Gumiguru 2021: Cabozantinib (Cabometyx, Exelixis, Inc.) yakatenderwa neChikafu neDrug Administration kune vakuru nevana vane makore gumi nemaviri ezera zvichikwira avo vakave nechepamusoro kana metastatic musiyano wegomarara rethyroid (DTC) iro rakafambira mberi zvichitevera kurapwa kwakanangana neVEGFR uye vasingabvumirwe kana kuramba kune radioactive iodine. .
COSMIC-311, a randomized (2: 1), kaviri-mapofu, placebo-inodzorwa, multicenter kliniki yekuedza (NCT03690388) kune varwere vane munharaunda yepamusoro kana metastatic DTC avo vakafambira mberi mushure mekutanga VEGFR-yakananga kurapa uye vakanga vasingabvumirwi kana kuti vanopesana neradioactive. iodine, yakashandiswa kuongorora kushanda. Varwere vakapiwa cabozantinib 60 mg kana placebo kana rubatsiro rwakanyanya rwekutsigira kusvikira chirwere chichikura kana chepfu isingagamuchirwi.
Iwo akakosha ekubudirira mhedzisiro matanho aive kufambira mberi-pasina kupona (PFS) mune chinangwa-ye-kubata-huwandu hwevanhu uye yakazara mhinduro mwero (ORR) mune yekutanga 100 randomized varwere, ese ari maviri akaongororwa neakapofumadzwa akazvimirira eradiological review komiti vachishandisa RECIST. 1.1 maitiro. Kuenzaniswa ne placebo, CABOMETYX yakaderedza zvakanyanya njodzi yekufambira mberi kwechirwere kana kufa (p0.0001). PFS yepakati mu cabozantinib ruoko yaiva 11.0 mwedzi (95 muzana CI: 7.4, 13.8), zvichienzaniswa nemwedzi 1.9 (95 muzana CI: 1.9, 3.7) muruwoko rwe placebo. Mumapoka e-cabozantinib uye placebo, maORR aiva 18 muzana (95 muzana CI: 10 muzana, 29 muzana) uye 0 muzana (95 muzana CI: 0 muzana, 11 muzana), maererano.
Manyoka, palmar-plantar erythrodysesthesia (PPE), kuneta, hypertension, uye stomatitis ndiyo yainyanya kuipa (25 muzana). Hypocalcemia yakaiswa seyambiro.
Kusvikira kufambira mberi kwechirwere kana huturu husingagamuchirwi, iyo inokurudzirwa imwe-agent cabozantinib dose ndeye 60 mg kamwe pazuva. Muvarwere vevana (vane makore gumi nemaviri uye vakuru vane BSA isingasviki 12 m1.2), iyo yakakurudzirwa cabozantinib dose ndeye 2 mg kamwe chete pazuva kusvika kufambira mberi kwechirwere kana kusashivirira chepfu.
