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Kenza Yemazamu Ekutanga: Verzenio angabatsira sei?

Press Release

IU.S. Chikafu neDrug Administration (FDA) yakabvumidza Eli Lilly uye Company's (NYSE: LLY) Verzenio® (abemaciclib), mukubatana ne endocrine therapy (tamoxifen kana aromatase inhibitor), yekurapa kweAdjuvant kwevakuru varwere vane hormone receptor- yakanaka (HR +), epidermal yemunhu yekukura factor receptor 2-negative (HER2-), node-positi, gomarara repazamu rekutanga (EBC) iri panjodzi yakanyanya yekudzokazve uye chikamu cheKi-67 che -20% sekusarudzwa neiyo FDA-inogamuchirwa bvunzo. Ki-67 mucherechedzo wekuwedzera kwemaseru. Verzenio ndiyo yekutanga uye chete CDK4 / 6 inhibitor inobvumidzwa kune vakawanda varwere.

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"Nekufamba kwenguva, mhedzisiro yemubatanidzwa weVerzenio kiriniki yekuvandudza chirongwa yakaratidza musiyano CDK4 / 6 inhibitor profil, uye data rakakosha kubva mukutongwa kweMonarchE iyo yakatsigira ichi chiratidzo chitsva muHR + HER2- gomarara repazamu rekutanga rinomiririra rimwe danho rakakosha pamberi pevanhu. ” "Tiri kufara nekubvumidzwa kwekutanga mumamiriro ekuwedzera uye sezvo data iri richiramba richikura, tinotarisira kuwana mimwe mikana yekushanda pamwe nevakuru vezvehutano kuwedzera kushandiswa kweVerzenio munzvimbo iyi."

iye Verzenio Phase 3 monarchE kutongwa kunoitwa zvisina kujairika (1: 1), yakavhurika-mavara, maviri cohort, multicenter kudzidza mune vakadzi vakuru nevarume vane HR + HER2-, node-positive, resected EBC nemakiriniki uye ehutachiona maficha anoenderana nenjodzi huru yezvirwere zvinodzokazve. Mukuyedzwa, varwere vakasarudzika kuti vagamuchire makore maviri eVerzenio 150 mg kaviri zuva nezuva pamwe nesarudzo yechiremba yeyakajairika endocrine kurapwa, kana yakajairwa endocrine kurapa chete. Varwere mune ese ekurapa maoko vakarairwa kuti varambe vachiwana yeadjuvant endocrine kurapwa kweanosvika makore mashanu kusvika kumakumi mashanu sekurudzirwa nachiremba wavo. Mhedzisiro yekupedzisira yechidzidzo iyi inopinda murwere-isina kupona (IDFS) uye yakasangana pane yakatarwa-kuongororwa kwenguva pfupi mune yekuda-kubata-vanhu (ITT) huwandu, ine huwandu hwakakosha hwekuvandudza muIDFS yevarwere vanobatwa neVerzenio plus ET ichienzaniswa neavo vanorapwa neET chete. Inoenderana nemazano ehunyanzvi, IDFS yakatsanangurwa sehurefu hwenguva kenza yemazamu isati yadzoka, chero kenza nyowani inokura, kana kufa. 

Mushure mekuwana yekupedzisira yekupedzisira yekudzidza muhuwandu hwese hwakanyoreswa, yakatsanangurwa-yakatarwa kuongororwa kweIDFS yakaitiswawo mune varwere vane njodzi-yakakura yekiriniki uye yehutachiona zvinhu uye Ki-67 mamakisi -20%. Iyi subgroup kuongorora (N = 2,003) yaisanganisira varwere vane ≥4 yakanaka axillary lymph node (ALN), kana 1-3 yakanaka ALN ine chirwere cheGrade 3 uye / kana saizi size ≥5 cm, uye vane mamota ane Ki-67 mamaki ye - 20%. Ikoko kwaivewo nekuvandudzwa kwakakosha muIDFS yeiyi pre-yakatsanangurwa subgroup yevarwere vanogamuchira Verzenio pamwe ET zvichienzaniswa nevaya vakagamuchira ET chete (HR = 0.643, 95% CI: 0.475, 0.872, p = 0.0042).1,3

Kubvumidzwa uku kunobva pamhedzisiro yekubudirira kubva mukuongororwa kweiyi subgroup nekuwedzera kwekutevera, kunoitwa post-hoc. Mune ongororo iyi, Verzenio yakapihwa pamwe chete neET yakaramba ichiratidza kubatsirwa kwakakosha, iine 37 muzana inoderera mungozi yekenza yemazamu kudzokororwa kana kufa zvichienzaniswa neyakajairwa adjuvant ET chete yevarwere vane njodzi huru yekiriniki uye yehutachiona maficha uye Ki -67 mamakisi ≥20% (HR: 0.626 [95% CI: 0.49-0.80]), uye mhedzisiro inobatsira muIDFS chiitiko chezviitiko zve7.1 muzana pamakore matatu. Huwandu hwezviitiko zveIDFS panguva yekuongorora uku zvaive 104 neVerzenio pamwe ET zvichienzaniswa ne158 neET chete. Pasi rese data rekupona rakanga risina kukura uye kuwedzeredza kuteedzera kuri kuenderera.

Maitiro akashata kubva monarchE aienderana neanozivikanwa maficha ekuchengetedza Verzenio.2 Kuchengetedza uye kushivirira zvakaongororwa muvarwere ve5,591. Mhedzisiro yakajairika yakashumwa (> 10%) muVerzenio pamwe neET (tamoxifen kana aromatase inhibitor) ruoko, uye> 2% yakakwira kupfuura iyo ET ruoko chete, yaive manyoka, hutachiona, kuneta, kuda kurutsa, kutemwa nemusoro, kurutsa, stomatitis , kuderera kwekudya, dzungu, mapundu, uye alopecia.3 Iwo akajairika kuwanda murabhoritari (ese mamakisi ≥10%) aive creatinine akawedzera, chena ropa masero kuverenga akaderera, neutrophil kuverenga yakaderera, kupererwa neropa, lymphocyte kuverenga kwakaderera, platelet kuverenga kwakaderera, ALT yakawedzera, AST yakawedzera, uye hypokalemia.

Iyi mvumo yeDAA inovaka pane yakasimbiswa dumbu reuchapupu hweVerzenio, iyo yakatobvumidzwa kurapwa kweimwe mhando dzeHR + HER2- yepamusoro kana metastatic kenza yemazamu. Panguva imwe chete nekutenderwa uku, iyo FDA yakawedzera kushandiswa kweVerzenio mune zvese zvinoratidza, painopihwa pamwe chete neiyo endocrine therapy, kusanganisira varume. Verzenio inowanikwa mune piritsi simba re200 mg, 150 mg, 100 mg, uye 50 mg.

"Dhizaini uye mhedzisiro ye monarchE kudzidza kuri kuita-kushanduka uye kunomiririra kufambira mberi kwekutanga mukurapa kweHR + HER2- kenza yemazamu munguva yakareba kwazvo," akadaro Sara M. Tolaney, MD, MPH, Harvard Medical School, Dana- Farber Cancer Institute, uye muongorori pane monarchE kudzidza. “Iyi mvumo yeDAA kuVerzenio mukubatana nemushonga we endocrine mukugadzwa kwegomarara repazamu rekutanga une mukana wekuve mwero mutsva wekutarisirwa kwevanhu ava. "Tinokurudzirwa nekudzikiswa kwakanyanya kwenjodzi yekudzoka kunyangwe kupfuura makore maviri ekurapwa muvarwere ava, uye ndinotenda kukwanisa kupa izvi senzira yekurapa kuvarwere vangu."  

“Vakadzi nevarume vari kurarama nenjodzi huru HR + HER2- gomarara repazamu rekutanga vanoda kuita zvese zvavanogona kudzora njodzi yechirwere ichi kudzoka, vaine tarisiro yekurarama vasina gomarara. Kubvumidzwa kwaVerzenio kunopa nzira itsva yekurapa kuvabatsira kuita izvo chaizvo, ”akadaro Jean Sachs, mukuru mukuru, Living Beyond Breast Cancer. "Kubvumidzwa uku kunounza tariro itsva kunharaunda yekenza yemazamu."

Dhata inotsigira iyi mvumo ichaunzwa ku Gumiguru 14European Society yeMedical Oncology (ESMO) Virtual Plenary.

Kunyorwa kweVerzenio kune yambiro uye matanho ekudzivirira, neutropenia, chirwere chemapapu chemukati (ILD / pneumonitis), hepatotoxicity, venous thromboembolism, uye embryo-fetal chepfu. Raira varwere pachiratidzo chekutanga chemasituru akasununguka kuti vatange kurapa kurapa kwemanyoka, kuwedzera zvinwiwa zvemumuromo, uye kuzivisa mupi wezvehutano. Ita zvakakwana kuwanda kweropa uye chiropa chekuita bvunzo usati watanga kurapwa kweVerzenio, vhiki mbiri dzese kwemwedzi miviri yekutanga, pamwedzi kwemwedzi miviri inotevera uye sekuratidzwa kwachiremba. Kubva pamhedzisiro, Verzenio ingangoda kuchinjwa kwedosi. Tarisa varwere nezviratidzo nezviratidzo zvetrombosis uye pulmonary embolism uye ubate sezvakakodzera pakurapa. Raira varwere nezvengozi ingangoitika kumucheche uye kuti vashandise dziviriro inoshanda.

Ona Zvakakosha Zvekuchengetedza Ruzivo pazasi uye zvizere Kunyora Ruzivo nokuti mamwe mashoko.

Click pano kuona yekutanga kenza yemazamu infographic.

Click pano kuona monarchE kiriniki kuyedzwa infographic.

Dzvanya kuti uone iyo Verzenio chigadzirwa mapikicha: 50 mg100 mg150 mg200 mg.

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Nezvomunyori

Juergen T Steinmetz

Juergen Thomas Steinmetz akaramba achishanda muindasitiri yekufambisa uye yekushanya kubva achiri mudiki kuGerman (1977).
Iye akatanga eTurboNews muna 1999 sebhuku rekutanga repamhepo pamhepo yepasirese yekushanya indasitiri yekushanya.

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