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Neratinib

 

  1. Ole Ka Anyị Maara Banyere Ọrịa ara?
  2. Nsonaazụ Clinical Site FDA Apprvoal
  3. Gịnị bụ Neratinib?
  4. Ratnye Nwere Ike Nechọ Neratinib?
  5. Etu ị ga - esi mara ma Neratinib Ziri Ezi Maka Gị?
  6. Kedu ka Neratinib si arụ ọrụ?
  7. Olee Otú Anyị Were Neratinib?
  8. Ihe anyị nwere ike ịhụ mmetụta dị na Neratinib?
  9. mmechi

 

Ihe Anyị Maara Banyere Ọrịa ara

Ọrịa ara ure bụ ụdị ọrịa kansa na-ahụkarị na ụmụ nwanyị, na-anọchite anya 15% nke ọrịa cancer ọhụrụ niile na United States. N’afọ 2017, ihe ruru mmadụ 252,710 ka ọria ọria kansa ara kara atụmatụ na achọpụtara, ma ihe karịrị ụmụ nwanyị 40,600 nwụrụ na ọrịa ahụ. Ọrịa ara ure nwekwara ike, adịkarịghị, na-emetụta ụmụ nwoke, ihe dị ka 2470 ọhụụ ọhụụ achọpụta kwa afọ.

Ihe dịka 15% gaa na 20% nke ọrịa cancer ara bụ HER2-nti. Ọrịa ara ara nwere ogo HER2 nwere nnukwu ihe egwu maka metastasis, ezughị ezu ọgwụgwọ nzaghachi, na nlọghachi.

Mmepe na ụdi US Food and Drug Administration (FDA) nkwado nke trastuzumab (Herceptin), onye na-anabata ihe mgbochi HER2, gbanwere usoro ọgwụgwọ maka ndị ọrịa nwere ọrịa HER2. Mgbe etinyere trastuzumab na chemotherapy, ọnụọgụ ndụ maka ụmụ nwanyị nwere oge mbụ Ọrịa HER2 nwere ọrịa ara ara mma site na 37%. Agbanyeghị, ihe dịka 26% nke ndị ọrịa nwere ọrịa na-abịanụ mgbe ọgwụgwọ trastuzumab gasịrị.

Usoro ọgwụgwọ ndị ọzọ na-elekwasị anya na HER2-ọrịa ara ure na-agụnye pertuzumab (Perjeta), ihe mgbochi monoclonal; ado-trastuzumab emtansine (Kadcyla), ihe na-alụso monoclonal ọgụ nke na-etinye aka na ọgwụ ọgwụ; na lapatinib (Tykerb), onye na-egbochi kinase.

 

Ihe Nlekọta Ọgwụ Site na FDA Apprvoal

Nkwado FDA nke Neratinib dabere na ikpe nke usoro III ExteNET, ọtụtụ mmadụ, nke a na-ahụkarị, onye isi abụọ, ebe a na-achịkwa ebebo nke neratinib na-agbaso ọgwụgwọ trastuzumab adjuvant. Ikpe a debanyere aha ụmụ nwanyị 2,840 nwere ọrịa cancer ara ara HER2 na n'ime afọ abụọ nke ịmecha adjuvant trastuzumab. Ejikọtara isiokwu ndị ahụ iji nweta neratinib (n = 1420) ma ọ bụ placebo (n = 1420) maka otu afọ. Nsonaazụ nke ikpe ikpe ExteNET gosipụtara na mgbe afọ abụọ nke nsonaazụ, nlanarị na-enweghị ọrịa (iDFS) bụ 94.2% na isiokwu ndị e mesoro neratinib ma e jiri ya tụnyere 91.9% na ndị na-enweta placebo.

A tụlere Neratinib na nyocha nke Phase III NALA, nyocha a na-achịkwa nke neratinib gbakwunyere capecitabine na ndị ọrịa nwere ọrịa ara ara HER2-nke na-enweta ọrịa abụọ ma ọ bụ karịa tupu usoro HER2. Ọnwụnwa ahụ debara aha ndị ọrịa 621 bụ ndị na-enweghị usoro (1: 1) iji nweta neratinib 240 mg okwu ọnụ otu ugboro n'ụbọchị 1-21 na njikọta na capecitabine 750 mg / m2 nyere ọnụ ugboro abụọ kwa ụbọchị na ụbọchị 1-14 maka ụbọchị 21 ọ bụla ( n = 307) ma ọ bụ lapatinib 1250 mg okwu ọnụ otu ugboro n'ụbọchị 1-21 yana capecitabine 1000 mg / m2 na-enye ọnụ ugboro abụọ kwa ụbọchị na ụbọchị 1-14 maka usoro ụbọchị 21 ọ bụla (n = 314). A na-agwọ ndị ọrịa ruo mgbe ọrịa na-aga n'ihu ma ọ bụ nsị na-adịghị anabata. Ọgwụgwọ na neratinib yana capecitabine mere ka mmụba dị ịrịba ama na nlanarị na-enweghị ọganihu (PFS) ma e jiri ya tụnyere ọgwụgwọ na lapatinib tinyere capecitabine. Ọnọdụ PFS na ọnwa 12 bụ 29% maka ndị ọrịa natara neratinib tinyere capecitabine na 15% maka ndị ọrịa natara lapatinib tinyere capecitabine; ọnụego PFS na ọnwa 24 bụ 12% vs 3%, n'otu n'otu. Median OS bụ ọnwa 21 maka ndị ọrịa natara neratinib yana capecitabine ma e jiri ya tụnyere ọnwa 18.7 maka ndị ọrịa natara lapatinib na ngwakọta tinyere capecitabine.

 

Neratinib

 

Kedu Is NEratinib?

Neratinib (CAS: 698387-09-6) bụ ọgwụ ọgwụ ezubere iche (nke ndu) nke na-egbochi uto na mgbasa nke ọrịa kansa. Neratinib bụ aha ọgwụ anaghị ewere aha ya. Aha ya bụ Nerlynx.

 

onye MIght Mkpa NEratinib?

Enwere ike ịnye Neratinib ndị nwere ọrịa ara ara isi bụ ma:

Rece Onye na - anabata ihe dị mma (ọrịa cancer ara nke na - akpali site na estrogen ma ọ bụ progesterone homonụ)

HER2 dị mma (ọrịa ara ara nke nwere ogo karịa protein HER2)

 

Etu ị ga - esi mara ma Neratinib Ziri Ezi Maka Gị?

Enwere ule dị iche iche iji chọpụta ma ọ bụrụ na ọrịa ara ure HER2. Abụọ n'ime ule kachasị dịkarịsịrị bụ:

 

 IHC (ImmunoHistoChemistry)

Nnwale IHC na-eji kemịkal kemịkal mee ka ndị na-edozi HER2. IHC na-enye akara nke 0 ruo 3 + nke na-atụle ego nke protein HER2 n'elu sel nke dị na anụ ahụ kansa kansa. Ọ bụrụ na akara ahụ bụ 0 ruo 1+, a na-ewere HER2-adịghị mma. Ọ bụrụ na akara ahụ bụ 2 +, a na-ewere ya na ókèala ya. Akara 3 + dị ka HER2.

Ọ bụrụ na nsonaazụ ule IHC bụ ókè, ọ ga-abụ na a ga-eme nyocha FISH na ihe atụ nke anụ ahụ kansa iji chọpụta ma ọ bụrụ na ọrịa kansa ahụ bụ HER2.

 

 Nri (Ọkpụkpụ na-eme ka nchịkwa dị iche iche)

Nyocha FISH na-eji akara mmado pụrụ iche nke na-etinye na protein HER2. Akara ndị pụrụ iche nwere kemịkal agbakwunye na ha ka ha gbanwee agba ma na-enwu gbaa n'ọchịchịrị mgbe ha tinyere na protein HER2. Nnwale a bụ nke kachasị ezi, mana ọ dị oke ọnụ ma were ogologo oge iji weghachi nsonaazụ. Nke a bụ ihe kpatara ule IHC na-abụkarị nyocha izizi emere iji hụ ma ọ bụrụ na ọrịa kansa bụ HER2. Site na ule FISH, ị na-enweta akara ma ọ bụ nke ọma ma ọ bụ nke ọjọọ (ụfọdụ ụlọ ọgwụ na-akpọ nsonaazụ nyocha adịghị mma "efu").

 

Kedu ka Neratinib si arụ ọrụ?

Ọrịa HER2 nwere ọmarịcha ara nwere ọtụtụ protein HER2. Mkpụrụ HER2 na-anọdụ n'elu mkpụrụ ndụ kansa na-enweta akara ngosi na-agwa kansa ka ọ na-eto ma gbasaa. Ihe dị ka otu n'ime ọrịa ara anọ ọ bụla bụ HER2-nti. Ọrịa HER2 nwere ọrịa ara na-eme ihe ike karịa ma sie ike ịgwọ karịa ọrịa kansa ara HER2. Neratinib bụ ihe na-enweghị ike igbochi pan-HER inhibitor. Neratinib na-alụ ọgụ kansa HER2 nwere nti ara site na igbochi mkpụrụ ndụ cancer ka ịnata akara ngosi.

Neratinib na-bụ ezubere iche ọgwụ, mana n'adịghị ka Herceptin (aha kemịkal: trastuzumab), Kadcyla (aha kemịkal: T-DM1 ma ọ bụ ado-trastuzumab emtansine), na Perjeta (aha kemịkalụ: pertuzumab), ọ bụghị usoro ọgwụgwọ ezubere iche. Usoro ọgwụgwọ a na-alụso ọrịa ọgụ bụ nsụgharị nke usoro nje na-arụ ọrụ dị ka nje ndị usoro ahụ ji alụso ọrịa ọgụ mere. Neratinib bụ ngwakọta kemịkalụ, ọ bụghị ihe na-egbochi ihe na-egbochi ihe mgbochi.

 

Olee Otú Anyị Were Neratinib?

Ngwadogwu neratinib a na-atụ aro bụ 240 mg (6 mbadamba), na-eji ọnụ ekwu otu ugboro kwa ụbọchị na nri, ma na-eji ya eme ihe ruo afọ 1. Neratinib dị ka mbadamba 40-mg.

Maka prorilaxis antidiarrheal, a ga-eji loperamide mee ihe n'ụzọ gara nke ọma na nke mbụ nke neratinib wee gaa n'ihu n'oge usoro 2 izizi (ntụgharị, ụbọchị 56) ọgwụgwọ, wee mesịa ọ dị mkpa. Ekwesịrị ịkụziri ndị ọrịa ka ha debe afọ 1 ruo 2 kwa ụbọchị, ma kụzie etu esi eji usoro ọgwụgwọ afọ ọsịsa.

A na-akọwapụta nkwụsịtụ ọgwụ na / ma ọ bụ belata mbelata ọgwụ, dabere na nnabata onye ọ bụla, na-akọwapụta ya na ozi ederede. Maka ndị ọrịa nwere nnukwu ọrịa hepatic, mmalite neratinib kwesịrị belata na 80 mg.

 

Mara: datas niile bụ naanị dị ka akwụkwọ, si Mbadamba NERLYNX (neratinib) (PDF)

 

Ihe anyị nwere ike ịhụ mmetụta dị na Neratinib? 

Oké afọ ọsịsa ngwa ngwa mgbe ịmalite neratinib bụ mmetụta dị oke mmetụta. Na ikpe ExteNET, ihe dị ka 40% nke ụmụ nwanyị na-agwọ neratinib nwere nnukwu afọ ọsịsa dịka mmetụta dị n'akụkụ.

Nkwado FDA na-atụ aro na loperamide (aha ndị a gụnyere Imodium, Kaopectate 1-D, na Pepto Diarr Control) na-enye ya neratinib maka ụbọchị iri isii na isii nke ọgwụgwọ na mgbe ahụ dịka ọ dị mkpa iji nyere aka ijikwa afọ ọsịsa.

 

Mmetụta ndị ọzọ metụtara neratinib bụ:

▪ na-agbọ agbọ

Ọgbụgbọ

▪ afọ mgbu

Ike ọgwụgwụ

▪ ọkụ ọkụ

▪ ọnụ mgbu

 

N'ọnọdụ ndị na-adịghị adị, neratinib nwere ike ibute nnukwu nsogbu imeju. Gwa dọkịta gị ozugbo ma ọ bụrụ na ị nwere nke ọ bụla n'ime ihe ịrịba ama ndị a nke nsogbu imeju:

Acha odo odo ma ọ bụ akpụkpọ anya

Urine mamịrị ojii ma ọ bụ aja aja

▪ inwe oké ike ọgwụgwụ

▪ agụụ iri nri

▪ mgbu n'elu aka nri nke afọ

▪ ọbara ọgbụgba ma ọ bụ ọnya na-adị mfe karịa ka ọ dị

 

mmechi

Nkwado FDA nke neratinib, onye na-emechi ọnụ kinase, gosipụtara nnweta nke usoro ọgwụgwọ adjuvant mbụ maka ndị ọrịa kwesịrị ekwesị nwere mmalite mmalite, ara HER2 cancer. Ndị ọrịa nwere HER2-nti ọrịa kansa onye natara neratinib maka afọ 1 rụpụtara ọganihu dị mma nke afọ 2 na-enweghị mmerụ ahụ na-enweghị atụ ma e jiri ya tụnyere ndị ọrịa natara placebo, mgbe ọgwụ ọgwụ adjuvant metụtara chemotherapy na trastuzumab.

 

Reference

[1] Chan A, Delaloge S, Holmes FA, et al; maka Studytù Na-amụ ExteNET. Neratinib mgbe ọgwụ adjuvant dabeere na trastuzumab na ndị ọrịa nwere ọrịa ara ara HER2positive (ExteNET): ọtụtụ, randomized, abụọ-ìsì, placebocontrolle, phase 3 ikpe. Lancet Oncol. 2016; 17: 367-377.

[2] Nchịkwa nri na ọgwụ ọjọọ na US. FDA kwadoro ọgwụgwọ ọhụrụ iji belata ihe ize ndụ nke ịrịa ara ara na-alọghachi. Mbipụta ndị nchụ nta akụkọ. Ọnwa Asaa 17, 2017.

[3] Mbadamba Nerlynx (neratinib) [na-edepụta ihe ọmụma]. Los Angeles, CA: Puma Nkà na ụzụ; Julaị 2017.

[4] Canlọ Ọrụ Ọrịa Mba. Ndị ọrụ ezubere iche na-arụ ọrụ megide ọrịa cancer ara HER2: ajụjụ na azịza. Emelitere June 1, 2014. www.cancer.gov/types/breast/research/altto-qa. Nabata September 22, 2017.

[5] Singh J, Petter RC, Baillie TA, Whitty A (Eprel 2011). "Resghaghachi nke ọgwụ ọjọọ". Nature Nyocha. Nchọpụta Ọgwụ. 10 (4): 307–17. ma ọ bụ: 10.1038 / nrd3410. PMID 21455239. S2CID 5819338.

[6] Minami Y, Shimamura T, Shah K, LaFramboise T, Glatt KA, Liniker E, et al. (Julaị 2007). "Nnukwu mutan ndị nwere ọrịa kansa nke sitere na ERBB2 bụ oncogenic ma jikọtara ya na uche nye onye na-emechi ihe EGFR / ERBB2 HKI-272 na-enweghị ike ịgbanwe agbanwe". Oncogene. 26 (34): 5023–7. ma ọ bụ: 10.1038 / sj.onc.1210292. PMID 17311002.

[7] Canlọ Ọrụ Ọrịa Mba. Nwoke na-agwọ ọrịa ara ure (PDQ) - ụdị ọkachamara ahụike. Emelitere May 25, 2017. www.cancer.gov/types/breast/hp/male-breast-treatment-pdq. Nabata September 22, 2017.

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