Musi wa30 Chikumi, webhusaiti yepamutemo yeNational Medical Products Administration (NMPA) yakazivisa kuti Anlotinib, mushonga mutsva weClass 1 wakagadzirwa naChia Tai Tianqing, wagamuchira mvumo yechiratidzo chitsva muChina: kurapwa kwakabatana nechemotherapy yekurapa varwere vane sarcoma (STS) isina kubviswa mushonga kana kuti isina kubatwa zvakanaka vasina kumbogamuchira kurapwa kwemuviri. Izvi zvinoratidza chiratidzo chechipfumbamwe chakatenderwa Anlotinib muChina uye zvinoratidza mvumo yepamutemo yekurapa kwekutanga kwechemotherapy pasi rose kwekurapa kwekutanga kweSTS yepamusoro kana yakapararira.
Anlotinib (AL3818, Anlotinib Hydrochloride) mushonga mutsva we tyrosine kinase inhibitor (TKI) unoshanda kudzivirira ma kinase akadai seVEGFR, PDGFR, FGFR, uye c-Kit, uchiita kuti bundu rirambe richikura uye kudzivirira kukura kwebundu rirambe richikura.
Sarcoma ye Soft tissue (STS) imhando yegomarara rinokonzera kenza rinobva munyama dzisina mapfupa, uye huwandu hwevanhu vanobatwa nechirwere ichi hunosvika 2.91 pagore pavanhu 100,000 muChina, zvichiratidza kuwedzera kuri kuita gore negore [1-3]. STS inosanganisira mhando gumi nepfumbamwe dze histological uye mhando dzinopfuura makumi mashanu dzakasiyana dzezvirwere. Kwemakumi emakore, chemotherapy yakavakirwa pa anthracycline yakashanda senzira huru yekurapa STS.
PaMusangano weGore negore weAmerican Society of Clinical Oncology (ASCO) wa2025, kambani iyi yakapa mhedzisiro yakanaka kubva muongororo yekiriniki yePhase III yeAnlotinib Hydrochloride Capsules pamwe chete nechemotherapy yekurapa STS yepamusoro kana kuti yakapararira isingarapwe.
Nzira: Mishonga inokodzera yakanga isati yamborapwa, yakasimbiswa kuti ine chirwere, isingabvisike STS yemuno kana kuti yakapararira. Mishonga yakarongerwa ne1:1 kuti iwane ALTN (12mg) nemuromo kamwe chete pazuva (vhiki mbiri pavhiki imwe chete) pamwe neEH (90 mg/m2) neropa kamwe chete pamavhiki matatu kusvika kumatanho matanhatu, ichiteverwa neALTN yekuchengetedza (12mg) nemuromo kamwe chete pazuva (vhiki mbiri pavhiki imwe chete) kana PBO (0mg) nemuromo kamwe chete pazuva (vhiki mbiri pavhiki imwe chete) pamwe neEH (90 mg/m2) neropa kamwe chete pamavhiki matatu kusvika kumatanho matanhatu, ichiteverwa nePBO yekuchengetedza (0mg) nemuromo kamwe chete pazuva (vhiki mbiri pavhiki imwe chete). Mugumo wekutanga waive wePFS wakaongororwa nekomiti yekuongorora yakazvimiririra yakazvimirira zvichienderana neRECIST 1.1. Mugumo wechipiri waisanganisira OS, Objective Response Rate (ORR), Disease control rate (DCR) uye kuchengetedzeka.
Mhedzisiro: Huwandu hwemapointi 272 hwakaitwa zvisina kurongeka: 135 ku ALTN + EH arm, 137 ku PBO + EH arm. Kubva muna Kukadzi 15, 2024, mushure mekutevera kwepakati pemwedzi 7.16, ALTN + EH arm yakawedzera PFS zvakanyanya (HR 0.30 [95% CI 0.21-0.44]; P < 0.001; yepakati 8.57 vs 3.02 mwedzi), uye ORR (17.8% vs 2.90%; P < 0.001), DCR (79.3% vs 54.7%; P < 0.001) zvichienzaniswa nePBO + EH arm. Yepakati OS haina kusvikwa muruoko rwese (HR = 0.78 [95% CI: 0.49-1.25]). Kubatsirwa kweALTN + EH arm kwakaonekwa mumapoka mazhinji akaedzwa, anosanganisira leiomyosarcoma, synovial sarcoma nedzimwe mhando dzezvirwere. Kuwanda kwezviitiko zvakaipa zveGiredhi ≥3 (AEs) (69.6% vs 59.1%), AEs zvakakonzera kurega kurapwa (3.7% vs 4.4%), AEs dzinouraya (3.7% vs 3.6%) zvaive zvakafanana pakati pemaoko maviri.
Parizvino, kuchine miedzo yakawanda yekiriniki yehunyanzvi hutsva hwekurwisa gomarara muChina huri kutsvaga varwere. Kana muchida kubvunzana nezvemishonga mitsva netekinoroji, munogona kubata Dhipatimendi reBeijing South Region Oncology Hospital International.
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Nguva yekutumira: Chikunguru-01-2025