Avgust 2021: FDA tasdiqladi Nivolumab (Opdivo, Bristol-Myers Squibb Company) to'liq rezektsiya qilingan qizilo'ngach yoki gastroezofagial birikma (GEJ) saratoni bo'lgan, neoadjuvan kimyoterapiya olgan va doimiy patologik kasalligi bo'lgan bemorlar uchun.
CHECKMATE-794 (NCT577) randomizatsiyalangan, ko'p markazli, ikki ko'rli ko'rikda bir vaqtda kimyoterapiya o'tkazilgandan keyin qoldiq patologik kasallikka chalingan, qizilo'ngach yoki GEJning to'liq rezektsiya qilingan (salbiy chegarasi) qizilo'ngachli yoki xatarli kasalliklari bo'lgan 02743494 bemorda samaradorligi baholandi. Bemorlarga tasodifiy tayinlangan (2: 1), har ikki haftada bir 240 hafta davomida 16 mg nivolumab yoki platsebo, so'ngra bir haftalik davolanish uchun 480 haftadan boshlab har to'rt haftada 17 mg nivolumab yoki platsebo.
Kasalliksiz omon qolish (DFS) samaradorlikning asosiy ko'rsatkichi edi. Bu saratonga qarshi keyingi terapiyadan oldin tergovchi tomonidan aniqlanganidek, randomizatsiyadan birinchi takrorlanish (mahalliy, mintaqaviy yoki birlamchi rezektsiya qilingan joydan uzoq) yoki har qanday sababdan o'lim o'rtasidagi vaqt sifatida aniqlandi.
In CHECKMATE-577, those who received nivolumab had a statistically significant improvement in DFS when compared to those who received placebo. The median DFS was 22.4 months (95 percent confidence interval: 16.6, 34.0) versus 11 months (95 percent confidence interval: 8.3, 14.3) (HR 0.69; 95 percent confidence interval: 0.56, 0.85; p=0.0003). Regardless of tumour PD-L1 expression or histology, the DFS advantage was seen.
Charchoq, toshma, mushak -skelet tizimining og'rig'i, qichishish, diareya, ko'ngil aynishi, asteniya, yo'tal, nafas qisilishi, ich qotishi, ishtahaning pasayishi, bel og'rig'i, artralgiya, yuqori nafas yo'llarining infektsiyasi, pireksiya, bosh og'rig'i, qorin og'rig'i va qusish - eng ko'p uchraydigan salbiy reaktsiyalar ( nivolumab olgan bemorlarda kasallanish 20%).
For adjuvant therapy of resected esophageal or GEJ cancer, the recommended nivolumab dose is 240 mg every 2 weeks or 480 mg every 4 weeks for a total treatment duration of 1 year. Both doses are given as intravenous infusions lasting 30 minutes.
Reference: https://www.fda.gov/
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