu (5%).
Umthamo we-tivozanib onconywayo ngu-1.34 mg kanye ngosuku (noma ngaphandle kokudla) izinsuku ezingama-21, kulandelwa ikhefu lezinsuku ezingama-28 kuze kube ukuqhubekela phambili kwesifo noma ubuthi obungabekezeleleki.
Inkomba: https://www.fda.gov/
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