Ku ya 30 Kamena, urubuga rwemewe rw’Ikigo cy’Igihugu gishinzwe Ibikoresho by’Ubuvuzi (NMPA) rwatangaje ko Anlotinib, umuti mushya wo mu cyiciro cya mbere wakozwe na Chia Tai Tianqing, wemejwe ku kimenyetso gishya mu Bushinwa: uburyo bwo kuvura hamwe na chimiotherapie mu buryo bwa mbere ku barwayi bafite sarcoma idakira cyangwa isanzwe iterwa n’imiti yoroshye (STS) batarigeze bahabwa ubuvuzi bw’umubiri. Iki kimenyetso cya cyenda cyemewe kuri Anlotinib mu Bushinwa kandi kigaragaza ko byemejwe ku mugaragaro ko imiti ya mbere ku isi ivanze na chimiotherapie ikoreshwa mu kuvura STS iteye imbere cyangwa iterwa n’imiti yo mu bwoko bwa STS.
Anlotinib (AL3818, Anlotinib Hydrochloride) ni umuti mushya wa tyrosine kinase inhibitor (TKI) ugabanya neza kinase nka VEGFR, PDGFR, FGFR, na c-Kit, urwanya angiogenesis ya tumor no gukumira gukura kwa tumor.
Sarcoma yoroshye y'uturemangingo (STS) ni ubwoko bw'ikibyimba kibi gikomoka ku ngingo zitari iz'inyuma y'amagufwa, aho igipimo cy'indwara kigera kuri 2.91 ku bantu 100.000 mu Bushinwa kizamuka buri mwaka [1-3]. STS igizwe n'ubwoko 19 bw'amagufwa n'ubwoko burenga 50 butandukanye bw'indwara. Mu myaka ibarirwa muri za mirongo, imiti ikomoka kuri anthracycline yabaye inkingi y'ingenzi mu kuvura STS ku rwego rwa mbere.
Mu nama ngarukamwaka y’Umuryango w’Abanyamerika wita ku ndwara za kanseri (ASCO) yo mu 2025, iyi sosiyete yagaragaje ibyavuye mu bushakashatsi bwakozwe ku cyiciro cya gatatu cya Anlotinib Hydrochloride Capsules hamwe na chemotherapy mu kuvura indwara za STS zidakira cyangwa zisanzwe.
Uburyo: Indwara zujuje ibisabwa zari zaravuwe mbere, zemejwe ko zifite uburwayi, zidashobora kuvurwa mu gace ziherereyemo cyangwa zidafite STS yanduye. Indwara zatanzwe ku buryo butaziguye mu gipimo cya 1: 1 kugira ngo zihabwe ALTN (12mg) mu kanwa rimwe ku munsi (ibyumweru 2 ku/icyumweru 1) hamwe na EH (90 mg/m2) mu mitsi rimwe mu byumweru 3 kugeza ku nshuro 6, hagakurikiraho ALTN yo kubungabunga (12mg) mu kanwa rimwe ku munsi (ibyumweru 2 ku/icyumweru 1) cyangwa PBO (0mg) mu kanwa rimwe ku munsi (ibyumweru 2 ku/icyumweru 1) hamwe na EH (90 mg/m2) mu mitsi rimwe mu byumweru 3 kugeza ku nshuro 6, hagakurikiraho PBO yo kubungabunga (0mg) mu kanwa rimwe ku munsi (ibyumweru 2 ku/icyumweru 1). Impanuka y'ibanze ni PFS yasuzumwe na komite yigenga isuzuma ryigenga nk'uko RECIST 1.1 ibivuga. Impanuka ya kabiri yari irimo OS, Igipimo cyo gusubiza intego (ORR), Igipimo cyo kurwanya indwara (DCR) n'umutekano.
Ibisubizo: Igiteranyo cy’amanota 272 cyakozwe ku buryo butaziguye: 135 kuri ALTN + EH arm, 137 kuri PBO + EH arm. Ku ya 15 Gashyantare 2024, nyuma yo gukurikirana hagati y’amezi 7.16, ALTN + EH arm yazamutse cyane PFS (HR 0.30 [95% CI 0.21-0.44]; P < 0.001; hagati y’amezi 8.57 vs 3.02), na ORR (17.8% vs 2.90%; P < 0.001), DCR (79.3% vs 54.7%; P < 0.001) ugereranije na PBO + EH arm. Impinduka za OS ntizagezweho mu kuboko kumwe (HR = 0.78 [95% CI: 0.49-1.25]). Akamaro ka ALTN + EH ku kuboko kagaragaye mu matsinda menshi yapimwe, harimo leiomyosarcoma, synovial sarcoma n'izindi ndwara. Ingano y'ingaruka mbi zo mu cyiciro cya ≥3 (AEs) (69.6% vs 59.1%), AEs zatumye hahagarara kuvurwa (3.7% vs 4.4%), AEs zica (3.7% vs 3.6%) zari zisa hagati y'amaboko abiri.
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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Igihe cyo kohereza: Nyakanga-01-2025