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Neratinib

 

  1. Re tseba hakae ka mofets'e oa letsoele?
  2. Liphello tsa Bongaka ka FDA Apprvoal
  3. Neratinib ke eng?
  4. Ke Mang ea ka Hlokang Neratinib?
  5. U ka tseba joang hore na Neratinib e Loketse Uena?
  6. Neratinib e Sebetsa Joang?
  7. Re Nka Neratinib Joang?
  8. Seo re ka se bonang litlamorao tsa Neratinib?
  9. fihlela qeto e

 

Re Tseba Hakae Ka Kankere ea matsoele

Kankere ea matsoele ke mofuta o atileng haholo oa mofets'e ho basali, e emelang 15% ea linyeoe tsohle tse ncha tsa mofets'e United States. Ka 2017, linyeoe tse ncha tse 252,710 40,600 tsa mofets'e li ile tsa hakanyetsoa ho fumanoa, 'me basali ba fetang 2470 ba bolaoa ke lefu lena. Kankere ea matsoele le eona, hangata, e ka ama banna, mme ho na le linyeoe tse ka bang XNUMX tse fumanoang selemo le selemo.

Hoo e ka bang karolo ea 15 ho isa ho 20 lekholong ea lihlahala tsa kankere ea matsoele li na le HER2-positive. Kankere ea matsoele e nang le maemo a phahameng a HER2 e na le kotsi e eketsehileng ea metastasis, karabelo e sa lekaneng ea kalafo, le ho pheta-pheta.

Nts'etsopele le tumello e latelang ea Tsamaiso ea Lijo le Lithethefatsi ea US (FDA) ea trastuzumab (Herceptin), mohanyetsi oa mofumahali oa HER2, e fetotse paradigm ea kalafo bakeng sa bakuli ba nang le lefu la HER2. Ha trastuzumab e eketsoa chemotherapy, litekanyetso tsa ho pholoha ka kakaretso bakeng sa basali ba nang le nako ea pele Kankere ea matsoele ea HER2 ntlafalitsoe ke ho fihla ho 37%. Leha ho le joalo, bakuli ba ka bang 26% ba na le mafu a iphetang kamora kalafo ea trastuzumab.

Mefuta e meng ea kalafo e shebaneng le mofetše oa matsoele oa HER2 e kenyelletsa pertuzumab (Perjeta), lesole la mmele le monoclonal; ado-trastuzumab emtansine (Kadcyla), lesole la 'mele le monoclonal le kopantsoeng le moriana oa chemotherapy; le lapatinib (Tykerb), kinase inhibitor.

 

Liphello tsa Bongaka Ke tumello ea FDA

Kamohelo ea FDA ea Neratinib e ne e ipapisitse le teko ea Phase III ExteNET, teko e laoloang ea placebo ea neratinib e nang le li-multicenter, randomised, blind-blind, e laoloang ke placebo ka mor'a kalafo ea adjuvant trastuzumab. Nyeoe e ngolisitse basali ba 2,840 ba nang le mofetše oa matsoele oa HER2-pele le nakong ea lilemo tse peli ho qeta adjuvant trastuzumab. Lihlooho li ne li hlophiselitsoe ho amohela neratinib (n = 1420) kapa placebo (n = 1420) selemo se le seng. Liphetho tsa teko ea ExteNET li bonts'itse hore kamora lilemo tse peli tsa ho latela, pholoho e se nang mafu (iDFS) e ne e le 94.2% lithutong tse ileng tsa phekoloa ka neratinib ha li bapisoa le 91.9% ho ba fumanang placebo.

Neratinib le eona e ile ea hlahlojoa tekong ea Phase III NALA, teko e laoloang ka nako e sa lekanyetsoang ea neratinib le capecitabine ho bakuli ba nang le kankere ea matsoele ea HER2-positive ba amohetseng mekhoa e 'meli kapa ho feta ea anti-HER2. Teko e ngolisitse bakuli ba 621 ba neng ba sa sebetse (1: 1) ho amohela neratinib 240 mg ka molomo hang ka letsatsi ka matsatsi a 1-21 a kopane le capecitabine 750 mg / m2 e fanoang ka molomo habeli ka letsatsi ka matsatsi a 1-14 bakeng sa potoloho e ngoe le e ngoe ea matsatsi a 21 ( n = 307) kapa lapatinib 1250 mg ka molomo hang ka letsatsi ka matsatsi a 1-21 hammoho le capecitabine 1000 mg / m2 e fanoang ka molomo habeli ka letsatsi matsatsing a 1-14 bakeng sa potoloho e ngoe le e ngoe ea matsatsi a 21 (n = 314). Bakuli ba ile ba phekoloa ho fihlela lefu le ntse le eketseha kapa chefo e sa amoheleheng. Kalafo e nang le neratinib e kopantsoe le capecitabine e felletse ka ntlafatso ea lipalo-palo ea pholoho e senang tsoelo-pele (PFS) ha e bapisoa le kalafo ea lapatinib hammoho le capecitabine. Sekhahla sa PFS likhoeling tse 12 e ne e le 29% bakeng sa bakuli ba fumaneng neratinib plus capecitabine vs 15% bakeng sa bakuli ba fumaneng lapatinib plus capecitabine; sekhahla sa PFS likhoeling tse 24 e ne e le 12% vs 3%, ka ho latellana. Median OS e ne e le likhoeli tse 21 bakeng sa bakuli ba fumaneng neratinib hammoho le capecitabine ha ba bapisoa le likhoeli tse 18.7 bakeng sa bakuli ba fumaneng lapatinib hammoho le capecitabine.

 

Neratinib

 

Eng Is Neratinib?

Neratinib (CAS: 698387-09-6) ke moriana oa kalafo o reretsoeng (oa tlhaho) o thibelang kholo le ho ata ha mofetše oa matsoele. Neratinib ke lebitso le se nang lebitso la sethethefatsi. Lebitso la eona ke Nerlynx.

 

Who Mho joalo Hloka Neratinib?

Neratinib e ka fuoa batho ba nang le kankere ea matsoele ea mantlha e leng:

Receptor Hormone receptor positive (kankere ea matsoele e hlohlellelitsoeng ho hola ke lihormone estrogen kapa progesterone)

❷ HER2 e ntle (kankere ea matsoele e nang le boemo bo phahameng ho feta bo tloaelehileng ba protheine ea HER2)

 

U ka tseba joang hore na Neratinib e Loketse Uena?

Ho na le liteko tse 'maloa tse sebelisetsoang ho fumana hore na mofetše oa matsoele o na le HER2-positive. Liteko tse peli tse tloaelehileng ke tsena:

 

 IHC (ImmunoHistoChemistry)

Teko ea IHC e sebelisa dae ea lik'hemik'hale ho silafatsa liprotheine tsa HER2. IHC e fana ka lintlha tsa 0 ho isa ho 3+ tse lekanyang palo ea liprotheine tsa HER2 tse ka holim'a lisele tse sampoleng ea mofetše oa kankere ea matsoele. Haeba lintlha li le 0 ho isa ho 1+, ho nkuoa HER2-negative. Haeba lintlha li le 2+, ho nkuoa e le moeli. Lintlha tse 3+ li nkoa e le HER2-positive.

Haeba sephetho sa liteko tsa IHC se le moeling, ho kanna ha etsahala hore tlhahlobo ea FISH e etsoe sampoleng ea lisele tsa mofetše ho fumana hore na mofetše o na le HER2-positive.

 

 FISH (Fluorescence In In Hybridization)

Teko ea FISH e sebelisa mabitso a ikhethileng a hoketsoeng liprotheine tsa HER2. Li-label tse khethehileng li na le lik'hemik'hale tse ekelitsoeng ho tsona kahoo li fetola 'mala le ho khanya lefifing ha li hokela liprotheine tsa HER2. Teko ena e nepahetse ka ho fetesisa, empa e theko e phahameng ebile e nka nako e telele ho khutlisa sephetho. Ke ka hona tlhahlobo ea IHC hangata e leng teko ea pele e etsoang ho bona hore na mofetše o na le HER2-positive. Ka tlhahlobo ea FISH, u fumana lintlha tse ntle kapa tse mpe (lipetlele tse ling li bitsa sephetho se fosahetseng sa "zero").

 

Neratinib e Sebetsa Joang?

Kankere ea matsoele ea HER2 e etsa protheine e ngata ea HER2. Protheine ea HER2 e lutse holim'a lisele tsa mofetše mme e amohela matšoao a bolellang mofets'e ho hola le ho hasana. Hoo e ka bang kankere e le 'ngoe ho tse' ne tsa matsoele ke HER2-positive. Kankere ea matsoele ea HER2 e atisa ho ba mabifi le ho ba thata ho e phekola ho feta kankere ea matsoele ea HER2. Neratinib ke pan-HER inhibitor e ke keng ea fetoha. Neratinib e loana le mofetše oa matsoele oa HER2 ka ho thibela bokhoni ba lisele tsa mofetše ho amohela matšoao a kholo.

Neratinib ke kalafo e shebiloeng, empa ho fapana le Herceptin (lebitso la lik'hemik'hale: trastuzumab), Kadcyla (lebitso la lik'hemik'hale: T-DM1 kapa ado-trastuzumab emtansine), le Perjeta (lebitso la k'hemik'hale: pertuzumab), ha se kalafo e reretsoeng ho itšireletsa mafung. Litlhare tse reretsoeng ho itšireletsa mafung ke mefuta ea lithibela-mafu tse itlhahisang ka tlhaho e sebetsang joalo ka lithibela-mafu tse entsoeng ke masole a rona a 'mele. Neratinib ke motsoako oa lik'hemik'hale, eseng antibody.

 

Re Nka Neratinib Joang?

Tekanyo e khothalletsoang ea neratinib ke 240 mg (matlapa a 6), e nooa ka molomo hang ka letsatsi le lijo, 'me e sebelisoa khafetsa selemo se le seng. Neratinib e fumaneha e le letlapa la 1-mg.

Bakeng sa antidiarrheal prophylaxis, loperamide e lokela ho sebelisoa ka nako e le 'ngoe le lethal dose ea pele' me e tsoelepele nakong ea liphekolo tse 2 tsa pele (ke hore, matsatsi a 56) a kalafo, ebe ha ho hlokahala. Bakuli ba lokela ho laeloa ho boloka mala a le mong ho isa ho a mabeli ka letsatsi, hape ba lokela ho laeloa mokhoa oa ho sebelisa mekhoa ea kalafo ea letshollo.

Tšitiso e khethehileng ea tekanyetso le / kapa likhothaletso tsa phokotso ea litekanyetso, ho ipapisitse le mamello ea motho ka mong ea mokuli, li thathamisitsoe boitsebisong bo hlalosang. Bakeng sa bakuli ba nang le ho holofala ho matla ha hepatic, methapo ea methapo ea methapo e lokela ho fokotsoa ho fihlela ho 80 mg.

 

E tsebahala: li-datas tsohle li ne li bua feela ka, ho tloha Matlapa a NERLYNX (neratinib) (PDF)

 

Seo re ka se bonang litlamorao tsa Neratinib? 

Letšollo le matla hang kamora ho qala neratinib ke litla-morao tse tloaelehileng haholo. Tekong ea ExteNET, basali ba ka etsang 40% ba ileng ba phekoloa ka neratinib ba ne ba na le letshollo le matla joalo ka litlamorao.

Kamohelo ea FDA e khothaletsa hore loperamide (mabitso a mabitso a kenyelletsa Imodium, Kaopectate 1-D, le Pepto Letšollo la Tahi) a fuoe neratinib matsatsing a pele a 56 a kalafo ebe joale ho hlokahala ho thusa ho laola lets'ollo.

 

Litla-morao tse ling tse tloaelehileng tsa mokokotlo ke:

▪ ho hlatsa

▪ ho nyekeloa ke pelo

▪ bohloko ba mpeng

▪ mokhathala

▪ lekhopho

▪ liso tsa molomo

 

Maemong a sa tloaelehang, mokokotlo e ka baka mathata a tebileng a sebete. Bolella ngaka hang-hang haeba u e-na le matšoao a latelang a mathata a sebete:

▪ bosehla ba letlalo kapa makhooa a mahlo

▪ moroto o lefifi kapa o sootho

▪ ho ikutloa u khathetse haholo

▪ ho felloa ke takatso ea lijo

▪ bohloko bo ka lehlakoreng le ka holimo le letona la mpa

Ho tsoa mali kapa ho longoa habonolo ho feta tloaelo

AASraw ke moetsi oa litsebi oa Neratinib.

Ka kopo tlanya mona bakeng sa tlhaiso-leseling e qotsitsoeng: Lethathamo la rona

 

fihlela qeto e

Kamohelo ea FDA ea neratinib, molomo oa kinase inhibitor, e tšoaea ho fumaneha ha khetho ea pele ea kalafo e atolositsoeng bakeng sa bakuli ba tšoanelehang ba nang le letsoele la HER2 tsoaroa ke kankere. Bakuli ba nang le tšoaetso ea HER2 kankere ea matsoele ea amohetseng mokokotlo bakeng sa selemo se le seng se fihletse pholoho e se nang ts'oaetso ea lilemo tse 1 e sa bapisoang le bakuli ba fumaneng placebo, kamora chemotherapy le trastuzumab-based adjuvant therapy.

 

Reference

[1] Chan A, Delaloge S, Holmes FA, le al; bakeng sa Sehlopha sa Boithuto sa ExteNET. Neratinib kamora 'kalafo ea adjuvant e thehiloeng ho trastuzumab ho bakuli ba nang le mofetše oa matsoele oa HER2positive (ExteNET): liteko tse ngata, tse sa sebetseng, tse foufetseng, tse laoloang ke sebaka sa 3. Lancet Oncol. 2016; 17: 367-377.

[2] Tsamaiso ea Tsamaiso ea Lijo le Lithethefatsi ea US. FDA e amohela kalafo e ncha ho fokotsa kotsi ea ho khutla ha mofetše oa matsoele. Tsebiso ea boralitaba. La 17 Phupu, 2017.

[3] Matlapa a Nerlynx (neratinib) [a behang tlhaiso-leseling]. Los Angeles, CA: Puma Biotechnology; Phupu 2017.

[4] Mokhatlo oa Naha oa Kankere. Lits'ebeletso tse lebisitsoeng li sebetsa khahlano le mofetše oa matsoele oa HER2: lipotso le likarabo. E ntlafalitsoe ka la 1 Phuptjane 2014. www.cancer.gov/types/breast/research/altto-qa. E fihliloe ka la 22 September, 2017.

[5] Singh J, Petter RC, Baillie TA, Whitty A (Mmesa 2011). "Ho tsosolosoa ha lithethefatsi tse covalent". Litlhahlobo tsa Tlhaho. Ho Fumana Lithethefatsi. 10 (4): 307-17. doi: 10.1038 / nrd3410. PMID 21455239. S2CID 5819338.

[6] Minami Y, Shimamura T, Shah K, LaFramboise T, Glatt KA, Liniker E, et al. (Phupu 2007). "Liphetoho tse kholo tse hlahisitsoeng ke mofets'e tsa matšoafo tsa ERBB2 li na le oncogenic mme li amahanngoa le kutloisiso ho EGFR / ERBB2 inhibitor e ke keng ea khutlisoa" HKI-272 ". Oncogene. 26 (34): 5023-7. doi: 10.1038 / sj.onc.1210292. PMID 17311002.

[7] Mokhatlo oa Naha oa Kankere. Kalafo ea kankere ea matsoele ea banna (PDQ) - mofuta oa litsebi tsa bophelo bo botle. E ntlafalitsoe ka la 25 Mots'eanong, 2017. www.cancer.gov/types/breast/hp/male-breast-treatment-pdq. E fihliloe ka la 22 September, 2017.

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