Agasti 2021: I-Pembrolizumab (Keytruda, Merck) kuhlangene nalo i-lenvatinib (Lenvima, Eisai) ivunyelwe yi-Food and Drug Administration yeziguli ezine-endometrial carcinoma esezingeni eliphakeme engeyona i-microsatellite instability-high (MSI-H) noma i-mismatch fix deficiant (dMMR), enezifo eziqhubekela phambili ngemuva kokwelashwa kwesistimu ngaphambi kwanoma yisiphi isilungiselelo futhi abangavotelwa ngokuhlinzwa noma ngemisebe yokwelapha.
NgoSepthemba 17, 2019, i-FDA yakhipha i-pembrolizumab kanye ne-lenvatinib yasheshisa ukugunyazwa komdlavuza we-endometrial osezingeni eliphezulu. I-multicenter, ilebula evulekile, okungahleliwe, okulawulwa okusebenzayo 309 / KEYNOTE-775 (NCT03517449) kwakudingeka ukuqinisekisa inzuzo yomtholampilo yalesi sigunyaziso esisheshayo.
Iziguli ezingama-827 ezinomdlavuza we-endometrial oseqophelweni eliphezulu zabhaliswa ku-Study 309/KEYNOTE-775, ebezikade okungenani zinemithi yokwelapha ngamakhemikhali esekelwe ku-platinum kunoma yisiphi isimo, okuhlanganisa nokwelashwa kwe-neoadjuvant kanye ne-adjuvant. Iziguli zabelwa ngokungahleliwe (1:1) ukuze zithole i-pembrolizumab 200 mg njalo emavikini angu-3 nge-lenvatinib 20 mg ngomlomo kanye ngosuku, noma i-doxorubicin noma i-paclitaxel, njengoba kunqunywe umphenyi.
Ukusinda kwe-Progression-free survival (PFS), njengoba kunqunywa isibuyekezo esizimele esiphuphuthekile (i-BICR), kanye nokusinda sekukonke (i-OS) kwakuyizinyathelo eziyinhloko zomphumela wokusebenza ngempumelelo. Izinga lokuphendula lenhloso (ORR) kanye nobude besikhathi sokuphendula (DOR), kokubili okuhlolwe yi-BICR, bekuyizinyathelo ezengeziwe zomphumela wokusebenza ngempumelelo.
I-median PFS yeziguli ezinomdlavuza ophakeme we-endometrium eyayingeyona i-MSI-H noma i-dMMR yayizinyanga eziyi-6.6 (95% CI: 5.6, 7.4) kulabo abathola i-pembrolizumab nelenvatinib nezinyanga eziyi-3.8 (95% CI: 3.6, 5.0) kulabo abathola i-chemotherapy ekhethwa umphenyi (HR 0.60; 95% CI: 0.50, 0.72; p0.0001) kulabo abathola i-chemotherapy ekhethwa umphenyi. I-median OS kwakuyizinyanga eziyi-17.4 (95% interval confidence: 14.2, 19.9) yamadoda nezinyanga eziyi-12.0 (95% interval confidence: 10.8, 13.3) kwabesifazane (HR 0.68; 95 percent interval confidence: 0.56, 0.84; p = 0.0001) . Ama-ORR ayengu-30% (isikhawu sokuzithemba samaphesenti angama-95: 26, 36) no-15% (isikhawu sokuzithemba samaphesenti angama-95: 12, 19), ngokulandelana (p0.0001). Izinyanga eziyi-9.2 (1.6+, 23.7+) nezinyanga ezingu-5.7 (0.0+, 24.2+) kwakungama-DOR aphakathi nendawo.
I-Hypothyroidism, umfutho wegazi ophakeme, ukukhathala, isifo sohudo, ukuphazamiseka kwemisipha, isicanucanu, ukuncipha kwesifiso sokudla, ukuhlanza, i-stomatitis, ukwehla kwesisindo, ubuhlungu besisu, ukutheleleka ngomgudu womchamo, i-proteinuria, ukuqunjelwa, ikhanda, imicimbi yokopha, i-palmar-plantar erythrodysestrophy, i-palmar-plantar erythrodysestrophy, i-palmar - i-erythrodysestrophy yesitshalo, i-palmar-plantar erythro
Pembrolizumab 200 mg every 3 weeks or 400 mg every 6 weeks with lenvatinib 20 mg orally once daily is the recommended dose for endometrial cancer.
Izikhombo: https://www.fda.gov/
Bheka imininingwane lapha.
