Kodi Ndi Mankhwala Otani Omwe Angathandize Kuchiza Khansa Ya m'mawere?
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Zamgululi

 

  1. Kodi Timadziwa Zambiri Zokhudza Khansa ya m'mawere?
  2. Zotsatira Zachipatala Mwa FDA Apprvoal
  3. Kodi Neratinib ndi Chiyani?
  4. Ndani Angafune Neratinib?
  5. Momwe Mungadziwire Ngati Neratinib Ndi Yoyenera kwa Inu?
  6. Kodi Neratinib Imagwira Bwanji?
  7. Momwe Timatenga Neratinib?
  8. Zomwe Tingawone Zotsatira Zoyipa Za Neratinib?
  9. Kutsiliza

 

Zambiri Zomwe Timadziwa Zokhudza Khansara ya m'mimba

Khansa ya m'mawere ndi khansa yodziwika kwambiri pakati pa akazi, yomwe imayimira 15% ya milandu yonse yatsopano ya khansa ku United States. Mu 2017, anthu 252,710 odwala khansa ya m'mawere akuti akupezeka, ndipo azimayi opitilira 40,600 amwalira ndi matendawa. Khansa ya m'mawere imathandizanso, kawirikawiri, kukhudza amuna, ndipo pafupifupi 2470 milandu yatsopano imapezeka pachaka.

Pafupifupi 15% mpaka 20% ya zotupa za khansa ya m'mawere ali ndi HER2-positive. Khansa ya m'mawere yomwe ili ndi kuchuluka kwa HER2 imakhala ndi chiopsezo chowonjezeka cha metastasis, kuyankha kosakwanira kwa chithandizo, komanso kubwereza.

Kukula ndi kuvomerezedwa kwa US Food and Drug Administration (FDA) kwa trastuzumab (Herceptin), wotsutsana ndi HER2 wolandila, adasintha chithandizo cha odwala omwe ali ndi matenda a HER2. Pamene trastuzumab idawonjezeredwa ku chemotherapy, ziwerengero zonse za amayi omwe ali ndi gawo loyambirira Khansa ya m'mawere ya HER2 bwino mpaka 37%. Komabe, pafupifupi 26% ya odwala ali ndi matenda obwerezabwereza atalandira chithandizo cha trastuzumab.

Mankhwala ena omwe amalimbana ndi khansa ya m'mawere ya HER2 ndi pertuzumab (Perjeta), antibody monoclonal; ado-trastuzumab emtansine (Kadcyla), mankhwala oteteza monoclonal ophatikizidwa ndi mankhwala a chemotherapy; ndi lapatinib (Tykerb), kinase inhibitor.

 

Zotsatira zachipatala Wolemba FDA

Kuvomerezeka kwa FDA kwa Neratinib kutengera kuyesedwa kwa Phase III ExteNET, kuyesa kosiyanasiyana, kosasinthika, kwakhungu kawiri, koyeserera kwa placebo kwa neratinib kutsatira chithandizo cha adjuvant trastuzumab. Mlanduwu udalembetsa azimayi 2,840 omwe ali ndi khansa ya m'mawere yoyambirira ya HER2 ndipo pasanathe zaka ziwiri atamaliza adjuvant trastuzumab. Maphunzirowa adasinthidwa mwachisawawa kuti alandire neratinib (n = 1420) kapena placebo (n = 1420) kwa chaka chimodzi. Zotsatira za kuyesa kwa ExteNET zidawonetsa kuti patatha zaka ziwiri kutsatira, kupulumuka kopanda matenda (iDFS) kunali 94.2% m'mitu yothandizidwa ndi neratinib poyerekeza ndi 91.9% mwa omwe amalandira malowa.

Neratinib adayesedwanso pamayeso a Phase III NALA, kuyesedwa kosasinthika kwa neratinib kuphatikiza capecitabine mwa odwala omwe ali ndi khansa ya m'mawere ya HER2 omwe alandila mitundu iwiri kapena ingapo isanachitike yotsutsana ndi HER2. Mlanduwo udalembetsa odwala 621 omwe adasinthidwa mwachisawawa (1: 1) kuti alandire neratinib 240 mg pakamwa kamodzi tsiku lililonse pa masiku 1-21 kuphatikiza ndi capecitabine 750 mg / m2 yoperekedwa pakamwa kawiri patsiku masiku 1-14 pakuzungulira kwamasiku 21 ( n = 307) kapena lapatinib 1250 mg pakamwa kamodzi tsiku lililonse pa masiku 1-21 kuphatikiza capecitabine 1000 mg / m2 yoperekedwa pakamwa kawiri patsiku masiku 1-14 pakuzungulira kwamasiku 21 (n = 314). Odwala amathandizidwa mpaka matenda atakula kapena poyizoni wosavomerezeka. Chithandizo cha neratinib chophatikizira ndi capecitabine chidapangitsa kuti pakhale kusintha kwakanthawi kochepa kopitilira muyeso (PFS) poyerekeza ndi chithandizo cha lapatinib kuphatikiza capecitabine. Mulingo wa PFS pamwezi wa 12 unali 29% kwa odwala omwe amalandira neratinib kuphatikiza capecitabine vs 15% ya odwala omwe adalandira lapatinib kuphatikiza capecitabine; kuchuluka kwa PFS pamiyezi 24 inali 12% vs 3%, motsatana. Median OS inali miyezi 21 kwa odwala omwe adalandira neratinib kuphatikiza capecitabine poyerekeza ndi miyezi 18.7 ya odwala omwe adalandira lapatinib kuphatikiza kuphatikiza capecitabine.

 

Zamgululi

 

Chani Is Neratinib?

Neratinib (CAS: 698387-09-6) ndi mankhwala omwe amalimbana ndi kukula kwa khansa ya m'mawere. Neratinib ndi dzina losadziwika la mankhwalawa. Dzina lake ndi Nerlynx.

 

amene Might Mukufuna Neratinib?

Neratinib itha kuperekedwa kwa anthu omwe ali ndi khansa yoyamba ya m'mawere yomwe ndi iyi:

Positive Hormone receptor positive (khansa ya m'mawere yomwe imalimbikitsidwa kukula ndi mahomoni a estrogen kapena progesterone)

Positive HER2 zabwino (khansa ya m'mawere yomwe imakhala ndi protein yotsika ya HER2)

 

Momwe Mungadziwire Ngati Neratinib Ndi Yoyenera kwa Inu?

Pali mayeso angapo omwe amagwiritsidwa ntchito kuti apeze ngati khansa ya m'mawere ili ndi HER2. Mayeso awiri ofala kwambiri ndi awa:

 

 IHC (ImmunoHistoChemistry)

Mayeso a IHC amagwiritsa ntchito utoto wamafuta kuti awononge mapuloteni a HER2. IHC imapereka mphotho ya 0 mpaka 3+ yomwe imayesa kuchuluka kwa mapuloteni a HER2 pamwamba pamaselo omwe ali mumtundu wa khansa ya m'mawere. Ngati malamulowo ndi 0 mpaka 1+, amawerengedwa kuti HER2 alibe. Ngati malowo ndi 2+, amadziwika kuti ndi amalire. Zolemba 3+ zimawerengedwa kuti ndi HER2-positive.

Ngati zotsatira za mayeso a IHC zili m'malire, mwina mayeso a FISH adzachitika pazitsanzo za minofu ya khansa kuti mudziwe ngati khansa ili ndi HER2-positive.

 

 Nsomba (Fluorescence In Situation Hybridization)

Mayeso a FISH amagwiritsa ntchito zilembo zapadera zomwe zimaphatikizidwa ndi mapuloteni a HER2. Malembo apadera amakhala ndi mankhwala omwe amawonjezerapo kotero amasintha mtundu ndikuwala mumdima akagwirizana ndi mapuloteni a HER2. Mayesowa ndi olondola kwambiri, koma ndiokwera mtengo ndipo amatenga nthawi yayitali kuti abweretse zotsatira. Ichi ndichifukwa chake kuyesedwa kwa IHC nthawi zambiri kumakhala koyesa koyamba kuti muwone ngati khansa ili ndi HER2-positive. Ndi mayeso a FISH, mumapeza mphambu ya zabwino kapena zoyipa (zipatala zina zimati zotsatira zoyesa "zero").

 

Kodi Neratinib Imagwira Bwanji?

Khansa ya m'mawere ya HER2 imapanga mapuloteni ambiri a HER2. Puloteni ya HER2 imakhala pamwamba pamaselo a khansa ndipo imalandira ma sign omwe amauza khansara kuti ikule ndikufalikira. Pafupifupi khansa imodzi mwa ma khansa anayi aliwonse ndi omwe ali ndi HER2. Khansa ya m'mawere ya HER2 imakhala yovuta komanso yovuta kuchiza kuposa khansa ya m'mawere ya HER2. Neratinib ndiyosasinthika pan-HER inhibitor. Neratinib imalimbana ndi khansa ya m'mawere ya HER2 potseka ma cell a khansa kuti athe kulandira zizindikilo zakukula.

Neratinib ndi mankhwala othandizira, koma mosiyana ndi Herceptin (dzina la mankhwala: trastuzumab), Kadcyla (dzina la mankhwala: T-DM1 kapena ado-trastuzumab emtansine), ndi Perjeta (dzina la mankhwala: pertuzumab), si mankhwala olimbana ndi chitetezo chamthupi. Njira zochizira chitetezo cha mthupi ndi mitundu ya ma antibodies omwe amapezeka mwachilengedwe omwe amagwira ntchito ngati ma antibodies opangidwa ndi chitetezo chathu chamthupi. Neratinib ndi mankhwala, osati antibody.

 

Momwe Timatenga Neratinib?

Mlingo woyenera wa neratinib ndi 240 mg (mapiritsi 6), otengedwa pakamwa kamodzi tsiku lililonse ndi chakudya, ndipo amagwiritsidwa ntchito mosalekeza kwa chaka chimodzi. Neratinib imapezeka ngati piritsi 1-mg.

Kwa antidiarrheal prophylaxis, loperamide iyenera kugwiritsidwa ntchito molumikizana ndi muyeso woyamba wa neratinib ndikupitilira munthawi ya 2 (mwachitsanzo, masiku 56) a chithandizo, kenako ndikufunika. Odwala ayenera kulangizidwa kuti azikhala ndi matumbo a 1 mpaka 2 tsiku lililonse, komanso alangizidwe momwe angagwiritsire ntchito mankhwala opatsirana m'mimba.

Kusokonekera kwamankhwala ndi / kapena malingaliro ochepetsa mlingo, kutengera kulekerera kwa wodwalayo, zafotokozedwazi. Kwa odwala omwe ali ndi vuto lalikulu la chiwindi, mlingo woyambira wa neratinib uyenera kuchepetsedwa mpaka 80 mg.

 

Odziwika: madata onse amangotchulidwa, kuchokera Mapiritsi a NERLYNX (neratinib) (PDF)

 

Zomwe Tingawone Zotsatira Zoyipa Za Neratinib? 

Kutsekula m'mimba kwambiri mutangoyamba kumene neratinib ndizovuta kwambiri. Mu kuyesedwa kwa ExteNET, pafupifupi 40% ya azimayi omwe amathandizidwa ndi neratinib anali ndi matenda otsekula m'mimba kwambiri.

Kuvomerezeka kwa FDA kumalimbikitsa kuti loperamide (mayina amtunduwu akuphatikizapo Imodium, Kaopectate 1-D, ndi Pepto Diarrhea Control) apatsidwe ndi neratinib kwa masiku 56 oyamba achipatala kenako pakufunika kuthandizira kutsekula m'mimba.

 

Zotsatira zina zofala za ntchentche ndi:

▪ kusanza

▪ nseru

▪ kupweteka m'mimba

▪ kutopa

▪ zidzolo

▪ zilonda mkamwa

 

Nthawi zambiri, ntchentche zingayambitse mavuto aakulu a chiwindi. Uzani dokotala wanu nthawi yomweyo ngati muli ndi zizindikiro izi:

▪ chikasu pakhungu kapena maso oyera

▪ mkodzo wakuda kapena wabulauni

▪ Kumva kutopa kwambiri

▪ kusowa chilakolako chofuna kudya

▪ ululu kumanja chakumanja kwa pamimba

▪ Kutaya magazi kapena kuphwanya msanga kuposa kale

AASraw ndi katswiri wopanga Neratinib.

Chonde dinani apa kuti mumve zambiri: Ochezera ife

 

Kutsiliza

Kuvomerezeka kwa FDA kwa neratinib, oral kinase inhibitor, idawonetsa kupezeka kwa chithandizo choyambirira cha adjuvant kwa odwala oyenera omwe ali ndi gawo loyambirira, bere la HER2 khansa. Odwala omwe ali ndi HER2-positive khansa ya m'mawere amene analandira ntchentche kwa chaka chimodzi adakwanitsa kupititsa patsogolo matenda opatsirana azaka ziwiri poyerekeza ndi odwala omwe adalandira placebo, atalandira chemotherapy ndi trastuzumab-based adjuvant therapy.

 

Reference

[1] (Adasankhidwa) Chan A, Delaloge S, Holmes FA, et al; a Gulu Lophunzira la ExteNET. Neratinib pambuyo pa trastuzumab-based adjuvant therapy kwa odwala omwe ali ndi khansa ya m'mawere ya HER2positive (ExteNET): mayesero osiyanasiyana, osasinthika, akhungu awiri, olamulira malungo, gawo lachitatu. Lancet Oncol. 3; 2016: 17-367.

[2] Ulamuliro wa Zakudya ndi Mankhwala ku US. A FDA amavomereza chithandizo chatsopano chochepetsera chiopsezo cha kubwereranso kwa khansa ya m'mawere. Cholengeza munkhani. Julayi 17, 2017.

[3] Nerlynx (neratinib) mapiritsi [opereka chidziwitso]. Los Angeles, CA: Puma Ukadaulo Wazamoyo; Julayi 2017.

[4] National Cancer Institute. Othandizira omwe akutenga nawo mbali polimbana ndi khansa ya m'mawere ya HER2: mafunso ndi mayankho. Idasinthidwa pa Juni 1, 2014. www.cancer.gov/types/breast/research/altto-qa. Inapezeka pa September 22, 2017.

[5] Singh J, Petter RC, Baillie TA, Whitty A (Epulo 2011). "Kuyambiranso kwa mankhwala osokoneza bongo". Ndemanga Zachilengedwe. Kupeza Mankhwala Osokoneza bongo. 10 (4): 307-17. onetsani: 10.1038 / nrd3410. MAFUNSO OTHANDIZA: PMID 21455239. S2CID 5819338.

[6] Minami Y, Shimamura T, Shah K, LaFramboise T, Glatt KA, Liniker E, et al. (Adasankhidwa) (Julayi 2007). "Mitundu yayikulu yotulutsa khansa yam'mapapo ya ERBB2 ndiyachabechabe ndipo imalumikizidwa ndi chidwi chosasinthika cha EGFR / ERBB2 inhibitor HKI-272". Oncogene. 26 (34): 5023-7. onetsani: 10.1038 / sj.onc.1210292. MAFUNSO: PMID 17311002.

[7] National Cancer Institute. Chithandizo cha khansa ya m'mawere yamwamuna (PDQ) - mtundu wazachipatala. Idasinthidwa pa Meyi 25, 2017. www.cancer.gov/types/breast/hp/male-breast-treatment-pdq. Inapezeka pa September 22, 2017.

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