Maris 2022: In the neoadjuvant setting, the FDA approved nivolumab (Opdivo, Bristol-Myers Squibb Company) in combination with platinum-doublet chemotherapy for adult patients with resectable non-small cell lung cancer (NSCLC).
Wannan shine karo na farko da FDA ta amince da maganin neoadjuvant don matakin farko na NSCLC.
Efficacy was assessed in CHECKMATE-816 (NCT02998528), a randomised, open-label trial in patients with detectable disease and resectable, histologically proven Stage IB (4 cm), II, or IIIA NSCLC (AJCC/UICC staging criteria) (RECIST v1.1.). Patients were included regardless of PD-L1 status in the tumour. A total of 358 patients were randomly assigned to undergo nivolumab plus platinum-doublet chemotherapy every three weeks for up to three cycles, or platinum-chemotherapy alone on the same schedule.
Ta hanyar bita ta tsakiya mai zaman kanta mai zaman kanta, mahimmin matakan sakamako na tasiri sune tsira mara-wuta (EFS) da cikakkiyar amsawar cuta (pCR). Matsakaicin EFS na waɗanda ke samun nivolumab + chemotherapy shine watanni 31.6 (kashi 95 tazarar amincewa: 30.2, ba a kai ba) idan aka kwatanta da watanni 20.8 (lokacin amincewa da kashi 95: 14.0, 26.7) ga waɗanda ke karɓar chemotherapy kaɗai. Matsakaicin haɗari shine 0.63 (p=0.0052; 97.38 bisa dari CI: 0.43, 0.91). Adadin pCR a cikin nivolumab da hannun chemotherapy shine kashi 24 cikin ɗari (95 bisa dari CI: 18.0, 31.0) da 2.2 bisa ɗari (95 bisa dari CI: 0.6, 5.6) a cikin hannun chemotherapy kaɗai.
Tashin zuciya, maƙarƙashiya, gajiya, rage cin abinci, da kurji sune abubuwan da suka fi faruwa a cikin marasa lafiya (abun ciki 20%). Ƙarin nivolumab zuwa chemotherapy bai haifar da karuwa a yawan jinkirin tiyata ko sokewa ba. Marasa lafiya a cikin duka makamai na gwajin suna da matsakaicin matsakaicin matsakaicin tsawon zaman asibiti bayan tabbataccen tiyata da ƙimar martani mara kyau da aka gane azaman rikitarwa na tiyata.
Matsakaicin nivolumab da aka ba da shawarar shine 360 MG kowane mako uku tare da chemotherapy na platinum-biyu a rana guda.
