2022 Maret: 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).
Ieu kahiji kalina FDA disatujuan terapi neoadjuvant pikeun NSCLC tahap awal.
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.
Ku review sentral bebas buta, ukuran hasilna efficacy konci éta survival bébas acara (EFS) jeung réspon lengkep pathologic (pCR). EFS median pikeun maranéhanana meunang nivolumab + kémoterapi éta 31.6 bulan (95 persén interval kapercayaan: 30.2, teu ngahontal) dibandingkeun 20.8 bulan (95 persén interval kapercayaan: 14.0, 26.7) pikeun maranéhanana narima kémoterapi nyalira. Babandingan bahaya éta 0.63 (p = 0.0052; 97.38 persen CI: 0.43, 0.91). Laju pCR dina nivolumab tambah panangan kémoterapi éta 24 persen (95 persen CI: 18.0, 31.0) jeung 2.2 persen (95 persen CI: 0.6, 5.6) dina kémoterapi nyalira panangan.
Seueul, kabebeng, kacapean, turun napsu, sareng ruam mangrupikeun kajadian ngarugikeun anu paling umum dina pasien (kajadian 20%). Penambahan nivolumab kana kémoterapi henteu nyababkeun paningkatan jumlah telat atanapi pembatalan operasi. Pasén dina duanana leungeun percobaan miboga panjangna median sarupa tetep rumah sakit handap bedah definitif jeung ongkos réspon ngarugikeun dipikawanoh salaku komplikasi bedah.
Dosis nivolumab anu disarankeun nyaéta 360 mg unggal tilu minggu kalayan kémoterapi platinum-doublet dina dinten anu sami.
