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Umdlavuza Webele Wasekuqaleni: Ungasiza kanjani uVerzenio?

Isitatimende sephephandaba

I-US Food and Drug Administration (i-FDA) ivume i-Eli Lilly and Company's (NYSE: LLY) iVerzenio® (abemaciclib), ngokuhlangana ne-endocrine therapy (tamoxifen noma i-aromatase inhibitor), yokwelashwa okunamandla kweziguli ezindala ezine-hormone receptor- i-positive (HR +), i-human epidermal growth factor receptor 2-negative (HER2-), i-node-positive, umdlavuza webele wokuqala (i-EBC) engcupheni enkulu yokuphindeka kanye nesilinganiso se-Ki-67 se- ~ 20% njengoba kunqunywe yi-FDA-evunyelwe yi-FDA ukuhlolwa. I-Ki-67 imaka yokwanda kwamaselula. IVerzenio iyona futhi i-CDK4 / 6 inhibitor yokuqala evunyelwe kulesi siguli.

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“Ngokuhamba kwesikhathi, imiphumela ehlanganyelwe yohlelo lokuthuthukiswa komtholampilo iVerzenio ikhombise umehluko wephrofayili ye-CDK4 / 6 inhibitor, kanye nedatha eyingqophamlando evela ocwaningweni lwe-monarchE olwasekela le nkomba entsha ku-HR + HER2- umdlavuza webele wokuqala imele esinye isinyathelo esibalulekile esidlulela phambili kubantu abadinga izindlela ezintsha zokwelashwa, ”kusho uJacob Van Naarden, iphini likamongameli omkhulu, isikhulu esiphezulu seLoxo Oncology eLilly kanye nomongameli, uLilly Oncology. "Sijabule ngalokhu kuvunyelwa kokuqala esimweni esisebenzisanayo futhi njengoba le mininingwane iqhubeka nokukhula, silangazelele ukuthola amanye amathuba okusebenzisana nabaphathi bezempilo ukukhulisa ukusetshenziswa kweVerzenio kulesi simo."

Isivivinyo se-Verzenio Phase 3 monarchE senziwa ngokungahleliwe (1: 1), ilebula evulekile, iqoqo lamaqembu amabili, isifundo se-multicenter kwabesifazane abadala nakwabesilisa abane-HR + HER2-, i-node-positive, baphinde bavusa i-EBC enezici zomtholampilo nezifo ezihambisana nobungozi obukhulu kokuphindaphinda kwezifo. Esivivinyweni, iziguli zazihlelwe ngokungahleliwe ukuthola iminyaka emibili kaVerzenio 150 mg kabili ngosuku kanye nokukhethwa kukadokotela kokwelapha okujwayelekile kwe-endocrine, noma ukwelashwa okujwayelekile kwe-endocrine kuphela. Iziguli ezingalweni zombili zokwelashwa ziyalelwe ukuthi ziqhubeke nokuthola ukwelashwa kwe-adjuvant endocrine kuze kube yiminyaka eyi-5-10 njengoba kunconywe udokotela wabo. Isiphetho esiyinhloko socwaningo ukusinda okungenasifo okungenasifo (i-IDFS) futhi kwahlangatshezwana naso ekuhlaziyweni kwesikhashana okucacisiwe kubantu bezinhloso zokwelapha (i-ITT), ngokuthuthuka okuphawulekayo kwe-IDFS kweziguli ezelashwa nge-Verzenio plus I-ET iqhathaniswa nalabo abaphathwa nge-ET kuphela. Ngokuhambisana nemihlahlandlela yochwepheshe, i-IDFS ichazwe njengobude besikhathi ngaphambi kokuba umdlavuza webele ubuye, noma yimuphi umdlavuza omusha uqala, noma ukufa. 

Ngemuva kokuthola iphuzu lokugcina eliyinhloko lokutadisha kulo lonke inani labantu ababhalisile, ukuhlaziywa kwangaphambilini kwe-IDFS kwenziwa futhi ezigulini ezinezinto ezinobungozi obukhulu bemitholampilo kanye nezifo kanye ne-Ki-67 score ≥20%. Lokhu kuhlaziywa kweqembu (N = 2,003) kufaka iziguli ezine-ill4 i-axillary lymph node (ALN), noma i-ALN eyi-1-3 enesifo seBanga 3 kanye / noma usayizi wesisu ≥5 cm, futhi izicubu zazo ezinamaphuzu e-Ki-67 kwe- ≥20%. Kwakukhona nokuthuthuka okuphawulekayo kwezibalo kuma-IDFS kuleli qembu elichazwe ngaphambilini leziguli ezithola iVerzenio kanye ne-ET uma kuqhathaniswa nalabo abathola i-ET kuphela (HR = 0.643, 95% CI: 0.475, 0.872, p = 0.0042).1,3

Lokhu kugunyazwa kusekelwe emiphumeleni yokusebenza okuhle kusukela ekuhlaziyweni kwaleli qembu elincane ngokulandelwa okungeziwe, okwenziwe ngemuva kwe-hoc. Kulokhu kuhlaziywa, iVerzenio enikezwe ihlanganiswe ne-ET iqhubeke nokukhombisa inzuzo ebonakalayo emtholampilo, ngehle ngamaphesenti angama-37 engozini yokuphindeka noma umdlavuza webele uma kuqhathaniswa ne-ET ejwayelekile ye-adjuvant yeziguli ezinengozi enkulu yezimpawu zomtholampilo kanye nezifo kanye ne-Ki -67 amaphuzu ≥20% (HR: 0.626 [95% CI: 0.49-0.80]), kanye nenzuzo ephelele kumazinga womcimbi we-IDFS wamaphesenti ayi-7.1 eminyakeni emithathu. Inani lemicimbi ye-IDFS ngesikhathi salokhu kuhlaziywa kwakungu-104 ngeVerzenio kanye ne-ET uma kuqhathaniswa ne-158 ne-ET kuphela. Imininingwane yokusinda isiyonke ibingavuthiwe futhi ukulandelelwa okungeziwe kuyaqhubeka.

Ukusabela okungekuhle okuvela ku-monarchE bekuhambisana nephrofayili yokuphepha eyaziwayo yeVerzenio.2 Ukuphepha nokubekezelelana kuhlolwe ezigulini ezingama-5,591. Ukuphendula okuvame kakhulu ukubikwa (> 10%) ku-Verzenio plus ET (tamoxifen noma i-aromatase inhibitor) ingalo, futhi> 2% ngaphezulu kunengalo ye-ET iyodwa, bekunguhudo, izifo, ukukhathala, isicanucanu, ikhanda, ukuhlanza, i-stomatitis , ukuncipha kokudla, isiyezi, ukuqubuka kanye ne-alopecia.3 Okungajwayelekile okwejwayelekile kwelabhorethri (wonke amamaki ≥10%) kwakhushulwe i-creatinine, kwehla isibalo samaseli amhlophe egazi, kwehla isibalo se-neutrophil, i-anemia, isibalo se-lymphocyte sehla, isibalo seplatelet sehla, i-ALT yanda, i-AST yanda, ne-hypokalemia.

Lokhu kuvunyelwa kwe-FDA kwakhela phezu kobufakazi obusunguliwe beVerzenio, obusuvele buvunyiwe ukwelashwa kwezinhlobo ezithile zomdlavuza webele we-HR + HER2- advanced noma we-metastatic. Ngokuhambisana nalokhu kugunyazwa, i-FDA ikhulise ukusetshenziswa kweVerzenio kuzo zonke izinkomba, lapho inikezwa ngokuhlanganiswa nokwelashwa kwe-endocrine, ukufaka amadoda. IVerzenio itholakala kumandla wethebulethi ka-200 mg, 150 mg, 100 mg, no-50 mg.

"Ukwakheka nemiphumela yocwaningo lwe-monarchE kuyashintsha futhi kumele inqubekela phambili yokuqala ekwelashweni okwenziwe ngomdlavuza webele kwabakwa-HR + HER2 esikhathini eside kakhulu," kusho uSara M. Tolaney, MD, MPH, Harvard Medical School, Dana- I-Farber Cancer Institute, nomphenyi ocwaningweni lwe-monarchE. “Lokhu kuvunyelwa kwe-FDA kuVerzenio kuhlangene nokwelashwa kwe-endocrine esimweni sokuqala komdlavuza webele kunamandla okuba yindinganiso entsha yokunakekelwa kwalaba bantu. Kuyasikhuthaza ukwehla okuphawulekayo engcupheni yokuphindeka ngisho nangemva kweminyaka emibili yokwelashwa kulezi ziguli, futhi ngiyabonga ngokukwazi ukunikeza lokhu njengendlela yokwelashwa ezigulini zami. ”  

“Abesifazane nabesilisa abaphila nengozi ephezulu yomdlavuza webele u-HR + HER2- bafuna ukwenza konke okusemandleni ukunciphisa ubungozi besifo obubuyayo, benethemba lokuphila ngaphandle komdlavuza. Ukugunyazwa kukaVerzenio kunikeza indlela entsha yokwelashwa ukubasiza benze lokho kanye, ”kusho uJean Sachs, isikhulu esiphezulu, i-Living Beyond Breast Cancer. "Lokhu kuvunywa kuletha ithemba elisha emphakathini womdlavuza webele."

Imininingwane esekela lokhu kuvunyelwa izokwethulwa ngo-Okthoba 14European Society for Medical Oncology (ESMO) Virtual Plenary.

Ukuphawulwa kweVerzenio kuqukethe izexwayiso nokuqapha isifo sohudo, i-neutropenia, isifo samaphaphu esiphakathi (i-ILD / pneumonitis), i-hepatotoxicity, i-venous thromboembolism, nobuthi bembungu-mbungu. Yala iziguli lapho kuqala uphawu lwezitulo ezixekethile ukuqala imishanguzo yokulwa nesifo sohudo, ukwandisa uketshezi lomlomo, nokwazisa umhlinzeki wazo wezokunakekelwa kwempilo. Yenza ukubalwa kwegazi okuphelele nokuhlolwa kokusebenza kwesibindi ngaphambi kokuqala kokwelashwa kukaVerzenio, njalo emavikini amabili ezinyangeni ezimbili zokuqala, njalo ngenyanga ezinyangeni ezimbili ezizayo futhi njengoba kukhonjisiwe emtholampilo. Ngokuya ngemiphumela, iVerzenio ingadinga ukuguqulwa komthamo. Gada iziguli ngezimpawu nezimpawu ze-thrombosis kanye ne-pulmonary embolism futhi uphathe njengokufanele ngokwezokwelapha. Ukweluleka iziguli ngobungozi obungase bube khona kumbungu nokuthi zisebenzise izindlela zokuvimbela inzalo ezisebenzayo.

Bheka Imininingwane Yezokuphepha Ebalulekile ngezansi futhi igcwele Kuchaza Ulwazi Ngolwazi olwengeziwe.

Chofoza lapha ukubuka umdlavuza webele wokuqala i-infographic.

Chofoza lapha ukubuka i-monarchE clinical trial infographic.

Chofoza ukuze ubuke izithombe zomkhiqizo we-Verzenio: I-50 mgI-100 mgI-150 mgI-200 mg.

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UJuergen T Steinmetz

UJuergen Thomas Steinmetz ubelokhu esebenza ngokuqhubekayo embonini yezokuvakasha nezokuvakasha kusukela esemusha eJalimane (1977).
Wasungula eTurboNews ngo-1999 njengencwajana yokuqala ye-inthanethi embonini yezokuvakasha yezokuvakasha emhlabeni jikelele.

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