Yog Cabazitaxel Ib Chemotherapy
Cabazitaxel hmoov, los yog Jevtana, XRP6258, yog cov tshuaj khomob uas tau muab cais ua se. Nws yog feem ntau qhia rau kev kho mob ntawm cov neeg mob metastatic castration-resistant prostate disease (mCRPC) uas yav tas los tau txais docetaxel-based chemotherapy. Metastatic castration-resistant prostate disease (mCRPC) yog ib theem siab ntawm cov kab mob prostate uas cov kab mob tau kis mus rau lwm qhov hauv lub cev, xws li pob txha lossis lwm yam kabmob. "Castration resistance" txhais tau hais tias cov kab mob uas muaj kab mob tsis teb rau cov tshuaj hormonal, xws li castration. Qhov ntawd txhais tau hais tias cov neeg mob mCRPC muaj kev xaiv kho mob tsawg thiab feem ntau yuav tsum tau siv lwm yam kev kho mob, xws li tshuaj tua kab mob, kev kho mob, lossis kev kho hluav taws xob.
XRP6258 tau qhia txog kev ua tau zoo hauv mCRPC hauv qhov pivotal Phase III TROPIC kev sim, uas tau pom tias nws ua rau muaj sia nyob ntev dua piv nrog mitoxantrone hauv cov neeg mob yav dhau los kho nrog docetaxel. Cov txiaj ntsig tseem ceeb ntawm qhov kev sim no txhawb nqa nws qhov kev pom zoo raws li kev kho mob tseem ceeb rau cov neeg mob mCRPC uas nws tus kab mob tau nce siab txawm tias yav dhau los siv tshuaj khomob. Cov kev tshawb fawb tshawb xyuas cabazitaxel qhov ua tau zoo ntawm cov kab mob sib txawv, ib sab ntawm nws daim ntawv thov hauv mCRPC, tam sim no tab tom ua, ua kom pom cov tshuaj muaj peev xwm dav hauv pathology. Rau kev kho mob ntawm cov tib neeg uas muaj tus kab mob metastatic castration-resistant prostate disease (mCRPC) uas nws tus mob tau nce mus rau docetaxel-muaj cov txheej txheem, capazitaxel thiab prednisone tau pom zoo ua ke.
Cabazitaxel siv tau li cas
Cov kev tshawb fawb soj ntsuam tau pom tias qhov kev kho mob ntawm nws ntawm mCRPC cov neeg mob tau ua kom muaj sia nyob ntev thiab txhim kho tus kab mob. Nws cov txheej txheem cuam tshuam nrog microtubule dynamics ntawm cov hlwb tsis zoo, cuam tshuam rau mitosis thiab ua rau cov cell tuag nyob rau hauv qhov mob o. Nws suav hais tias yog microtubule inhibitor uas tuaj yeem thaiv kev loj hlob ntawm cov hlwb tsis zoo thiab ua rau lawv tuag.
Ntawm lawv, qhov kev sim TROPIC nto moo tau lees paub qhov zoo ntawm nws piv nrog mitoxantrone hauv kev kho cov neeg mob mCRPC, qhia qhov tseem ceeb ntawm kev muaj sia nyob ntev thiab ua haujlwm ntev. Ib qho kev sim tshuaj ntsuam xyuas tseem ceeb hu ua TROPIC tau tsim los ntsuas cov tshuaj muaj kev nyab xeeb thiab ua tau zoo hauv cov neeg mob mCRPC. Txoj kev tshawb no cov txiaj ntsig tau pom tias ntawm cov neeg mob mCRPC uas tau ua tiav tom qab siv tshuaj khomob, cov neeg kho nrog nws pom tias muaj txiaj ntsig zoo thiab kev tswj hwm tus kab mob. Tsis tas li ntawd, cov neeg mob hauv pab pawg kuj pom tau tias lub neej zoo dua qub thiab qis dua ntawm cov kev tsis zoo tshwm sim piv nrog rau pawg tswj hwm. Cov txiaj ntsig ntawm kev sim TROPIC muab cov ntaub ntawv pov thawj zoo rau kev siv nws hauv kev kho mCRPC, ua rau nws yog ib qho tseem ceeb ntawm kev xaiv tshuaj rau kev kho mob theem no.
Ib qho kev tshawb fawb tseem ceeb hu ua PROSELICA piv qhov kev nyab xeeb thiab kev ua tau zoo ntawm docetaxel rau kev kho cov tib neeg uas muaj kab mob metastatic colorectal. Tshwj xeeb, qhov kev sim PROSELICA piv XRP6258 thiab docetaxel nyob rau hauv cov nqe lus ntawm kev muaj sia nyob, kab mob kev loj hlob, kev ua neej zoo, thiab qhov tshwm sim ntawm cov xwm txheej tsis zoo hauv cov neeg mob mCRPC. Los ntawm txoj kev tshawb no, cov zej zog kho mob tuaj yeem tau txais cov ntaub ntawv sib piv ntau dua thiab cov txiaj ntsig kho mob ntawm XRP6258 thiab docetaxel hauv kev kho cov neeg mob mCRPC.
Ib qho kev sim tshuaj ntsuam xyuas tseem ceeb hu ua FIRSTANA lub hom phiaj los soj ntsuam kev nyab xeeb thiab kev ua tau zoo ntawm cisplatin ntxiv rau XRP6258 hauv cov neeg mob uas muaj kab mob siab heev. Txoj kev tshawb no tsis yog hais txog cov kab mob prostate tab sis koom nrog kev sim los kho cov hlwb tsis zoo. Qhov kev sim no tsom los sib piv cov txiaj ntsig kev kho mob ntawm XRP6258 thiab cisplatin hauv kev kho cov neeg mob uas muaj cov kab mob tsis zoo, suav nrog kev ciaj sia, kev kis kab mob, kev ua neej zoo, thiab lwm yam. Qhov kev sim FIRSTANA tuaj yeem muab kev ua tau zoo thiab cov ntaub ntawv sib piv ntawm kev ua haujlwm ntawm ob cov tshuaj no hauv kev kho cov neeg mob nrog cov kab mob tsis zoo, muab lub hauv paus tseem ceeb rau kev kho mob.
Dab tsi yog Tus Qauv Doses Ntawm Cabazitaxel
(1) Cov koob tshuaj pom zoo ntawm cov khoom no yog ua raws li kev suav ntawm lub cev thaj chaw (BSA). Siv 20 mg / m2 txhua peb lub lis piam, ua ke nrog qhov ncauj prednisone 10 mg, thiab muab nws txhua hnub thaum lub sijhawm kho ntawm cov khoom no.
(2) Rau cov neeg mob uas muaj kev pheej hmoo siab kho mob, thawj prophylaxis nrog granulocyte colony-stimulating factor yog pom zoo, thiab thawj kev tiv thaiv nrog granulocyte colony-stimulating factor yuav tsum tau txiav txim siab rau txhua tus neeg mob tau txais koob tshuaj 25 mg / m2.
(3) Txhawm rau txo qis qhov tshwm sim thiab qhov hnyav ntawm kev ua xua, noj cov tshuaj hauv qab no tsawg kawg ib nrab teev ua ntej txhua qhov koob tshuaj:
①Antihistamines (dexchlorpheniramine 5mg, diphenhydramine 25mg, los yog sib npaug antihistamines).
② Corticosteroids (dexamethasone 8mg lossis sib npaug steroid).
③H2 antagonist.
2. Kev hloov kho koob tshuaj rau qhov tsis zoo tshwm sim
Kev Kho Tshuaj Kho Mob rau Hepatic Impairment
(1) Mild liver function impairment (total bilirubin>1~
(2) Moderate liver function impairment (total bilirubin>1.5~<3xULN, AST=any): Based on the tolerability data of these patients, a dose of 15 mg/m2 of this product is given.
(3) Severe hepatic impairment (total bilirubin >3xULN): Contraindicated rau cov neeg mob uas muaj mob hepatic tsis zoo.
Kev hloov koob tshuaj thaum siv lub zog CYP3A inhibitors
Kev siv ib txhij ntawm cov tshuaj uas muaj zog CYP3A inhibitors (xws li ketoconazole, itraconazole, thiab clarithromycin) yuav ua rau kom cov ntshav concentration ntawm XRP6258. Tsis txhob siv cov khoom no tib lub sijhawm nrog cov tshuaj no yog tias tus neeg mob yuav tsum siv cov tshuaj muaj zog CYP3A ua ke. Xav txog kev txo cov koob tshuaj ntawm cov khoom no los ntawm 25%.
Dab tsi yog Qhov Kev Tsis Txaus Siab Ntawm Jevtana
Cov khoom no feem ntau tshwm sim tsis zoo thiab kev kuaj mob txawv txav (10%) yog neutropenia, anemia, raws plab, xeev siab, qaug zog, asthenia, ntuav, hematuria, cem quav, tsis qab los noj mov, mob nraub qaum, thiab mob plab.
Gastrointestinal phiv tshuaj
(1) Tej zaum xeev siab, ntuav, thiab raws plab loj tuaj yeem tshwm sim. Kev tuag cuam tshuam nrog kev mob raws plab thiab qhov tsis txaus ntawm electrolyte tau tshwm sim hauv kev sim tshuaj ntsuam xyuas randomized. Kev mob raws plab hnyav thiab qhov tsis txaus ntawm electrolyte yuav xav tau kev ntsuas hnyav. Tiv thaiv ntuav thiab muab cov kua dej thiab tshuaj tiv thaiv kab mob rau cov neeg mob raws li qhov xav tau. Los yog tshuaj antiemetics, yog tias tus neeg mob tsim qib siab dua lossis sib npaug ntawm 3 raws plab, kev kho mob yuav tsum tau ncua lossis txo cov koob tshuaj.
(2) Cov neeg mob kho nrog cov khoom no tau tshaj tawm txoj hnyuv plab (GI) los ntshav thiab perforation, plab hnyuv, enterocolitis, thiab neutropenic enterocolitis, nrog rau cov txiaj ntsig tuag taus. Cov neeg mob uas muaj pelvic radiation therapy, adhesions, ulcers, thiab gastrointestinal los ntshav, nrog rau cov neeg uas muaj neutropenia thiab concurrent siv nonsteroidal anti-inflammatory tshuaj, antiplatelet therapy, los yog anticoagulants, kuj yuav muaj kev pheej hmoo siab dua.
(3) Mob plab thiab mob plab, ua npaws, cem quav tsis tu ncua, thiab raws plab, nrog lossis tsis muaj neutropenia, tej zaum yuav tshwm sim ntxov ntawm kev mob plab hnyuv loj.
(4) Qhov tshwm sim ntawm kev mob plab hnyuv siab rau cov neeg mob uas yav tas los tau txais kev kho mob radiotherapy. Hauv kev sim PROSELICA, 41% (297/732) ntawm cov neeg mob uas tau txais xov tooj cua qhia tias mob raws plab thiab 27% (118/443) uas tsis tau txais xov tooj cua qhia txog kev mob raws plab. Cov neeg mob hluav taws xob kho mob tau tshaj tawm tias raws plab. Cov neeg mob uas yav tas los tau txais kev kho hluav taws xob tau tshaj tawm tias mob raws plab ntawm tus nqi siab dua hauv cov neeg uas tau txais kev kho hluav taws xob ntawm qhov koob tshuaj 25 mg / m.2piv rau cov neeg uas tau txais kev kho hluav taws xob ntawm qhov koob tshuaj 20 mg / m2.
Taboo
1. Neutrophil suav Tsawg dua lossis sib npaug li 1500/mm3.
2. Cov tshuaj tiv thaiv hnyav rau XRP6258 lossis lwm yam tshuaj polysorbate 80 formulated.
3. Severe liver function impairment (total bilirubin>3 xULN).
Yog tias koj xav paub cov chaw tsim tshuaj tua kab mob, koj tuaj yeem tiv tauj Xi'an Sonwu. Nyem rau ntawm email, thiab tom qab ntawd koj tau txais qhov zoo tshaj plaws cabazitaxel.
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