August 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 vhiki mbiri dzese ne mFOLFOX6 (fluorouracil, leucovorin, uye oxaliplatin) kana mFOLFOX6 vhiki mbiri dzese
Mavhiki ese matatu, Nivolumab 3 mg neCapeOX (capecitabine uye oxaliplatin) kana 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).
Seimwe yekuwedzera mhedzisiro mhedzisiro chiyero, vese varwere vakasarudzika (n = 1,581), zvisinei neCPS, vaive nekuvandudzwa kwakakosha muOS, ine median OS yemwedzi 13.8 (95 muzana CI: 12.6, 14.6) mune nivolumab plus chemotherapy ruoko vs. 11.6 mwedzi (95 muzana CI: 10.9, 12.5) mune chemotherapy chete ruoko (HR 0.80; 95 muzana CI: 0.71, 0.90; p = 0.0002).
Peripheral neuropathy, kuda kurutsa, kuneta, manyoka, kurutsa, kushomeka kwekuda kudya, kurwadziwa mudumbu, kuzvimbirwa, uye musculoskeletal marwadzo ndiwo maitiro akajairika (zviitiko 20%) zvakaonekwa kune varwere vanogamuchira nivolumab pamwe ne fluoropyrimidine- uye platinum ine chemotherapy.
Aya anotevera ndiwo akakurudzirwa nivolumab dosages:
Mavhiki matatu ega ega, tora 360 mg pamwe chete ne fluoropyrimidine- uye platinum-ine kurapwa.
Mavhiki maviri ega ega, tora 240 mg pamwe chete ne fluoropyrimidine- uye platinum-ine kurapwa.
Referensi: https://www.fda.gov/
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