Avgust 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 har ikki haftada har ikki haftada mFOLFOX6 (ftoruratsil, leykovorin va oksaliplatin) yoki mFOLFOX6 bilan.
Har 3 haftada Nivolumab 360 mg CapeOX (kapetsitabin va oksaliplatin) yoki CapeOX bilan.
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).
Qo'shimcha samaradorlik natijasi sifatida, barcha randomizatsiyalangan bemorlar (n = 1,581), KSSdan qat'i nazar, nivolumab va kimyoterapiya qo'lida 13.8 oylik (95 % CI: 12.6, 14.6) o'rtacha OS bilan OSda statistik jihatdan sezilarli yaxshilanishga ega bo'lishdi. faqat kimyoterapiya qo'lida 11.6 oyga (95 foiz CI: 10.9, 12.5) (HR 0.80; 95 foiz CI: 0.71, 0.90; p = 0.0002).
Periferik neyropatiya, ko'ngil aynishi, charchoq, diareya, qusish, ishtahaning pasayishi, qorin og'rig'i, ich qotishi va tayanch-harakat apparati og'rig'i nivolumabni ftoropirimidin va platina o'z ichiga olgan kimyoterapiya bilan birgalikda qabul qilingan bemorlarda eng ko'p uchraydigan nojo'ya reaktsiyalar (chastotasi 20%) bo'lgan.
Tavsiya etilgan nivolumab dozalari quyidagilar:
Har uch haftada floropirimidin va platina o'z ichiga olgan davolash bilan birgalikda 360 mg qabul qiling.
Har ikki haftada floropirimidin va platina o'z ichiga olgan davolash bilan birgalikda 240 mg qabul qiling.
Malumot: https://www.fda.gov/
Tafsilotlarni tekshiring Bu yerga.
