2021 Agustus: Pembrolizumab (Keytruda, Merck) dina kombinasi kalayan lenvatinib (Lenvima, Eisai) parantos disatujuan ku Administrasi Pangan sareng Narkoba pikeun penderita karsinoma endometrial canggih anu henteu stabilitas tinggi-microsatelit (MSI-H) atanapi kirang paséa perbaikan (dMMR), anu ngagaduhan kamajuan panyakit saatos terapi sistemik sateuacanna dina setting mana waé sareng henteu calon pikeun bedah kuratif atanapi radiasi.
Dina 17 Séptémber 2019, FDA masihan pembrolizumab ditambah lenvatinib persetujuan gancang pikeun kanker endometrium maju. The multicenter, open-labél, randomised, aktip-dikawasa ulikan 309 / KEYNOTE-775 (NCT03517449) ieu diperlukeun pikeun ngonfirmasi mangpaat klinis tina otorisasina gancangan ieu.
827 patients with advanced endometrial cancer were enrolled in Study 309/KEYNOTE-775, who had previously had at least one platinum-based chemotherapy regimen in any setting, including neoadjuvant and adjuvant treatments. Patients were randomly assigned (1:1) to receive pembrolizumab 200 mg intravenously every 3 weeks with lenvatinib 20 mg orally once daily, or doxorubicin or paclitaxel, as determined by the investigator.
Progression-free survival (PFS), as determined by blinded independent central review (BICR), and overall survival (OS) were the primary efficacy outcome measures. The objective response rate (ORR) and duration of response (DOR), both assessed by the BICR, were additional efficacy outcome measures.
PFS median pikeun penderita kanker endometrial maju anu sanés MSI-H atanapi dMMR nyaéta 6.6 bulan (95 persén CI: 5.6, 7.4) pikeun anu nampi pembrolizumab sareng lenvatinib sareng 3.8 bulan (95 persén CI: 3.6, 5.0) pikeun anu nampi kémoterapi pilihan investigator (HR 0.60; 95 persén CI: 0.50, 0.72; p0.0001) pikeun anu nampi kémoterapi pilihan panyidik. OS median 17.4 bulan (95 persén kapercayaan interval: 14.2, 19.9) pikeun lalaki sareng 12.0 bulan (95 persén kapercayaan interval: 10.8, 13.3) pikeun awéwé (HR 0.68; 95 persén kapercayaan interval: 0.56, 0.84; p = 0.0001) . ORRs 30% (95 perséntase interval kapercayaan: 26, 36) sareng 15% (95 persén kapercayaan interval: 12, 19), masing-masing (p0.0001). 9.2 bulan (1.6+, 23.7+) sareng 5.7 bulan (0.0+, 24.2+) mangrupikeun DOR median.
Hypothyroidism, hipertensi, kacapean, diare, gangguan musculoskeletal, seueul, turun napsu, utah, stomatitis, leungitna beurat, nyeri beuteung, inféksi saluran kemih, proteinuria, kabebeng, nyeri sirah, kajadian hemorrhagic, palry-plantar erythrodysestrophy, palmar-plantar erythrodysestrophy, palmar -plantar érythrodysestrophy, palmar-plantar érythro
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.
rujukan: https://www.fda.gov/
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