Lúnasa 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 gach coicís le mFOLFOX6 (fluorouracil, leucovorin, agus oxaliplatin) nó mFOLFOX6 gach coicís
Gach 3 seachtaine, Nivolumab 360 mg le CapeOX (capecitabine agus oxaliplatin) nó 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).
Mar bheart toraidh éifeachtúlachta breise, bhí feabhas suntasach ó thaobh staitistice ar OS ag gach othar randamach (n = 1,581), beag beann ar CPS, le meánmheánach OS de 13.8 mí (95 faoin gcéad CI: 12.6, 14.6) sa lámh nivolumab móide ceimiteiripe vs 11.6 mhí (95 faoin gcéad CI: 10.9, 12.5) sa lámh cheimiteiripe amháin (HR 0.80; 95 faoin gcéad CI: 0.71, 0.90; p = 0.0002).
Ba iad neuropathy forimeallach, nausea, tuirse, buinneach, vomiting, appetite laghdaithe, pian bhoilg, constipation, agus pian mhatánchnámharlaigh na frithghníomhartha díobhálacha is coitianta (minicíocht 20%) a breathnaíodh in othair a fhaigheann nivolumab i gcomhcheangal le ceimiteiripe fluairopyrimidine- agus platanam.
Seo a leanas na dáileoga molta nivolumab:
Gach trí seachtaine, glac 360 mg i gcomhcheangal le cóireáil fluairopyrimidine- agus platanam.
Gach coicís, glac 240 mg i gcomhcheangal le cóireáil fluairopyrimidine- agus platanam.
Tagairt: https://www.fda.gov/
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