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Neratinib

 

  1. O le a le tele o lo tatou iloa e uiga i le kanesa o le susu?
  2. Iʻuga Fomaʻi Saunia e le FDA Apprvoal
  3. O le a le Neratinib?
  4. O Ai e Manaʻomia Neratinib?
  5. Faʻafefea Ona E Iloa Pe Neratinib E Saʻo Mo Oe?
  6. Faʻafefea ona galue Neratinib?
  7. Faʻafefea ona matou ave Neratinib?
  8. O a ni mea tatou te ono vaʻaia i itu itu o Neratinib?
  9. iʻuga

 

O le a le tele o lo tatou iloa e uiga i Tue kanesa o le susu

O le kanesa o le susu o le ituaiga masani lea o kanesa i fafine, e fai ma sui o le 15% o mataupu fou o le kanesa i le Iunaite Setete. I le 2017, e 252,710 tala fou o le kanesa o le susu na fuafuaina e faʻamaonia, ma e ova atu i le 40,600 fafine na feoti i lenei faʻamaʻi. O le kanesa o le susu e mafai foi, seasea ona aʻafia ai aliʻi, ma le tusa ma le 2470 mataupu fou e maua i tausaga taʻitasi.

E tusa ma le 15% i le 20% o kanesa o le kanesa o le kanesa o HER2-e lelei. Kanesa o le susu ma maualuga maualuga o le HER2 o loʻo i ai se faʻateleina lamatiaga mo metastasis, le lava togafitiga tali, ma toe tupu.

O le atinaʻeina ma le US Food and Drug Administration (FDA) faʻamaonia o le trastuzumab (Herceptin), o le HER2 receptor antagonist, suia le faʻataʻitaʻiga togafitiga mo tagata mamaʻi ma le HER2-lelei faʻamaʻi. Ina ua faʻaopoopo le trastuzumab i le chemotherapy, o le aofai o le ola fua mo fafine i le amataga-tulaga Kanesa o le susu lelei HER2-lelei faʻaleleia atili e oʻo atu i le 37%. Peitaʻi, tusa o le 26% o tagata mamaʻi e maua faʻamaʻi soʻo pe a maeʻa togafitiga ma le trastuzumab.

O isi togafiti e faʻatatau i le kanesa o le susu o le HER2-positive e aofia ai le pertuzumab (Perjeta), o le monoclonal antibody; ado-trastuzumab emtansine (Kadcyla), o le monoclonal antibody faʻapipiʻi i se chemotherapy vailaʻau; ma lapatinib (Tykerb), o le kinase taofiofia.

 

Iʻuga faʻapitoa E le FDA Apprvoal

O le faʻamaonia a le FDA o Neratinib na faʻavae i luga o le Phase III ExteNET faʻataʻitaʻiga, o le multicenter, randomized, lua-blind, placebo-pulea faʻataʻitaʻiga o neratinib mulimuli ane adjuvant trastuzumab togafitiga. O le faʻamasinoga na lesitalaina ai fafine e 2,840 ma le kanesa o le susu i le amataga o le HER2, ma i totonu o le lua tausaga talu ona maeʻa le adjuvant trastuzumab. O mataʻupu na faʻasolosolo ona talia ia neratinib (n = 1420) poʻo le placebo (n = 1420) mo le tausaga e tasi. O iʻuga o le ExteNET faʻataʻitaʻiga na faʻaalia ai, i le maeʻa ai o le lua tausaga o le tulitatao, o le faʻaolaola faʻamaʻi e aunoa ma se faʻamaʻi (iDFS) o le 94.2% i mataupu na togafitia ma le neratinib faʻatusatusa i le 91.9% ia i latou na mauaina le placebo.

Neratinib na iloiloina foi i le Phase III NALA faʻataʻitaʻiga, o se faʻatonutonuina faʻatonutonuina o neratinib ma capecitabine i tagata mamaʻi ma HER2-lelei metastatic kanesa o le susu na mauaina lua pe sili atu muamua anti-HER2-faʻavae tulafono. O le faʻamasinoga na lesitalaina ai 621 tagata mamaʻi na faʻasolosolo (1: 1) ia maua neratinib 240 mg tuʻufaʻatasi taimi i aso uma i aso 1-21 faʻatasi ma le capecitabine 750 mg / m2 tuʻuina faʻalua faalua i aso uma i aso 1-14 mo taʻamilosaga e 21 aso ( n = 307) poʻo le lapatinib 1250 mg tuʻufaʻatasi taʻitasi aso i aso 1-21 faʻatasi ma capecitabine 1000 mg / m2 tuʻuina faʻalua faalua i aso uma i aso 1-14 mo taʻamilosaga 21-aso uma (n = 314). Tagata mamaʻi na togafitia seʻia oʻo i le gasologa o faʻamaʻi poʻo se taliaina oona. Togafitiga ma le neratinib faatasi ai ma capecitabine na mafua ai le tele o faʻamaumauga taua i le alualu i luma-leai se ola (PFS) faʻatusatusa i togafitiga ma lapatinib ma capecitabine. Ole fua ole PFS ile 12 masina e 29% mo tagata mamaʻi na mauaina neratinib plus capecitabine vs 15% mo tagata mamaʻi na mauaina le lapatinib ma le capecitabine; o le PFS fua faatatau i le 24 masina e 12% vs 3%, faʻatulagaina. Median OS o 21 masina mo tagata mamaʻi na mauaina neratinib faatasi ma capecitabine faʻatusatusa i le 18.7 masina mo tagata mamaʻi na mauaina lapatinib i le tuʻufaʻatasia ma capecitabine.

 

Neratinib

 

ā Is Neratinib?

Neratinib (CAS: 698387-09-6) o se faʻatatauina (moni) togafitiga vailaʻau e poloka le tuputupu ae ma salalau o le kanesa kanesa. Neratinib o le vailaʻau igoa le faʻailoga igoa. O lona igoa igoa Nerlynx.

 

O MA'oa'oga Manaʻomia Neratinib?

Neratinib mafai ona ofaina i tagata o loʻo i ai muamua kanesa kanesa o uma ia:

❶ Hormone receptor positive (kanesa o le susu na faʻaosofia e tupu i le homone estrogen poʻo le progesterone)

❷ HER2 lelei (kanesa o le susu e sili atu lona maualuga nai lo le tulaga masani o le HER2 protein)

 

Faʻafefea Ona E Iloa Pe Neratinib E Saʻo Mo Oe?

E tele faʻataʻitaʻiga faʻaaoga e suʻe ai pe o le kanesa o le susu o le HER2-positive. Lua o suʻega taʻatele e:

 

 IHC (ImmunoHistoChemistry)

O le suʻega IHC faʻaaogaina le vailaʻau vailaʻau e pisia ai le polotini HER2. O le IHC aumaia le togi o le 0 i le 3+ e fua ai le aofaʻi o HER2 polotini luga o sela o loʻo i ai le kanesa kanesa vaega. Afai o le togi e 0 i le 1+, e manatu HER2-leaga. Afai o le togi e 2+, e manatu o le tuaoi. O se togi o le 3+ ua manatu HER2-lelei.

Afai o le IHC suʻega iʻuga e tuaʻoi, e foliga mai o le FISH suʻega o le a faia i luga o se faʻataʻitaʻiga o le kanesa sela e iloa ai pe o le kanesa o le HER2-lelei.

 

 FANU (Fluorescence In Situ Hybridization)

O le suʻega FISH faʻaaogaina faʻailoga faʻapitoa o loʻo faapipii atu i le HER2 proteins. O faʻailoga faʻapitoa o loʻo faʻaopopo i ai vailaʻau ma latou suia ai lanu ma susulu i le pogisa pe a latou pipii atu i le polotini HER2. O lenei suʻega e sili ona saʻo, ae e taugata ma e umi atu foi e faʻafoʻi mai ai faʻaiuga. Ole mea lea e masani ai ole suʻega IHC o le muamua suʻesuʻega faia e iloa ai pe o le kanesa e HER2-lelei. Faatasi ai ma le suʻega FISH, oe maua se togi o le lelei pe le lelei (o nisi falemaʻi taʻua o le le lelei suʻega iʻuga "zero").

 

Faʻafefea ona galue Neratinib?

HER2-lelei susu kanesa faia tele o le HER2 polotini. O le HER2 protein e nofo i luga o sela kanesa ma maua faʻailoga e taʻu ai le kanesa e tupu ma salalau. E tusa o le tasi mai le fa o kanesa o le kanesa o le HER2-lelei. HER2-lelei susu kanesa foliga mai e sili atu faʻasauā ma faigata e togafitia nai lo HER2-le lelei fatafata susu. Neratinib o se mea e le mafai ona toe suia pan-HER taofi. Neratinib fusuʻaga HER2-lelei kanesa o le susu e ala i le poloka o sela kanesa 'mafai ona maua tuputupu aʻe faʻailoga.

Neratinib o le togafitiga faʻatatau, ae le pei o Herceptin (igoa vailaʻau: trastuzumab), Kadcyla (igoa vailaʻau: T-DM1 poʻo ado-trastuzumab emtansine), ma Perjeta (igoa vailaʻau: pertuzumab), e le o se puipuia faʻamoemoeina togafitiga. Ole togafiti faʻapitoa e faʻataʻitaʻia togafitiga o faʻaupuga ia o vailaʻau e masani ona tutupu e pei o ni vailaʻau na faia e a tatou tino puipuia. Neratinib o se vailaʻau oona, ae le o se vailaʻau.

 

Faʻafefea ona matou ave Neratinib?

Ole fualaʻau fautuaina ole neratinib ole 240 mg (6 papala), ave tuufofoga tasi i aso uma ma meaʻai, ma faʻaauau pea mo le 1 tausaga. Neratinib o loʻo avanoa e pei o se 40-mg laupapa.

Mo antidiarrheal prophylaxis, loperamide tatau ona faʻaaogaina faʻatasi ma le muamua inumaga o neratinib ma faʻaauau i le taimi o muamua 2 taʻamilosaga (ie, 56 aso) o togafitiga, ona manaʻomia lea. O tagata maʻi e tatau ona faʻatonuina e faʻaauau le 1 i le 2 manava gaioiga i aso uma, ma e tatau ona faʻatonuina pe faʻafefea ona faʻaaoga tulafono togafitiga antidiarrheal.

Faʻapitoa fualaʻau vaʻavaʻaia ma / poʻo tui faʻaititia faʻaititia fautuaga, faʻavae i luga o le onosaʻi taʻitasi onosaʻi, o loʻo otooto mai i le faʻavasegaina faʻamatalaga. Mo tagata mamaʻi ma le le lelei o le hepatic, o le amataga o le neratinib fualaʻau e tatau ona faʻaititia i le 80 mg.

 

Faʻailoa: o datas uma naʻo le faʻasino, mai NERLYNX (neratinib) laupapa (PDF)

 

O a ni mea tatou te ono vaʻaia i itu itu o Neratinib? 

O le manava tatā i se taimi lata mai ina ua amata le neratinib o se masani taatele itu aafiaga. I le ExteNET faʻataʻitaʻiga, tusa o le 40% o fafine na togafitia i le neratinib na maua ai i le manava tata o se aʻafiaga.

Ua fautuaina e le faamaoniga a le FDA ia loperamide (igoa o igoa e aofia ai le Imodium, Kaopectate 1-D, ma le Pepto Diarrhea Control) ave i le neratinib mo le muamua 56 aso o togafitiga ona manaʻomia lea e fesoasoani i le puleaina o le manava tata.

 

Isi aʻafiaga masani masani o neratinib o le:

▪ puaʻi

▪ niniva

▪ tiga o le manava

▪ lelava

▪ mageso

▪ papala gutu

 

I se tulaga le masani ai, neratinib ono tupu ai ni faʻafitauli ogaoga i le ate. Taʻu vave i lau fomaʻi pe a iai ni faʻailoga nei o faʻafitauli o le ate:

▪ samasama o le paʻu poʻo le paʻepaʻe o mata

▪ mimi pouliuli pe enaena

▪ lagona le lelava

▪ leai se fiaai

▪ tiga i le itu taumatau i luga o le manava

▪ faigofie ona tafetoto pe gagau toto nai lo le mea masani

AASraw o le polofesa gaosi oloa o Neratinib.

Faʻamolemole kiliki ii mo upusii faʻamatalaga: Faʻafesoʻotaʻi matou

 

iʻuga

O le faʻamaonia e le FDA o le neratinib, o le oral kinase inhibitor, na maitauina ai le mauaina o le muamua faʻalauteleina togafitiga faʻapitoa mo tagata mamaʻi e iai le laumua, HER2-positive breast. kanesa. Tagata mamaʻi ma HER2-lelei kanesa o le susu o le na mauaina neratinib mo le 1 tausaga ausia se sili atu le alualu i luma 2-tausaga osofaʻiga osofaʻi-leai se ola faʻatusatusa i tagata mamaʻi na mauaina placebo, ina ua maeʻa chemotherapy ma trastuzumab-faʻavae togafitiga adjuvant.

 

Tusitaiala

[1] Chan A, Delaloge S, Holmes FA, et al; mo le ExteNET Suesuega Vaega. Neratinib i le maeʻa ai o le trastuzumab-based adjuvant togafitiga i tagata mamaʻi ma le kanesa o le susu o le HER2positive (ExteNET): o le multicentre, randomized, double-blind, placebocontrolled, phase 3 trial. Lancet Oncol. 2016; 17: 367-377.

[2] US Taumafa ma Vailaau Faʻafoeina. Ua faʻamaonia e le FDA ni togafitiga fou e faʻaititia ai le toe foʻi o le kanesa o le susu. Faʻasalalauga Iulai 17, 2017.

[3] Nerlynx (neratinib) papa [faʻatonuina faʻamatalaga]. Los Angeles, CA: Puma Biotechnology; Iulai 2017.

[4] National Cancer Institute. Sui faʻatulagaina faʻagaioia e teteʻe ile HER2-positive kanesa ole susu: fesili ma tali. Faʻafouina ia Iuni 1, 2014. www.cancer.gov/types/breast/research/altto-qa Avanoa ia Setema 22, 2017.

[5] Singh J, Petter RC, Baillie TA, Whitty A (Aperila 2011). "O le toe tulaʻi mai o vailaʻau oona". Natura Iloiloga. Mauaina o Vailaau Faʻasaina. 10 (4): 307–17. faia: 10.1038 / nrd3410. PMID 21455239. S2CID 5819338.

[6] Minami Y, Shimamura T, Shah K, LaFramboise T, Glatt KA, Liniker E, et al. (Iulai 2007). "O le tele o le kanesa o le mama na maua mai i le ERBB2 o oncogenic ma e fesoʻotaʻi ma le maaleale i le le mafai ona suia EGFR / ERBB2 taofiofia HKI-272". Oncogene 26 (34): 5023–7. fai: 10.1038 / sj.onc.1210292. PMID 17311002.

[7] National Cancer Institute. Togafitiga o le kanesa o le susu o le tane (PDQ) –health professional version. Faʻafouina Me 25, 2017. www.cancer.gov/types/breast/hp/male-breast-treatment-pdq. Avanoa ia Setema 22, 2017.

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