Dib-u-eegista Dacomitinib Dacomitinib: Sidee Loo Daweeyaa NSCLC? - AASraw
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Dacomitinib

 

  1. FDA waxay ansaxisay dacomitinib oo loogu talagay kansarka sanbabada unugyada unugyada yar-yar
  2. Waa maxay Kansarka Sambabka ee Unugyada Yar Yar?
  3. Codsiga daaweynta Dacomitinib ee kansarka sanbabada ee unugyada yar-yar
  4. Dib u eegista Dacomitinib
  5. Mashruuca ficilka 'Dacomitinib'
  6. Dacomitinib Isticmaala
  7. Waxyeelada Dacomitinib
  8. Daaweynta Kansarka Sambabka Sambabka ee aan-yareyn: Dacomitinib VS Gefitinib
  9. Sidee Loo Iibsadaa Budada Dacomitinib online?

 

FDA waxay u ansixisaa dacomitinib kansarka sanbabada unugyada unugyada yar-yar

Bishii Sebtember 27, 2018, Maamulka Cuntada iyo Dawooyinka ayaa ansixiyay kiniiniyada dacomitinib (VIZIMPRO, Shirkadda Daawada ee Pfizer) daaweynta ugu horreysa ee bukaanada leh metastatic kansarka sanbabada ee aan yareyn (NSCLC) oo leh soo-saareha kobaca epidermal factor (EGFR) exon 19 tirtirka ama exon 21 L858R beddelaadda beddelka sida lagu ogaadey tijaabada FDA-ansaxisay.

Ansixinta waxay ku saleysneyd kala sooc, xarumo kala duwan, calaamadeyn furan, tijaabo la xakameeyey oo firfircoon (ARCHER 1050; NCT01774721) oo isbarbar dhigeysa badbaadada iyo waxtarka dacomitinib ilaa gefitinib ee bukaanada 452 oo aan la daaweyn karin, metastatic NSCLC Bukaan-socodka waxaa looga baahnaa inaysan haysan daaweyn hore oo loogu talagalay cudurka metastatic ama cudur soo noqnoqda oo ugu yaraan 12 bilood aan lahayn cudur la'aan ka dib marka la dhammeeyo daaweynta aan-EGFR TKI-ku-daweynta ah; heerka waxqabadka Kooxda Iskaashatada Oncology ee Bariga ee 0 ama 1; iyo EGFR exon 19 tirtirka ama exon 21 L858R beddelaadda beddelaadda. Bukaannada ayaa loo kala soocay (1: 1) si ay u helaan midkoodna dacomitinib 45 mg afka ah hal mar maalintii ama gefitinib 250 mg afka ah hal mar maalintii ilaa cudurka uu ka sii socdo ama sun aan la aqbali karin.

Tijaabadu waxay muujisay horumar la taaban karo oo ku saabsan badbaadada horumarka-free; wax horumar ah oo ku yimid heerka jawaabta guud ama badbaadada guud lama muujin. Badbaadinta dhex-dhexaadnimada-dhexdhexaad, sida ay go'aamiyeen guddiga dib-u-eegista madaxbannaan. wuxuu ahaa 14.7 iyo 9.2 bilood dacoditinib iyo gefitinib hubka, siday u kala horreeyaan (heerka halista 0.59; 95% CI: 0.47, 0.74; p <0.0001).

Macluumaadka loo qoro wuxuu ka kooban yahay digniino iyo taxaddarro loogu talagalay cudurrada sanbabada ee kaladuwan (ILD), shuban, iyo fal-celinta xun ee maqaarka. 394 bukaan ah oo helay dacomitinib, falcelinno daran oo daran ayaa ka dhacay 27%. Dareen-celinta xun ee ugu caansan ee keenta joojinta dacomitinib waxay ahaayeen shuban iyo ILD. Kuwa ugu caansan (> 20%) falcelinta xun ee dacomitinib waxay ahaayeen shuban, firiiric, paronychia, stomatitis, rabitaanka cuntada oo yaraada, maqaarka oo qallalan, miisaanka oo yaraada, alopecia, qufac, iyo pruritus).

 

Waa maxay Kansarka Sambabka ee Unugyada Yar Yar?

Kansarka sambabka waa kansarka ugu caansan adduunka oo dhan, in ka badan laba milyan oo kiisas cusub ayaa laga helay adduunka oo dhan 2018. Qiyaastii boqolkiiba 85 dhammaan kansarrada sanbabada waxaa loo aqoonsaday inay yihiin unug yar, oo ku dhowaad 75 boqolkiiba kuwani waa metastatic, ama heer sare ah, marka la ogaado .

Egfr waa borotiin ka caawiya unugyada inay koraan oo kala qaybsamaan. Marka hiddo-wadaha EGFR la beddelo wuxuu sababi karaa borotiinka inuu noqdo mid kacsan oo keena unugyada kansarka inay sameystaan. Isbedelada EGFR waxaa laga yaabaa inay ku dhacaan 10 ilaa 35 boqolkiiba burooyinka NSCLC ee adduunka, iyo isbeddelada ugu badan ee dhaqdhaqaaqa ayaa ah tirtiridda exon 19 iyo beddelka 21 L858R, oo wadajir u ah in ka badan boqolkiiba 80 ee loo yaqaan 'EGFR mutation activation'. Cudurku wuxuu la xiriiraa heerarka badbaadada oo hooseeya iyo horumarka cudurka ayaa weli ah caqabad.

AASraw waa soo saaraha xirfadlaha ah ee Dacomitinib.

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

 

Codsiga daaweynta Dacomitinib ee kansarka sanbabada ee unugyada yar-yar

Dacomitinib waa jiilka labaad ee EGFR tyrosine kinase inhibitor (TKI) kaas oo si aan macquul aheyn ugu xiraya kuna joojinayo EGFR / Her1, Her2 iyo noocyada hoosaadyada Her4 oo leh waxtar u dhigma TKI-yada kale. Tijaabada 'ARCHER 1050', badbaadada horusocodka-bilaashka ah waxaa hagaajiyay dacomitinib marka la barbardhigo gefitinib, taageerida dacomitinib oo ah ikhtiyaarka daaweynta ugu horeysa ee kansarka sanbabada ee aan unugyada yareyn oo leh isbedel xasaasi ah EGFR. Marka la eego heerka dhacdooyinka xun ee sarreeya, yaraynta qiyaasta ma yarayn waxtarka dacomitinib waxayna si wax ku ool ah u yareyn kartaa dhacdooyinka iyo darnaanta dhacdooyinka xun. Iyadoo la tixgelinayo isbeddelka muuqaalka EGFR-mutant kansarka sanbabada ee unugyada yar, madaxa mustaqbalka isbarbardhiga u dhexeeya dacomitinib iyo osimertinib ayaa bixin kara macluumaad muhiim ah si loo go'aamiyo jadwalka daaweynta ugu wanaagsan ee TKI.

 

Dacomitinib

 

Dhacdooyinka sare ee Kansarka Sambabka ee Unugyada Yar Yar ayaa nagu qasbay inaan ka fikirno xulashooyinka daaweynta, sida loo helo habab wax ku ool ah? Dacomitinib daaweynta ayaa lagula talin doonaa qof walba. Marka xigta, aan eegno Dacomitinib:

 

Dib u eegista Dacomitinib

Dacomitinib, oo loogu talagalay (2E) -N-16-4- (piperidin-1-yl) laakiin-2-enamide, waa qayb quinazalone si heer sare ah loo xusho oo ka mid ah jiilka labaad ee tyrosine kinase inhibitors kaas oo lagu garto ku noqoshada aan laga noqon karin domainka ATP ee cunsuriyaha kobaca epidermal ee qaata qoysaska kinase. Dacomitinib waa daawo loogu talagalay daaweynta kansarka sanbabada ee unugyada yar-yar (NSCLC). Waa xakameyn xulasho iyo dib-u-celin la'aan EGFR.

Dacomitinib waxaa soo saaray shirkadda Pfizer Inc oo ay ansixisay FDA bishii Sebtember 27, 2018. Qaar ka mid ah cadeymaha ku jira suugaanta waxay soo jeedinayaan awoodda daweynta ee dacomitinib ee qaabka kansarka ugxan-sidaha epithelial, in kasta oo baaritaanno dheeraad ah loo baahan yahay.

Hada, budada Dacomitinib (CAS:1110813-31-4) waxaa bixin kara AASraw oo ka socda Shiinaha.

 

Mashruuca ficilka 'Dacomitinib'

Dacomitinib waa xannibaadaha yar-yar ee ka-hortagga wax-qabadka ee wax-qabadka cunsur-ku-soo-kiciyaha cuncunka bini-aadamka (EGFR) (EGFR / HER1, HER2, iyo HER4) tyrosine kinases. Waxay ku guuleysataa ka-hortagga aan la-soo-celin karin iyada oo loo marayo isku-xirnaanta isku-dhafan ee haraaga cysteine-ka ee ku yaal qaybaha soo-saarka ee HER reseptors. Isku xirnaanta dacomitinib ayaa la muujiyay inay leedahay IC50 oo ah 6 nmol / L.

ErbB ama cunsur koritaanka epidermal (EGF) qoysku wuxuu door ka ciyaaraa koritaanka burooyinka, metastasis, iyo iska caabinta daaweynta iyadoo la dhaqaajinayo dariiqyada gudbinta calaamadaha hoose sida sida Ras-Raf-MAPK, PLCgamma-PKC-NFkB iyo PI3K / AKT iyada oo loo marayo tyrosine fosforyaalka loo yaqaan 'kinase-driven phosphorylation at the carboxy-terminus.1' Qiyaastii 40% kiisaska ayaa muujinaya kordhinta hidda-wadaha EGFR iyo 50% kiisaska waxay soo bandhigaan isbeddelka 'EGFRvIII' kaasoo metelaya tirtiridda soo saarta firfircooni joogto ah ee qaybta 'tyrosine kinase domain of reseptor'

 

Dacomitinib Isticmaala

Dacomitinib waa la oggol yahay in lagu daaweeyo: Kansarka sambabka ee unugyada aan-yareyn (NSCLC) ee metastasized (ku faafay qaybaha kale ee jirka). Waxaa loo isticmaalaa daaweynta ugu horreysa ee bukaanka burooyinka burooyinkoodu ay leeyihiin isbeddellada hiddo-wadaha EGFR qaarkood.

Dacomitinib sidoo kale waxaa lagu baranayaa daaweynta noocyada kale ee kansarka.

 

Waxyeelada Dacomitinib

Waxyaabaha muhiimka ah ee laga xasuusto waxyeelada dacomitinib:

Dadka badankood ma dareemi doonaan dhammaan dhibaatooyinka soo raaca dacomitinib halkan ayey ku taxan yihiin.

Effects Dhibaatooyinka soo raaca ee 'Dacomitinib' ayaa badanaa la saadaalin karaa marka loo eego bilowgooda, muddadooda iyo darnaanta ay leeyihiin.

Effects Dhibaatooyinka soo raaca ee 'Dacomitinib' ayaa soo hagaagaya ka dib marka daaweynta la dhammeeyo.

Effects Dhibaatooyinka soo raaca ee 'Dacomitinib' waxaa laga yaabaa inay yihiin kuwo la maareeyo. Waxaa jira ikhtiyaarro badan oo lagu yareeyo ama looga hortago dhibaatooyinka soo raaca ee dacomitinib.

AASraw waa soo saaraha xirfadlaha ah ee Dacomitinib.

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

 

Dhibaatooyinka soo socda ee soo socdaa waa wax caadi ah (oo ku dhaca in ka badan 30%) bukaanada qaata dacomitinib:

Rash Finan maqaarka ah

Infection Infekshanka jeermiska bakteeriyada ama fungal (paronychia)

Skin Maqaar qallalan

Alb Albumin yar

Kalsiyum hooseeya

Levels Heerarka gulukoosta dhiigga oo sarreeya

Arrhea Shuban

So Af xanuun

Appet Rabitaanka cuntada oo yaraada

Em Dhiig yaraan (haemoglobin hoose)

Count Tirinta unugyada dhiigga cad oo hooseeya

Z Enzymis-ka beerka oo kordha

 

Kuwani waa waxyeellooyin aan caadi ahayn (oo ku dhaca 10-29%) bukaannada qaata dacomitinib:

Pain Xabad xanuun

Hurdo la'aan

▪ Timo lumis

Ching Cuncun

▪ Casaan, barar, iyo xanuun ku dhaca calaacalaha gacmaha iyo / ama cagaha cagaha

Potassium Heerarka potassium, magnesium iyo sodium

Ight Miisaan lumis

▪ Lallabo

Ip Calool fadhiga

▪ Xanuun xanuun

Pain Xanuunka muruqyada

Tabar yari / tamar la'aan

Lam Caabuq ama infekshinka indhaha

Um Kordhinta serum creatinine

Qufac, astaamaha sanka iyo astaamaha, neefsashada oo dhib ku ah iyo infekshinka neef mareenka sare

Dhibaatooyinka oo dhan kuma qorna kor. Dhibaatooyinka soo raaca ee aad u yar - ee ku dhaca in ka yar 10 boqolkiiba bukaannada - halkan kuma qorna. Laakiin waa inaad marwalba ogeysiisaa bixiyaha xanaanada caafimaadkaaga hadii aad isku aragto calaamado aan caadi aheyn.

 

Daaweynta Kansarka Sambabka Sambabka ee aan-yareyn: Dacomitinib VS Gefitinib

Bukaannada qaba EGFR-positive, kansarka sanbabada ee unugyada aan yareyn ee maskaxda (NSCLC), dacomitinib safka koowaad wuxuu hagaajiyaa badbaadada horumarka-bilaashka ah (PFS) ee gefitinib, sida lagu sheegay daraasad wajiga 3 ah oo lagu daabacay The Lancet Oncology.Dacomitinib

Jiilka koowaad ee EGFR-tyrosine kinase inhibitors (TKIs), oo ay kujirto gefitinib, ayaa loo adeegsadaa safka ugu horeeya ee bukaanada qaba cudurka EGFR-position disease, oo ka kooban inta udhaxeysa 10% iyo 44% dhamaan sambabada adenocarcinomas. Daraasad hore looma go'aamin in jiilka labaad ee EGFR-TKIs ay ka sareeyaan jiilka koowaad.

Calaamadan furan, daraasad aan kala sooca lahayn (ARCHER 1050; ClinicalTrials.gov Aqoonsiga: NCT01774721), oo qorayaashu sheegeen waa wajiga koowaad ee 3 daraasad si loo barbardhigo jiilka labaad ee EGFR-TKI iyo jiilka koowaad EGFR-TKI ee goobtan , cilmi baarayaashu waxay qoreen bukaanada 452 si ay u helaan dacomitinib (227 bukaan) ama gefitinib (225 bukaan). Bukaannada qaba metastases-ka maskaxda uma qalmin.

Dabagalka dhexdhexaadka ee 22.1 bilood, dhexdhexaadka PFS wuxuu ahaa 14.7 bilood dacomitinib vs 9.2 bilood gefitinib; falanqaynta koox-hoosaadyada ayaa sidoo kale doorbiday dacomitinib. Laba iyo toban jawaabood oo dhameystiran ayaa laga duubay kooxda dacomitinib vs 4 ee kooxda gefitinib. Heerarka jawaabta ujeedadu waxay ahaayeen, si kastaba ha noqotee, isku mid (75% dacomitinib iyo 72% gefitinib; P = .4234).

Kow iyo labaatan bukaan ah oo qaata dacomitinib waxay lahaayeen dhacdo halis ah oo daaweyn la xiriirta (AE); tani waxay ahayd run 10 bukaan ah oo qaata gefitinib. Dhimashada la xiriirta daaweynta ayaa loo soo sheegay 2 bukaan qaata dacomitinib vs 1 gefitinib.

Qorayaashu waxay ku soo gabagabeeyeen "daaweynta dacomitinib way ka fiicnayd gefitinib iyadoo la tixraacayo [PFS] iyo muddada jawaabta laga bixinayo daweynta koowaad ee bukaannada qaba EGFR-mutation-mutation-positive NSCLC waana in loo tixgeliyaa inay tahay ikhtiyaar daaweyn cusub oo dadkan ah. ”

 

Sidee Loo Iibsadaa Budada Dacomitinib online?

Waxaa jira alaab-qeybiyeyaal / soosaarayaal badan oo ka sameysan budada dacomitinib oo suuqa ku jira, helitaanka mid dhab ah ayaa aad muhiim ugu ah dhammaan dadka u baahan badeecadan si deg deg ah. Markii aan go'aansanayno inaan ka iibsano budada dacomitinib suuqa, waxaan ubaahanahay inaan waxbadan kabarano, ogaano sida loo isticmaalo iyo qaabka wax u qabadka, wixii khatar ah markaan qaadano budada dacomitinib…. Intaas waxaa sii dheer, qiimaha iyo tayada waa inay ahaadaan waxyaabaha aan ka walwalsanahay ka hor intaanan iibsan.

Ka dib markii aan ka baarnay xog uruurinta suuqa, marka la barbardhigo alaab-qeybiyeyaal badan, AASraw waxay u muuqataa xulasho wanaagsan dadka doonaya inay waxbadan iibsadaan budada dacomitinib, waxsoosaarkooda si adag ayaa loo xakameeyay iyada oo loo marayo xaalada cGMP, tayada waa lala socon karaa wakhti kasta waxaana laga yaabaa inay bixiyaan dhammaan warbixinnada baaritaanka markaad dalbato. Sida kharashka / qiimaha budada dacomitinib, waa inay macquul tahay, indhahayga. Sababtoo ah waxaan ka helay qiimayaal badan alaab-qeybiyeyaal kala duwan, marka la barbardhigo tayada, waxaan u maleynayaa aasraw inaysan noqon doonin xulasho xun.

 

Tixraaca

[1] Kobayashi Y, Fujino T, Nishino M, iyo al. Isbedelada EGFR T790M iyo C797S oo ah farsamooyin iska caabin ah oo loo helay dacomitinib. J Thorac Oncol. 2018; 13 (5): 727-731. doi: 10.1016 / j.jtho.2018.01.009.

[2] Kris MG, Camidge DR, Giaccone G, iyo al. Beegsiga HER2 aberrations sida darawallada waxqabadka leh ee kansarka sanbabada: tijaabada wajiga II ee pan-HER tyrosine kinase inhibitor dacomitinib ee bukaanada qaba burooyinka HER2-mutant ama burooyinka la kordhiyay. Ann Oncol. 2015; 26 (7): 1421–1427. doi: 10.1093 / annonc / mdv383.

[3] Park K, Tan EH, O'Byrne K, iyo al. Afatinib iyo gefitinib oo ah daaweynta ugu horeysa ee bukaanada qaba EGFR isbeddel-kansarka sanbabada ee unugyada yar-yar (LUX-Lung 7): wejiga 2B, calaamadda furan, tijaabada kontoroolka la kala saaray. Lancet Oncol. 2016; 17 (5): 577-589. doi: 10.1016 / S1470-2045 (16) 30033-X.

[4] Lacouture ME, Keefe DM, Sonis S, iyo al. Daraasad wajiga II ah (ARCHER 1042) si loo qiimeeyo daaweynta kahortaga dacumitinib ee ay keento cudurka maqaarka iyo caloosha iyo caloosha dhacdooyinka xun ee kansarka sanbabada ee unugyada yar-yar. Ann Oncol. 2016; 27 (9): 1712–1718. doi: 10.1093 / annonc / mdw227.

[5] Reckamp KL, Giaccone G, Camidge DR, iyo al. Tijaabada wajiga 2 ee dacomitinib (PF ‐ 00299804), oo ah afka, aan la celin karin ‐ HER (falceliyaha falceliska koritaanka bini'aadamka epidermal) xannibaadaha, bukaanada qaba kansarka sanbabada ee unugyada aan yareyn ka dib markii lagu guuldareystay daaweynta kiimikada iyo erlotinib. Kansarka. 2014; 120 (8): 1145–1154. doi: 10.1002 / cncr.28561.

[6] Engelman JA, Zejnullahu K, Mitsudomi T, iyo al. Kordhinta MET waxay u horseedaa iska caabin gefitinib ah oo ku dhaca kansarka sanbabada iyadoo la dhaqaajinayo calaamadaha ERBB3. Sayniska. 2007; 316 (5827): 1039–1043. doi: 10.1126 / science.1141478.

[7] Liu X, Wang P, Zhang C, iyo al. Daawada cuncunka Epidermal factor reseptor (EGFR): Xiddig soo kacaya xilligii dawada saxda ah ee kansarka sanbabada. Oncotarget. 2017; 8 (30): 50209-50220.

[8] Girard N. Natiijooyinka ka soo baxa EGFR isku-beddelka wanaagsan ee NSCLC: waa maxay tyrosine kinase inhibitor iyo goorma? Mustaqbalka Oncol 2018.

[9] Inoue A, Kobayashi K, Maemondo M, iyo al. Natiijooyinka guud ee badbaadada guud ee NEJ002, tijaabada wajiga III ee isbarbar dhiga gefitinib iyo karboplatin (CBDCA) oo lagu daray paclitaxel (TXL) oo ah daaweynta ugu horeysa ee daaweynta kansarka sanbabada ee unugyada aan yareyn (NSCLC) oo leh isbeddelada EGFR. J Clin Oncol 2011; 29: 7519.

[10] Sequist LV, Yang JC, Yamamoto N, iyo al. Daraasada Wejiga III ee afatinib ama cisplatin oo lagu daray pemetrexed ee bukaanada qaba sambabada adenocarcinoma ee metastatic leh isbadalada EGFR. J Clin Oncol 2013; 31: 3327-34.

[11] Lin JJ, Cardarella S, Lydon CA, iyo al. Badbaadinta Shanta Sano ee EGFR-Mutant Metastatic Lung Adenocarcinoma Waxaa lagu daaweeyaa EGFR-TKIs. J Thorac Oncol 2016; 11: 556-65.

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