Okthoba 2021: I-Food and Drug Administration igunyaze abemaciclib (Verzenio, Eli Lilly and Company) ngokuhlanganiswa nokwelashwa kwe-endocrine (i-tamoxifen noma i-aromatase inhibitor) yokwelashwa kwe-adjuvant yeziguli ezikhulile ezine-hormone receptor (HR) -positive, human epidermal growth factor receptor 2 (HER2) -negative, node-positive, umdlavuza webele wasekuqaleni osengcupheni enkulu yokugula. ukuphindaphinda kanye nesikolo se-Ki-67 esingaphansi kuka-20%, njengoba kunqunywa i-FDA- Lesi isivimbeli sokuqala se-CDK 4/6 esigunyazwe ukwelashwa kwe-adjuvant yomdlavuza webele.
I-Agilent, Inc. ithumele uhlolo lwe-Ki-67 IHC MIB-1 pharmDx (Dako Omnis), olugunyazwe yi-FDA njengoxilongo oluhambisana nalesi sibonakaliso.
Abesifazane abadala namadoda ane-HR-positive, HER2-negative, node-positive, resected, umdlavuza webele wakuqala onezici zomtholampilo kanye ne-pathological ezihambisana nobungozi obukhulu bokuphindaphinda kwesifo babandakanyeka ku-monarchE (NCT03155997), okungahleliwe (1: 1) , ilebula evulekile, isivivinyo samaqembu amabili amaningi. Iziguli zanikezwa iminyaka emi-2 ye-abemaciclib kanye nokukhetha kuzo udokotela ngemithi evamile ye-endocrine noma ukwelashwa okuvamile kwe-endocrine kuphela.
Ukusinda okungenazifo okuhlaselayo kwakuyisilinganiso sokuqala somphumela wokuphumelela (IDFS). Ukuhlolwa kwathola ukuthuthukiswa okuphawulekayo kwezibalo ku-IDFS (HR 0.626; 95 amaphesenti CI: 0.488, 0.803; p=0.0042) ezigulini ezisengozini enkulu yokuphinda kanye ne-Ki-67 Score engaphansi kuka-20% (N=2003). Iziguli ezithola i-abemaciclib nge-tamoxifen noma i-aromatase inhibitor zine-IDFS engamaphesenti angu-86.1 (amaphesenti angu-95 CI: 82.8, 88.8) ezinyangeni ezingu-36, kuyilapho lezo ezithola i-tamoxifen noma i-aromatase inhibitor zine-IDFS engamaphesenti angu-79.0 (amaphesenti angu-95): ). Ngesikhathi sokuhlaziywa kwe-IDFS, idatha yokusinda iyonke ayizange iphelele.
Uhudo, izifo, i-neutropenia, ukukhathala, i-leukopenia, isicanucanu, i-anemia, kanye nekhanda elibuhlungu kwakuyimiphumela emibi kakhulu (20%).
Umthamo wokuqala onconyiwe we-abemaciclib ngu-150 mg kabili ngosuku kuhlanganiswe ne-tamoxifen noma i-aromatase inhibitor iminyaka engu-2 noma kuze kube yilapho isifo siphindaphinda noma ubuthi obungabekezeleleki, kuye ngokuthi ikuphi okuza kuqala.
