Maarso 2023: Abemaciclib (Verzenio, Eli Lilly iyo Company) iyo daawaynta endocrine (tamoxifen ama aromatase inhibitor) ayaa waxaa ansixiyay Maamulka Cuntada iyo Dawooyinka (FDA) ee daawaynta kaaliyaha ee bukaanada qaangaarka ah ee leh marxalad hore, node-positive, HR-positive kansarka naasaha oo halis sare ugu jira soo noqoshada.
Shakhsiyaadka qaba 4 pALN (pathologic axillary lymph nodes) ama 1-3 pALN iyo midkood fasalka 3 ama buro cabbirkeedu yahay 50 mm ayaa loo kala saaray khatar sare.
Dadka khatarta sare leh ee aan kor ku soo sheegnay, abemaciclib waxaa markii hore lagu ansixiyay shuruudo dheeraad ah oo ah in la haysto dhibcaha Ki-67 ee 20% ama ka hooseeya. Shuruudaha tijaabada Ki-67 waa la tuuray ogolaanshaha maanta.
MonarchE (NCT03155997), la kala soocay (1:1), sumad furan, laba koox oo isku dhafan oo tijaabo ah oo ku lug leh dumarka qaangaarka ah iyo ragga leh HR-positive, HER2-negative, node-positive, la soo saaray, kansarka naasaha hore iyo sifooyinka cudurrada iyo bukaan-socodka soo jeedinta khatarta sare ee soo noqoshada, qiimeeyay waxtarka. Bukaanku waa inay haystaan 4 paALN ama 1-3 pALN, buro fasalka 3 ama cabirka buro 50 mm si loogu daro kooxda 1. Bukaanada looga baahan yahay inay leeyihiin buro Ki-67 dhibcood 20%, 1-3 pALN, oo aan u qalmin loogu talagalay kooxda 1 si loogu shaqaaleysiiyo kooxda 2. Ka qaybgalayaasha ayaa si aan kala sooc lahayn loo qoondeeyay inay helaan midkood daaweynta endocrine caadiga ah oo keliya muddo 2 sano ah, ama daaweynta caadiga ah ee endocrine oo lagu daray doorashada dhakhtarka ee daaweynta caadiga ah ee endocrine (tamoxifen ama aromatase inhibitor).
Badbaadinta cudur-la'aanta ah ee faafa waxay ahayd mitirka natiijada waxtarka aasaasiga ah (IDFS). Dadka ujeedo-daawaynta ah (ITT), farqi weyn oo tirakoob ah ayaa la arkay kaas oo inta badan loo aaneyn karo kooxda 1 bukaan (koox 1 N = 5120 [91%); IDFS HR 0.653 (95% CI: 0.567, 0.753) ). Abemaciclib marka lagu daro daaweynta endocrine ee joogtada ah waxay keentay IDFS 48 bilood oo ah 85.5% (95% CI: 83.8, 87.0) halka daaweynta caadiga ah ee endocrine kaliya ay keentay 78.6% (95% CI: 76.7, 80.4). Xogta guud ee badbaadada ayaa weli ku jirta dhallaankooda, laakiin kooxda 2, abemaciclib iyo daaweynta joogtada ah ee endocrine ayaa lala xiriiriyay heer dhimasho sare ah (10/253 vs. 5/264). Sidaa darteed tilmaantu waxay ku koobnayd kooxda 1.
Shuban, caabuq, neutropenia, daal, leukopenia, lallabbo, dhiig-yaraan, iyo madax xanuun ayaa ah dhibaatooyinka soo noqnoqda (20%).
Qiyaasta bilawga ah ee abemaciclib waa 150 mg laba jeer maalintii oo leh tamoxifen ama aromatase inhibitor ilaa 2 sano ama ilaa uu cudurku soo noqnoqonayo ama suntan aan loo dulqaadan karin, hadba kii soo hormara.
U fiirso xogta buuxda ee Verzenio.
