Ku ya 17 Nyakanga, Ikigo gishinzwe Isuzuma ry'Imiti (CDE) cy'Ikigo cy'Igihugu gishinzwe Ibikoresho by'Ubuvuzi (NMPA) cyatangaje ko ubusabe bwo kwamamaza bwa Trastuzumab Deruxtecan (Enhertu®) bwo kuvura kanseri y'igifu mu buryo bwa kabiri bwemewe n'Ikigo gishinzwe Isuzuma ry'Imiti (NMPA). Ubu busabe bugenewe kuvura abarwayi bakuru bafite HER2-positive gastric adenocarcinoma cyangwa gastroesophageal junction mu buryo bwa kabiri.
ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki muri Amerika gusa) ni ADC iyobowe na HER2. Yakozwe hifashishijwe ikoranabuhanga rya Daiichi Sankyo rya DXd ADC, ENHERTU niyo ADC iyoboye mu bushakashatsi bwa oncology bwa Daiichi Sankyo kandi ikaba ari na gahunda igezweho cyane mu bushakashatsi bwa ADC bwa AstraZeneca. ENHERTU igizwe na antibody ya monoclonal ya HER2 ifatanye n'imiti myinshi ya topoisomerase I inhibitor payloads (ikomoka kuri exatecan, DXd) binyuze mu miyoboro ihuza ingirabuzimafatizo ishingiye kuri tetrapeptide.
Kugeza ubu, haracyari igeragezwa ryinshi ry’ikoranabuhanga rishya rirwanya kanseri mu Bushinwa rishaka abarwayi. Inama ku miti mishya n’ikoranabuhanga, ushobora kuvugana n’Ishami Mpuzamahanga ry’Ibitaro bya Oncology bya Beijing mu Karere k’Amajyepfo.
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Iyi porogaramu yo gushyira ku rutonde ishingiye ahanini ku bisubizo by’ingenzi n’ibifatika by’ubushakashatsi bwa DESTINY-Gstric04 (byatanzwe mu nama ya ASCO y’Umuryango w’Abanyamerika w’Ubuvuzi bw’Imiti mu Kanwa mu 2025).
DESTINY-Gastric04 (NCT04704934), inyigo mpuzamahanga, yakozwe ku buryo butaziguye, ifite amashami menshi, ifunguye, icyiciro cya 3, isuzuma imikorere n'umutekano wa T DXd ugereranije na RAM + PTX mu matsinda afite HER2+ idakira/ishobora kwangirika muri GC/GEJA muri ubu buryo bwa kabiri.
Uburyo:
Nyuma yo kwemeza ko HER2+ ihagaze (IHC 3+ cyangwa IHC 2+/ISH+), amanota yashyizwe ku rutonde rwa 1: 1 kuri T-DXd 6.4 mg/kg cyangwa RAM + PTX. Igice cy'ingenzi cyari ubuzima rusange (OS). Porogaramu hagati y'amaboko abiri yagereranyijwe hakoreshejwe ikizamini cya log-rank cyashyizwe mu byiciro hakoreshejwe ibintu bitarahinduka. Igice cya kabiri cyakozwe n'isuzuma ry'ubushakashatsi harimo ubuzima budafite iterambere (PFS), igipimo cyemewe cyo gusubiza neza (cORR), igipimo cyo kurwanya indwara (DCR), n'umutekano.
Ibisubizo:
Ku igabanuka ry'amakuru (Ku ya 24 Ukwakira 2024), amanota 494 yatanzwe (T-DXd, n = 246; RAM + PTX, n = 248). Hashingiwe ku byabaye kuri OS 266 byagaragaye (igice cy'amakuru = 78.5%), ubushobozi bwo gukora neza bwagezweho (P < 0.0228 ku mpande ebyiri). Ikurikirana rya OS hagati (m) (95% CI) ryari amezi 16.8 (14.0-20.0) kuri T-DXd na amezi 14.4 (13.1-19.7) kuri RAM + PTX. mOS (95% CI) yari amezi 14.7 (12.1-16.6) kuri T-DXd ugereranije na amezi 11.4 (9.9-15.5) kuri RAM + PTX (igipimo cy'ibyago [HR], 0.70; P = 0.0044). Amakuru y'inyongera ku buryo bwo gukora neza ari mu mbonerahamwe. Igihe cyo kuvurwa cyari amezi 5.4 (0.7-30.3) kuri T-DXd na amezi 4.6 (0.9-34.9) kuri RAM + PTX. Ingaruka mbi zagaragaye mu kuvura (TEAEs) zagaragaye muri 244/244 (100%) ugereranije na 228/233 pts (97.9%) kuri T-DXd ugereranije na RAM + PTX, uko bikurikirana; 68.0% ugereranije na 73.8% byari urwego (G) ≥3. Ingano zikomeye za T-DXd ugereranije na RAM + PTX zagaragaye muri 41.0% ugereranije na 43.3% by'ingingo; Ingano zijyanye no guhagarika imiti zagaragaye kuri 14.3% ugereranije na 17.2% by'ingingo. Indwara y’ibihaha/pneumonite iterwa n’imiti yagaragaye ku giti cyayo ku manota 34 (13.9%) hamwe na T-DXd (1 G3, 0 G4/5) ugereranije na manota 3 (1.3%) hamwe na RAM + PTX (2 G3, 1 G5).
Kugeza ubu, haracyari igeragezwa ryinshi ry’ikoranabuhanga rishya rirwanya kanseri mu Bushinwa rishaka abarwayi. Inama ku miti mishya n’ikoranabuhanga, ushobora kuvugana n’Ishami Mpuzamahanga ry’Ibitaro bya Oncology bya Beijing mu Karere k’Amajyepfo.
Nimero ya Terefone: 4008803716
Email：myimmnet@163.com
Igihe cyo kohereza: 22 Nyakanga-2025