Agoosto 2021: Pembrolizumab (Keytruda, Merck & Co.) Marka lagu daro trastuzumab, fluoropyrimidine-, iyo platinum-ka ku jira kiimoterabi ayaa la siiyay ogolaansho degdeg ah Maamulka Cuntada iyo Dawooyinka ee daaweynta safka koowaad ee bukaanada leh deegaanka horumarsan ee aan la sixi karin ama metastatic HER2 togan gastric ama gastroesophageal junction (GEJ) adenocarcinoma.
Tijaabada KEYNOTE-811 (NCT03615326), tijaabo badan, la kala soocay, laba-indho la ', tijaabinta kontoroolka placebo ee bukaanada qaba HER2 gaastarro sare oo wanaagsan ama isgoyska gastroesophageal (GEJ) adenocarcinoma oo aan hore u helin daaweyn nidaamsan oo loogu talagalay cudurka metastatic ku saabsan falanqayn ku -meel -gaar ah oo ku -meel -gaar ah ee 264 bukaan ee ugu horreeya. Pembrolizumab 200 mg ama placebo ayaa la siiyay bukaanka saddexdii toddobaadba mar iyadoo lala kaashanayo trastuzumab iyo fluorouracil plus cisplatin ama capecitabine plus oxaliplatin.
Heerka jawaabcelinta guud (ORR) ayaa ahaa qiyaasta wax -ku -oolnimada asaasiga ah ee loo adeegsaday daraasaddan, taas oo ay baareen guddi dib -u -eegis madaxbannaan oo indho la '. ORR-ka gacanta pembrolizumab wuxuu ahaa 74 boqolkiiba (95 boqolkiiba CI 66, 82) iyo gacanta placebo wuxuu ahaa 52 boqolkiiba (95 boqolkiiba CI 43, 61) (hal dhinac p-qiimaha 0.0001, tirakoob ahaan muhiim ah). Muddada dhexdhexaadka ah ee jawaabta (DoR) ee ka -qaybgalayaasha lagu daaweeyay pembrolizumab waxay ahayd 10.6 bilood (qiyaasta 1.1+, 16.5+) iyo 9.5 bilood (qiyaasta 1.4+, 15.4+) ee kuwa ku jira gacanta placebo.
Xogta jawaab-celinta xun ayaa lagu soo sheegay Daraasadda KEYNOTE-811 shaqsiyaadka qaata pembrolizumab waxay la mid tahay astaanta badbaadada pembrolizumab.
Bukaanada qaangaarka ah ee leh HER2 caloosha oo aan fiicnayn ama metastatic HER200 ama adenocarcinoma GEJ waa inay qaataan 3 mg 400dii toddobaadba ama 6 mg XNUMXdii toddobaadba ee pembrolizumab oo ay weheliso trastuzumab iyo chemotherapy.
Tixraac: https://www.fda.gov/
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