2021 yil oktyabr: Cabozantinib (Cabometyx, Exelixis, Inc.) Oziq-ovqat va farmatsevtika idorasi tomonidan 12 yosh va undan katta yoshdagi kattalar va pediatrik bemorlarda mahalliy rivojlangan yoki metastatik differensial qalqonsimon saratoni (DTC) bo'lgan, oldingi VEGFR-maqsadli terapiyadan keyin rivojlangan va radioaktiv yodga mos kelmaydigan yoki o'tga chidamli bo'lgan bemorlar uchun tasdiqlangan. .
COSMIC-311, oldingi VEGFR- maqsadli terapiyadan so'ng rivojlangan va radioaktiv ta'sirga yaroqsiz yoki o'tga chidamli bo'lgan mahalliy rivojlangan yoki metastatik DTC bo'lgan bemorlarda randomizatsiyalangan (2:1), ikki marta ko'r, platsebo-nazorat qilinadigan, ko'p markazli klinik sinov (NCT03690388). yod, samaradorlikni baholash uchun ishlatilgan. Bemorlarga 60 mg kabozantinib yoki platsebo yoki kasallikning kuchayishi yoki qabul qilib bo'lmaydigan toksiklik paydo bo'lguncha eng yaxshi yordam ko'rsatildi.
The key effectiveness outcome measures were progression-free survival (PFS) in the intent-to-treat population and overall response rate (ORR) in the first 100 randomised patients, both of which were assessed by a blinded independent radiological review committee using the RECIST 1.1 criteria. Compared to placebo, CABOMETYX significantly reduced the risk of illness progression or death (p0.0001). The median PFS in the cabozantinib arm was 11.0 months (95 percent CI: 7.4, 13.8), compared to 1.9 months (95 percent CI: 1.9, 3.7) in the placebo arm. In the cabozantinib and placebo groups, the ORRs were 18 percent (95 percent CI: 10 percent, 29 percent) and 0 percent (95 percent CI: 0 percent, 11 percent), respectively.
Diareya, palmar-plantar eritrodizesteziya (PPE), charchoq, gipertenziya va stomatit eng ko'p tarqalgan nojo'ya ta'sirlar edi (25 foiz). Gipokalsemiya ogohlantiruvchi eslatma sifatida kiritilgan.
Kasallikning kuchayishi yoki qabul qilinishi mumkin bo'lmagan toksik ta'sirga qadar kabozantinibning tavsiya etilgan yagona dozasi kuniga bir marta 60 mg ni tashkil qiladi. Pediatrik bemorlarda (BSA 12 m1.2 dan kam bo'lgan 2 yosh va undan katta) kabozantinibning tavsiya etilgan dozasi kasallikning kuchayishi yoki chidab bo'lmas toksiklik paydo bo'lguncha kuniga bir marta 40 mg ni tashkil qiladi.
