August 2021: Iyo FDA yakabvumidza Nivolumab (Opdivo, Bristol-Myers Squibb Kambani) kune varwere vane chirwere chegomarara chesophagus kana gastroesophageal junction (GEJ) vakagamuchira neoadjuvant chemoradiotherapy uye vane chirwere chinoramba chiripo.
Kubudirira kwakaongororwa mu794 varwere vane rese reseeded (isina kunaka margins) esophageal kana GEJ malignancies avo vakasara pathologic chirwere mushure mekubatana chemoradiotherapy muCHECKMATE-577 (NCT02743494) yakasarudzika, multicenter, kaviri-bofu kuyedzwa. Varwere vaiwanzopihwa (2: 1) kuti vagamuchire 240 mg ye nivolumab kana placebo vhiki mbiri dzese kwemasvondo gumi nematanhatu, uyezve 16 mg ye nivolumab kana placebo mavhiki mana ese kutanga pavhiki 480 kwegore rimwe chete rekurapwa.
Kurarama-kusununguka kwehosha (DFS) ndiyo yaive yekutanga yekubudirira mhedzisiro chiyero. Yakatsanangurwa seyo nguva iri pakati pekusarongeka uye kutanga kudzokorodza (yemuno, yedunhu, kana kure kubva kune yekutanga resected saiti) zuva, kana kufa, kubva kune chero chikonzero, sekugadzwa nemuferefisi pamberi peanotevera anti-cancer kurapwa.
MuCHECKMATE-577, avo vakagamuchira nivolumab vaiva nenhamba yakakosha yekuvandudza muDFS kana vachienzaniswa nevaya vakagamuchira placebo. Iyo yepakati DFS yaive 22.4 mwedzi (95 muzana yekuvimba nguva: 16.6, 34.0) maringe nemwedzi gumi neimwe (11 muzana yekuvimba nguva: 95, 8.3) (HR 14.3; 0.69 muzana yekuvimba nguva: 95, 0.56; p = 0.85). Pasinei nebundu PD-L0.0003 kutaura kana histology, iyo DFS mukana wakaonekwa.
Kuneta, kuputika, musculoskeletal pain, pruritus, manyoka, kusvotwa, asthenia, kukosora, dyspnea, kuzvimbirwa, kushomeka kwekuda kudya, kurwadziwa musana, arthralgia, chirwere chepamusoro chekufema, pyrexia, kurwadziwa nemusoro, kurwadziwa mudumbu, uye kurutsa ndiwo maitiro akajairika ( zviitiko 20%) muvarwere vanogamuchira 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.
Dheuteronomio: https://www.fda.gov/
Tarisa uone pano.
