Agusta 2021: Pembrolizumab (Keytruda, Merck & Co.) a hade tare da trastuzumab, fluoropyrimidine-, da platinum-dauke da chemotherapy an ba da izinin gaggawa ta Hukumar Abinci da Magunguna don maganin layin farko na marasa lafiya tare da ci gaba na gida wanda ba shi da tushe ko metastatic HER2 tabbatacce na ciki ko gastroesophageal junction (GEJ) adenocarcinoma.
Gwajin KEYNOTE-811 (NCT03615326), multicenter, bazuwar, makafi biyu, gwajin sarrafa wuribo a cikin marasa lafiya tare da HER2 tabbatacce ci gaba na ciki ko gastroesophageal junction (GEJ) adenocarcinoma wanda bai riga ya karɓi tsarin tsarin jiyya don cututtukan metastatic ba, ya sami amincewa bisa tushen. akan wani takamaiman bincike na wucin gadi na marasa lafiya 264 na farko. An ba da Pembrolizumab 200 MG ko placebo ga marasa lafiya kowane mako uku tare da trastuzumab da ko dai fluorouracil da cisplatin ko capecitabine da oxaliplatin.
Matsakaicin ƙimar amsa gabaɗaya (ORR) shine ma'aunin ingancin inganci na farko da aka yi amfani da shi a cikin wannan binciken, wanda kwamitin bita mai zaman kansa ya bincika. ORR a cikin hannun pembrolizumab shine kashi 74 bisa dari (95 bisa dari CI 66, 82) kuma a cikin hannun placebo shine kashi 52 cikin dari (95 bisa dari CI 43, 61) (P-darajar 0.0001 mai gefe ɗaya, ƙididdiga). Matsakaicin matsakaicin lokacin amsawa (DoR) ga mahalarta waɗanda aka bi da su tare da pembrolizumab shine watanni 10.6 (kewayon 1.1+, 16.5+) da watanni 9.5 (kewayon 1.4+, 15.4+) ga waɗanda ke cikin hannun placebo.
Bayanan martaba mara kyau da aka ruwaito a cikin Nazarin KEYNOTE-811 mutane masu karɓar pembrolizumab yayi daidai da sanannen bayanin martabar aminci na pembrolizumab.
Manya marasa lafiya tare da ci gaba na gida wanda ba a iya ganewa ba ko metastatic HER2 tabbatacce na ciki ko GEJ adenocarcinoma yakamata su ɗauki 200 MG kowane mako 3 ko 400 MG kowane mako 6 na pembrolizumab tare da trastuzumab da chemotherapy.
Magana: https://www.fda.gov/
Duba cikakkun bayanai nan.
