March 2024: I-Food and Drug Administration inikeze imvume yokusetshenziswa kwe-nivolumab (i-Opdivo, i-Bristol-Myers Squibb Company) ngokubambisana ne-cisplatin kanye ne-gemcitabine njengokwelashwa kokuqala kweziguli ezikhulile ezine-urrothelial carcinoma (UC) engahlanjululwa noma ye-metastatic.
Ukusebenza kokwelashwa kwahlolwa esivivinyweni somtholampilo esibizwa nge-CHECKMATE-901 (NCT03036098). Lolu cwaningo lwabhalisa iziguli ezingama-608 ezinomdlavuza wesinye somchamo osuthuthukisiwe ongakwazanga ukususwa ngokuhlinzwa noma osusakazekele kwezinye izingxenye zomzimba. Abahlanganyeli babelwa ngokungahleliwe ngesilinganiso esingu-1:1 ukuze bathole noma inhlanganisela ye-nivolumab, i-cisplatin, ne-gemcitabine (umkhawulo wemijikelezo engu-6), kulandele i-nivolumab iyodwa kuze kube iminyaka emibili, noma i-cisplatin ne-gemcitabine (ubuningi bemijikelezo engu-6). 1 imijikelezo). Iziguli eziyeke ukusebenzisa i-cisplatin zavunyelwa ukuthi ziqale ukuthatha i-carboplatin kuzo zombili izingalo. Inqubo ye-randomization yahlukaniswa ngamaqembu ngokusekelwe ekukhulumeni kwe-PD-LXNUMX ku-tumor kanye nokuba khona kwama-metastases esibindi.
Izinyathelo eziyinhloko zokusebenza kwaba ukusinda okuphelele (i-OS) kanye ne-progression-free survival (PFS), okuhlolwe ukubuyekezwa okumaphakathi okungachemi kusetshenziswa i-RECIST v1.1.
Inhlanganisela ye-nivolumab ene-cisplatin ne-gemcitabine, elandelwa yi-nivolumab iyodwa, ibonise ukuthuthukiswa okuphawulekayo kwezibalo kukho kokubili ukusinda okuphelele (i-OS) nokusinda okungenayo i-progression-free (PFS) uma kuqhathaniswa nokwelashwa nge-cisplatin ne-gemcitabine kuphela. Ukusinda okuphelele okumaphakathi (OS) kwakuyizinyanga ezingu-21.7 (isikhawu sokuzethemba esingu-95% [CI]: 18.6, 26.4) ezigulini ezithole inhlanganisela ye-nivolumab, i-cisplatin, ne-gemcitabine. Ngokuphambene, i-median OS yayiyizinyanga ezingu-18.9 (95% CI: 14.7, 22.4) kulabo abathole i-cisplatin ne-gemcitabine kuphela. Isilinganiso sengozi (HR) eqhathanisa namaqembu amabili kwakungu-0.78 (95% CI: 0.63, 0.96), okubonisa ingozi ephansi yokufa eqenjini lenhlanganisela ye-nivolumab. I-p-value ezinhlangothi ezimbili yayingu-0.0171, iphakamisa umehluko obalulekile ngokwezibalo phakathi kwamaqembu amabili okwelapha. Ukusinda kwe-median progression-free survival (PFS) kwakuyizinyanga ezingu-7.9 (isikhawu sokuzithemba esingu-95% [CI]: 7.6, 9.5) nezinyanga ezingu-7.6 (95% CI: 6.0, 7.8), ngokulandelanayo. Isilinganiso sengozi (HR) sasingu-0.72 (95% CI: 0.59, 0.88), enevelu ye-p yezinhlangothi ezimbili engu-0.0012.
Imiphumela engathandeki evelele (≥15%) ebonwe ezigulini ezelashwa nge-nivolumab ngokuhlanganiswa ne-platinum-doublet chemotherapy yayihlanganisa isicanucanu, ukukhathala, ukungakhululeki kwemisipha namathambo, ukuqunjelwa, ukuncipha kwesifiso sokudla, ukuqubuka, ukuhlanza, i-peripheral neuropathy, ukutheleleka komgudu womchamo, isifo sohudo, ukuqunjelwa, hypothyroidism kanye ne-pruritus.
