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Khansa ya m'mawere yoyambirira: Kodi Verzenio angathandize bwanji?

Press Kumasulidwa

US Food and Drug Administration (FDA) yavomereza Eli Lilly and Company's (NYSE: LLY) Verzenio® (abemaciclib), kuphatikiza mankhwala a endocrine (tamoxifen kapena aromatase inhibitor), pochiza adjuvant odwala achikulire omwe ali ndi hormone receptor- zabwino (HR +), epidermal growth factor receptor 2-negative (HER2-), node-positive, khansa ya m'mawere yoyambirira (EBC) yomwe ili pachiwopsezo chachikulu choti ingabwererenso komanso kuchuluka kwa Ki-67 kwa ≥20% malinga ndi kuvomerezedwa ndi FDA yesani. Ki-67 ndi chodziwitsa kuchuluka kwa ma cell. Verzenio ndiye woyamba kupatula CDK4 / 6 inhibitor yovomerezeka kwa odwalawa.

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"Popita nthawi, zotsatira zonse za pulogalamu ya chitukuko cha Verzenio zawonetsa mbiri yosiyanitsa ya CDK4 / 6, komanso mbiri yodziwika bwino yoyesedwa ndi monarchE yomwe idathandizira izi ku HR + HER2- khansa ya m'mawere yoyambirira ikuyimira gawo lina lofunikira kwa anthu omwe akusowa njira zatsopano zamankhwala, "atero a Jacob Van Naarden, wachiwiri kwa wachiwiri kwa wamkulu wa Loxo Oncology ku Lilly komanso purezidenti, Lilly Oncology. "Ndife okondwa ndi kuvomerezedwa koyamba pamasamba a adjuvant ndipo popeza manambalawa akupitilira kukula, tikuyembekeza mwayi wina wogwira ntchito ndi azaumoyo kukulitsa kugwiritsa ntchito Verzenio munthawi imeneyi."

iye Verzenio Phase 3 monarchE kuyeserera ndi kosasintha (1: 1), lotseguka, magulu awiri, ophunzirira ambiri mwa akazi achikulire ndi amuna omwe ali ndi HR + HER2-, node-positive, resected EBC yokhala ndi zovuta zamankhwala komanso zamatenda zomwe zili pachiwopsezo chachikulu matenda obwereza. Poyeserera, odwala adasinthidwa kuti alandire zaka ziwiri za Verzenio 150 mg kawiri tsiku lililonse kuphatikiza kusankha kwa mankhwala a endocrine, kapena mankhwala a endocrine okha. Odwala m'manja onse azachipatala adalangizidwa kuti apitilize kulandira mankhwala a adjuvant endocrine kwa zaka 5-10 malinga ndi momwe adokotala awo akuwalimbikitsira. Mapeto oyambira a phunziroli ndi kupulumuka kopanda matenda (IDFS) ndipo adakumana nawo pakuwunika kwakanthawi komwe kudachitika mwa anthu ofuna chithandizo (ITT), ndikuwunika kwakukulu kwa IDFS kwa odwala omwe amathandizidwa ndi Verzenio kuphatikiza ET poyerekeza ndi omwe amathandizidwa ndi ET okha. Mogwirizana ndi malangizo a akatswiri, IDFS idatanthauzidwa ngati nthawi yayitali khansa ya m'mawere isanabwerere, khansa yatsopano iliyonse imayamba, kapena kufa. 

Atakwaniritsa gawo lomaliza la phunziroli mwa anthu onse omwe adalembetsa, kusanthula kwa IDFS kudachitidwanso kwa odwala omwe ali pachiwopsezo chazachipatala komanso zamatenda komanso Ki-67 ≥20%. Kufufuza kwamaguluwa (N = 2,003) kunaphatikizapo odwala omwe ali ndi ≥4 ma axillary lymph node (ALN), kapena 1-3 ya ALN yokhala ndi matenda a grade 3 ndi / kapena kukula kwa chotupa cm5 cm, ndipo omwe zotupa zawo zidali ndi Ki-67 ya ≥20%. Panalinso kusintha kwakukulu kwa IDFS pagulu latsambali la odwala omwe amalandira Verzenio kuphatikiza ET poyerekeza ndi omwe adalandira ET yokha (HR = 0.643, 95% CI: 0.475, 0.872, p = 0.0042).1,3

Chivomerezochi chimachokera pazotsatira zothandiza pakuwunika kwa kagulu kameneka ndikuwonjezeranso kwina, kochitidwa pambuyo pa hoc. Pakuwunika uku, Verzenio woperekedwa limodzi ndi ET adapitilizabe kuwonetsa phindu lake, ndikuchepetsa kwa 37% pachiwopsezo cha kubwereranso kwa khansa ya m'mawere kapena kufa poyerekeza ndi adjuvant ET yokhayo kwa odwala omwe ali pachiwopsezo chazachipatala komanso zamatenda komanso Ki -67 mphambu ≥20% (HR: 0.626 [95% CI: 0.49-0.80]), ndi phindu lenileni pamiyeso ya IDFS ya 7.1% pazaka zitatu. Chiwerengero cha zochitika za IDFS panthawi yakusanthula iyi zinali 104 ndi Verzenio kuphatikiza ET poyerekeza ndi 158 ndi ET yokha. Zambiri pakupulumuka sizinali zokhwima ndipo zina zikuchitika.

Zoyipa kuchokera ku monarchE zinali zogwirizana ndi mbiri yodziwika yachitetezo cha Verzenio.2 Chitetezo ndi kulolerana adayesedwa mwa odwala 5,591. Zotsatira zoyipa kwambiri zomwe zanenedwa (> 10%) mu Verzenio kuphatikiza ET (tamoxifen kapena aromatase inhibitor) mkono, ndipo> 2% kuposa mkono wa ET wokha, anali kutsegula m'mimba, matenda, kutopa, nseru, mutu, kusanza, stomatitis , kuchepa kwa njala, chizungulire, zotupa, ndi alopecia.3 Zovuta zopezeka kwambiri mu labotale (magiredi onse ≥10%) anali creatinine kuchuluka, kuchuluka kwa maselo oyera am'magazi kunachepa, kuchuluka kwa neutrophil kunachepa, kuchepa kwa magazi, kuchuluka kwa ma lymphocyte kunachepa, kuchuluka kwa ma platelet kunachepa, ALT idakwera, AST idakulira, ndi hypokalemia.

Kuvomerezeka kwa FDA kumakhazikika pa umboni wokwanira wa Verzenio, womwe wavomerezedwa kale kuti athetse mitundu ina ya khansa ya m'mawere ya HR + HER2- kapena yotupa. Pogwirizana ndi kuvomereza uku, a FDA adakulitsa kugwiritsa ntchito Verzenio m'njira zonse, akapatsidwa kuphatikiza mankhwala a endocrine, kuphatikiza amuna. Verzenio imapezeka piritsi lamphamvu la 200 mg, 150 mg, 100 mg, ndi 50 mg.

"Mapangidwe ndi zotsatira za kafukufuku wa monarchE akusintha ndikuwonetsa kupita patsogolo koyamba kwa chithandizo chamankhwala cha khansa ya m'mawere ya HR + HER2 nthawi yayitali," atero a Sara M. Tolaney, MD, MPH, Harvard Medical School, Dana- Farber Cancer Institute, komanso wofufuza kafukufuku wa monarchE. "Kuvomerezeka kwa FDA iyi kwa Verzenio kuphatikiza mankhwala a endocrine m'matenda oyambilira a khansa ya m'mawere kumatha kukhala chisamaliro chatsopano cha anthuwa. Tili olimbikitsidwa ndi kuchepa kwa chiopsezo chobwereranso ngakhale kupitirira zaka ziwiri zothandizira odwalawa, ndipo ndikuthokoza kuti nditha kupereka izi ngati chithandizo kwa odwala anga. ”  

"Amayi ndi abambo omwe ali pachiwopsezo chachikulu khansa ya m'mawere ya HR + HER2- akufuna kuchita zonse zomwe angathe kuti achepetse matendawa, ndi chiyembekezo chokhala opanda khansa. Kuvomerezeka kwa Verzenio kumapereka njira yatsopano yothandizira kuti athe kuchita izi, "atero a Jean Sachs, wamkulu wamkulu, Living Beyond Breast Cancer. "Kuvomerezedwa kumeneku kumabweretsa chiyembekezo chatsopano pagulu la khansa ya m'mawere."

Zambiri zovomereza izi zidzafotokozedwa pa Okutobala 14European Society for Medical Oncology (ESMO) Virtual Plenary.

Kulemba kwa Verzenio kuli ndi machenjezo ndi zodzitetezera m'mimba, neutropenia, matenda am'mapapo am'mapapo (ILD / pneumonitis), hepatotoxicity, venous thromboembolism, ndi poizoni wa mluza. Langizani odwala pachizindikiro choyamba chazinyalala kuti ayambitse mankhwala oletsa kutsegula m'mimba, kuwonjezera zakumwa zam'kamwa, ndikudziwitsa omwe amawapatsa chithandizo chamankhwala. Yesetsani kuwerengera magazi kwathunthu ndikuwunika kwa chiwindi ntchito isanayambike ya Verzenio, milungu iwiri iliyonse kwa miyezi iwiri yoyambirira, mwezi uliwonse kwa miyezi iwiri ikubwerayi komanso monga akuwonetsera kuchipatala. Kutengera zotsatira, Verzenio angafunike kusintha kwa mlingo. Onetsetsani odwala pazizindikiro za thrombosis ndi embolism pulmonary embolism ndikuwathandiza ngati azachipatala. Kulangiza odwala za chiopsezo kwa mwana wosabadwayo ndi kugwiritsa ntchito njira zolera zothandiza.

Onani Zambiri Zachitetezo pansipa ndi zonse Kupanga Zidziwitso Kuti mudziŵe.

Dinani Pano kuti muwone khansa ya m'mawere yoyambirira infographic.

Dinani Pano kuti muwone monarchE yachipatala infographic.

Dinani kuti muwone zithunzi za Verzenio: 50 mg100 mg150 mg200 mg.

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Wachinyamata T Steinmetz

Juergen Thomas Steinmetz wakhala akugwirabe ntchito zapaulendo komanso zokopa alendo kuyambira ali wachinyamata ku Germany (1977).
Iye adayambitsa eTurboNews mu 1999 ngati nkhani yoyamba yapaintaneti yantchito zapaulendo padziko lonse lapansi.

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