Agusta 2021: For advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) in conjunction with fluoropyrimidine- and platinum-containing treatment.
CHECKMATE-649 (NCT02872116) was a randomised, multicenter, open-label trial that enrolled 1,581 patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma who had previously received no treatment. The Agilent/Dako PD-L1 IHC 28-8 pharmDx test was used to calculate the combined positive score (CPS) for PD-L1. Patients were given nivolumab in combination with chemotherapy (n=789) or chemotherapy alone (n=792), with the following study treatment regimen:
Nivolumab 240 MG kowane mako biyu tare da mFOLFOX6 (fluorouracil, leucovorin, da oxaliplatin) ko mFOLFOX6 kowane mako biyu.
Kowane mako 3, Nivolumab 360 MG tare da CapeOX (capecitabine da oxaliplatin) ko CapeOX.
Progression-free survival (PFS) measured by blinded independent central review and overall survival were the key efficacy outcome measures in patients with PD-L1 CPS 5 (n=955) (OS). For patients with PD-L1 CPS 5, CHECKMATE-649 showed a statistically significant increase in PFS and OS. The median OS in the nivolumab + chemotherapy arm was 14.4 months (95 percent confidence interval: 13.1, 16.2) compared to 11.1 months (95 percent confidence interval: 10.0, 12.1) in the chemotherapy alone arm (HR 0.71; 95 percent confidence interval: 0.61, 0.83; p0.0001). The median PFS in the nivolumab + chemotherapy arm was 7.7 months (95 percent CI: 7.0, 9.2) versus 6.0 months (95 percent CI: 5.6, 6.9) in the chemotherapy alone arm (HR 0.68; 95 percent CI: 0.58, 0.79; p0.0001).
A matsayin ƙarin ma'aunin sakamako na inganci, duk marasa lafiya bazuwar (n=1,581), ba tare da la'akari da CPS ba, sun sami ci gaba mai mahimmanci a cikin OS, tare da matsakaicin OS na watanni 13.8 (kashi 95 na CI: 12.6, 14.6) a cikin nivolumab tare da hannun chemotherapy vs. 11.6 watanni (95 kashi CI: 10.9, 12.5) a cikin chemotherapy kadai hannu (HR 0.80; 95 kashi CI: 0.71, 0.90; p=0.0002).
Na gefe neuropathy, tashin zuciya, gajiya, zawo, amai, rage cin abinci, ciwon ciki, maƙarƙashiya, da kuma musculoskeletal zafi sun kasance mafi na kowa m halayen (lalacewar 20%) lura a marasa lafiya samun nivolumab a hade tare da fluoropyrimidine- da platinum-dauke da chemotherapy.
Abubuwan da aka ba da shawarar nivolumab sune:
Kowane mako uku, ɗauki 360 MG a hade tare da fluoropyrimidine- da magani mai ɗauke da platinum.
Kowane mako biyu, ɗauki 240 MG a hade tare da fluoropyrimidine- da magani mai ɗauke da platinum.
Magana: https://www.fda.gov/
Duba cikakkun bayanai nan.
