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Neratinib

 

  1. Pehea ka ʻike e pili ana i ka maʻi ʻaʻai umauma?
  2. Nā Hopena Lapaʻau Na FDA Apprvoal
  3. He aha ka Neratinib?
  4. ʻO wai ka mea e pono ai iā Neratinib?
  5. Pehea e ʻike ai inā kūpono ʻo Neratinib iā ʻoe?
  6. Pehea e hana ai ʻo Neratinib?
  7. Pehea mākou e lawe ai iā Neratinib?
  8. He aha kā mākou e ʻike ai i nā hopena ʻaoʻao o Neratinib?
  9. Panina

 

Pehea kā mākou ʻike e pili ana ʻO ka maʻi kanulau

ʻO ka maʻi ʻaʻai ʻo ka ʻano maʻi ʻaʻai nui loa ia o nā wahine, e hōʻike ana he 15% o nā hihia maʻi ʻaʻai hou i United States. I ka 2017, 252,710 mau hihia hou o ka maʻi ʻaʻai umauma i manaʻo ʻia e ʻike ʻia, a ʻoi aku ma mua o 40,600 mau wahine e make i kēia maʻi. Hiki nō hoʻi i ka maʻi ʻaʻai umauma, me ka liʻiliʻi loa, ke hoʻopili i nā kāne, me 2470 mau hihia hou i ʻike ʻia i kēlā me kēia makahiki.

Ma kahi o 15% a 20% o nā tumors cancer cancer he HER2-maikaʻi. ʻO nā maʻi maʻi umauma me nā kiʻekiʻe kiʻekiʻe o HER2 i ka nui o ka makaʻu no ka metastasis, ka lawa ʻole o ka hoʻoponopono ʻana, a me ka hoʻi hou ʻana.

ʻO ka hoʻomohala ʻana a me ka US Food and Drug Administration (FDA) ʻae ʻia o trastuzumab (Herceptin), kahi antagonist receptor HER2, i hoʻololi i ke ʻano mālama no nā mea maʻi me ka maʻi HER2-maikaʻi. Ke hoʻohui ʻia ʻo trastuzumab i ka chemotherapy, ke ola holoʻokoʻa no nā wahine me ka pae mua Maʻi ʻaʻai umauma HER2-maikaʻi hoʻomaikaʻi ʻia a hiki i 37%. Eia nō naʻe, ma kahi o 26% o nā maʻi e loaʻa hou i ka maʻi ma hope o ka mālama ʻana me trastuzumab.

ʻO nā hoʻoponopono ʻē aʻe i kuhi ʻia i ka maʻi ʻaʻai umauma HER2-maikaʻi me ka pertuzumab (Perjeta), kahi monoclonal antibody; ado-trastuzumab emtansine (Kadcyla), kahi monoclonal antibody i hoʻopili ʻia i kahi lāʻau chemotherapy; a me lapatinib (Tykerb), kahi mea kūpina kinase.

 

Nā Hopena Lapaʻau Na FDA Apprvoal

Ua hoʻokumu ʻia ka ʻae ʻia a FDA o Neratinib ma ka hoʻāʻo Phase III ExteNET, kahi multicenter, randomized, double-blind, placebo-control trial o neratinib ma hope o adjuvant trastuzumab lapaʻau. Ua kākau inoa ʻia ka hoʻokolokolo he 2,840 mau wahine me ka maʻi ʻōpū HER2-maikaʻi i ka wā mua a i loko o ʻelua mau makahiki o ka hoʻopau ʻana i ka adjuvant trastuzumab. Hoʻohui ʻia nā kumuhana e loaʻa iā neratinib (n = 1420) a i ʻole placebo (n = 1420) no hoʻokahi makahiki. Ua hōʻike ʻia nā hopena o ka hoʻāʻo ExteNET ma hope o ʻelua mau makahiki o ka ukali ʻana, ua ola ka maʻi kūlohelohe ʻole (iDFS) he 94.2% i nā kumuhana i mālama ʻia me neratinib i hoʻohālikelike ʻia me 91.9% i ka poʻe e loaʻa ana i ka placebo.

Ua loiloi ʻia ʻo Neratinib i ka hoʻokolohua Phase III NALA, kahi hoʻokolohua hoʻokolohua kaulike ʻole o neratinib me capecitabine i nā mea maʻi me ka HER2-positive metastatic cancer cancer i loaʻa i ʻelua a ʻoi paha regimens i hoʻokumu ʻia anti-HER2. Ua kākau inoa ʻia ka hoʻokolokolo he 621 mau mea maʻi i randomized (1: 1) e loaʻa neratinib 240 mg waha waha hoʻokahi i kēlā me kēia lā i nā lā 1-21 me ka capecitabine 750 mg / m2 i hāʻawi waha ʻia i ʻelua mau lā i nā lā 1-14 no kēlā me kēia lā 21 lā ( n = 307) a i ʻole lapatinib 1250 mg waha waha hoʻokahi i kēlā me kēia lā i nā lā 1-21 i hui pū ʻia me capecitabine 1000 mg / m2 i hāʻawi waha ʻia i ʻelua mau lā i nā lā 1-14 no kēlā me kēia lā 21-lā (n = 314). Ua mālama ʻia nā mea maʻi a hiki i ka holomua ʻana o ka maʻi a i ʻole ka ʻawahia ʻae ʻole ʻia. ʻO ka mālama ʻana me neratinib me ka capecitabine me ka capecitabine i hopena i kahi hoʻomaikaʻi koʻikoʻi i ke ola manuahi holomua (PFS) ke hoʻohālikelike ʻia me ka lapatinib plus capecitabine. ʻO ka helu PFS ma 12 mau mahina he 29% no nā mea maʻi i loaʻa i ka neratinib plus capecitabine me 15% no nā mea maʻi i loaʻa ka lapatinib plus capecitabine; ʻo ka helu PFS ma 24 mau mahina he 12% vs 3%. ʻO Median OS he 21 mau mahina no nā mea maʻi i loaʻa i ka neratinib me ka capecitabine i hoʻohālikelike ʻia me 18.7 mau mahina no nā mea maʻi i loaʻa ka lapatinib me ka capecitabine.

 

Neratinib

 

Heaha Is Naiai?

Neratinib (CAS: 698387-09-6) he lāʻau hoʻomohala hoʻomōhala (biological) e ālai ana i ka ulu a hoʻolaha ʻana o ka maʻi ʻaʻai umauma. ʻO Neratinib ka inoa inoa ʻole o ka lāʻau. ʻO Nerlynx kona inoa.

 

ka mea Mʻike Pono Naiai?

Hāʻawi ʻia ʻo Neratinib i ka poʻe i loaʻa i ka maʻi ʻaʻai umauma mua ʻo ia ʻelua:

Positive Hormone receptor positive (cancer o ka umauma e hoʻonāukiuki ʻia e ulu e nā homone estrogen a progesterone)

❷ HER2 maikaʻi (ʻo ka maʻi ʻaʻai umauma i ʻoi aku ke kiʻekiʻe ma mua o ka pae maʻamau o ka protein HER2)

 

Pehea e ʻike ai inā kūpono ʻo Neratinib iā ʻoe?

Hoʻohana ʻia kekahi mau hoʻokolohua e ʻike inā he HER2-maikaʻi ka maʻi ʻaʻai umauma. ʻElua mau ho'āʻo maʻamau ʻo:

 

 IHC (ImmunoHistoChemistry)

Hoʻohana ka hōʻike IHC i kahi kala kemika e poke i nā protein HER2. Hāʻawi ka IHC i kahi helu o 0 a 3+ e ana i ka nui o nā protein HER2 ma ka ʻili o nā pūnaewele i kahi laʻana maʻi maʻi maʻi umauma. Inā 0 a 1+ ka helu, manaʻo ʻia ʻo HER2-maikaʻi ʻole. Inā 2+ ka helu, manaʻo ʻia ka palena palena. Kuhi ʻia kahi helu o 3+ ʻo HER2-maikaʻi.

Inā palena palena nā hopena hōʻike IHC, malia paha e hana ʻia kahi hōʻike FISH ma kahi laʻana o ka maʻi ʻaʻai e hoʻoholo inā he HER2-maikaʻi ka maʻi ʻaʻai.

 

 KA LAWU (Fluorescence In Situ Hoʻohuiʻia)

Hoʻohana ka hōʻike FISH i nā lepili kūikawā e hoʻopili ʻia i nā protein HER2. Hoʻohui ʻia nā lepili kūikawā iā lākou no laila hoʻololi lākou i ke kala a ʻlamalama i ka pouli ke pili lākou i nā protein HER2. ʻO kēia hōʻoia ka mea pololei loa, akā ʻoi aku ka pipiʻi a ʻoi aku ka lōʻihi o ka hoʻihoʻi ʻana i nā hopena. ʻO kēia ke kumu o ka hoʻāʻo IHC ʻo ia ka hōʻike mua i hana ʻia e ʻike inā he HER2-maikaʻi ka maʻi ʻaʻai. Me ka hōʻike FISH, loaʻa iā ʻoe ka helu o ka maikaʻi a maikaʻi ʻole paha (kāhea kekahi mau haukapila i kahi hopena hōʻike maikaʻi ʻole "zero").

 

Pehea e hana ai ʻo Neratinib?

ʻO nā kanesa umauma HER2-maikaʻi e hana i ka nui o ka protein HER2. Noho ka protein HER2 ma luna o nā hunaola maʻi ʻaʻai a loaʻa nā hōʻailona e haʻi i ka maʻi ʻaʻai e ulu a pāhola. Ma kahi o hoʻokahi o kēlā me kēia kanulau umauma ʻehā ʻo HER2-maikaʻi. ʻOi aku ka ikaika o ka maʻi ʻōpio HER2-ʻoi aku ka paʻakikī a paʻakikī hoʻi e mālama ma mua o nā maʻi maʻi umauma HER2-maikaʻi ʻole. ʻO Neratinib kahi mea pāpā pan-HER i hiki ʻole ke hoʻoliʻiliʻi. E hakakā ʻo Neratinib i ka maʻi ʻaʻai umauma HER2-maikaʻi ma ka pale ʻana i ka hiki i nā hunaola maʻi 'aʻai ke loaʻa nā hōʻailona ulu

ʻO Neratinib kahi hoʻomālama mākaukau, akā ʻaʻole like me Herceptin (inoa kemika: trastuzumab), Kadcyla (inoa kemika: T-DM1 a i ʻole ado-trastuzumab emtansine), a me Perjeta (inoa kemika: pertuzumab), ʻaʻole ia he pale pale pale pale pale maʻi. ʻO nā ʻōnaehana pale pale imunona nā mana o nā ʻōpala kūlohelohe maoli e hana e like me nā mea ʻino i hana ʻia e kā mākou pūnaewele immune. ʻO Neratinib kahi hui kemika, ʻaʻole kahi antibody.

 

Pehea mākou e lawe ai iā Neratinib?

ʻO ka mahele lāʻau i koi ʻia o neratinib he 240 mg (6 papa), lawe waha ʻia i hoʻokahi manawa i kēlā me kēia lā me ka meaʻai, a hoʻohana mau ʻia no hoʻokahi makahiki. Loaʻa ʻo Neratinib ma ke ʻano he papa 1-mg.

No ka prophylaxis antidiarrheal, pono e hoʻohana pū ʻia ka loperamide me ka mahele mua o ka neratinib a hoʻomau ʻia i loko o nā pōʻaiapuni 2 (ʻo ia hoʻi, 56 mau lā) o ka mālama ʻana, a laila inā pono. Pono e aʻo i nā mea maʻi e mālama i ka 1 a 2 i ka neʻe ʻana o ka ʻōpū i kēlā me kēia lā, a pono e aʻo ʻia pehea e hoʻohana ai i nā regimens antidiarrheal.

ʻO nā kahakaha kūpana kikoʻī a me / a i ʻole nā ​​koi hōʻemi hōʻemi, e pili ana i ka hoʻomanawanui ʻana o ka mea hoʻomanawanui, ua kahakaha ʻia i ka ʻike palapala. No nā mea maʻi me ka hōʻino hepatic koʻikoʻi, pono e hoʻemi ʻia ka hopena neratinib e hoʻomaka ana i 80 mg.

 

Hoʻomaopopo ʻia: ʻo nā ʻikepili āpau he kuhikuhi wale nō, mai NERLYNX (neratinib) mau papa (PDF)

 

He aha kā mākou e ʻike ai i nā hopena ʻaoʻao o Neratinib? 

ʻO ka diarrhea nui ma hope koke o ka hoʻomaka ʻana o neratinib kahi hopena ʻaoʻao maʻamau. I ka hoʻokolokolo ExteNET, ma kahi o 40% o nā wahine i mālama ʻia me neratinib i loaʻa i ka maʻi nui e like me ka hopena.

Paipai ka ʻae a FDA e hāʻawi ʻia ka loperamide (inoa inoa me Imodium, Kaopectate 1-D, a me Pepto Diarrhea Control) me neratinib no nā lā 56 mua o ka mālama ʻana a laila inā pono e kōkua i ka mālama ʻana i ka palahī.

 

Nā hopena ʻaoʻao ʻē aʻe o neratinib ua:

▪ luaʻi

▪ nausea

▪ ʻeha o ka ʻōpū

▪ luhi

▪ ʻāwīwī

▪ ʻeha nā waha

 

I nā pilikia pinepine loa neratinib hiki ke hoʻopilikia i nā pilikia o ke ake. E haʻi koke i kāu kauka inā loaʻa iā ʻoe kekahi o nā hōʻailona o nā pilikia o ke ake.

▪ melemele o ka ʻili a i ʻole nā ​​keʻokeʻo o nā maka

▪ mimi ʻeleʻele a ʻeleʻele paha

▪ luhi loa

▪ nalo o ka makemake ʻole

▪ ʻeha ma ka ʻaoʻao ʻākau o luna o ka ʻōpū

▪ ʻoi aku ka maʻalahi o ke kahe ʻana a i ʻole ka palapū ʻana ma mua o ka maʻamau

ʻO AASraw ka mea hana ʻoihana Neratinib.

E ʻoluʻolu e kaomi ma aneʻi no ka ʻike ʻōlelo. Hana iā mākou

 

Panina

Ua ʻae ʻia ka FDA o neratinib, kahi mea hoʻopuka kinase waha, i kaha ʻia i ka loaʻa ʻana o kahi koho lapaʻau adjuvant i hoʻonui mua ʻia no nā mea maʻi kūpono me ka pae mua, HER2-maikaʻi umauma. Ka maʻi 'aʻai. ʻO nā mea maʻi me HER2-maikaʻi umauma maʻi 'aʻai ka mea i loaʻa neratinib no 1 makahiki i loaʻa i kahi ola ʻoi loa o ka maʻi invasive 2 makahiki i hoʻohālikelike ʻia me nā mea maʻi i loaʻa kahi placebo, ma hope o ka chemotherapy a me ka trastuzumab-based adjuvant therapy.

 

Reference

[1] Chan A, Delaloge S, Holmes FA, et al; no ka Pūʻulu Study ExteNET. Neratinib ma hope o trastuzumab-based adjuvant therapy i nā mea maʻi me ka HER2positive umauma maʻi 'aʻai (ExteNET): he multicentre, randomized, papalua-makapo, placebocontrolled, pae 3 hoʻokolokolo. Lancet Oncol. 2016; 17: 367-377.

[2] ʻO US Food and Drug Administration. Ua ʻae ʻo FDA i kahi lāʻau hou e hōʻemi ai i ka hopena o ka hoʻi ʻana o ka maʻi ʻaʻai. Ka hoʻokuʻu paʻi. Lulai 17, 2017.

[3] Nerlynx (neratinib) papa [kuhikuhi ʻikepili]. Los Angeles, CA: Puma Biotechnology; Iulai 2017.

[4] Ke Kula Kaiapuni ʻAi Mokuʻāina. ʻO nā ʻākena i māka ʻia e kū kūʻē iā HER2-maikaʻi i ka maʻi ʻaʻai umauma: nā nīnau a me nā pane. Hoʻohou ʻia Iune 1, 2014. www.cancer.gov/types/breast/research/altto-qa. Loaʻa iā Kepakemapa 22, 2017.

[5] Singh J, Petter RC, Baillie TA, Whitty A (ʻApelila 2011). "Ke ala hou ʻana o nā lāʻau covalent". Nā Loiloi Kūlohelohe. ʻIke lāʻau. 10 (4): 307-17. hana: 10.1038 / nrd3410. PMID 21455239. S2CID 5819338.

[6] Minami Y, Shimamura T, Shah K, LaFramboise T, Glatt KA, Liniker E, et al. (Iulai 2007). "ʻO nā mutants nui i loaʻa i ka maʻi ʻaʻaiā o ERBB2 oncogenic a pili pū me ka noʻonoʻo i ka mea hoʻohuli ʻole ʻo EGFR / ERBB2 i hōʻole ʻia HKI-272". ʻO Oncogene. 26 (34): 5023-7. hana: 10.1038 / sj.onc.1210292. PMID 17311002.

[7] Ke Kula Kaiapuni ʻAi Mokuʻāina. ʻO ka mālama ʻana i ka maʻi ʻaʻai umauma kāne (PDQ) - mana ʻoihana olakino. Hoʻohou i Mei 25, 2017. www.cancer.gov/types/breast/hp/male-breast-treatment-pdq. Loaʻa iā Kepakemapa 22, 2017.

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