Luulyo 17, Xarunta Qiimaynta Daawada (CDE) ee Maamulka Badeecadaha Caafimaadka Qaranka (NMPA) ayaa ku dhawaaqday in codsiga suuqgeynta ee Trastuzumab Deruxtecan (Enhertu®) ee daaweynta kansarka caloosha ee safka labaad uu si rasmi ah u aqbalay NMPA. Codsigan waxaa loogu talagalay daaweynta bukaanada qaangaarka ah ee qaba adenocarcinoma-ga caloosha ama mindhicirka ee HER2-positive ee ku jira qaybta labaad.
ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki oo keliya Mareykanka) waa ADC oo HER2 ah. Waxaa lagu sameeyay iyadoo la adeegsanayo Tiknoolajiyadda DXd ADC ee gaarka loo leeyahay ee Daiichi Sankyo, ENHERTU waa ADC-ga hormuudka ka ah faylalka kansarka ee Daiichi Sankyo iyo barnaamijka ugu horumarsan ee madal cilmiyeedka ADC ee AstraZeneca. ENHERTU waxay ka kooban tahay antibody monoclonal HER2 oo ku xiran tiro ka mid ah topoisomerase I inhibitor oo lacag ah (oo ah derivative exatecan, DXd) iyada oo loo marayo isku xirayaasha la kala saari karo ee ku salaysan tetrapeptide.
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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Codsigan liiska waxa uu inta badan ku salaysan yahay natiijooyinka tirakoob ahaan muhiimka ah iyo kuwa caafimaad ahaan muhiimka ah ee daraasadda DESTINY-Gstric04 (kuwaas oo lagu soo bandhigay Shirka ASCO ee Bulshada Mareykanka ee Cudurrada Kiliinikada sanadkii 2025).
DESTINY-Gastric04 (NCT04704934), daraasad heer caalami ah, oo aan kala sooc lahayn, oo xarumo badan leh, oo furan, oo qiimeynaysa waxtarka iyo badbaadada T DXd vs RAM + PTX ee dhibcaha leh HER2+ aan la kala saari karin/metastatic GC/GEJA ee ku jira habkan safka labaad.
Hababka:
Ka dib markii la xaqiijiyay xaaladda HER2+ ee baaritaanka dhiigga (IHC 3+ ama IHC 2+/ISH+), natiijooyinka waxaa loo kala saaray 1:1 ilaa T-DXd 6.4 mg/kg ama RAM + PTX. Dhibcaha ugu horreeya waxay ahaayeen badbaadada guud (OS). OS-ka u dhexeeya labada gacmood waxaa lagu barbar dhigay tijaabo darajada diiwaanka ah oo loo kala saaray iyadoo la adeegsanayo arrimaha kala soocidda. Dhibcaha labaad ee qiimeynta baaraha waxaa ka mid ah badbaadada aan horumarka lahayn (PFS), heerka jawaab celinta ujeeddada la xaqiijiyay (cORR), heerka xakamaynta cudurka (DCR), iyo badbaadada.
Natiijooyinka:
Markii la jaray xogta (Oktoobar 24, 2024), 494 dhibcood ayaa la qoondeeyay (T-DXd, n = 246; RAM + PTX, n = 248). Iyada oo lagu saleynayo 266 dhacdo oo OS ah oo la arkay (jajab macluumaad = 78.5%), waxaa la gaaray heer sare oo wax ku ool ah (2-dhinac P < 0.0228). Dabagalka OS ee dhexdhexaadka ah (m) (95% CI) wuxuu ahaa 16.8 mo (14.0-20.0) T-DXd iyo 14.4 mo (13.1-19.7) RAM + PTX. mOS (95% CI) wuxuu ahaa 14.7 mo (12.1-16.6) T-DXd vs 11.4 mo (9.9-15.5) RAM + PTX (saamiga khatarta [HR], 0.70; P = 0.0044). Xog waxtar dheeraad ah ayaa ku jirta Jadwalka. Muddada daaweynta dhexdhexaadka ah (inta u dhaxaysa) waxay ahayd 5.4 bilood (0.7-30.3) oo leh T-DXd iyo 4.6 bilood (0.9-34.9) oo leh RAM + PTX. Dhacdooyinka soo noqnoqda ee daaweynta (TEAEs) ayaa lagu soo warramey 244/244 (100%) iyo 228/233 dhibcood (97.9%) oo leh T-DXd iyo RAM + PTX, siday u kala horreeyaan; 68.0% vs 73.8% waxay ahaayeen heer (G) ≥3. TEAE-yada daran ee leh T-DXd iyo RAM + PTX waxay dhaceen 41.0% vs 43.3% ee dhibcood; TEAE-yada la xiriira joojinta daawada waxay dhaceen 14.3% vs 17.2% ee dhibcood. Cudurka sambabada/oof-wareenka ee la xiriira daroogada ee si madax-bannaan loo go'aamiyay ayaa ka dhacay 34 dhibcood (13.9%) iyadoo T-DXd (1 G3, 0 G4/5) iyo 3 dhibcood (1.3%) oo leh RAM + PTX (2 G3, 1 G5).
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.
Lambarka Taleefanka: 4008803716
Email：myimmnet@163.com
Waqtiga boostada: Luulyo-22-2025