Nuwamba 2021: Pembrolizumab (Keytruda, Merck) tare da haɗin gwiwa tare da chemotherapy, tare da ko ba tare da bevacizumab, Hukumar Abinci da Magunguna ta amince da ita don marasa lafiya da ke fama da ciwon daji na mahaifa, mai maimaitawa, ko metastatic wanda ciwace-ciwacen daji ke bayyana PD-L1 (CPS 1), kamar yadda gwajin da FDA ta amince.
Pembrolizumab kuma an ba shi izini na yau da kullun azaman magani guda ɗaya ta FDA don marasa lafiya da ke fama da cutar sankara mai maimaitawa ko metastatic waɗanda ke da ci gaban cuta a kan ko bayan cutar sankara kuma wanda ciwace-ciwacen su ke bayyana PD-L1 (CPS 1), kamar yadda wani gwajin da FDA ta amince da shi. FDA ta ba da saurin amincewa ga wannan nuni a cikin Yuni 2018, tare da gwajin abokin tarayya, PD-L1 IHC 22C3 pharmDx (Dako North America Inc.).
Pembrolizumab with paclitaxel and cisplatin or paclitaxel and carboplatin, with or without bevacizumab, was studied in KEYNOTE-826 (NCT03635567), a multicenter, randomised, double-blind, placebo-controlled trial. The experiment involved 617 patients who had not been treated with chemotherapy and had chronic, recurring, or first-line metastatic ciwon sankarar mahaifa. Patients were enrolled regardless of whether or whether they had PD-L1 expression. Pembrolizumab 200 mg with chemotherapy with or without bevacizumab or placebo plus chemotherapy with or without bevacizumab were randomly assigned (1:1) to one of two treatment groups. Pembrolizumab was given until disease progression, intolerable toxicity, or 24 months had passed from the start of the study.
Rayuwa gabaɗaya (OS) da tsira ba tare da ci gaba ba (PFS) sune mahimman matakan sakamako na tasiri, waɗanda mai binciken ya tantance ta amfani da RECIST v1.1, wanda aka daidaita don bin matsakaicin raunin 10 da aka yi niyya da matsakaicin 5 manufa raunuka. kowace gaba. Hakanan an yi amfani da ORR da tsayin amsawa azaman ƙarin matakan sakamako (DoR). OS na tsakiya a cikin hannun pembrolizumab ba a kai ba (95 bisa dari CI: 19.8, NR) kuma ya kasance watanni 16.3 (95 bisa dari CI: 14.5, 19.4) a cikin hannun placebo (HR 0.64; 95 kashi CI: 0.50, 0.81; 1- Sided p-darajar = 0.0001) ga marasa lafiya tare da ciwace-ciwacen da ke bayyana PD-L1 (CPS 1, N = 548). Matsakaicin PFS a cikin hannun pembrolizumab shine watanni 10.4 (95 bisa dari CI: 9.7, 12.3), yayin da hannun placebo ya kasance watanni 8.2 (95 bisa dari CI: 6.3, 8.5) (HR 0.62; 95 bisa dari CI: 0.50, 0.77; 1- Sided p-darajar 0.0001). A cikin pembrolizumab da placebo makamai, ƙimar amsawar haƙiƙa sune 68 bisa dari (95 bisa dari CI: 62, 74) da 50 bisa dari (95 bisa dari CI: 44, 56), bi da bi, tare da tsaka-tsakin DoRs na 18.0 da 10.4 watanni.
Pembrolizumab, chemotherapy, da bevacizumab sun haɗu da neuropathy na gefe, alopecia, anemia, gajiya / asthenia, tashin zuciya, neutropenia, zawo, hauhawar jini, thrombocytopenia, maƙarƙashiya, arthralgia, amai, urinary tract infection, rash, leukopenia a cikin hypoppetite. Kashi 20 na marasa lafiya.
Ana ba da Pembrolizumab a kashi na 200 MG kowane mako 3 ko 400 MG kowane mako 6 har sai cutar ta ci gaba ko rashin yarda da guba ya faru, wanda zai iya wucewa har zuwa watanni 24.
