August 2021: Tivozanib (Fotivda, AVEO Mishonga, Inc.), kinase inhibitor, yakagamuchirwa neDFA kune vanhu vakuru varwere vakadzokazve kana kuramba vachibvisa renal cell carcinoma (RCC) mushure memaviri kana kupfuura apfuura systemic therapy.
TIVO-3 (NCT02627963), a randomized (1: 1), yakazaruka-label, multicenter muedzo we tivozanib versus sorafenib kune varwere vane kudzoka zvakare kana kupandukira kwepamusoro RCC avo vakagamuchira maviri kana matatu ekutanga maitiro ekurapa, kusanganisira imwe VEGFR kinase inhibitor. kunze kwe sorafenib kana tivozanib, yakashandiswa kuongorora kushanda. Varwere vakapiwa kana tivozanib 1.34 mg muromo kamwe chete zuva nezuva kwemazuva 21 akatevedzana mazuva ose e28 kana sorafenib 400 mg muromo kaviri pazuva kusvikira kufambira mberi kwechirwere kana kusagadzikana kunotyisa, chero ipi zvayo yakatanga.
Progression-free Survival (PFS) ndiyo yaive yekutanga kushanda kwemhedzisiro, iyo yakaongororwa nekomiti yakapofumadzwa yakazvimirira yeradiological review. Kupona kwese (OS) uye mwero wekupindura chinangwa zvaive zvimwe zviviri zvinobudirira zvinangwa (ORR).
Iyo yepakati PFS mune tivozanib ruoko (n = 175) yaive 5.6 mwedzi (95 muzana CI: 4.8, 7.3), zvichienzaniswa nemwedzi 3.9 (95 muzana CI: 3.7, 5.6) mune sorafenib ruoko (HR 0.73; 95 muzana CI: 0.56, 0.95; p = 0.016). Iyo yepakati OS yeiyo tivozanib uye sorafenib mapoka aive gumi nematanhatu emwedzi (16.4 muzana CI: 95, 13.4) uye 21.9 mwedzi (19.2 muzana CI: 95, 14.9), zvichiteerana (HR 24.2; 0.97 muzana CI: 95, 0.75). Iyo ORR yeiyo tivozanib ruoko yaive 1.24 muzana (18 muzana CI: 95 muzana, 12 muzana) uye kune sorafenib ruoko hwaive 24 muzana (8 muzana CI: 95 muzana, 4 muzana).
Kuneta, hypertension, manyoka, kushomeka kwekuda kudya, kuda kurutsa, dysphonia, hypothyroidism, kukosora, uye stomatitis ndizvo zvakakomba zvakanyanya (20%) mhedzisiro. Yakadzikira sodium, yakawedzera lipase, uye yakadzikira phosphate ndiyo yaive yakanyanya kuwanda giredhi 3 kana 4 murabhoritari zvisizvo (5%).
Iyo yakakurudzirwa tivozanib dosi ndeye 1.34 mg kamwe pazuva (uine kana usina kudya) kwemazuva makumi maviri nerimwe, uchiteverwa nekuzorora kwemazuva makumi maviri nemasere kusvikira chirwere chichiwedzera kana kusagadzikana kwehuturu.
Referensi: https://www.fda.gov/
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