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Neratinib

 

  1. Immisa ayaan ka ognahay kansarka naasaha?
  2. Natiijooyinka Caafimaadka Ee Ansixinta FDA
  3. Waa maxay Neratinib?
  4. Ayaa U Baahan Kara Neratinib?
  5. Sidee loo ogaadaa in Neratinib kugu habboon yahay adiga?
  6. Sidee Neratinib u shaqeeyaa?
  7. Sidee Ayaan U Qaadanaa Neratinib?
  8. Maxaan arki karnaa Saameynaha Neratinib?
  9. Gunaanad

 

Imisa Ayaan Ka Ognahay Kansarka naasaha

Kansarka naasaha waa nooca ugu badan ee kansarka haweenka, oo matalaya 15% dhammaan kiisaska cusub ee kansarka ee Maraykanka. Sanadkii 2017, 252,710 kiis oo cusub oo kansarka naasaha ah ayaa lagu qiyaasey in laga helay, in ka badan 40,600 oo haween ah ayaa u dhinta cudurka. Kansarka naasaha sidoo kale, marar dhif ah, wuxuu ku dhacaa ragga, iyadoo qiyaastii 2470 kiisas cusub la ogaado sanadkiiba.

Qiyaastii 15% ilaa 20% burooyinka kansarka naasaha waa HER2-positive. Kansarka naasaha ee heerarka sare ee HER2 waxay leeyihiin halis dheeraad ah ee metastasis, jawaab celinta aan ku filnayn, iyo soo noqoshada.

Horumarinta iyo Maamulka xiga ee Maamulka Cuntada iyo Dawooyinka (FDA) ee ansixinta trastuzumab (Herceptin), HER2 antagonist antagonist, ayaa bedeshay qaabka daaweynta ee bukaanada qaba cudurka HER2-positive. Markii trastuzumab lagu daray kiimoteraabiga, guud ahaan heerarka badbaadada dumarka leh marxaladda hore HER2-kansarka naasaha oo wanaagsan waxaa lagu hagaajiyay ilaa 37%. Si kastaba ha noqotee, qiyaastii 26% bukaannada ayaa qaba cudur soo noqnoqda ka dib daaweynta trastuzumab.

Daaweynta kale ee lagu bartilmaameedsado kansarka naasaha ee HER2-positive waxaa ka mid ah pertuzumab (Perjeta), oo ah monoclonal antibody; ado-trastuzumab emtansine (Kadcyla), oo ah monoclonal antibody oo ku lifaaqan daweynta kemotherabi; iyo lapatinib (Tykerb), ka hortage kinase.

 

Natiijooyinka Caafimaadka Waxaa qoray FDA Apprvoal

Ansixinta FDA ee Neratinib waxay ku saleysneyd tijaabada Wajiga III ExteNET, iskudhafyo badan, kala soocid, laba-indhoole, tijaabinta xakamaynta placebo ee neratinib ka dib daaweynta adjuvant trastuzumab. Tijaabadu waxay qortay 2,840 haween ah oo qaba marxaladda hore ee kansarka naasaha ee HER2 iyo laba sano gudahood markay dhammaystiraan trajujumab dheeri ah Mawduucyada waxaa loo kala soocay si loo helo ama neratinib (n = 1420) ama placebo (n = 1420) hal sano. Natiijooyinka tijaabada ExteNET waxay muujiyeen in ka dib laba sano oo dabagal ah, badbaadin aan cudur lahayn (iDFS) ay ahayd 94.2% maadooyinka lagu daaweeyay neratinib marka la barbar dhigo 91.9% kuwa hela placebo.

Neratinib ayaa sidoo kale lagu qiimeeyay tijaabada Wajiga III NALA, tijaabin la kantaroolay oo laxiriira neratinib oo lagu daray capecitabine ee bukaanada qaba kansarka naasaha ee HER2-positive oo helay laba ama kabadan kahor anti-HER2-ku-saleysan. Tijaabadu waxay qortay bukaanada 621 ee la kala soocay (1: 1) si ay u helaan neratinib 240 mg afka ah hal mar maalin kasta maalmaha 1-21 oo ay weheliso capecitabine 750 mg / m2 oo afka laga siiyo laba jeer maalintii 1-14 wareeg kasta oo 21-maalin ah ( n = 307) ama lapatinib 1250 mg afka ah hal mar maalintii maalintii 1-21 oo lagu daro capecitabine 1000 mg / m2 oo afka laga siiyo labo jeer maalintii 1-14 wareeg kasta oo 21-maalin ah (n = 314). Bukaanka ayaa la daaweeyay ilaa cudurka uu ka sii socdo ama sun aan la aqbali karin. Daaweynta neratinib oo ay weheliso capecitabine waxay dhalisay horumarin xagga tirakoobka ah oo ku saabsan badbaadada horusocodka la'aan (PFS) marka la barbar dhigo daaweynta laatinatinib iyo capecitabine. Qiyaasta PFS ee 12 bilood waxay ahayd 29% bukaannada helay neratinib oo lagu daray capecitabine vs 15% bukaannada helay lapatinib oo lagu daray capecitabine; heerka PFS ee 24 bilood wuxuu ahaa 12% vs 3%, siday u kala horreeyaan. Median OS wuxuu ahaa 21 bilood bukaanada helay neratinib oo lagu daro capecitabine marka loo eego 18.7 bilood bukaanada helay lapatinib isku dhafan oo lagu daray capecitabine.

 

Neratinib

 

Waa maxay Is Neratinib?

Neratinib (CAS: 698387-09-6) waa daawayn lagu daaweynayo (bayooloji) oo xannibaya koritaanka iyo faafida kansarka naasaha. Neratinib waa daroogada magac aan summad lahayn. Magaca shirkadeed waa Nerlynx.

 

Yaa MCiraaq Baahan Neratinib?

Neratinib waa la siin karaa dadka qaba kansarka naasaha ee aasaasiga ah oo labadaba ah:

Hormone reseptor positive (kansarka naasaha ee loo kiciyo inuu ku koro hoormoonka estrogen ama progesterone)

Positive HER2 oo wanaagsan (kansarka naasaha oo leh heer ka sarreeya heerka caadiga ah ee borotiinka HER2)

 

Sidee loo ogaadaa in Neratinib kugu habboon yahay adiga?

Waxaa jira tijaabooyin dhowr ah oo loo isticmaalo in lagu ogaado in kansarka naasuhu uu yahay HER2-positive. Laba ka mid ah tijaabooyinka ugu caansan waa:

 

 IHC (ImmunoHistoChemistry)

Tijaabada IHC waxay isticmaashaa dheeh kiimiko ah si loogu sumeeyo borotiinada HER2. IHC waxay siisaa dhibco 0 ilaa 3+ ah oo cabiraya xaddiga borotiinada HER2 ee dusha sare ee unugyada ee sambalka unugyada kansarka naasaha. Haddii dhibcaha uu yahay 0 illaa 1+, waxaa loo tixgeliyaa HER2-diidmo. Haddii dhibcaha uu yahay 2 +, waxaa loo tixgeliyaa xadka. Dhibcaha 3 + waxaa loo tixgeliyaa HER2-wanaagsan.

Haddii natiijooyinka baaritaanka IHC ay xudduud yihiin, waxay u badan tahay in baaritaanka FISH lagu sameyn doono qayb ka mid ah unugyada kansarka si loo go'aamiyo haddii kansarku yahay HER2-positive.

 

 BALAN (Fluorescence In Mashruuca Lagu Sameeyo)

Imtixaanka FISH wuxuu adeegsadaa sumado gaar ah oo ku dhegan borotiinka HER2. Calaamadaha gaarka ah ayaa kiimikooyin lagu daray si ay u beddelaan midabka oo u dhalaalaan mugdiga markay ku dhegaan borotiinada HER2. Tijaabadani waa tan ugu saxsan, laakiin way ka qaalisan tahay waxayna qaadataa waqti dheer in la soo celiyo natiijooyinka. Tani waa sababta baaritaanka IHC uu badanaa u yahay baaritaanka ugu horreeya ee la sameeyo si loo arko haddii kansarku yahay HER2-positive. Imtixaanka FISH, waxaad kuheleysaa dhibic midkoodna mid togan ama mid taban (isbitaalada qaar waxay ugu yeeraan natiijo tijaabo taban "eber").

 

Sidee Neratinib u shaqeeyaa?

Kansarrada naasaha ee HER2-positive waxay aad uga dhigaan borotiinka HER2. Borotiinka HER2 wuxuu ku fadhiyaa dusha unugyada kansarka wuxuuna helayaa calaamado u sheegaya kansarka inuu koro oo uu fido. Qiyaastii mid ka mid ah afartii kansar ee naasaha ah waa HER2-positive. Kansarrada naasaha ee HER2-positive waxay u muuqdaan kuwo ka dagaal badan kana adag daaweynta kansarka naasaha ee HER2-taban. Neratinib waa kahortag pan-HER-celin la'aan. Neratinib wuxuu la dagaallamaa kansarka naasaha HER2-positive isagoo ka horjoogsanaya awoodda unugyada kansarka inay helaan calaamadaha koritaanka.

Neratinib waa a daaweynta la beegsaday, laakiin ka duwan Herceptin (magaca kiimikada: trastuzumab), Kadcyla (magaca kiimikada: T-DM1 ama ado-trastuzumab emtansine), iyo Perjeta (magaca kiimikada: pertuzumab), maahan daaweyn lala beegsado. Daaweynta la-bartilmaameedsaday ee difaaca jirka ayaa ah noocyada difaaca jirka ee sida dabiiciga ah u dhaca oo u shaqeeya sida unugyada difaaca jirka ee ay sameeyaan nidaamyada difaaca jirka. Neratinib waa iskudhis kiimiko ah, mana ahan antibody.

 

Sidee Ayaan U Qaadanaa Neratinib?

Qiyaasta lagu taliyey ee neratinib waa 240 mg (6 kiniin), waxaa lagu qaataa afka hal mar maalintii cunno, waxaana loo isticmaalaa si isdaba joog ah 1 sano. Neratinib waxaa loo heli karaa kiniin 40-mg ah.

Daawada ka hortagga shubanka, loperamide waa in si isku mid ah loogu istcimalaa qiyaasta ugu horreysa ee neratinib waana la sii wadaa inta lagu jiro 2da wareeg ee ugu horreeya (ie, 56 maalmood) ee daaweynta, ka dibna sidii loogu baahdo. Bukaanka waa in lagu amraa inay joogteeyaan 1 ilaa 2 saxaro maalin kasta, waana in la baraa sida loo isticmaalo nidaamyada daaweynta shubanka.

Kala goynta xaddiga gaarka ah iyo / ama talooyinka dhimista qiyaasta, oo ku saleysan dulqaadka shaqsiyeed ee bukaanka, ayaa lagu sharxay macluumaadka qoritaanka. Bukaannada qaba naafonimo daran, cabiraadda neratinib ee bilowga ah waa in loo dhigaa 80 mg.

 

Ogaysiis: dhammaan macluumaadka waxay ahaayeen kaliya tixraac, laga bilaabo Kiniiniyada NERLYNX (neratinib) (PDF)

 

Maxaan arki karnaa Saameynaha Neratinib? 

Shuban ba'an isla marka uu bilaabo neratinib waa waxyeelo aad u badan. Tijaabada ExteNET, qiyaastii 40% dumarka lagu daweeyay neratinib waxay qabeen shuban daran oo saameyn xun leh.

Ansixinta FDA waxay ku talineysaa in loperamide (magacyada calaamadaha ay ka mid yihiin Imodium, Kaopectate 1-D, iyo Xakamaynta Shubanka Pepto) la siiyo neratinib maalmaha ugu horreeya ee 56 ee daaweynta ka dibna loo baahan yahay si looga caawiyo maaraynta shubanka.

 

Dhibaatooyinka kale ee caadiga ah ee neratinib waxay kala yihiin:

▪ matagid

▪ lallabo

▪ calool xanuun

▪ daal

▪ finan

So nabarrada afka

 

Marar dhif ah, neratinib waxay sababi kartaa dhibaatooyin beerka ah oo daran. U sheeg dhakhtarkaaga isla markiiba haddii aad leedahay mid ka mid ah calaamadaha soo socda ee dhibaatooyinka beerka:

▪ maqaarka oo huruud noqda ama indhaha cad

Urine kaadi madow ama bunni ah

▪ dareemid daal badan

Ite cunto xumo

▪ xanuun dhinaca sare ee midig ee caloosha

▪ dhiigbax ama nabar ka fudud sida caadiga ah

AASraw waa soo saaraha xirfadlaha ah ee Neratinib.

Fadlan halkan guji si aad u hesho macluumaadka xigashada: Nala soo xiriir

 

Gunaanad

Ansixinta FDA ee neratinib, oo ah kahortaga 'kinase inhibitor', ayaa calaamadeeyay helitaanka ikhtiyaarka daaweynta ugu horreysa ee dheeriga ah ee loogu talagalay bukaannada ku habboon marxaladda hore, naaska HER2 kansarka. Bukaanka qaba HER2-positive kansarka naasaha yaa helay neratinib muddo 1 sano ah ayaa si weyn u soo hagaagtay 2-sano jiritaan badbaado oo aan cudur lahayn marka la barbar dhigo bukaanada la siiyay placebo, ka dib daaweynta kiimoteraabiga iyo daaweynta ku-saleysan trastuzumab.

 

Tixraaca

[1] Chan A, Delaloge S, Holmes FA, et al; ee Kooxda Daraasada ExteNET. Neratinib ka dib daaweynta adjuvant ee ku saleysan trastuzumab ee bukaanada qaba kansarka naasaha HER2positive (ExteNET): iskudhafyo badan, kala soocid, laba-indhoole, xakameyn xakameyn ah, tijaabada wajiga 3. Lancet Oncol. 2016; 17: 367-377.

[2] Maamulka Cuntada iyo Dawooyinka ee Mareykanka. FDA waxay ansixisay daaweyn cusub si loo yareeyo halista kansarka naasaha ku soo laabto. War-saxaafadeed. Luulyo 17, 2017.

[3] Kiniiniyada Nerlynx (neratinib) [macluumaadka qorista]. Los Angeles, CA: Puma Biotechnology; Luulyo 2017.

[4] Machadka Kansarka Qaranka. Wakiilada la bartilmaameedsaday ee kahortaga kansarka naasaha ee HER2-positive: su'aalaha iyo jawaabaha. La cusbooneysiiyay Juun 1, 2014. www.cancer.gov/types/breast/research/altto-qa. La helay Sebtember 22, 2017.

[5] Singh J, Petter RC, Baillie TA, Whitty A (Abriil 2011). "Soo noolaanshaha daroogada covalent". Faallooyinka Dabeecadda. Daawada La Ogaaday. 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. (Luulyo 2007). "Isbedelada waaweyn ee kansarka sanbabada ee ka soo baxa ERBB2 waa oncogenic waxayna la xiriiraan xasaasi u ahaanshaha ka-hortaggaha EGFR / ERBB2 HKI-272". Oncogene. 26 (34): 5023-7. doi: 10.1038 / sj.onc.1210292. PMID 17311002.

[7] Machadka Kansarka Qaranka. Daaweynta kansarka naasaha ee ragga (PDQ) - nooc caafimaad oo xirfad leh. La cusbooneysiiyay May 25, 2017. www.cancer.gov/types/breast/hp/male-breast-treatment-pdq. La helay Sebtember 22, 2017.

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