Thaum Lub Rau Hli 30, lub vev xaib official ntawm National Medical Products Administration (NMPA) tau tshaj tawm tias Anlotinib, ib hom tshuaj tshiab Class 1 uas Chia Tai Tianqing tsim, tau txais kev pom zoo rau ib qho cim tshiab hauv Suav teb: kev kho mob ua ke nrog chemotherapy rau kev kho mob thawj kab ntawm cov neeg mob uas tsis tuaj yeem phais tau hauv zos lossis metastatic soft tissue sarcoma (STS) uas tsis tau txais kev kho mob systemic yav dhau los. Qhov no yog qhov cim cuaj uas tau pom zoo rau Anlotinib hauv Suav teb thiab qhia txog kev pom zoo ntawm thawj zaug chemotherapy ua ke hauv ntiaj teb rau kev kho mob thawj kab ntawm advanced lossis metastatic STS.
Anlotinib (AL3818, Anlotinib Hydrochloride) yog ib qho tshuaj tshiab me me uas muaj ntau lub hom phiaj tyrosine kinase inhibitor (TKI) uas tiv thaiv tau cov kinases xws li VEGFR, PDGFR, FGFR, thiab c-Kit, ua rau muaj kev tiv thaiv kab mob qog nqaij hlav thiab kev loj hlob ntawm qog nqaij hlav.
Mob qog nqaij mos mos (STS) yog ib hom qog nqaij hlav phem uas pib los ntawm cov nqaij mos sab nraud uas tsis yog epithelial, nrog rau tus nqi txhua xyoo ntawm kwv yees li 2.91 rau 100,000 tus pej xeem hauv Suav teb, qhia txog kev nce siab txhua xyoo [1-3]. STS muaj 19 hom histological thiab ntau dua 50 hom kab mob sib txawv. Tau ntau xyoo, kev kho mob siv tshuaj anthracycline tau ua lub hauv paus tseem ceeb ntawm kev kho mob thawj kab rau STS.
Xyoo 2025 Lub Rooj Sib Tham Txhua Xyoo ntawm American Society of Clinical Oncology (ASCO), lub tuam txhab tau nthuav tawm cov txiaj ntsig zoo los ntawm kev tshawb fawb theem III ntawm Anlotinib Hydrochloride Capsules ua ke nrog kev kho mob chemotherapy rau kev kho mob thawj kab ntawm STS uas tsis tuaj yeem phais tau.
Txoj Kev: Cov pts tsim nyog tau muaj STS uas tsis tau kho dua, tau lees paub tias muaj kab mob, tsis tuaj yeem phais tau hauv zos lossis metastatic. Pts raug xaiv ua random hauv qhov sib piv 1: 1 kom tau txais ALTN (12mg) noj ib zaug ib hnub (2-lub lim tiam rau/1-lub lim tiam so) ntxiv rau EH (90 mg / m2) intravenously ib zaug txhua 3 lub lis piam txog 6 lub voj voog, ua raws li kev saib xyuas ALTN (12mg) noj ib zaug ib hnub (2-lub lim tiam rau/1-lub lim tiam so) lossis PBO (0mg) noj ib zaug ib hnub (2-lub lim tiam rau/1-lub lim tiam so) ntxiv rau EH (90 mg / m2) intravenously ib zaug txhua 3 lub lis piam txog 6 lub voj voog, ua raws li kev saib xyuas PBO (0mg) noj ib zaug ib hnub (2-lub lim tiam rau/1-lub lim tiam so). Lub ntsiab lus tseem ceeb yog PFS ntsuas los ntawm pawg neeg saib xyuas kev ywj pheej dig muag raws li RECIST 1.1. Lub ntsiab lus thib ob suav nrog OS, Lub Hom Phiaj Teb (ORR), Tus nqi tswj kab mob (DCR) thiab kev nyab xeeb.
Cov Txiaj Ntsig: Tag nrho ntawm 272 pts tau raug xaiv los ntawm random: 135 rau ALTN + EH caj npab, 137 rau PBO + EH caj npab. Txij li Lub Ob Hlis 15, 2024, tom qab kev saib xyuas nruab nrab ntawm 7.16 mo, ALTN + EH caj npab tau txhim kho PFS (HR 0.30 [95% CI 0.21-0.44]; P < 0.001; nruab nrab 8.57 vs 3.02 mo), thiab ORR (17.8% vs 2.90%; P < 0.001), DCR (79.3% vs 54.7%; P < 0.001) piv rau PBO + EH caj npab. Qhov nruab nrab OS tsis tau mus txog hauv ob caj npab (HR = 0.78 [95% CI: 0.49-1.25]). Qhov txiaj ntsig ntawm ALTN + EH caj npab tau pom thoob plaws feem ntau cov pab pawg me uas tau sim, suav nrog leiomyosarcoma, synovial sarcoma thiab lwm yam kab mob. Qhov tshwm sim ntawm Qib ≥3 cov xwm txheej tsis zoo (AEs) (69.6% vs 59.1%), AEs ua rau tsis kho (3.7% vs 4.4%), AEs tuag taus (3.7% vs 3.6%) zoo sib xws ntawm ob caj npab.
Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.
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Lub sijhawm tshaj tawm: Lub Xya Hli-01-2025