August 2021: Pembrolizumab (Keytruda, Merck) pamwe chete lenvatinib (Lenvima, Eisai) yakagamuchirwa neKudya neDrug Administration kune varwere vane endometrial carcinoma yepamusoro isiri microsatellite kusagadzikana-yakakwira (MSI-H) kana kusakwana kwekugadzirisa kushomeka (dMMR), vane hutachiona hwekuenderera mberi mushure mekutanga kurapwa kwese mune chero marongero uye havasi vavhoterwa yekurapa kurapwa kana radiation.
Musi waGunyana 17, 2019, iyo FDA yakapa pembrolizumab pamwe nelenvatinib mvumo yekuchimbidza yegomarara reendometrial. The multicenter, open-label, randomised, active-controlled study 309/KEYNOTE-775 (NCT03517449) yaidiwa kusimbisa rubatsiro rwekiriniki rwemvumo iyi yakakurumidza.
Varwere mazana masere nemakumi maviri nevanomwe vane cancer endometrial yakakwira vakanyoreswa muChidzidzo 827/KEYNOTE-309, avo vakambove neplatinum-based chemotherapy regimen mune chero marongero, kusanganisira neoadjuvant uye adjuvant marapirwo. Varwere vakagoverwa (775: 1) kuti vagamuchire pembrolizumab 1 mg intravenously masvondo ose e200 ne lenvatinib 3 mg muromo kamwe chete zuva nezuva, kana doxorubicin kana paclitaxel, sezvakatemwa nemuongorori.
Kufambira mberi-kusina kupona (PFS), sekutemerwa nekupofumadzwa kwakazvimirira kwepakati wongororo (BICR), uye kupona kwese (OS) ndiwo aive matanho ekutanga ekubudirira. Chinangwa chekupindura mwero (ORR) uye nguva yekupindura (DOR), ese akaongororwa neBICR, aive ekuwedzera efficacy mhedzisiro matanho.
Iyo yepakati PFS yevarwere vane yakakwira endometrial kenza iyo yakanga isiri MSI-H kana dMMR yaive 6.6 mwedzi (95 muzana CI: 5.6, 7.4) kune avo vanogamuchira pembrolizumab uye lenvatinib uye 3.8 mwedzi (95 muzana CI: 3.6, 5.0) kune avo vanogamuchira. muongorori sarudzo chemotherapy (HR 0.60; 95 muzana CI: 0.50, 0.72; p0.0001) yeavo vanogamuchira chemushori chemotherapy chemotherapy. Iyo yepakati OS yaive nemwedzi 17.4 (95 muzana nguva yekuvimba: 14.2, 19.9) yevarume nemwedzi gumi nemaviri (12.0 muzana yekuvimba nguva: 95, 10.8) yevakadzi (HR 13.3; 0.68 muzana nguva yekuvimba: 95, 0.56; p = 0.84) . ORRs yaive 0.0001% (30 muzana yekuvimba nguva: 95, 26) uye 36% (15 muzana yekuvimba nguva: 95, 12), zvichiteerana (p19). 0.0001 mwedzi (9.2+, 1.6+) uye 23.7 mwedzi (5.7+, 0.0+) aive epakati maDOR.
Hypothyroidism, hypertension, kuneta, manyoka, kushushikana kwemusculoskeletal, kusvotwa, kuderera kwechido, kurutsa, stomatitis, kurasikirwa uremu, kurwadziwa mudumbu, chirwere cheweti, hutachiona, kuputirwa, kutemwa nemusoro, zviitiko zvekubuda ropa, palmar-plantar erythrodysestrophy, palmar-plantar erythrodysestrophy, palmar -kusima erythrodysestrophy, palmar-plantar erythro
Pembrolizumab 200 mg masvondo ega ega e3 kana 400 mg masvondo matanhatu ega ega ane lenvatinib 6 mg nemuromo kamwe chete pazuva ndiyo inokurudzirwa dosi ye endometrial cancer.
Dheuteronomio: https://www.fda.gov/
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