Kiniiniyada 'Trifluridine / tipiracil' (LONSURF, Taiho Pharmaceutical Co., Ltd.) waxaa ansixiyay Maamulka Cuntada iyo Dawada Febraayo 22, 2019 bukaanada qaangaarka ah ee qaba metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma horey loogu daaweeyay ugu yaraan laba saf hore adenocarcinomas , isku-dhafan go'an oo ah 'trifluridine', a nucleoside metabolism, iyo tipiracil, a thymidine fosforylase inhibitor
TAGS (NCT02500043), caalami ah, randomized, laba-indho la'aan, tijaabo placebo-koontarool, ayaa laga aqbalay 507 bukaan qaba gastric metastatic ama GEJ adenocarcinoma kuwaas oo hore u maray ugu yaraan laba khad kiimiko daaweynta hore. Bukaannada ayaa la kala soocay 2:1 si ay u helaan Lonsurf (n=337) 35 mg/m2 afka laba jeer maalin kasta maalmaha 1-5 iyo 8-12 ee wareeg kasta oo 28-maalmood ah oo leh daryeelka taageerada ugu wanaagsan (BSC) ama placebo ku habboon (n=170). ) oo leh BSC ilaa cudurku ka sii socdo ama sunta aan la aqbali karin.
Celceliska celceliska dhexdhexaadka ee bukaanka lagu daaweeyay Lonsurf wuxuu ahaa bilooyin 5.7 (4.8, 6.2) iyo 3.6 bilood (3.1, 4.1) kuwa lagu daaweeyay placebo (heerka halista: 0.69; 95% CI: 0.56, 0.85; p = 0.0006). Bukaannada loo qoondeeyey gacanta Lonsurf (saamiga halista ee 0.56; 95 boqolkiiba CI: 0.46, 0.68; p <0.0001), badbaadada horumarka aan xorta ahayn sidoo kale way sii dheereyd.
Warbixinta TAGS, neutropenia, dhiig-yaraan, lallabbo, rabitaanka cuntada oo yaraada, thrombocytopenia, matag iyo shuban ayaa ahaa falcelinta xun ee ugu badan ama cilladaha shaybaarka (qiyaastii 10% dhacdooyinka) bukaannada lagu daweeyay Lonsurf, oo ku dhaca heer ka sarreeya bukaannada lagu daweeyay. placebo.
Qiyaasta loo qoray iyo jadwalka loogu talagalay 'Lonsurf' waa 35 mg / m2 / qiyaas afka ah laba jeer maalintii iyadoo la siinayo cunto maalin kasta 28-maalin gudaheeda Maalmaha 1 illaa 5 iyo Maalmaha 8 illaa 12.
View full prescribing information for LONSURF.
FDA waxay siisay codsigan dib u eegis mudnaanta leh iyo magacaabista daroogada agoonta. Sharraxaadda barnaamijyada degdegga ah ee FDA waxay ku jirtaa Hagidda Warshadaha: Barnaamijyada Degdega ah ee Xaaladaha Halis ah-Drugs iyo Bayoloji.
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.
