Agosto 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:
Nivolumabe 240 mg a cada duas semanas com mFOLFOX6 (fluorouracil, leucovorina e oxaliplatina) ou mFOLFOX6 a cada duas semanas
A cada 3 semanas, Nivolumab 360 mg com CapeOX (capecitabina e oxaliplatina) ou 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).
Como uma medida de resultado de eficácia adicional, todos os pacientes randomizados (n = 1,581), independentemente do CPS, tiveram uma melhora estatisticamente significativa na OS, com uma OS mediana de 13.8 meses (IC de 95 por cento: 12.6, 14.6) no braço de nivolumabe mais quimioterapia vs. 11.6 meses (IC de 95 por cento: 10.9, 12.5) no braço de quimioterapia sozinha (HR 0.80; IC de 95 por cento: 0.71, 0.90; p = 0.0002).
Neuropatia periférica, náusea, fadiga, diarreia, vômito, diminuição do apetite, dor abdominal, constipação e dor musculoesquelética foram as reações adversas mais comuns (incidência de 20%) observadas em pacientes recebendo nivolumabe em combinação com quimioterapia contendo fluoropirimidina e platina.
A seguir estão as dosagens recomendadas de nivolumabe:
A cada três semanas, tome 360 mg em combinação com tratamento contendo fluoropirimidina e platina.
A cada duas semanas, tome 240 mg em combinação com tratamento contendo fluoropirimidina e platina.
Referência: https://www.fda.gov/
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