Nyamavhuvhu 2021: Sacituzumab govitecan (Trodelvy, Immunomedics Inc.) yakawana mvumo yeFDA yenguva dzose kune varwere vane isingagadzirike munharaunda yepamusoro kana metastatic katatu-negative kenza yemazamu (mTNBC) vakagamuchira maviri kana anopfuura ekutanga marapirwo ehurongwa, imwe yacho yaive yechirwere chemetastatic.
Sacituzumab govitecan yakapihwa mvumo yekukurumidza muna Kubvumbi 2020 yevarwere vane MTNBC avo vaimbove nemishonga ingangoita mbiri yekurapa kwemastastatic. Kuedzwa kwekusimbiswa kwekukurumidza mvumo yaive inotevera nhanho.
Kubudirira uye kuchengetedzeka kwakaongororwa muvarwere ve529 vasina kurongeka munharaunda yepamusoro kana mTNBC vakange vadzokera shure mushure memazuva maviri ekare echemotherapies, imwe yacho inogona kunge iri muNeoadjuvant kana adjuvant setting, kana kufambira mberi kwakaitika mukati memwedzi ye12, munzvimbo yakawanda, yakazaruka- label, randomized trial (ASCENT; NCT02574455). Pamazuva 1 uye 8 emazuva makumi maviri nemaviri (n = 21) kutenderera, varwere vakagadziriswa (267: 1) kuti vagamuchire sacituzumab govitecan, 1 mg / kg sekuisa intravenous infusion, kana sarudzo yachiremba ye single agent chemotherapy (n = 10).
Mhedzisiro yekutanga yekubudirira yaive kufambira mberi-pasina kupona (PFS) kune varwere vasina metastases muuropi pakutanga kwechidzidzo, sekutsanangurwa kwakapofumadzwa, kwakazvimirira, kwepakati pekuongorora uchishandisa RECIST 1.1 maitiro. PFS yeboka rose (rine uye isina metastases yehuropi) uye kupona kwese kwakaverengerwa sezvinangwa zvinobudirira (OS).
Varwere vanogamuchira sacituzumab govitecan vaive nepakati PFS yemwedzi 4.8 (95 muzana yekuvimba nguva: 4.1, 5.8) zvichienzaniswa nemwedzi 1.7 (95 muzana yekuvimba nguva: 1.5, 2.5) kune avo vanogamuchira chemotherapy (HR 0.43; 95 muzana nguva yekuvimba: 0.35, 0.54; p0.0001). Iyo yepakati OS yaive 11.8 mwedzi (95 muzana nguva yekuvimba: 10.5, 13.8) yevarume nemwedzi 6.9 (95 muzana yekuvimba nguva: 5.9, 7.6) yevakadzi (HR 0.51; 95 muzana nguva yekuvimba: 0.41, 0.62; p0.0001) .
Nausea, neutropenia, manyoka, kuneta, alopecia, kupererwa neropa, kurutsa, kuzvimbirwa, kuputika, kuderera kwechido, uye kusagadzikana kwemudumbu ndiko kwakanyanya kuitika zviitiko (zviitiko> 25%) kune varwere vanotora sacituzumab govitecan.
Kusvikira kukura kwechirwere kana kusashivirika chepfu, iyo yakakurudzirwa sacituzumab govitecan dose ndeye 10 mg / kg kamwe pavhiki pamazuva 1 uye 8 ezuva makumi maviri nemasere ekurapa kutenderera.
Referensi: https://www.fda.gov/
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