An amince da Cabozantinib don bambancin ciwon daji na thyroid

Share Wannan Wallafa

Oktoba 2021: Cabozantinib (Cabometyx, Exelixis, Inc.) Cibiyar Abinci da Magunguna ta amince da ita ga manya da yara marasa lafiya masu shekaru 12 da haihuwa waɗanda suka sami ci gaba a cikin gida ko metastatic bambance-bambancen ciwon daji na thyroid (DTC) wanda ya ci gaba biyo bayan maganin VEGFR da aka yi niyya a baya kuma waɗanda ba su cancanta ko masu ƙin yarda da iodine radioactive .

 

COSMIC-311, bazuwar (2: 1), makafi biyu, mai sarrafa wuribo, gwaji na asibiti da yawa (NCT03690388) a cikin marasa lafiya tare da ci gaba a cikin gida ko metastatic DTC waɗanda suka ci gaba bayan farfagandar VEGFR da aka yi niyya a baya kuma sun kasance marasa cancanta ko rashin yarda da rediyoaktif. aidin, an yi amfani dashi don tantance inganci. An ba marasa lafiya ko dai cabozantinib 60 MG ko placebo ko mafi kyawun kulawar tallafi har sai cutar ta ci gaba ko rashin yarda da guba.

Mahimman matakan sakamako masu tasiri sune tsira ba tare da ci gaba ba (PFS) a cikin niyya don magance yawan jama'a da kuma jimlar amsawa gabaɗaya (ORR) a cikin marasa lafiya 100 na farko da aka bazu, duka biyun an tantance su ta hanyar kwamitin nazarin rediyo mai zaman kansa mai zaman kansa ta amfani da RECIST. 1.1 ma'auni. Idan aka kwatanta da placebo, CABOMETYX ya rage haɗarin ci gaban rashin lafiya ko mutuwa (p0.0001). Matsakaicin PFS a cikin hannun cabozantinib shine watanni 11.0 (95 bisa dari CI: 7.4, 13.8), idan aka kwatanta da watanni 1.9 (95 bisa dari CI: 1.9, 3.7) a cikin hannun placebo. A cikin cabozantinib da ƙungiyoyin placebo, ORRs sun kasance 18 bisa dari (95 bisa dari CI: 10 bisa dari, 29 bisa dari) da 0 bisa dari (95 bisa dari CI: 0 bisa dari, 11 bisa dari), bi da bi.

Zawo, palmar-plantar erythrodysesthesia (PPE), gajiya, hauhawar jini, da stomatitis sune mafi yawan illa (kashi 25). An saka Hypocalcemia azaman bayanin kula.

Har sai cutar ta ci gaba ko cutar da ba a yarda da ita ba, shawarar da aka ba da shawarar wakili guda ɗaya na cabozantinib shine 60 MG sau ɗaya kowace rana. A cikin marasa lafiya na yara (shekaru 12 da haihuwa tare da BSA na ƙasa da 1.2 m2), shawarar cabozantinib shawarar shine 40 MG sau ɗaya a rana har sai cutar ta ci gaba ko rashin haƙuri.

Ɗauki ra'ayi na biyu akan ciwon daji na thyroid


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