Nuwamba 2022: Ga manya masu fama da ciwon daji na biliary fili ko metastatic, Hukumar Abinci da Magunguna ta amince da durvalumab (Imfinzi, AstraZeneca UK Limited) tare da gemcitabine da cisplatin (BTC).
A tasiri na TOPAZ-1 (NCT03875235), Multiregional, bazuwar, biyu-makafi, placebo-sarrafawa gwajin da aka sanya 685 marasa lafiya tare da histologically tabbatar da ci gaba a cikin gida, unresectable, ko metastatic BTC amma wanda ba a baya samu tsarin far ga ci gaba cuta. aka tantance.
Waɗannan su ne ɓarna na kabilanci da jinsi na gwaji: 50% na maza da 50% na mace; matsakaicin shekaru 64 (shekaru 20-85); kuma 47% na mahalarta sun kasance shekaru 65 ko fiye. Baya ga ciwon daji na gallbladder da extrahepatic cholangiocarcinoma, kashi 56 na marasa lafiya kuma suna da cholangiocarcinoma na cikin hepatic.
An sanya majiyyata ba da gangan ba don karɓar:
Durvalumab 1,500 MG a rana ta 1, da gemcitabine 1,000 mg/m2 da cisplatin 25 mg/m2 a ranakun 1 da 8 na kowane zagayowar kwanaki 21 har zuwa hawan keke 8, sannan 1,500 MG na durvalumab kowane mako hudu, ko
Placebo a ranar 1+ ya biyo bayan placebo kowane mako hudu, sannan gemcitabine 1,000 mg/m2 da cisplatin 25 mg / m2 a kan Kwanaki 1 da 8 na kowane zagaye na 21-day har zuwa 8 hawan keke.
Har sai cutar ta ci gaba ko kuma illar da ke tattare da ita ta zama ba za a iya jurewa ba, an ci gaba da durvalumab ko placebo. Idan mai haƙuri ya kasance a kwance a asibiti kuma yana samun fa'idar asibiti, kamar yadda mai binciken ya kimanta, an ba da izinin magani fiye da ci gaban cuta.
Sakamakon tasiri na farko shine rayuwa gaba ɗaya (OS). A cikin makonni 24 na farko, an yi gwajin ƙwayar cuta a kowane mako 6; bayan haka, ana yin su a kowane mako 8, har sai an tabbatar da ci gaban cutar. Mutanen da aka ba da izini don karɓar durvalumab tare da gemcitabine da cisplatin sun nuna ci gaba mai mahimmanci a cikin OS idan aka kwatanta da marasa lafiya da aka ba da izini don karɓar placebo tare da gemcitabine da cisplatin. A cikin durvalumab da ƙungiyoyin placebo, OS na tsakiya shine watanni 12.8 (95% CI: 11.1, 14) da watanni 11.5 (95% CI: 10.1, 12.5), bi da bi (rabin haɗari 0.80; 95% CI: 0.66, 0.97; = 0.021). A cikin durvalumab da ƙungiyoyin placebo, rayuwa marar ci gaba na tsaka-tsaki shine watanni 7.2 (95% CI: 6.7, 7.4) da watanni 5.7 (95% CI: 5.6, 6.7), bi da bi. A cikin durvalumab da placebo makamai, mai binciken ya kimanta jimlar ƙimar amsawa shine 27% (95% CI: 22% - 32%) da 19% (95% CI: 15% - 23%), bi da bi.
Abubuwan da suka fi dacewa da marasa lafiya (20%) sun kasance pyrexia, lethargy, tashin zuciya, maƙarƙashiya, rage cin abinci, da ciwon ciki.
Lokacin da aka haɗa tare da gemcitabine da cisplatin, shawarar da aka ba da shawarar na durvalumab shine 1,500 MG kowane mako uku ga marasa lafiya da nauyin jiki a ƙarƙashin 30 kg, sannan 1,500 MG kowane mako hudu a matsayin wakili guda har sai cutar ta ci gaba ko rashin haƙuri. Shawarar da aka ba da shawarar ga mutanen da ke da nauyin jiki na kasa da 30 kg shine 20 mg / kg kowane mako uku tare da gemcitabine da cisplatin, sannan 20 mg / kg kowane mako hudu har sai cutar ta ci gaba ko kuma akwai rashin jin daɗi.
View full prescribing information for Imfinzi.
