March 2023: Abemaciclib (Verzenio, Eli Lilly uye Kambani) uye endocrine therapy (tamoxifen kana an aromatase inhibitor) yakabvumidzwa neFood and Drug Administration (FDA) yekurapa adjuvant yevarwere vakuru vane nhanho yekutanga, node-positive, HR-positive. gomarara rezamu avo vari panjodzi huru yekudzokazve.
Vanhu vane 4 pALN (pathologic axillary lymph nodes) kana 1-3 pALN uye vangave bundu giredhi 3 kana bundu saizi ye50 mm vakaiswa munjodzi huru.
Pahuwandu hwenjodzi huru yataurwa pamusoro apa, abemaciclib yakatanga kubvumidzwa neimwe chirevo chekuve neKi-67 chibodzwa che20% kana pasi. Izvo zvinodikanwa zvekuongororwa kweKi-67 zvinodonhedzwa nemvumo yanhasi.
MonarchE (NCT03155997), a randomized (1: 1), yakazaruka-label, maviri-cohort multicenter muedzo unosanganisira vakadzi vakuru nevarume vane HR-positive, HER2-negative, node-positive, resected, kenza yezamu yekutanga uye pathological uye kliniki maitiro. zvinokurudzira njodzi huru yekudzokazve, yakaongororwa kushanda. Varwere vanofanira kunge vaine 4 pALN kana 1-3 pALN, bundu giredhi 3 kana bundu saizi 50 mm kuitira kuti vabatanidzwe muboka 1. Varwere vanofanirwa kuve nebundu Ki-67 mamakisi 20%, 1-3 pALN, uye vasingabvumirwe. nokuda kwechikwata 1 kuitira kuti vanyore muboka re 2. Vatori vechikamu vakagoverwa kuti vagamuchire chero chiyero che endocrine therapy chete kwemakore 2, kana chiyero che endocrine therapy pamwe nesarudzo yechiremba yehutano hwe endocrine (tamoxifen kana aromatase inhibitor).
Invasive chirwere-isina kupona yaive yekutanga efficacy mhedzisiro metric (IDFS). Muhuwandu hwekuvavarira kurapa (ITT), mutsauko wakakosha wakaonekwa wainyanya kukonzerwa nevarwere veboka 1 (cohort 1 N = 5120 [91%]; IDFS HR 0.653 (95% CI: 0.567, 0.753) ) Abemaciclib pamwe chete neagara ari endocrine therapy yakaguma neIDFS pamwedzi 48 ye85.5% (95% CI: 83.8, 87.0) asi yakajairika endocrine therapy chete yakaguma ne 78.6% (95% CI: 76.7, 80.4). Kupona kwese data kuchiri muhucheche hwavo, asi muboka re2, abemaciclib plus routine endocrine therapy yakabatanidzwa nehuwandu hwekufa (10/253 vs. 5/264). Saka chiratidzo chaive chakaganhurirwa kune cohort 1.
Manyoka, zvirwere, neutropenia, kuneta, leukopenia, kusvotwa, kupererwa neropa, uye kutemwa nemusoro ndizvo zvainyanya kuitika (20%).
Nhamba yekutanga yeabemaciclib ndeye 150 mg kaviri zuva nezuva ne tamoxifen kana aromatase inhibitor kwemakore 2 kana kusvika chirwere chekudzoka kana kutyisa kusingagoneki, chero ipi zvayo inotanga kutanga.
Wona ruzivo rwakazara rwekurayira Verzenio.
