Maris 2023: Abemaciclib (Verzenio, Eli Lilly da Kamfanin) da kuma maganin endocrin (tamoxifen ko mai hana aromatase) an amince da su ta Cibiyar Abinci da Magunguna (FDA) don kula da marasa lafiya marasa lafiya tare da matakin farko, kumburi-tabbatacce, HR-tabbatacce. ciwon nono wanda ke cikin haɗarin sake dawowa.
Mutanen da ke da 4 pALN (pathologic axillary lymph nodes) ko 1-3 pALN da ko dai nau'in ƙari 3 ko girman ƙari na 50 mm an rarraba su azaman babban haɗari.
Ga masu yawan haɗarin da aka ambata a sama, abemaciclib an amince da asali tare da ƙarin sharadi na samun maki Ki-67 na 20% ko ƙasa. An yi watsi da buƙatun gwajin Ki-67 tare da amincewar yau.
MonarchE (NCT03155997), bazuwar (1: 1), alamar buɗewa, gwaji mai yawa na ƙungiyoyi biyu wanda ya shafi mata manya da maza tare da HR-tabbatacce, HER2-negative, node-positive, resected, farkon ciwon nono da cututtukan cututtuka da na asibiti yana nuna babban haɗarin sake dawowa, kimanta tasiri. Dole ne majinyata su sami ko dai 4 pALN ko 1-3 pALN, matakin ƙari 3 ko girman ƙari 50 mm domin a haɗa su cikin ƙungiyar 1. Marasa lafiya da ake buƙatar samun ƙwayar ƙwayar cuta Ki-67 maki 20%, 1-3 pALN, kuma su kasance marasa cancanta. don ƙungiyar 1 don a ɗauka a cikin ƙungiyar 2. An ba da izini ga mahalarta don karɓar ko dai daidaitaccen maganin endocrin kadai na tsawon shekaru 2, ko daidaitaccen tsarin maganin endocrin tare da zabin likita na daidaitaccen maganin endocrin (tamoxifen ko mai hana aromatase).
Rayuwa ba tare da cututtuka masu haɗari ba shine ma'aunin sakamako na farko (IDFS). A cikin yawan niyya-da-magana (ITT), an ga bambanci mai mahimmanci na ƙididdiga wanda galibi ana danganta shi ga marasa lafiya na ƙungiyar 1 (ƙungiyar 1 N = 5120 [91%]; IDFS HR 0.653 (95% CI: 0.567, 0.753) ). Abemaciclib a hade tare da maganin endocrin na yau da kullum ya haifar da IDFS a cikin watanni 48 na 85.5% (95% CI: 83.8, 87.0) yayin da maganin endocrin na al'ada kadai ya haifar da 78.6% (95% CI: 76.7, 80.4). Gabaɗaya bayanan rayuwa har yanzu suna cikin ƙuruciya, amma a cikin ƙungiyar 2, abemaciclib tare da maganin endocrin na yau da kullun yana da alaƙa da adadin mutuwa mafi girma (10/253 vs. 5/264). Don haka alamar ta iyakance ga ƙungiyar 1.
Zawo, cututtuka, neutropenia, gajiya, leukopenia, tashin zuciya, anemia, da ciwon kai sune abubuwan da suka fi dacewa (20%).
Matsakaicin farawa na abemaciclib shine 150 MG sau biyu a rana tare da tamoxifen ko mai hana aromatase na shekaru 2 ko har sai cutar ta sake dawowa ko rashin haƙuri, duk wanda ya fara zuwa.
Duba cikakken bayanin rubutawa na Verzenio.
