Agasti 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:
I-Nivolumab 240 mg njalo emavikini amabili nge-mFOLFOX6 (i-fluorouracil, i-leucovorin, ne-oxaliplatin) noma i-mFOLFOX6 njalo emavikini amabili
Njalo emavikini ama-3, i-Nivolumab 360 mg ne-CapeOX (i-capecitabine ne-oxaliplatin) noma i-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).
Njengesilinganiso esengeziwe somphumela wokusebenza ngempumelelo, zonke iziguli ezingahleliwe (n=1,581), kungakhathaliseki i-CPS, zibe nokuthuthuka okuphawulekayo kwezibalo ku-OS, nge-OS emaphakathi yezinyanga ezingu-13.8 (amaphesenti angu-95 CI: 12.6, 14.6) ku-nivolumab kanye nengalo ye-chemotherapy ngokumelene nezinyanga ezingu-11.6 (amaphesenti angu-95 CI: 10.9, 12.5) engalweni yokwelapha ngamakhemikhali iyodwa (HR 0.80; 95 amaphesenti CI: 0.71, 0.90; p=0.0002).
I-peripheral neuropathy, isicanucanu, ukukhathala, isifo sohudo, ukuhlanza, ukuncipha kwesifiso sokudla, ubuhlungu besisu, ukuqunjelwa, nobuhlungu be-musculoskeletal kwakuyizimo ezimbi ezivame kakhulu (izigameko ezingama-20%) ezibonwa ezigulini ezithola i-nivolumab ngokuhambisana ne-fluoropyrimidine- kanye ne-chemotherapy equkethe i-platinum.
Okulandelayo imithamo enconyiwe ye-nivolumab:
Njalo emavikini amathathu, thatha u-360 mg uhlanganiswe ne-fluoropyrimidine- kanye nokwelashwa okuqukethe i-platinum.
Njalo emavikini amabili, thatha u-240 mg uhlanganiswe ne-fluoropyrimidine- kanye nokwelashwa okuqukethe i-platinum.
Inkomba: https://www.fda.gov/
Bheka imininingwane lapha.
