2021 Agustus: FDA parantos disatujuan Nivolumab (Opdivo, Bristol-Myers Squibb Company) pikeun penderita esophagus pinuh resected atanapi gastroesophageal simpang (GEJ) kanker anu geus narima chemoradiotherapy neoadjuvant sarta boga kasakit pathologic pengkuh.
Efficacy ieu ditaksir di 794 penderita kalawan sagemblengna resected (margin négatip) esophageal atanapi GEJ malignancies anu miboga kasakit pathologic residual sanggeus chemoradiotherapy concomitant dina CHECKMATE-577 (NCT02743494) randomised, multicenter, sidang ganda-buta. Pasén ditugaskeun sacara acak (2: 1) pikeun nampi 240 mg nivolumab atanapi plasebo unggal dua minggu salami 16 minggu, teras 480 mg nivolumab atanapi plasebo unggal opat minggu dimimitian dina minggu 17 dugi ka sataun perlakuan.
survival bébas kasakit (DFS) éta ukuran hasilna efficacy primér. Ieu ditetepkeun salaku waktu antara randomization jeung kanceuh munggaran (lokal, régional, atawa jauh ti loka primér resected) tanggal, atawa maot, tina sagala sabab, sakumaha ditangtukeun ku investigator saméméh terapi anti kanker saterusna.
Dina CHECKMATE-577, jalma anu nampi nivolumab ngagaduhan paningkatan anu signifikan sacara statistik dina DFS nalika dibandingkeun sareng anu nampi plasebo. DFS median nyaéta 22.4 bulan (95 persén interval kapercayaan: 16.6, 34.0) versus 11 bulan (95 persén interval kapercayaan: 8.3, 14.3) (HR 0.69; 95 persén interval kapercayaan: 0.56, 0.85; p = 0.0003). Henteu paduli éksprési tumor PD-L1 atanapi histologi, kauntungan DFS katingali.
Kacapean, ruam, nyeri musculoskeletal, pruritus, diare, seueul, asthenia, batuk, dyspnea, kabebeng, turun napsu, nyeri tonggong, arthralgia, inféksi saluran pernapasan luhur, pyrexia, nyeri sirah, nyeri beuteung, sareng utah mangrupikeun réaksi ngarugikeun anu paling umum ( incidence 20%) dina penderita narima nivolumab.
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.
rujukan: https://www.fda.gov/
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