Aqoonyahan Dong-Wan Kim oo ka socda Isbitaalka Jaamacadda Qaranka ee Seoul ee South Korea ayaa bixin doona warbixin afka ah oo ku saabsan kulanka gaarka ah ee kansarka sanbabada unugyada unugyada yaryar ee 52nd Shirka Sannadlaha ah ee Bulshada Maraykanka ee Oncology (ASCO) ee Chicago June 6 , 2016 waqtiga maxalliga ah: warbixinta ugu horreysa Wajiga labaad ee tijaabada caafimaadka ee muhiimka ah ee waxtarka iyo badbaadada isticmaalka Brigatinib (BRG) ee bukaannada qaba ALK + crizotinib u adkaysta kansarka sanbabada unugyada yaryar (NSCLC).
BRG waa daawada afka laga qaato ee tyrosine kinase inhibitor (TKI) xilliga fiirsashada. Waxay leedahay hawlo caafimaad oo sax ah oo ka dhan ah dib-u-habaynta ALK iyo isbeddellada u adkaysta CRZ. Marxaladdan caafimaad ee 1/2 tijaabada waxay muujinaysaa rajooyin wanaagsan oo BRG ah. Heerka jawaabta BRG iyo AE-yada labaduba way ku kala duwanaan karaan qiyaasta bilawga ah, sidaa darteed, daraasaddan la kala soocay ee socota, laba ikhtiyaar oo isticmaalka BRG ayaa la qiimeeyay.
Natiijooyinka daraasaddan ayaa muujinaya in BRG ay leedahay jawaab cad oo daaweyn ah, PFS deggan, iyo sifooyin badbaado oo la aqbali karo. Sidaa darteed, waxay qorsheynayaan inay sameeyaan tijaabo caafimaad oo waji III ah marka la barbar dhigo CRZ BRG 90 mg qd * 7 days iyo 180 mg qd bukaanada qaba ALK + NSCLC horumarsan iyo CRZ bukaanada aan isticmaalin TKI.
Tijaabadaan, bukaanada ≥ 18 sano jir, ALK + NSCLC way horumareen ka dib markii ay isticmaaleen CRZ mana jiraan bukaanno kale oo ALK TKI ah oo la heli karo. Marka loo eego haddii bukaanku leeyahay xaalad asaasiga ah ee metastasis intracranial iyo jawaabta ugu fiican ee isticmaalkii hore ee CRZ, bukaannada ayaa si aan kala sooc lahayn loo qaybiyay 1: 1 afka BRG 90 mg qd (koox A) ama 90 mg qd x 7d iyo 180 mg qd (kooxda B).
The primary endpoint is observation-assessment-confirmation of ORR per RECIST v1.1. Key secondary endpoints include PFS and IRC to assess formal ORR and CNS responses. 222 patients were randomly divided into A / B group, n = 112 / n = 110. As of September 21, 2015, the last patient was included. The average age was 51/57 years old, and 71% / 67% had brain metastases.
The proportion of patients in groups A and B was 63% / 74% while the experiment was still in progress on December 7, 2015, and the average duration of treatment was 25 weeks / 23 weeks. Observation-assessment of group A: 46% of confirmed ORR (39 confirmed reactions + 12 single responses waiting to be confirmed), including 1 confirmed complete response (CRs); ORR of group B: 54% (49 confirmed reactions) + 10 responses awaiting confirmation), including 5 confirmed CRs. The median PFS for A / B is 8.8 months / 11.1 months.
Dhacdooyinka sunta ah ee kooxda A / B waxay ahaayeen 44/25, daawaynta degdega ah ee ugu badan ee AEs fasalka ≥ 3, kooxda A / B waxaa ka mid ah: korodhay CPK (3% / 8%), hypertension (4% / 5%), caabuq sambabada (3% / 5%), finan (1% / 4%), dufannada dhiigga oo sarreeya (3% / 2%) iyo oof-wareen (2% / 3%). 6% bukaanada, dhacdooyinka sambabada ayaa dhacay marxalad hore (3% ≥ fasalka 3 gudaha 7 maalmood ee bilawga daaweynta); Dhacdadan laguma arag kooxda B waxayna kor u kacday 180 mg gudahood 7 maalmood ee bilawga daaweynta iyo ka dib. Joojinta iyo dhimista kooxda A / B ee ay ugu wacan tahay AE-yada waxay ahaayeen 3% / 6% iyo 7% / 18%, siday u kala horreeyaan.
