Ağustos 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 iki haftada bir mFOLFOX240 (florourasil, lökovorin ve oksaliplatin) veya iki haftada bir mFOLFOX6 ile 6 mg
Her 3 haftada bir, CapeOX (kapesitabin ve oksaliplatin) veya CapeOX ile Nivolumab 360 mg.
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).
Ek bir etkililik sonuç ölçüsü olarak, CPS'den bağımsız olarak tüm randomize hastalar (n=1,581), nivolumab artı kemoterapi kolunda medyan OS'si 13.8 ay (yüzde 95 GA: 12.6, 14.6) ile OS'de istatistiksel olarak anlamlı bir iyileşmeye sahipti. karşı 11.6 ay (yüzde 95 GA: 10.9, 12.5) tek başına kemoterapi kolunda (HR 0.80; yüzde 95 GA: 0.71, 0.90; p=0.0002).
Periferik nöropati, bulantı, yorgunluk, ishal, kusma, iştah azalması, karın ağrısı, kabızlık ve kas-iskelet ağrısı, nivolumab ile floropirimidin ve platin içeren kemoterapi kombinasyonu alan hastalarda gözlenen en yaygın advers reaksiyonlardır (insidans %20).
Aşağıdakiler önerilen nivolumab dozlarıdır:
Her üç haftada bir, floropirimidin ve platin içeren tedavi ile birlikte 360 mg alın.
İki haftada bir, floropirimidin ve platin içeren tedavi ile birlikte 240 mg alın.
Referans : https://www.fda.gov/
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