Octobris 2021: Cabozantinib (Cabometyx, Exelixis, Inc.) Approbata est a Cibus et medicamentis Administrationis aegris adultis et pediatricis 12 annis et maioribus, qui localiter progressi vel metastatici differentiati cancri thyreoidei (DTC) progressi sunt, sequentem priorum VEGFR theraphim iaculis et qui in iodi radioactivo ineligibiles vel refractores sunt. .
COSMIC-311, temere (II, 2), duplex caecum, placebo moderatum, iudicium clinicum multicenter (NCT1) patientibus localiter provectis vel metastaticis DTC qui post prioratum VEGFR-iaculatum theraphim progressi erant et ineligibiles vel refractores radioactivi erant. iodi, assident adhibita efficacia. Aegroti vel cabozantinib 03690388 mg medicamentum vel placebo vel optimae curae adminiculae datae sunt donec morbus progressionis vel toxicitatis acceptabilis.
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.
Fluxus, palmareo-plantar erythrodysesthesia (PPE), lassitudo, hypertension, et stomatitis adversae effectus praevalent (25 percent). Hypocalcemia inserta est nota cautionis.
Usque ad morbum progressum vel toxicitatem acceptam commendatur dosis cabozantinib unius agentis 60 mg semel cottidiana. In aegris pediatricis (XII annis et senior cum BSA minore quam 12 m1.2), dosis cabozantinib suadetur 2 mg semel in die usque ad morbum progressum vel toxicitatem intolerabilem.
