Novemba 2022: Ezigulini ezikhulile ezinomdlavuza we-biliary othuthukile endaweni noma we-metastatic, i-Food and Drug Administration igunyaze i-durvalumab (Imfinzi, AstraZeneca UK Limited) ngokuhlanganiswe ne-gemcitabine ne-cisplatin (BTC).
Ukusebenza kwe-TOPAZ-1 (NCT03875235), isilingo esilawulwa yizifunda eziningi, esingahleliwe, esingaboni kabili, esine-placebo esibhalise iziguli ezingama-685 ezine-BTC ethuthukisiwe ngokwesayensi yendawo, enganqandeki, noma ye-metastatic kodwa engakaze ithole ukwelashwa okuhlelekile kwesifo esithuthukile, yahlolwa.
Lokhu okulandelayo kube ukuhlukaniswa kwecala lobuhlanga nobulili: abesilisa abangama-50% nabesifazane abangama-50; iminyaka emaphakathi 64 (ububanzi 20-85); futhi u-47% wabahlanganyeli babeneminyaka engama-65 noma ngaphezulu. Ngaphezu komdlavuza we-gallbladder kanye ne-extrahepatic cholangiocarcinoma, amaphesenti angu-56 eziguli nawo abe ne-intrahepatic cholangiocarcinoma.
Iziguli zabelwa ngokungahleliwe ukuthi zithole:
I-Durvalumab 1,500 mg ngosuku loku-1, kanye ne-gemcitabine 1,000 mg/m2 kanye ne-cisplatin 25 mg/m2 ngezinsuku ezingu-1 no-8 zomjikelezo ngamunye wezinsuku ezingu-21 kuze kufike kumjikelezo we-8, bese kuba ngu-1,500 mg we-durvalumab njalo emavikini amane, noma
I-Placebo Ngosuku 1+ ilandelwa i-placebo njalo emavikini amane, ilandelwa i-gemcitabine 1,000 mg/m2 kanye ne-cisplatin 25 mg/m2 Ezinsukwini 1 kanye ne-8 zomjikelezo ngamunye wezinsuku ezingama-21 kuze kufike emijikelezweni eyi-8.
Kuze kube yilapho isifo siqhubeka noma imiphumela emibi ingabekezeleleki, i-durvalumab noma i-placebo yaqhubeka. Uma isiguli sasizinzile emtholampilo futhi sithola inzuzo yomtholampilo, njengoba ihlolwe umphenyi, ukwelashwa kwakuvunyelwe ngaphezu kokuqhubeka kwesifo.
Umphumela oyinhloko wokusebenza ngempumelelo kwaba ukusinda okuphelele (OS). Emavikini okuqala angama-24, ukuhlolwa kwesimila kwenziwa njalo emavikini ayi-6; emva kwalokho, zenziwa njalo emavikini angu-8, kuze kube yilapho kuqinisekiswa ukuqhubeka kwesifo. Abantu ababelwe ngokungahleliwe ukuthola i-durvalumab nge-gemcitabine ne-cisplatin babonise ukuthuthukiswa okuphawulekayo kwe-OS uma kuqhathaniswa neziguli ezabelwa ngokungahleliwe ukuthola i-placebo nge-gemcitabine ne-cisplatin. Emaqenjini e-durvalumab nawe-placebo, i-median OS yayiyizinyanga ezingu-12.8 (95% CI: 11.1, 14) nezinyanga ezingu-11.5 (95% CI: 10.1, 12.5), ngokulandelana (isilinganiso sengozi 0.80; 95% CI: 0.66, p0.97; =0.021). Emaqenjini e-durvalumab kanye ne-placebo, ukusinda kwe-median-free-free provival kwakuyizinyanga ezingu-7.2 (95% CI: 6.7, 7.4) kanye nezinyanga ezingu-5.7 (95% CI: 5.6, 6.7), ngokulandelana. Ezingalo ze-durvalumab ne-placebo, amazinga okuphendula ahlolwe umphenyi ayengama-27% (95% CI: 22% - 32%) kanye ne-19% (95% CI: 15% - 23%), ngokulandelana.
Izenzakalo ezimbi kakhulu ezivame ukutholwa iziguli (20%) kwakuyi-pyrexia, ukukhathala, isicanucanu, ukuqunjelwa, ukuncipha kwesifiso sokudla, nobuhlungu besisu.
Uma kuhlanganiswe ne-gemcitabine ne-cisplatin, umthamo onconywayo we-durvalumab ngu-1,500 mg njalo emavikini amathathu ezigulini ezinesisindo somzimba esingaphansi kwe-30 kg, kulandelwa i-1,500 mg njalo emavikini amane njenge-ejenti eyodwa kuze kube yilapho isifo siqhubeka noma ubuthi obungabekezeleleki. Umthamo onconywayo wabantu abanesisindo somzimba esingaphansi kwe-30 kg ngu-20 mg/kg njalo emavikini amathathu nge-gemcitabine ne-cisplatin, kulandele i-20 mg/kg njalo emavikini amane kuze kube yilapho isifo siqhubeka noma kukhona ubuthi obungabekezeleleki.
View full prescribing information for Imfinzi.
