Agasti 2021: I-FDA igunyaze I-Nivolumab (Opdivo, Bristol-Myers Squibb Company) ezigulini ezinomdlavuza we-esophagus noma we-gastroesophageal junction (GEJ) okhishwe ngokuphelele kabusha ezithole i-neoadjuvant chemoradiotherapy futhi ezinesifo esiqhubekayo se-pathologic.
Ukusebenza kahle kwahlolwa ezigulini ze-794 ezine-resected ngokuphelele (negative margins) i-esophageal noma i-GEJ malignancies ababenesifo se-pathologic esisele ngemva kwe-chemoradiotherapy ehambisanayo ku-CHECKMATE-577 (NCT02743494) isivivinyo esingahleliwe, esineziningi, esiyimpumputhe kabili. Iziguli zabelwa ngokungahleliwe (2:1) ukuze zithole i-240 mg ye-nivolumab noma i-placebo njalo emavikini amabili amaviki angu-16, bese kuthi i-480 mg ye-nivolumab noma i-placebo njalo emavikini amane kusukela evikini le-17 kuze kube unyaka owodwa wokwelashwa.
Ukusinda okungenazifo (i-DFS) kwakuyisilinganiso esiyinhloko somphumela wokusebenza ngempumelelo. Kwachazwa njengesikhathi esiphakathi kwe-randomization kanye nokuphindaphinda kokuqala (indawo, isifunda, noma kude nesayithi elihlanjululwe kabusha) usuku, noma ukufa, kusukela kunoma yisiphi isizathu, njengoba kunqunywe umphenyi ngaphambi kokwelashwa okulwa nomdlavuza okwalandela.
Ku-CHECKMATE-577, labo abathole i-nivolumab babe nokuthuthuka okuphawulekayo kwezibalo ku-DFS uma kuqhathaniswa nalabo abathole i-placebo. I-DFS emaphakathi yayiyizinyanga ezingama-22.4 (isikhawu sokuzithemba samaphesenti angama-95: 16.6, 34.0) ngokuqhathaniswa nezinyanga eziyi-11 (isikhawu sokuzithemba samaphesenti angama-95: 8.3, 14.3) (HR 0.69; isikhawu sokuzithemba samaphesenti angama-95: 0.56, 0.85; p=0.0003). Kungakhathalekile ukuthi i-tumor PD-L1 expression noma i-histology, inzuzo ye-DFS ibonwe.
Ukukhathala, ukuqubuka, ubuhlungu be-musculoskeletal, pruritus, isifo sohudo, isicanucanu, i-asthenia, ukukhwehlela, i-dyspnea, ukuqunjelwa, ukuncipha kwesifiso sokudla, izinhlungu emhlane, i-arthralgia, ukutheleleka komgudu wokuphefumula ongenhla, i-pyrexia, ikhanda elibuhlungu, izinhlungu zesisu kanye nokuhlanza kuyizimpawu ezivame kakhulu zokungezwani komzimba. izehlakalo ezingama-20% ezigulini ezithola i-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.
Izikhombo: https://www.fda.gov/
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