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Umhlaza Webele: Unganceda njani uVerzenio?

cinezela Ukhupho

I-US Food and Drug Administration (i-FDA) yamkele u-Eli Lilly kunye neNkampani (i-NYSE: LLY) iVerzenio® (abemaciclib), ngokudibanisa nonyango lwe-endocrine (tamoxifen okanye i-aromatase inhibitor), kunyango olongezelelekileyo lwezigulana zabantu abadala ezine-hormone receptor- I-HIV (HR +), ukukhula kwe-epidermal factor receptor 2-negative (HER2-), i-node-positive, umdlavuza webele kwangoko (i-EBC) emngciphekweni omkhulu wokuphindaphinda kunye nenqaku le-Ki-67 le -20% njengoko kumiselwe yi-FDA-evunyiweyo vavanyo. I-Ki-67 ngummakishi wokwanda kwamaselula. IVerzenio yeyokuqala kwaye kuphela CDK4 / 6 inhibitor evunyiweyo kwesi sigulana.

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“Ixesha elingaphezulu, iziphumo ezihlangeneyo zenkqubo yophuhliso lweklinikhi yaseVerzenio ibonakalise umahluko we-CDK4 / 6 inhibitor, kunye nedatha ebalaseleyo evela kuvavanyo lwe-monarchE olwaxhasa lo mqondiso mtsha kwi-HR + HER2- umhlaza webele kwangoko umele elinye inyathelo elibalulekileyo eliya phambili ebantwini. abo bafuna unyango olutsha, ”utshilo uJacob Van Naarden, usekela mongameli omkhulu, u-CEO weLoxo Oncology eLilly nakumongameli, Lilly Oncology. "Siyavuya ngale mvume yokuqala kwisimo se-adjuvant kwaye njengoko ezi datha ziqhubeka nokukhula, sijonge phambili kumathuba ongezelelweyo okusebenzisana nabasemagunyeni kwezempilo ukwandisa ukusetyenziswa kweVerzenio kwesi simo."

Uvavanyo lwe-Verzenio Phase 3 monarchE lucwangcisiwe (1: 1), ileyibhile evulekileyo, amaqela amabini, ukufundisisa kwabasetyhini abadala kunye nabesilisa abane-HR + HER2-, i-node-positive, bavuselela i-EBC ngeempawu zeklinikhi kunye nezifo ezihambelana nomngcipheko omkhulu zokuphindaphinda kwesifo. Kwilingo, abaguli babengenamkhethe ukuba bafumane iminyaka emibini yeVerzenio 150 mg kabini yonke imihla kunye nokukhethwa ngugqirha kunyango oluqhelekileyo lwe-endocrine, okanye unyango oluqhelekileyo lwe-endocrine kuphela. Izigulana zozibini iingalo zonyango ziyalelwe ukuba ziqhubeke nokufumana unyango lwe-endocrine ukuya kwi-5-10 iminyaka njengoko kucetyisiwe ngugqirha wabo. Isiphelo sokugqibela sesifundo kukungabikho kwezifo ezingenasifo (i-IDFS) kwaye kwahlangatyezwana nakohlalutyo lwethutyana oluchaziweyo kwinani lokunyanga (i-ITT), kunye nokuphuculwa okubalulekileyo kwe-IDFS kwizigulana eziphathwe ngeVerzenio plus ET xa kuthelekiswa nezo ziphathwe nge-ET kuphela. Ngokuhambelana nezikhokelo zeengcali, i-IDFS yachazwa njengobude bexesha ngaphambi kokuba umhlaza webele ubuye, nawuphina umhlaza omtsha uvela, okanye ukufa. 

Emva kokufikelela kwinqanaba lokugqibela lokufunda kubemi bonke ababhalisileyo, uhlalutyo oluchazwe kwangaphambili lwe-IDFS lwaluqhutyelwa nakwizigulana ezinobungozi obukhulu bezonyango kunye nezifo kunye nenqaku le-Ki-67 ≥20%. Olu hlalutyo lweqelana (N = 2,003) lubandakanya abaguli abane-ill4 i-axillary lymph node (ALN), okanye i-1-3 elungileyo ye-ALN enesifo seBakala 3 kunye / okanye ubungakanani besisu ≥5 cm, kunye nezidumba ezinamanqaku e-Ki-67 ye ~ 20%. Kwakukho nophuculo olubalulekileyo ngokweenkcukacha-manani kwi-IDFS yeli qela lichazwe kwangaphambili lezigulana ezifumana iVerzenio kunye ne-ET xa kuthelekiswa nabo bafumana i-ET kuphela (HR = 0.643, 95% CI: 0.475, 0.872, p = 0.0042).1,3

Oku kuvunywa kusekwe kwiziphumo zokusebenza kakuhle kuhlalutyo lweli qelana kunye nolandelelo olongezelelekileyo, olwenziwe emva kwe-hoc. Kolu hlalutyo, iVerzenio inikwe ngokudibeneyo ne-ET iyaqhubeka nokubonisa isibonelelo esibonakalayo eklinikhi, nge-37 yeepesenti yokuncipha komngcipheko wokuphindaphinda komhlaza wamabele okanye wokufa xa kuthelekiswa ne-ET yesiqhelo ye-adjuvant kuphela kwizigulana ezinobungozi obukhulu beempawu zeklinikhi kunye nezifo kunye ne-Ki. Amanqaku -67 amanqaku ≥20% (HR: 0.626 [95% CI: 0.49-0.80]), kunye nesibonelelo esipheleleyo kwizinga lomsitho we-IDFS weepesenti ze-7.1 kwiminyaka emithathu. Inani leziganeko ze-IDFS ngexesha lolu hlalutyo lwaluyi-104 kunye neVerzenio kunye ne-ET xa kuthelekiswa ne-158 ne-ET kuphela. Idatha yokuphila ngokubanzi yayingakhuli kwaye ukulandelelwa okongeziweyo kuyaqhubeka.

Iziphumo ezingalunganga ezivela ku-monarchE zazingqinelana neprofayili yokhuseleko eyaziwayo yeVerzenio.2 Ukhuseleko kunye nokunyamezelana kuvavanywe kwizigulana ezingama-5,591. Ezona mpembelelo zixhaphakileyo zixeliweyo (> 10%) kwiVerzenio kunye ne-ET (tamoxifen okanye iaromatase inhibitor) ingalo, kunye> 2% ngaphezulu kwengalo ye-ET iyodwa, yayisisifo sorhudo, usulelo, ukudinwa, isicaphucaphu, intloko ebuhlungu, ukugabha, isifo sokuqaqanjelwa sisisu , ukuncipha kokutya, isiyezi, irhashalala kunye nealopecia.3 Ezona zinto zixhaphakileyo elebhu (onke amabakala ≥10%) ayonyusa i-creatinine, inani leeseli ezimhlophe zehla, ukubala kwe-neutrophil kwehla, i-anemia, ukubala kwe-lymphocyte kwehla, ukubala kweplatelet kwehla, i-ALT yanda, i-AST yanda, kunye ne-hypokalemia.

Oku kuvunywa kwe-FDA kwakhela kubungqina obusekiweyo beVerzenio, esele ivunyiwe kunyango lweentlobo ezithile ze-HR + HER2- yomhlaza webele we-HR okanye ye-metastatic. Ngaxeshanye nalo mvume, i-FDA ikwandisile ukusetyenziswa kweVerzenio kuzo zonke izikhombisi, xa inikwa ngokudibeneyo nonyango lwe-endocrine, ukubandakanya amadoda. IVerzenio iyafumaneka kumandla eethebhulethi ye-200 mg, 150 mg, 100 mg, kunye ne-50 mg.

"Uyilo kunye neziphumo zophononongo lwe-monarchE ziyatshintsha kwaye zibonisa inkqubela phambili yokuqala kunyango lwe-HR + HER2- umhlaza webele kwithuba elide, utshilo uSara M. Tolaney, MD, MPH, Harvard Medical School, Dana- IZiko lomhlaza le-Farber, kunye nomphandi kwisifundo se-monarchE. “Oku kuvunywa kwe-FDA kuVerzenio kudityaniswe nonyango lwe-endocrine kuseto lomhlaza webele webele kusenokwenzeka ukuba lube ngumgangatho omtsha wokhathalelo kwabahlali. Kuyasikhuthaza ukuncitshiswa okuphezulu komngcipheko wokuphinda uvele nangaphaya kweminyaka emibini yonyango kwezi zigulana, kwaye ndinombulelo ngokukwazi ukunika oku njengonyango kunyango lwezigulana zam. ”  

“Abasetyhini kunye namadoda aphila emngciphekweni omkhulu we-HR + HER2- umhlaza webele kwangoko bafuna ukwenza konke okusemandleni abo ukunciphisa umngcipheko wesifo ukubuya, benethemba lokuphila ngaphandle komhlaza. Ukuvunywa kukaVerzenio kunika unyango indlela entsha yokubanceda benze kanye loo nto, utshilo uJean Sachs, igosa eliyintloko, Living Beyond Cancer Breast. "Oku kuvunywa kuzisa ithemba elitsha kuluntu olunomhlaza wamabele."

Idatha exhasa oku kuvunywa iya kuboniswa ngo-Okthobha u-14 uMbutho wase-Europe we-Medical Oncology (ESMO) iPlenary eyiyo.

Ilebhile yeVerzenio iqulethe izilumkiso kunye nokuthintela isifo sohudo, i-neutropenia, isifo semiphunga (i-ILD / pneumonitis), i-hepatotoxicity, i-venous thromboembolism, kunye ne-embryo-fetal toxicity. Yalela abaguli kwisibonakaliso sokuqala sezitulo ezikhululekileyo zokuqalisa unyango lwe-antidiarrheal, ukwandisa ulwelo lomlomo, kunye nokwazisa umboneleli wabo wezempilo. Yenza ubalo olupheleleyo lwegazi kunye novavanyo lomsebenzi wesibindi ngaphambi kokuqala konyango lweVerzenio, rhoqo emva kweeveki ezimbini kwiinyanga ezimbini zokuqala, inyanga nenyanga kwiinyanga ezimbini ezizayo nanjengoko kubonisiwe eklinikhi. Ngokusekwe kwiziphumo, iVerzenio inokufuna ukuguqulwa kwedosi. Ukubeka iliso kwizigulana kwiimpawu kunye neempawu ze-thrombosis kunye ne-pulmonary embolism kunye nokunyanga ngokufanelekileyo ngokwezonyango. Ukucebisa abaguli ngomngcipheko onokubakho kwimveku engekazalwa kwaye basebenzise indlela efanelekileyo yokuthintela ukukhulelwa.

Jonga Iinkcukacha zoKhuseleko eziBalulekileyo apha ngezantsi kwaye ugcwele Ukuchaza Ulwazi Ngolwazi olongezelelweyo.

nqakraza Apha ukujonga isifo somhlaza webele kwangoko.

nqakraza Apha ukujonga i-monarchE klinikhi yolingo infographic.

Cofa ukujonga iifoto zemveliso yeVerzenio: 50 mg100 mg150 mg200 mg.

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UJuergen T Steinmetz

UJuergen Thomas Steinmetz uqhubekile esebenza kwishishini lokuhamba nokhenketho okoko wafikisa eJamani (1977).
Uye waseka eTurboNews ngo-1999 njengephepha leendaba lokuqala kwi-intanethi kushishino lokhenketho lwehlabathi.

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