Juun 30, bogga rasmiga ah ee Maamulka Badeecadaha Caafimaadka Qaranka (NMPA) ayaa ku dhawaaqay in Anlotinib, oo ah daawo cusub oo heerka 1aad ah oo ay soo saartay Chia Tai Tianqing, ay heshay oggolaansho tilmaam cusub oo Shiinaha ah: daawaynta isku-dhafka ah ee la socota kiimoterabiga si loogu daaweeyo safka koowaad ee bukaanada qaba sarcoma-da jilicsan ee unugyada aan la tirtiri karin ee maxalliga ah ama metastatic tissue (STS) kuwaas oo aan hore u helin daaweyn nidaamsan. Tani waxay calaamad u tahay tilmaantii sagaalaad ee loo ansixiyey Anlotinib ee Shiinaha waxayna muujinaysaa oggolaanshaha rasmiga ah ee daaweynta isku-darka kiimoterabiga ee ugu horreysa adduunka ee daaweynta safka koowaad ee STS-da horumarsan ama metastatic.
Anlotinib (AL3818, Anlotinib Hydrochloride) waa daawo cusub oo tyrosine kinase inhibitor ah oo molecule yar yar oo bartilmaameed badan leh (TKI) oo si wax ku ool ah u joojisa kinases sida VEGFR, PDGFR, FGFR, iyo c-Kit, iyadoo sameysa saameyn ka hortagta angiogenesis-ka burooyinka iyo yareynta koritaanka burooyinka.
Buro-maskaxeed oo jilicsan (STS) waa nooc ka mid ah burooyinka halista ah ee ka soo jeeda unugyada aan ahayn epithelial-ka ee dheeraadka ah, iyadoo heerka dhacdooyinka sanadlaha ah uu yahay qiyaastii 2.91 100,000 oo qof oo ku nool Shiinaha, taasoo muujinaysa isbeddel kor u kacaya sannad kasta [1-3]. STS waxay ka kooban tahay 19 nooc oo histological ah iyo in ka badan 50 nooc oo kala duwan oo cudurro ah. Tobannaan sano, kiimoterabiga ku salaysan anthracycline wuxuu u adeegay aasaaska daaweynta safka hore ee STS.
Shirkii Sanadlaha ahaa ee Ururka Caafimaadka ee Mareykanka (ASCO) ee 2025, shirkaddu waxay soo bandhigtay natiijooyin horumar ah oo ka soo baxay daraasadda caafimaad ee Wajiga III ee Kaabsulyada Anlotinib Hydrochloride iyadoo lagu daray kiimoterabiga si loogu daaweeyo STS-ka aan la tirtiri karin ama aan la daaweyn karin.
Hababka: Bukaannada u qalma waxaa hore loogu daaweeyay, si cudur ah loo xaqiijiyay, aan la tirtiri karin oo aan la daaweyn karin, oo aan la tirtiri karin oo deegaanka ah ama aan la daaweyn karin. Bukaannada waxaa lagu kala soocay saamiga 1:1 si loogu qaato ALTN (12mg) afka hal mar maalintii (2 toddobaad oo fasax ah/1 toddobaad) oo lagu daray EH (90 mg/m2) xididka hal mar saddexdii toddobaadba mar ilaa 6 wareeg, oo ay ku xigto dayactirka ALTN (12mg) afka hal mar maalintii (2 toddobaad oo fasax ah/1 toddobaad) ama PBO (0mg) afka hal mar maalintii (2 toddobaad oo fasax ah/1 toddobaad) oo lagu daray EH (90 mg/m2) xididka hal mar saddexdii toddobaadba mar ilaa 6 wareeg, oo ay ku xigto dayactirka PBO (0mg) afka hal mar maalintii (2 toddobaad oo fasax ah/1 toddobaad). Dhibcaha ugu horreeya waxaa qiimeeyay PFS oo ay qiimeeyeen guddiga dib u eegista madaxa-bannaan ee indhoolayaasha ah sida ku xusan RECIST 1.1. Dhibcaha labaad waxaa ka mid ahaa OS, Heerka Jawaabta Ujeeddada (ORR), Heerka xakamaynta cudurrada (DCR) iyo badbaadada.
Natiijooyinka: Wadarta 272 dhibcood ayaa la kala soocay: 135 ilaa ALTN + gacanta EH, 137 ilaa gacanta PBO + EH. Laga bilaabo Febraayo 15, 2024, ka dib dabagal dhexdhexaad ah oo ah 7.16 bilood, gacanta ALTN + EH si weyn ayay u horumarisay PFS (HR 0.30 [95% CI 0.21-0.44]; P < 0.001; dhexdhexaadka 8.57 vs 3.02 bilood), iyo ORR (17.8% vs 2.90%; P < 0.001), DCR (79.3% vs 54.7%; P < 0.001) marka loo eego gacanta PBO + EH. OS-ka dhexdhexaadka ah laguma gaarin labada gacan (HR = 0.78 [95% CI: 0.49-1.25]). Faa'iidada gacanta ALTN + EH ayaa lagu arkay inta badan kooxaha la baaray, oo ay ku jiraan leiomyosarcoma, synovial sarcoma iyo noocyada kale ee cudurrada. Dhacdooyinka dhacdooyinka xun ee Darajada ≥3 (AEs) (69.6% vs 59.1%), AEs oo horseeday joojinta daaweynta (3.7% vs 4.4%), AEs dilaa ah (3.7% vs 3.6%) waxay isku mid ahaayeen labada gacmood.
Waqtigan xaadirka ah, waxaa weli jira tijaabooyin caafimaad oo badan oo ku saabsan teknoolojiyada cusub ee ka hortagga kansarka ee Shiinaha oo raadinaya bukaanno. La-tashi ku saabsan daawooyinka cusub iyo teknoolojiyada, waxaad la xiriiri kartaa Waaxda Caalamiga ah ee Isbitaalka Oncology ee Gobolka Koonfureed ee Beijing.
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Waqtiga boostada: Luulyo-01-2025