Kenza Yekutanga Yezamu: Verzenio inogona kubatsira sei?

Press Release
Avatar yeJuergen T Steinmetz

Iyo US Food and Drug Administration (FDA) yakabvumidza Eli Lilly uye Kambani's (NYSE: LLY) Verzenio® (abemaciclib), pamwe chete ne endocrine therapy (tamoxifen kana aromatase inhibitor), yekurapa adjuvant yevarwere vakuru vane hormone receptor- positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, kenza yemazamu yekutanga (EBC) iri panjodzi huru yekudzokazve uye chibodzwa cheKi-67 che ≥20% sezvakatemwa neFDA-inotenderwa. test. Ki-67 chiratidzo chekuwanda kwemaserura. Verzenio ndiyo yekutanga uye yega CDK4/6 inhibitor yakatenderwa kune iyi huwandu hwevarwere.

"Nekufamba kwenguva, mhedzisiro yeVerzenio kiriniki yekuvandudza chirongwa yakaratidza yakasarudzika CDK4 / 6 inhibitor mbiri, uye data repamusoro kubva kumuyedzo we monarchE yakatsigira chiratidzo chitsva ichi muHR + HER2- kenza yemazamu yekutanga inomiririra imwe nhanho yakakosha yekumberi kuvanhu. avo vari kuda nzira nyowani dzekurapa, "akadaro Jacob Van Naarden, mutevedzeri wemutungamiri wepamusoro, CEO weLoxo Oncology kuLilly uye mutungamiri, Lilly Oncology. "Tinofara nemvumo iyi yekutanga mune adjuvant marongero uye sezvo data iri richiramba richikura, tinotarisira mimwe mikana yekushanda nevakuru vehutano kuwedzera kushandiswa kweVerzenio mumamiriro ezvinhu aya."

iye Verzenio Phase 3 monarchE kuyedza ndeye randomized (1: 1), yakavhurika-label, maviri cohort, multicenter kudzidza muvakadzi vakuru nevarume vane HR+ HER2-, node-positive, yakadzokororwa EBC ine kiriniki uye pathological maficha anoenderana nenjodzi huru. kwekudzoka kwechirwere. Mukuedzwa, varwere vakaverengerwa kuti vagamuchire makore maviri eVerzenio 150 mg kaviri pazuva pamwe nesarudzo yachiremba yeyakajairwa endocrine therapy, kana chiyero endocrine therapy chete. Varwere vari mumaoko maviri ekurapa vakarairwa kuti varambe vachigamuchira adjuvant endocrine therapy kusvika kumakore 5-10 sezvakakurudzirwa nachiremba wavo. Mhedzisiro yekutanga yekudzidza ndeye invasive-free-free survival (IDFS) uye yakasangana pane yakatsanangurwa yenguva pfupi yekuongorora mune chinangwa chekurapa (ITT) vanhu, nenhamba yakakura yekuvandudza IDFS kune varwere vanobatwa neVerzenio plus. ET zvichienzaniswa nevaya vanobatwa neET chete. Zvichienderana nemirayiridzo yenyanzvi, IDFS yakatsanangurwa sehurefu hwenguva kenza yemazamu isati yadzoka, chero kenza nyowani inokura, kana kufa. 

Sezvo tawana mhedziso yekutanga yekudzidza muhuwandu hwese vakanyoresa, kuongororwa kwakafanotaurwa kweIDFS kwakaitwawo kune varwere vane njodzi yakakura yekiriniki uye pathological factor uye Ki-67 mamakisi ≥20%. Ongororo iyi yeboka diki (N=2,003) yaisanganisira varwere vane ≥4 positive axillary lymph nodes (ALN), kana 1-3 yakanaka ALN ine chirwere cheGrade 3 uye/kana saizi yebundu ≥5 cm, uye mapundu aive neKi-67 chibodzwa. ye ≥20%. Paivawo nenhamba yakakosha yekuvandudza muIDFS yeiyi diki diki rakatarwa revarwere vanogamuchira Verzenio plus ET vachienzaniswa nevaya vakagamuchira ET chete (HR = 0.643, 95% CI: 0.475, 0.872, p = 0.0042).1,3

Mvumo iyi inobva pamigumisiro yekubudirira kubva pakuongorora kweboka iri nekuwedzera kwekutevera, kwakaitwa post-hoc. Mukuongorora uku, Verzenio yakapiwa pamwe chete neET yakaramba ichiratidza kubatsirwa kwekliniki, uye kuderera kwe37 muzana mungozi yekenza yemazamu kudzoka kana kufa kana ichienzaniswa neyakajairwa adjuvant ET chete kune varwere vane njodzi yakakura yekiriniki uye pathological features uye Ki. -67 chikamu ≥20% (HR: 0.626 [95% CI: 0.49-0.80]), uye rubatsiro rwakakwana muIDFS chiitiko che 7.1 muzana pamakore matatu. Nhamba yezviitiko zveIDFS panguva yekuongorora iyi yaiva 104 neVerzenio plus ET yakaenzaniswa ne158 neET chete. Yese data yekupona yanga isina kukura uye kumwe kuteedzera kuri kuenderera mberi.

Kuita kwakashata kubva kumonarchE kwaienderana neiyo inozivikanwa kuchengetedza nhoroondo yeVerzenio.2 Kuchengeteka uye kushivirira kwakaongororwa muvarwere ve5,591. Izvo zvinowanzoitika zvakashata zvakashumwa (> 10%) muVerzenio plus ET (tamoxifen kana aromatase inhibitor) ruoko, uye> 2% yakakwirira kudarika ET ruoko chete, yaiva manyoka, zvirwere, kuneta, kushungurudza, musoro, kurutsa, stomatitis. , kuderera kwekuda kudya, dzungu, mapundu, uye alopecia.3 Izvo zvinowanzoitika murabhoritari zvisizvo (magiredhi ese ≥10%) aive creatinine akawedzera, chena masero eropa akadzikira, neutrophil count yakaderera, anemia, lymphocyte count yakaderera, platelet count yakaderera, ALT yakawedzera, AST yakawedzera, uye hypokalemia.

Iyi mvumo yeFDA inovaka pamutumbi wakagadzwa wehumbowo weVerzenio, uyo wakatotenderwa kurapwa kwemamwe marudzi eHR+ HER2- advanced kana metastatic breast cancer. Sangana nemvumo iyi, iyo FDA yakawedzera kushandiswa kweVerzenio mune zvese zviratidzo, kana yapihwa musanganiswa ne endocrine therapy, kusanganisira varume. Verzenio inowanikwa mumapiritsi masimba e200 mg, 150 mg, 100 mg, uye 50 mg.

"Magadzirirwo nemigumisiro yeongororo ye monarchE iri kudzidzira-kuchinja uye inomiririra kufambira mberi kwekutanga mukurapa adjuvant yeHR + HER2- kenza yepazamu munguva yakareba," akadaro Sara M. Tolaney, MD, MPH, Harvard Medical School, Dana- Farber Cancer Institute, uye muongorori pa monarchE kudzidza. "Iyi mvumo yeFDA yeVerzenio yakasanganiswa ne endocrine kurapwa mukutanga kenza yemazamu ine mukana wekuve chiyero chitsva chekutarisira vanhu ava. Tinokurudzirwa nekudzikira kwakanyanya kwenjodzi yekudzokazve kunyangwe kupfuura makore maviri ekurapwa muvarwere ava, uye ndinotenda kukwanisa kupa izvi senzira yekurapa kuvarwere vangu.  

“Madzimai nevarume vari kurarama nenjodzi huru yeHR+ HER2- gomarara repazamu rekutanga vanoda kuita zvese zvavanogona kuderedza njodzi yechirwere ichi kudzoka, vaine tarisiro yekurarama vasina gomarara. Kubvumidzwa kweVerzenio kunopa nzira nyowani yekurapa kuvabatsira kuita izvozvo," akadaro Jean Sachs, mukuru mukuru, Living Beyond Breast Cancer. "Mvumo iyi inounza tariro itsva kunharaunda yegomarara rezamu."

Dhata inotsigira iyi mvumo ichaunzwa paGumiguru 14European Society for Medical Oncology (ESMO) Virtual Plenary.

Mazita eVerzenio ane yambiro nedziviriro dzemanyoka, neutropenia, interstitial lung disease (ILD/pneumonitis), hepatotoxicity, venous thromboembolism, uye embryo-fetal toxicity. Raira varwere pachiratidzo chekutanga chezvituru zvakasununguka kuti vatange kurapa manyoka, kuwedzera mvura yemumuromo, uye kuzivisa mupi wehutano. Ita huwandu hweropa rakazara uye bvunzo dzekushanda kwechiropa usati watanga kurapwa kweVerzenio, mavhiki maviri ega ega kwemwedzi miviri yekutanga, pamwedzi kwemwedzi miviri inotevera uye sekuratidzwa kwekiriniki. Zvichienderana nemhedzisiro, Verzenio ingangoda kushandurwa kwedosi. Chengetedza varwere kune zviratidzo uye zviratidzo zve thrombosis uye pulmonary embolism uye ubate sezvinoenderana nemishonga. Rairira varwere nezvenjodzi kumwana ari mudumbu uye kuti vashandise nzira dzekudzivirira nadzo pamuviri.

Ona Ruzivo Rwakakosha Chekuchengetedza pazasi uye ruzere Kunyora Ruzivo nokuti mamwe mashoko.

Click pano kuona kenza yezamu yekutanga infographic.

Click pano kuona iyo monarchE kliniki yekuedza infographic.

Dzvanya kuti uone mafoto echigadzirwa cheVerzenio: 50 mg100 mg150 mg200 mg.

Nezvomunyori

Avatar yeJuergen T Steinmetz

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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