Xtandi (Enzalutamide) Phase 3 Clinically Significantly Prolongs Survival--1/2

Astellas thiab Pfizer nyuam qhuav tshaj tawm Xtandi (enzalutamide) rau kev kho mob ntawm metastatic hormone-sensitive prostate cancer (mHSPC) qhov tseem ceeb Phase 3 ARCHS txoj kev tshawb fawb (NCT02677896) ntawm 2021 European Society of Medical Oncology (ESMO) lub rooj sib tham virtual Tag nrho cov ciaj sia taus (OS) tshwm sim. Cov ntaub ntawv qhia tau hais tias kev kho Xtandi txhim kho OS.

mHSPC tseem hu ua metastatic castration-sensitive prostate cancer (mCSPC). Cov txiv neej kuaj mob nrog mHSPC feem ntau muaj cov tsos mob tsis zoo, nrog kev muaj sia nyob nruab nrab ntawm 3-4 xyoo, uas qhia txog qhov xav tau ceev rau kev kho mob tshiab.

Raws li cov ntaub ntawv los ntawm ARCHS txoj kev tshawb fawb, Xtandi tau pom zoo hauv ntau lub tebchaws thiab thaj chaw thoob ntiaj teb rau kev kho cov txiv neej cov neeg mob nrog mCSPC. Raws li tam sim no, Xtandi tau pom zoo rau kev kho mob ntawm 3 ntau hom mob qog noj ntshav prostate, suav nrog: non-metastatic thiab metastatic castration-resistant prostate cancer (CRPC), mHSPC.

Hauv Suav teb, Xtandi (enzalutamide) tau pom zoo nyob rau lub Kaum Ib Hlis 2019 thiab Kaum Ib Hlis 2020 raws li: (1) Rau kev kho mob asymptomatic lossis cov tsos mob me thiab tsis tau txais kev kho mob tom qab ua tsis tiav ntawm androgen deprivation therapy (ADT) Cov neeg laus uas muaj mob qog noj ntshav metastatic castration-resistant prostate cancer (mCRPC); (2) Rau kev kho mob ntawm non-metastatic castration-resistant prostate cancer (nmCRPC) cov neeg laus uas muaj kev pheej hmoo siab ntawm metastasis.

ARCHS yog randomized, ob-dig muag, placebo-tswj theem 3 kev tshawb fawb soj ntsuam uas tau tso npe rau 1150 mHSPC cov neeg mob thiab tshawb xyuas qhov ua tau zoo thiab kev nyab xeeb ntawm Xtandi thiab placebo ua ke nrog androgen deprivation therapy (ADT). OS yog qhov tseem ceeb thib ob qhov kawg ntawm txoj kev tshawb fawb.

Cov txiaj ntsig tau tshaj tawm yav dhau los tau pom tias thaum lub sijhawm kev tshuaj xyuas ua ntej, txoj kev tshawb fawb tau mus txog qhov kawg ntawm kev muaj sia nyob tsis muaj hluav taws xob (rPFS): Piv nrog cov placebo+ADT regimen pawg, Xtandi+ADT Cov pab pawg neeg tswj hwm tau muaj kev pheej hmoo tseem ceeb ntawm kev mob hluav taws xob lossis kev tuag A txo qis ntawm 61% (HR=0.39 [95% CI: 0.30-0.50]; p< 0.0001).="" qhov="" nruab="" nrab="" kev="" soj="" ntsuam="" yog="" 14.4="" lub="" hlis.="" qhov="" nruab="" nrab="" pfs="" hauv="" xtandi+="" pawg="" adt="" tsis="" tau="" mus="" txog="" (95%="" ci:nr-nr),="" thiab="" cov="" placebo+="" pawg="" adt="" yog="" 19.0="" hli="" (95%="" ci:="" 16.6-22.2="" lub="" hlis).="" thaum="" lub="" sij="" hawm="" ntawm="" kev="" soj="" ntsuam="" ua="" ntej,="" os="" cov="" ntaub="" ntawv="" tseem="" tsis="" tau="" paub="">