March 2023: I-Abemaciclib (Verzenio, Eli Lilly and Company) kanye nokwelapha kwe-endocrine (tamoxifen noma i-aromatase inhibitor) kuvunywe yi-Food and Drug Administration (FDA) ukuze kusetshenziswe i-adjuvant yeziguli ezikhulile ezine-HR-positive esigabeni sakuqala, esine-node-positive, ne-HR. umdlavuza webele abasengozini enkulu yokuphinda uvele.
Abantu abane-4 pALN (i-pathologic axillary lymph nodes) noma i-1-3 pALN kanye nebanga lesi-3 lesimila noma usayizi wesimila ongu-50 mm bachazwa njengengozi enkulu.
Kubantu abasengozini enkulu okukhulunywe ngayo ngenhla, i-abemaciclib yavunywa ekuqaleni ngombandela owengeziwe wokuba nesikolo se-Ki-67 esingu-20% noma ngaphansi. Isidingo sokuhlolwa kwe-Ki-67 siyehliswa ngokugunyazwa kwanamuhla.
I-MonarchE (NCT03155997), ilebula engahleliwe (1:1), i-open-lebula, isivivinyo samaqembu amabili esihlanganisa abesifazane abadala namadoda ane-HR-positive, HER2-negative, node-positive, resected, umdlavuza wamabele wasekuqaleni kanye nezici ze-pathological nezomtholampilo. okusikisela ukuba sengozini enkulu yokuphinda, kuhlolwe ukusebenza kahle. Iziguli kufanele zibe no-4 pALN noma 1-3 pALN, ibanga lesimila 3 noma usayizi wesimila ongu-50 mm ukuze zifakwe eqenjini 1. Iziguli kudingeka zibe ne-tumor Ki-67 score 20%, 1-3 pALN, futhi zingafaneleki. kweqembu 1 ukuze libuthwe eqenjini 2. Abahlanganyeli babelwa ngokungahleliwe ukuthi bathole ukwelashwa okujwayelekile kwe-endocrine kuphela iminyaka engu-2, noma ukwelashwa okujwayelekile kwe-endocrine kanye nokukhetha kukadokotela kokwelashwa okujwayelekile kwe-endocrine (tamoxifen noma i-aromatase inhibitor).
Ukusinda okungenazifo okuhlaselayo bekuyi-primary efficacy result metric (IDFS). Esibalweni sabantu esihloselwe ukwelapha (ITT), umehluko obalulekile ngokwezibalo wabonakala ukuthi udalwe ikakhulukazi ezigulini ezi-1 (iqembu 1 N=5120 [91%]; IDFS HR 0.653 (95% CI: 0.567, 0.753) ). I-Abemaciclib ngokuhlanganiswa nokwelashwa okuvamile kwe-endocrine kubangele i-IDFS ezinyangeni ezingu-48 ze-85.5% (95% CI: 83.8, 87.0) kuyilapho ukwelapha okujwayelekile kwe-endocrine kukodwa kuholele ku-78.6% (95% CI: 76.7, 80.4). Sekukonke idatha yokusinda isasewusana, kodwa eqenjini 2, i-abemaciclib plus routine endocrine therapy yayihlotshaniswa nezinga lokufa eliphezulu (10/253 vs. 5/264). Ngakho-ke inkomba yayilinganiselwe kuqoqo 1.
Uhudo, izifo, i-neutropenia, ukukhathala, i-leukopenia, isicanucanu, i-anemia, kanye nekhanda elibuhlungu kwakuyimiphumela emibi kakhulu (20%).
Umthamo wokuqala we-abemaciclib ngu-150 mg kabili ngosuku nge-tamoxifen noma i-aromatase inhibitor iminyaka engu-2 noma kuze kube yilapho isifo siphindaphinda noma ubuthi obungabekezeleleki, noma yikuphi okuza kuqala.
Buka imininingwane egcwele ye-Verzenio.
