March 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).
Aka ndekekutanga iyo FDA yakabvumidza neoadjuvant kurapa kwekutanga-nhanho 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.
Nekupofumadzwa kwakazvimirira kwepakati ongororo, iyo yakakosha yemhedzisiro mhedzisiro matanho aive echiitiko-isina kupona (EFS) uye pathologic yakakwana mhinduro (pCR). EFS yepakati kune avo vanowana nivolumab + chemotherapy yaiva 31.6 mwedzi (95 muzana yenguva yekuvimba: 30.2, isati yasvika) ichienzaniswa nemwedzi ye20.8 (95 muzana yekuvimba nguva: 14.0, 26.7) kune avo vanogamuchira chemotherapy chete. Huwandu hwengozi yaive 0.63 (p=0.0052; 97.38 muzana CI: 0.43, 0.91). The pCR rate mu nivolumab plus chemotherapy arm yaiva 24 muzana (95 muzana CI: 18.0, 31.0) uye 2.2 muzana (95 muzana CI: 0.6, 5.6) mune chemotherapy chete ruoko.
Nausea, kuvimbiswa, kuneta, kuderera kwechido, uye kuputika kwaiva zviitiko zvakanyanya kuipa kune varwere (chiitiko 20%). Kuwedzerwa kwe nivolumab kune chemotherapy hakuna kukonzera kuwedzera kwenhamba yekuvhiyiwa kunonoka kana kubviswa. Varwere vari mumaoko ose ekuedza vaiva nehurefu hwakafanana hwekugara muchipatara mushure mekuvhiyiwa kwechokwadi uye mazinga emhinduro dzakaipa dzinozivikanwa sematambudziko ekuvhiya.
Iyo yakakurudzirwa nivolumab dose ndeye 360 mg masvondo matatu oga oga neplatinum-doublet chemotherapy pazuva rimwe chete.
