Mart 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).
Bu FDA birinchi marta erta bosqichdagi NSCLC uchun neoadjuvan terapiyani tasdiqladi.
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.
Ko'r-ko'rona mustaqil markaziy tekshiruv natijasida samaradorlikning asosiy ko'rsatkichlari hodisasiz omon qolish (EFS) va patologik to'liq javob (pCR) edi. Nivolumab + kimyoterapiya olganlar uchun o'rtacha EFS 31.6 oyni (95 foiz ishonch oralig'i: 30.2, erishilmagan) 20.8 oyni (95 foiz ishonch oralig'i: 14.0, 26.7) faqat kimyoterapiya olganlar uchun tashkil etdi. Xavf darajasi 0.63 ni tashkil etdi (p=0.0052; 97.38 foiz CI: 0.43, 0.91). Nivolumab plyus kimyoterapiya qo'lida pCR darajasi faqat kimyoterapiya qo'lida 24 foizni (95 foiz CI: 18.0, 31.0) va 2.2 foizni (95 foiz CI: 0.6, 5.6) tashkil etdi.
Ko'ngil aynishi, ich qotishi, charchoq, ishtahaning pasayishi va toshma bemorlarda eng ko'p uchraydigan nojo'ya hodisalar edi (20%). Kimyoterapiyaga nivolumab qo'shilishi operatsiyani kechiktirish yoki bekor qilish sonining ko'payishiga olib kelmadi. Eksperimentning ikkala qo'lidagi bemorlarda aniq jarrohlikdan so'ng kasalxonada qolishning o'rtacha davomiyligi va jarrohlik asoratlari sifatida tan olingan salbiy reaktsiyalar darajasi o'xshash edi.
Tavsiya etilgan nivolumab dozasi har uch haftada 360 mg ni tashkil qiladi, shu kunning o'zida platinali dublet kimyoterapiya.
