2021 Ogos: 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 setiap dua minggu dengan mFOLFOX6 (fluorouracil, leucovorin, dan oxaliplatin) atau mFOLFOX6 setiap dua minggu
Setiap 3 minggu, Nivolumab 360 mg dengan CapeOX (capecitabine dan oxaliplatin) atau 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).
Sebagai ukuran hasil keberkesanan tambahan, semua pesakit secara rawak (n = 1,581), tanpa mengira CPS, mengalami peningkatan yang signifikan secara statistik dalam OS, dengan OS rata-rata 13.8 bulan (95 peratus CI: 12.6, 14.6) pada bahagian kemoterapi nivolumab plus berbanding 11.6 bulan (95 peratus CI: 10.9, 12.5) di lengan kemoterapi sahaja (HR 0.80; 95 peratus CI: 0.71, 0.90; p = 0.0002).
Neuropati periferal, mual, keletihan, cirit-birit, muntah, penurunan selera makan, sakit perut, sembelit, dan sakit muskuloskeletal adalah reaksi buruk yang paling biasa (kejadian 20%) yang diperhatikan pada pesakit yang menerima nivolumab dalam kombinasi dengan kemoterapi yang mengandung fluoropyrimidine dan platinum.
Berikut adalah dos nivolumab yang disyorkan:
Setiap tiga minggu, ambil 360 mg bersama dengan rawatan yang mengandungi fluoropyrimidine dan platinum.
Setiap dua minggu, minum 240 mg bersama dengan rawatan yang mengandungi fluoropyrimidine dan platinum.
Rujukan: https://www.fda.gov/
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