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INeratinib

 

  1. Sazi kangakanani malunga nomhlaza webele?
  2. Iziphumo zeKlinikhi yi-FDA Apprvoal
  3. Yintoni iNeratinib?
  4. Ngubani onokufuna iNeratinib?
  5. Ukwazi njani ukuba i-Neratinib ilungile kuwe?
  6. Isebenza njani iNeratinib?
  7. Siyithatha njani iNeratinib?
  8. Yintoni esinokuyibona kwiziphumo ebezingalindelekanga zeNeratinib?
  9. isiphelo

 

Sazi kangakanani malunga Umhlaza webele

Umhlaza webele lolona hlobo luqhelekileyo lomhlaza kwabasetyhini, emele i-15% yazo zonke iimeko zomhlaza eMelika. Ngo-2017, iimeko ezingama-252,710 ezitsha zomhlaza wamabele zaqikelelwa ukuba zafunyaniswa, kwaye ngaphezulu kwabafazi abangama-40,600 babulawa sesi sifo. Umhlaza wamabele nawo, kunqabile, unokuchaphazela amadoda, malunga nama-2470 amatyala amatsha afunyaniswa minyaka le.

Malunga ne-15% ukuya kwi-20% yamathumba omhlaza webele ane-HER2-positive. Umhlaza wamabele onamanqanaba aphezulu e-HER2 unobungozi obonyukayo be-metastasis, impendulo engonelanga yonyango, kunye nokuphindaphinda.

Ukuphuhliswa kunye noLawulo olulandelayo lwe-US Food and Drug Administration (FDA) lwe-trastuzumab (Herceptin), i-HER2 receptor antagonist, itshintshe iparadigm yonyango kwizigulana ezinesifo esine-HER2. Xa i-trastuzumab yongezwa kwi-chemotherapy, amaxabiso okusinda kwabafazi abanamanqanaba okuqala Umhlaza webele ongu-HER2 ziphuculwe ukuya kuthi ga kwiipesenti ezingama-37. Nangona kunjalo, malunga ne-26% yezigulana ezinezifo eziphindaphindayo emva konyango nge-trastuzumab.

Olunye unyango olujolise kumhlaza webele we-HER2-positive lubandakanya i-pertuzumab (Perjeta), i-anti-monoclonal antibody; ado-trastuzumab emtansine (Kadcyla), i-monoclonal antibody eqhotyoshelwe kwichiza le-chemotherapy; kunye ne-lapatinib (iTykerb), i-kinase inhibitor.

 

Iziphumo zonyango Ngu-Apprvoal ka-FDA

Ukuvunywa kwe-FDA kweNeratinib kwakusekwe kwilingo leSigaba III se-ExteNET, isilingo esinezixhobo ezininzi, esingahleliwe, esingaboniyo, esilawulwa yi-placebo se-neratinib elandela unyango lwe-adjuvant trastuzumab. Ityala labhalisa abasetyhini abangama-2,840 abanesifo somhlaza webele we-HER2-inqanaba lokuqala kwaye kwisithuba seminyaka emibini yokugqiba i-adjuvant trastuzumab. Izifundo bezingahleliwe ukuba zifumane i-neratinib (n = 1420) okanye i-placebo (n = 1420) unyaka omnye. Iziphumo zovavanyo lwe-ExteNET zibonise ukuba emva kweminyaka emibini yokulandela, ukusinda okungenasifo (i-iDFS) kwakuyi-94.2% kwizifundo eziphathwe nge-neratinib xa kuthelekiswa ne-91.9% kwabo bafumana i-placebo.

I-Neratinib yavavanywa kwakhona kuvavanyo lweSigaba III NALA, ulingo olulawulwa ngokungakhethiyo lwe-neratinib kunye ne-capecitabine kwizigulana ezine-HER2-positive metastatic cancer cancer ezifumene ezimbini okanye nangaphezulu ngaphambili kwe-anti-HER2-based regimens. Ityala labhalisa izigulana ezingama-621 ezazingahleliwe (1: 1) ukufumana i-neratinib 240 mg ngomlomo kube kanye ngemini nge-1-21 ngokudibeneyo ne-capecitabine 750 mg / m2 enikwa ngomlomo kabini ngemini ngeentsuku 1-14 kumjikelo ngamnye weentsuku ezingama-21 ( n = 307) okanye i-lapatinib 1250 mg ngomlomo kanye ngemini nge-1-21 ngokudibeneyo ne-capecitabine 1000 mg / m2 enikezelwa ngomlomo kabini ngemini ngeentsuku 1-14 kumjikelo ngamnye weentsuku ezingama-21 (n = 314). Izigulana zanyangwa zada zaqhubela phambili isifo okanye isifo esingamkelekanga. Unyango kunye ne-neratinib ngokudibeneyo ne-capecitabine kukhokelele kuphuculo olubonakalayo kwinkqubela phambili yokuphila (PFS) xa kuthelekiswa nonyango lwe-lapatinib kunye ne-capecitabine. Izinga le-PFS kwiinyanga ezili-12 lalingama-29% kwizigulana ezifumana i-neratinib kunye ne-capecitabine vs 15% yezigulana ezifumene i-lapatinib kunye ne-capecitabine; ireyithi ye-PFS kwiinyanga ezingama-24 yayiyi-12% vs 3%, ngokwahlukeneyo. I-Median OS ibiziinyanga ezingama-21 kwizigulana ezifumene i-neratinib ngokudibeneyo ne-capecitabine xa kuthelekiswa ne-18.7 iinyanga zezigulana ezifumene i-lapatinib ngokudibeneyo kunye ne-capecitabine.

 

INeratinib

 

Intoni Is Neratinib?

INeratinib (CAS: 698387-09-6) sisiyobisi sonyango ekujoliswe kuso (kwibhayiloji) esithintela ukukhula kunye nokusasazeka komhlaza wamabele. INeratinib ligama elingelophawu leziyobisi. Igama lalo nguNerlynx.

 

Ngubani MEbusuku Ufuna uNeratinib?

I-Neratinib inokunikezelwa kubantu abanomdlavuza wesibeleko oyintloko:

Receptor IHormone receptor eyakhayo (umhlaza webele okhuthazwe ukuba ukhule ngamahomoni eestrogen okanye iprogesterone)

Positive I-HER2 inesifo (umhlaza webele onenqanaba eliphezulu kuneprothini ye-HER2)

 

Ukwazi njani ukuba i-Neratinib ilungile kuwe?

Kukho iimvavanyo ezininzi ezisetyenziselwa ukufumanisa ukuba umhlaza webele une-HER2-positive. Ezona mvavanyo ziqhelekileyo zezi:

 

 IHC (ImmunoHistoChemistry)

Uvavanyo lwe-IHC lusebenzisa idayi yemichiza ukungcolisa iiproteni ze-HER2. I-IHC inika amanqaku e-0 ukuya ku-3 + alinganisa inani leeproteni ze-HER2 kumphezulu weeseli kwisampulu yomhlaza webele. Ukuba amanqaku ayi-0 ukuya ku-1 +, ithathwa njenge-HER2-negative. Ukuba amanqaku angama-2 +, athathelwa ingqalelo njengomda. Amanqaku e-3 + athathwa njenge-HER2-positive.

Ukuba iziphumo zovavanyo lwe-IHC zingumda, kusenokwenzeka ukuba uvavanyo lwe-FISH luyakwenziwa kwisampulu yomhlaza womzimba ukufumanisa ukuba umhlaza une-HER2-positive.

 

 I-FISH (i-Fluorescence In Situation Hybridation)

Uvavanyo lwe-FISH lusebenzisa iilebhile ezikhethekileyo eziqhotyoshelwe kwiiproteni ze-HER2. Iilebheli ezizodwa zineekhemikhali ezongeziweyo kubo ngoko ke batshintsha umbala kunye nokukhanya ebumnyameni xa benamathela kwiiproteni ze-HER2. Olu vavanyo lolona luchanekileyo, kodwa kuyabiza kakhulu kwaye kuthatha ixesha elide ukubuyisa iziphumo. Kungenxa yoko le nto uvavanyo lwe-IHC luhlala luvavanyo lokuqala olwenziwe ukubona ukuba umhlaza une-HER2-positive. Kuvavanyo lwe-FISH, ufumana amanqaku nokuba ngawakhayo okanye awalunganga (ezinye izibhedlele zibiza iziphumo zovavanyo olubi "zero").

 

Isebenza njani iNeratinib?

Iimpawu zomhlaza webele ze-HER2 zenza kakhulu iprotein ye-HER2. Iprotein ye-HER2 ihleli kumphezulu weeseli zomhlaza kwaye ifumana imiqondiso exelela umhlaza ukuba ukhule kwaye usasazeke. Phantse enye kwezine zomhlaza webele yi-HER2-positive. I-HER2-inomdlavuza webele isondeza ukuba ibe nobudlova kwaye kunzima ukunyanga kune-HER2-negative cancer cancer. INeratinib yipan-HER inhibitor engenakuphikiswa. I-Neratinib ilwa nomhlaza webele we-HER2 ngokuthintela amandla eeseli zomhlaza ekufumaneni imiqondiso yokukhula.

INeratinib yi unyango ekujoliswe kulo, Kodwa ngokungafaniyo neHerceptin (igama leekhemikhali: trastuzumab), iKadcyla (igama leekhemikhali: T-DM1 okanye ado-trastuzumab emtansine), kunye nePerjeta (igama leekhemikhali: pertuzumab), ayilolonyango ekujoliswe kulo lomzimba. Unyango ekujoliswe kulo ekukhuselweni ngumzimba ziinguqulelo zamachiza omzimba ahlasela ngokwendalo asebenza njengezikhuseli zomzimba ezenziwa ngamajoni ethu I-Neratinib yinkomfa yeekhemikhali, kungekhona i-antibody.

 

Siyithatha njani iNeratinib?

Umthamo ocetyiswayo we-neratinib yi-240 mg (iipilisi ezi-6), zithathwa ngomlomo kube kanye yonke imihla ngokutya, kwaye zisetyenziswa ngokuqhubekayo unyaka omnye. INeratinib iyafumaneka njengepilisi ye-1-mg.

Kwi-antidiarrheal prophylaxis, i-loperamide kufuneka isetyenziswe ngokudibeneyo kunye nedosi yokuqala ye-neratinib kwaye iqhubeke ngexesha lemijikelezo yokuqala ye-2 (okt, iintsuku ezingama-56) zonyango, emva koko njengoko kufuneka. Izigulana kufuneka zifundiswe ukugcina i-1 ukuya kwi-2 yamathumbu mihla le, kwaye kufuneka ziyalelwe ngendlela yokusebenzisa iirejimeni zonyango zokuthintela urhudo.

Ukuphazamiseka kwethamo elithile kunye / okanye iingcebiso zokunciphisa idosi, ngokusekwe kunyamezelo lomntu ngamnye, zichaziwe kulwazi olumiselweyo. Kwizigulana ezinokukhubazeka okukhulu kwesibindi, idosi yokuqala ye-neratinib kufuneka yehliswe iye kwi-80 mg.

 

Qaphela: zonke iidatha zazisalathiso kuphela, ukusuka Iipilisi ze-NERLYNX (neratinib) (PDF)

 

Yintoni esinokuyibona kwiziphumo ebezingalindelekanga zeNeratinib? 

Urhudo olubi emva nje kokuqala kwe-neratinib sisiphumo esibi kakhulu. Kwilingo le-ExteNET, malunga neepesenti ezingama-40 zabasetyhini abaphathwe nge-neratinib babenorhudo olubi njengempembelelo esecaleni.

Imvume ye-FDA icebisa ukuba i-loperamide (amagama egama elibandakanya i-Imodium, iKaopectate 1-D, kunye noLawulo lwe-Pepto Diarrhea) inikwe i-neratinib kwiintsuku zokuqala ezingama-56 zonyango kwaye emva koko njengoko kufuneka ukunceda ukulawula urhudo.

 

Ezinye iziphumo ebezingalindelekanga eziqhelekileyo neratinib zezi:

▪ ukugabha

▪ isicaphucaphu

▪ iintlungu esiswini

▪ ukudinwa

▪ irhashalala

Izilonda zomlomo

 

Kwiimeko ezinqabileyo, neratinib kunokubangela iingxaki zesibindi. Tshela ugqirha wakho kwangoko ukuba unayo nayiphi na le miqondiso ilandelayo yeengxaki zesibindi:

▪ ukuba tyheli kolusu okanye ezimhlophe zamehlo

▪ umchamo omnyama okanye omdaka

▪ Ndiziva ndidiniwe

Ukuphelelwa ngumdla wokutya

▪ iintlungu kwicala elingasekunene kwicala lesisu

▪ ukopha okanye ukugruzuka ngokulula kunesiqhelo

I-AASraw ngumenzi wobugcisa weNeratinib.

Nceda ucofe apha ngolwazi locaphulo: Unxibelelwano nathi

 

isiphelo

Ukwamkelwa kwe-FDA ye-neratinib, i-kinase inhibitor yomlomo, iphawule ukubakho kokhetho lokuqala lwonyango olongezelelekileyo kwizigulana ezifanelekileyo ezinamanqanaba okuqala, isifuba se-HER2 umhlaza. Izigulana ezine-HER2-positive umhlaza webele ngubani ofumene neratinib Unyaka o-1 uphucule kakhulu ukusinda okungenasifo seminyaka emi-2 xa kuthelekiswa nezigulana ezifumene i-placebo, emva konyango lwe-chemotherapy kunye nonyango olusebenzayo olusekwe kwitrastuzumab.

 

isingqiniso

[1] UChan A, uDelaloge S, uHolmes FA, et al; yeQela loFundo lwe-ExteNET. I-Neratinib emva kwonyango olusekwe kwi-trastuzumab olusekwe kwizigulana ezinomhlaza webele we-HER2positive (i-ExteNET): i-multicentre, i-randomized, i-blind-blind, i-placebocontroll, isigaba se-3. ILancet Oncol. Ngo-2016; 17: 367-377.

[2] Ulawulo lwezoKutya kunye noLawulo lweziyobisi. I-FDA ivuma unyango olutsha ukunciphisa umngcipheko wokubuya komhlaza wamabele. Upapasho ndaba zekhampani. Nge-17 kaJulayi 2017.

[3] Iipilisi zeNerlynx (neratinib) [ezichaza ulwazi]. ELos Angeles, CA: IPuma Biotechnology; Julayi 2017.

[4] IZiko leSizwe loMhlaza. Iiarhente ekujoliswe kuzo ezisebenza ngokuchasene nomhlaza webele we-HER2: imibuzo kunye neempendulo. Ukuhlaziywa ngoJuni 1, 2014. www.cancer.gov/types/breast/research/altto-qa. Kufumaneka ngoSeptemba 22, 2017.

[5] U-Singh J, uPetter RC, uBaillie TA, uWhitty A (Epreli 2011). "Ukuvuka kwakhona kwamachiza adibeneyo". Uphengululo lweNdalo. Ukufunyanwa kweziyobisi. 10 (4): 307-17. ikhonkco: 10.1038 / nrd3410. IINKCUKACHA:

[6] UMinami Y, Shimamura T, Shah K, LaFramboise T, Glatt KA, Liniker E, et al. (Julayi 2007). "Olona tshintsho luphambili lomhlaza wemiphunga lwe-ERBB2 zine-oncogenic kwaye zinxulunyaniswa nobuntununtunu kwi-EGFR / ERBB2 inhibitor engenakuphikiswa ye-HKI-272". Oncogene. 26 (34): 5023-7. ikhonkco: 10.1038 / sj.onc.1210292. IINKCUKACHA:

[7] IZiko leSizwe loMhlaza. Unyango lomhlaza wamabele wamadoda (PDQ) -uhlobo lobungcali kwezempilo. Ukuhlaziywa ngoMeyi 25, 2017. www.cancer.gov/types/breast/hp/male-breast-treatment-pdq. Kufumaneka ngoSeptemba 22, 2017.

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