Agusta 2021: Pembrolizumab (Keytruda, Merck) a hade tare da lenvatinib (Lenvima, Eisai) Cibiyar Abinci da Magunguna ta amince da marasa lafiya tare da ciwon daji na endometrial mai ci gaba wanda ba microsatellite rashin zaman lafiya-high (MSI-H) ko rashin daidaituwa na gyaran gyare-gyare (dMMR), waɗanda ke da ci gaba da cututtuka bayan tsarin tsarin rigakafi a kowane wuri kuma ba 'yan takara ba. don aikin tiyata ko radiation.
A ranar 17 ga Satumba, 2019, FDA ta ba da pembrolizumab da lenvatinib da sauri yarda don ci gaba da ciwon daji na endometrial. Multicenter, buɗaɗɗen lakabin, bazuwar, bincike mai sarrafa aiki 309/KEYNOTE-775 (NCT03517449) ya zama dole don tabbatar da fa'idar asibiti na wannan ingantaccen izini.
An shigar da marasa lafiya 827 masu fama da ciwon daji na endometrial a cikin Nazarin 309/KEYNOTE-775, waɗanda a baya suna da aƙalla tsarin chemotherapy na tushen platinum a kowane wuri, gami da neoadjuvant da jiyya. An ba da marasa lafiya bazuwar (1: 1) don karɓar pembrolizumab 200 MG a cikin jini a kowane mako 3 tare da lenvatinib 20 mg na baki sau ɗaya kowace rana, ko doxorubicin ko paclitaxel, kamar yadda mai binciken ya ƙaddara.
Rayuwa marar ci gaba (PFS), kamar yadda aka ƙaddara ta hanyar nazari na tsakiya mai zaman kansa (BICR), da rayuwa gabaɗaya (OS) sune matakan ingantaccen sakamako na farko. Matsakaicin martani na haƙiƙa (ORR) da tsawon lokacin amsawa (DOR), duka biyun da BICR ta tantance, sun kasance ƙarin matakan sakamako na inganci.
Matsakaicin PFS ga marasa lafiya da ciwon daji na endometrial wanda ba MSI-H ko dMMR ba shine watanni 6.6 (95 bisa dari CI: 5.6, 7.4) ga waɗanda ke karɓar pembrolizumab da lenvatinib da watanni 3.8 (95 bisa dari CI: 3.6, 5.0) ga waɗanda ke karɓar. zaɓin chemotherapy na mai binciken (HR 0.60; 95 bisa dari CI: 0.50, 0.72; p0.0001) ga waɗanda ke karɓar zaɓin chemotherapy mai bincike. Tsakanin OS ya kasance watanni 17.4 (kashi 95 tazarar amincewa: 14.2, 19.9) na maza da watanni 12.0 (lokacin amincewa da kashi 95: 10.8, 13.3) na mata (HR 0.68; 95% tazarar amincewa: 0.56, 0.84; p=0.0001). . ORRs sun kasance 30% (95 bisa dari tazarar amincewa: 26, 36) da 15% (95% tazarar amincewa: 12, 19), bi da bi (p0.0001). Watanni 9.2 (1.6+, 23.7+) da watanni 5.7 (0.0+, 24.2+) sune DORs na tsakiya.
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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.
reference: https://www.fda.gov/
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