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Cabozantinib

 

    1. Faʻamatalaga Cabozantinib
    2. Cabozantinib Faʻatinoina o gaioiga
    3. Aafiaga ole Itu ole Cabozantinib
    4. Fou atinae o Cabozantinib
    5. Cabozantinib Togafitiga Manuia Tala
    6. aotelega

 

Cabozantinib faʻamatalaga

Cabozantinib (CAS:849217-68-1) e faʻaogaina e togafitia ai le kanesa o le fatugao ua alualu i luma, o nisi taimi e tuʻufaʻatasia ma leisi vailaʻau e taʻua ole nivolumab Cabozantinib e faʻaaogaina foi e togafitia ai le kanesa o le ate i tagata na uma na togafitia muamua i le sorafenib. O le Cabozantinib e faʻaaoga e togafitia ai le kanesa o le thyroid ua sosolo atu i isi vaega o le tino. Cabozantinib mafai foi ona faʻaaogaina mo mafuaʻaga e le o lisiina i lenei vailaʻau taʻitaʻi.

 

Cabozantinib Masini o Faatinoga

O togafitiga faʻapitoa o le iʻuga o le tusa ma le 100 tausaga o suʻesuʻega tuʻufaʻatasia e malamalama ai i eseesega i le va o sela kanesa ma sela masani. I le taimi nei, o togafitiga o le kanesa ua taulaʻi lava i le fasiotia vave o vaevaega sela ona o se tasi vaega o kanesa sela o le latou vaeluaina vave. Ae paga lea, o nisi o tatou sela masani e vave vaelua foʻi, ma mafua ai le tele o aʻafiaga.

O togafitiga faʻalauiloa e uiga i le faʻamalamalamaina o isi vala o laulaau o le kanesa. Ua suʻesuʻe e saienitisi ni eseesega eseese i le kanesa o le kanesa ma sosoʻo masani. O lenei faʻamatalaga e faʻaaogaina e fatu ai se togafitiga faʻapitoa e osofaia ai sela o le kanesa e aunoa ma le faaleagaina o sela masani, ma oʻo ai i le itiiti ifo o aʻafiaga. O ituaiga uma o togafitiga e taulai i ai e ese lava le eseese ae o mea uma e faalavelaveina ai le malosi o le kanesa kanesa e tupu ai, fevaevaeaʻi, toe faaleleia ma / poʻo fesoʻotaʻi ma isi siama.

E eseese ituaiga o togafitiga faʻatulagaina, faʻamatalaina i ni vaega tetele se tolu. O nisi o togafitiga e taulai i ai le taulai atu i vaega ma galuega a le kanesa kanesa. O togafitiga faʻatulagaina e faʻaaoga ai ni meaola laiti e mafai ona ulu atu i totonu o le masini ma faʻalavelave ai le gaioiga o sela, ma mafua ai ona oti. E tele ituaiga o togafitiga faʻatulagaina e taulaʻi i totonu o vaega o siama. O isi folasia o togafitiga faʻapitoa o togafitiga o loʻo i fafo o le masini. O togafitiga e faʻatatau i tagata na talia e lauiloa foi o siama monoclonal. O tagata initiata a Antiangiogenesis e faʻatatau i vaʻa toto o loʻo tuʻuina atu le okesene i sulu, ma iu ai ina afua ai sela i le fiaai.

Cabozantinib o se faʻataʻitaʻia togafitiga e faʻatatau ma fusifusia i le tyrosine kinase taliaina ma taofia le gaioiga o le tele o tyrosine kinases, e aofia ai le RET, MET, ma le VEGF i luga o le sela. E ala ile fusifusia o nei talipupuni, e poloka ai e le cabozantinib auala taua e faʻatupu ai le vaevaeina o sela.

O suʻesuʻega e faʻaauau pea ona iloa po o fea e mafai ona sili atu ona togafitigaina le kanesa ma togafitiga faʻatulagaina ma ia maua ai faʻamatalaga faaopoopo mo nisi ituaiga o kanesa.

 

Cabozantinib Aafiaga itu

Maua se fesoasoani faafomaʻi faʻapitoa pe afai o iai lau faʻailoga o se faʻafitauli o le faʻalavelave; manava malosi; fulafula o ou foliga, laugutu, laulaufaiva, poo le faai.

Cabozantinib ono mafua ai se perforation (se pu poʻo loimata) poʻo se fistula (o se auala masani) i totonu o lou manava poʻo ou manava. Valaʻau lau fomaʻi pe a tiga tele i lou manava, pe afai e te lagona o loʻo e fetinaʻi ma gagging pe ae 'ai pe inu.

Valaau lau fomaʻi i le taimi lava e tasi pe'āfai e te:

▪ Ogaoga le tiga o le ulu, pupula le vaai, tata lou ua poʻo taliga;

▪ Faanoi, manava tata, poʻo manava manava na ogaoga ma faifai pea;

▪ Fula i ou lima, lima, vae poʻo vae;

▪ Faigofie ona gagase pe palapala toto (nifo nifo, nifo toto, palapala toto masaʻa, poʻo se palapala toto e le taofia);

▪ Fano toto pe faʻatali, faʻasusu ma le puaa toto poʻo le puaʻi e pei o le kofe;

▪ Jaundice (samasama o le paʻu po o mata);

▪ Paʻu, paʻu, palapala toto, poʻo le papala i ou alofilima poʻo alofivae o ou vae;

▪ Le mautonu, mafaufau i faʻafitauli, vaivaiga, vaʻaia suiga, faoa faamalosi;

▪ O se lagona māmā, e pei o oe atonu ua mou atu;

▪ Paʻu o le auvae poʻo le mageso, mumu pe fulafula nifo, nifo lemu, poʻo le tuai faʻamalolo pe a maeʻa galuega o nifo;

▪ Maʻa maualalo le sela papaʻe – fiva, papala gutu, papala, papala faʻaʻi, tale, faʻafitauli manava;

▪ Faʻafitauli o le manava ole adrenal – niniva, puaʻi, matuaʻi lelava, niniva, vaivai, matapogia; pe

▪ Faʻailoga o le papala poʻo le palapala toto - faʻafuaseʻi poʻo le vaivai i le tasi itu o lou tino, faʻafitauli ma le vaʻai poʻo le paleni, faʻafitauli e tautala pe malamalama i mea o fai atu ai ia te oe, tiga o le fatafata, faʻafitauli manava, fulafula poʻo tiga i se lima poʻo se vae .

O tui i le lumanaʻi o le cabozantinib e ono tuai pe tumau tumau foi pe a iai ni ou aʻafiaga.

 

O aʻafiaga lautele masani e aofia ai:

▪ Manava manava, niniva, puaʻi, leai se manaʻo, manava manava, papala;

▪ Paʻu, mumu, mumu, poʻo le papala i lou gutu poʻo le faʻaʻi;

▪ Faʻalavelave i le tautala, suia i le tofo;

▪ Malulu faʻailoga e pei o le isu, faʻasusu, tiga faʻaʻi, tale;

▪ mageso;

▪ Tiga i ou maso, ponaivi, ma sooga o ponaivi;

▪ Suʻega masani ole faʻaoga ile ate poʻo isi suʻega toto;

▪ Lagona lelava;

▪ Paʻu pauna; pe

▪ E emo māmā le lanu o lauulu.

E leʻo se lisi atoa o aʻafiaga i itu ma isi e ono tupu. Valaau lau fomaʻi mo fautuaga faʻafomaʻi e uiga i aʻafiaga o le itu. E mafai ona e lipotia aʻafiaga i le FDA i 1-800-FDA-1088.

 

Fou Atinae O Cabozantinib 

O Cabozantinib na faʻatagaina le tulaga o fualaʻau matuaoti e le US Food and Drug Administration (FDA) ia Novema 2010 ma ia Fepuari 2017.

O Exelixis na failaina se apalai fou mo fualaʻau ma le FDA i le afa muamua o le 2012 ma ia Novema 29, 2012 cabozantinib i lana fusipepa na faʻatagaina le faʻatagaina e le US FDA i lalo o le igoa Cometriq mo le togafitia o gasegase e maua i le kanesa o lou thyroid faamaonia i le Iuni a Europa mo le tutusa faamoemoe i le 2014.

Ia Mati 2016 Exelixis laiseneina Ipsen aia i le lalolagi atoa (i fafo atu o le US, Kanata, ma Iapani) e maketi ai cabozantinib.

Exelixis 'Phase III faʻataʻitaʻiga faʻaiuga o le suʻesuʻeina o le vailaʻau i fatugaʻo kanesa lolomiina i le NEJM i le 2015. Ia Aperila 2016 na faʻatagaina e le FDA le faʻatauaina mo le maketiina o le laulau faʻatulagaina o se laina lona lua togafitiga mo fatugaʻo kanesa ma le tutusa na faamaonia i le Iuni a Europa ia Setema o lena tausaga.

Ia Tesema 2017, na faʻatagaina ai e le FDA le cabozantinib (Cabometyx, Exelixis, Inc.) mo togafitiga o tagata e iai le sela o le sela o le fatu (RCC). O le faʻamaoniga sa faʻavae i luga o faʻamaumauga mai CABOSUN (NCT01835158), o se avanoa, tatala-igoa vaega II multicenter suʻesuʻega i 157 tagata auai ma le va feololo ma le lelei-ono lamatia muamua togafitia RCC.

I Ianuari 2019, le Faʻamaonia e le FDA le cabozantinib (Cabometyx, Exelixis, Inc.) mo tagata e maua i le hepatocellular carcinoma (HCC) na uma na togafitia muamua i le sorafenib. O le faʻamaoniga sa faʻavae i luga o le CELESTIAL (NCT01908426), o se faʻavasega (2: 1), faʻalua-tauaso, placebo-pulea, multicenter faʻataʻitaʻiga i tagata auai ma HCC oe na mauaina muamua le sorafenib ma sa maua ai le tamaititi Pugh Class A faʻaletonu le ate.

Cabozantinib o loʻo suʻesuʻeina mo le aoga o se togafitiga mo neurofibromatosis ituaiga 1.

O le Food and Drug Administration (FDA) talu ai nei na faʻamaonia le cabozantinib mo le togafitia o le hepatocellular carcinoma i tagata mamaʻi na mauaina muamua le sorafenib.

O le Cabozantinib o le oral tyrosine kinases inhibitor o le MET, VEGFR, ma le AXL. O le receptor tyrosine kinases e taua tele i gaioiga masani o sela ma gaioiga faʻasolosolo, e aofia ai le oncogenesis, metastasis, tum angiogenesis, ma le tumo microen environment tausia.

Na faʻamaonia muamua e le FDA le cabozantinib mo togafitiga o medullary kanesa o lou totoa. Mulimuli ane, ua faʻamaonia e le FDA lona faʻaaogaina i le sela o le sela sela.

 

Cabozantinib Togafitiga Manuia Tala 

Tala 1: Cabozantinib togafiti muamua togafitiga o le Advanced Renal Cell Carcinoma

O Tesema 19, 2017, na faʻatagaina ai e le US Food and Drug Administration (FDA) le faʻamaonia masani i le cabozantinib (Cabometyx) mo togafitiga o tagata mamaʻi ua leva ona maua le kanesa o le sela (RCC).

Na faʻamaonia muamua e le FDA le cabozantinib ile 2016 mo ​​togafitiga o tagata mamaʻi ua iai le RCC alualu i luma na mauaina muamua le antiangiogenic therapy. O le faʻamaonia i aso nei e maua ai togafitiga i le tulaga muamua.Cabozantinib

O lenei faʻamaoniga sa faʻavae i luga o faʻamaumauga mai le CABOSUN faʻataʻitaʻiga, o se faʻavasegaina, tatala-igoa vaega II multicenter suʻesuʻega i 157 tagata gasegase i le ogatotonu- ma le le lelei-ono lamatia muamua le togafitia RCC. Tagata mamaʻi maua cabozantinib (n = 79) 60 mg tuʻu fofoga i aso uma po sunitinib (Sutent) (n = 78) 50 mg tuʻu fofoga i aso uma (4 vaiaso i togafitiga faʻasolosolo e 2 vaiaso ese) seia faʻamaʻi alualu i luma poʻo le taliaina taliaina. Fuafuaina median alualu i luma-leai se ola (pei ona iloiloina e le tauaso tutoatasi tutoatasi iloiloina komiti) mo tagata mamaʻi ave cabozantinib o 8.6 masina (95% talitonuina va [CI] = 6.8-14.0) faatusatusa i 5.3 masina (95% CI = 3.0-8.2) mo tagata mamaʻi ave sunitinib (lamatiaga fuataga = 0.48; 95% CI = 0.31-0.74; P = .0008).

O le sili ona taatele lipotia (ad 25%) leaga tali i le cabozantinib falemaʻi polokalama o manava tata, lelava, niniva, faaitiitia manaʻoga, toto maualuga, palmar-plantar erythrodysesthesia, mamafa leiloa, puaʻi, disgeusia, ma stomatitis.

Ole tali masani ile 3-4 tala le lelei (≥ 5%) i tagata mamaʻi na togafitia ile cabozantinib ile CABOSUN ole toto maualuga, manava tatā, hyponatremia, hypophosphatemia, palmar-plantar erythrodysesthesia, lelava, ALT faʻateleina, faʻaititia le manaʻoga, stomatitis, tiga, faʻafitauli, ma synope O le fualaʻau fautuaina o le cabozantinib o le 60 mg i gutu, tasi le aso.

Cabozantinib ua faʻamaonia foʻi mo le togafitiga o kanesa o lou toto medullary ma o loʻo maketiina i lalo o le igoa fefaʻatauaʻi, Cometriq. Cometriq ma Cabometyx e eseese faʻamatalaga ma e le fesuiaʻi.

 

tala 2: Cabozantinib Togafitiga Medullary Thyroid Kanesa

Na faʻamaonia e le FDA le cabozantinib (Cometriq) e togafitia ai le kanesa o gasegase oona (MTC) i le masina o Novema 2012. Na faʻavae i luga o faʻaiʻuga mai le faʻavaomalo, multicenter, randomized, double-blind, control trial e aofia ai ma mataupu e 330. Tagata auai na manaʻomia le faʻaalia alualu i luma faʻamaʻi i totonu o le 14 masina ao le i ulufale le suʻesuʻega, lea na faʻamaonia e ala i se tutoatasi leitio iloiloina komiti poʻo le togafitia fomaʻi.

O tagata mamaʻi na faʻasolosolo ona maua uma cabozantinib 140 mg poʻo le placebo tuʻufaʻatasi taimi i aso uma seʻia oʻo i le gasologa o faʻamaʻi poʻo le oona onosaʻi. O le faʻatulagaina sa faʻaalia e tusa ma le matua <65 tausaga vs> 65 tausaga ma le faʻaogaina muamua o le tyrosine kinase taofi.Cabozantinib

Tulaga muamua tulagalua o le alualu i luma-leai se ola (PFS), faamoemoe tali (OR), ma tali umi faʻataʻitaʻia suia fesuiaʻi aiaiga. O tagata mamaʻi i le vaega o le cabozantinib na faʻaumiumi le PFS faʻatusatusa ia i latou na mauaina le placebo (P <.0001). Faʻapitoa, median PFS i le cabozantinib arm o 11.2 masina ma median PFS i le placebo arm o 4.0 masina.

Naʻo tagata mamaʻi na ave le cabozantinib na maua se tali faʻatatau (27% vs 0; P <.0001). E le gata i lea, o le umi o le vaitaimi ole OR o le 14.7 masina mo i latou e togafitia i le vailaʻau. Leai ni eseesega taua i le aotelega o le ola na maitauina i le va o lima.

I le 2019 meta- ma le tamaoaiga suʻesuʻega iloiloina le aoga o cabozantinib ma vandetanib i tagata mamaʻi o Egelani National Soifua Maloloina Auaunaga, Tappenden et al. Faaiu.

"O faʻailoaina tofotofoga fautua mai o le cabozantinib ma le vandetanib faaleleia PFS sili atu nai lo le placebo; ae ui i lea, o aoga taua OS e leʻi faʻaalia. O suʻesuʻega o le tamaoaiga ua taʻu mai ai i totonu o le EU-igoa o le faitau aofai o tagata, o le ICER [faaopoopoga tau aoga tele) mo cabozantinib ma vandetanib e> £ 138,000 i le QALY (lelei-fetuʻunaʻi olaga tausaga) maua. I totonu o le EU faʻatapulaʻaina (Europa Iuni) -label faitau aofai, o le ICER mo vandetanib e faʻamoemoe e> £ 66,000 i le QALY mauaina. "

 

tala 3: Togafitiga o Cabozantinib Ma'i Hepatocellular Carcinoma

Ia Ianuari 2019, na faʻamaonia e le FDA papaʻu cabozantinib mo tagata mamaʻi kanesa o le hepatocellular (HCC) na togafitia muamua i le sorafenib. O le faʻamaoniga na faʻavae i luga o iʻuga mai le CELESTIAL faʻamasinoga.

I le randomized (2: 1), faʻalua-tauaso, placebo-pulea, multicenter faʻataʻitaʻiga, tagata gasegase na faʻasolosolo i le cabozantinib 60 mg tuʻufaʻatasi taimi i aso uma (n = 470) poʻo placebo (n = 237) seʻia oʻo i le taimi o faʻamaʻi alualu i luma pe le taliaina. oʻonaCabozantinib

O le pito muamua o le OS. PFS ma ORR, iloiloina e tagata suʻesuʻe faʻaaogaina le RESIST 1.1, na fuaina foi. O le faʻaaogaina o Cabozantinib na fesoʻotaʻi ma le median OS o le 10.2 masina (95% CI: 9.1-12.0) vs 8 masina (95% CI: 6.8-9.4) mo i latou na mauaina placebo (HR 0.76; 95% CI: 0.63, 0.92; P = .0049). Median PFS o 5.2 masina (4.0-5.5) i le cabozantinib arm faʻatusatusa i le 1.9 masina (1.9-1.9) i le placebo arm (HR 0.44; 95% CI, 0.36, 0.52; P <.001). O le ORR e 4% (95% CI, 2.3, 6.0) ia i latou o loʻo ave le cabozantinib vs 0.4% (95% CI, 0.0, 2.3) ia i latou o loʻo ave placebo.

Vasega 3 poʻo le 4 o mea leaga na tutupu na sili atu le maualuga i tagata mamaʻi na ave le cabozantinib (68%) nai lo i latou na ave placebo (36%).

O tusitala o le faamasinoga CELESTIAL na faaiuina i mea nei: “Faatasi ai ma tagata mamaʻi na maua muamua i le gasegase o le hepatocellular carcinoma, o le togafitiga ma le cabozantinib na mafua ai le umi o le ola ma le alualu i luma-leai se ola nai lo le placebo. O le fua faatatau o mea leaga na tutupu i le vaega o le cabozantinib e tusa e faalua na matauina i le placebo. ”

 

aotelega

Cabozantinib o le tyrosine kinase taofi e faʻaaoga e togafitia ai le alualu i luma o le sela sela sela, hepatocellular carcinoma, ma medullary kanesa kanesa. Cabozantinib na muamua faʻamaonia i le 2012 ma o se le faʻapitoa tyrosine kinase taofi. Na faʻamaonia muamua i le US i lalo o le igoa igoa Cometriq, lea ua faʻailoa mai mo le togafitia o le metastatic medullary thyroid cancer. I le 2016, o se capsule formulate (Cabometyx) na faʻamaonia mo le togafitia o le alualu i luma o le sela sela kanesa, ma o lenei lava faʻatulagaina maua maua faʻamaonia faʻaopoopo i le US ma Kanata i le 2019 mo le togafitiga o le hepatocellular carcinoma i tagata na togafitia muamua.

 

Tusitaiala

[1] Choueiri TK, Escudier B, Powles T, et al. Cabozantinib versus everolimus in advanced renal cell carcinoma (METEOR): iʻuga mulimuli mai le faʻasolosolo, tatala-igoa, vaega 3 faʻataʻitaʻiga. Lancet Oncol. 2016; 17: 917–27.

[2] Tappenden P, Carroll C, Hamilton J, et al. Cabozantinib ma vandetanib mo le le mafaamatalaina i le lotoifale alualu i luma poʻo metastatic medullary kanesa kanesa: o se faʻavasega iloiloga ma tamaoaiga faʻataʻitaʻiga. Soifua Maloloina Tekinolosi Iloilo. 2019; 23: 1-144.

[3] George DJ, Hessel C, Halabi S, et al. Cabozantinib versus sunitinib mo tagata mamaʻi e leʻo togafitia ma le alualu i luma sela o le sela sela o le ogatotonu pe le lelei le lamatiaga: subgroup auiliiliga o le Alliance A031203 CABOSUN faamasinoga. Oncologist. 2019; 24: 1–5.

[4] Kurzrock R, Sherman SI, Ball DW, Forastiere AA, Cohen RB, Mehra R, Pfister DG, Cohen EE, Janisch L, Nauling F, Hong DS, Ng CS, Ye L, Gagel RF, Frye J, Muller T, Ratain MJ , Salgia R: Gaoioiga o XL184 (Cabozantinib), o le oral tyrosine kinase inhibitor, i tagata mamaʻi ma medullary thyroid cancer. J Clin Oncol. 2011 Iulai 1; 29 (19): 2660-6. faia: 10.1200 / JCO.2010.32.4145. Epub 2011 Me 23.

[5] Abou-Alfa GK, Meyer T, Cheng AL, et al. Cabozantinib i tagata mamaʻi ma le alualu i luma o le hepatocellular kanesa. N Engl J Med. 2018; 379: 54-63.

[6] US Taumafa ma Vailaau Faʻafoeina. Ua faamaonia e le FDA le cabozantinib mo le kanesa o le hepatocellular. Avanoa i: https://www.fda.gov/drugs/fda-approves-cabozantinib-hepatocellular-carcinoma Avanoa Aukuso 28, 2019.

[7] Yakes FM, Chen J, Tan J, Yamaguchi K, Shi Y, Yu P, Qian F, Chu F, Bentzien F, Cancilla B, Orf J, You A, Laird AD, Engst S, Lee L, Lesch J, Chou YC , Joly AH: Cabozantinib (XL184), o le novel MET ma le VEGFR2 inhibitor, i le taimi e tasi na te taofia le metastasis, angiogenesis, ma le tuputupu aʻe o le tumo. Mol Kanesa Ther. 2011 Tes; 10 (12): 2298-308. faia: 10.1158 / 1535-7163.MCT-11-0264. Epub 2011 Setema 16.

[8] "O le kanesa o le kanesa o le kanesa (thyroid cancer) cabozantinib e faʻaumi ai le PFS". Faʻamaumauga mai le amataga i le 2012-04-02. Toe aumai ile 24 Oketopa 2011.

[9] "Cabozantinib Orphan Orphan Drugs Tofia ma Faʻamaonia". US Taumafa ma Vailaau Faʻafoeina (FDA). 29 Novema 2010. Toe aumai 11 Novema 2020.

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