Nov 2021: Kudya neDrug Administration kwave kubvumidza atezolizumab (Tecentriq, Genentech, Inc.) yekurapa adjuvant muvarwere vane nhanho II kusvika IIIA isiri-diki cell yemapapu cancer (NSCLC) ine mabundu ane PD-L1 kutaura pane isingasviki 1% yemamota maseru, sekuongororwa neFDA-yakatenderwa bvunzo.
Iyo VENTANA PD-L1 (SP263) Assay (Ventana Medical Systems, Inc.) yakabvumidzwawo neFDA nhasi sechishandiso chekuongorora chekusarudza varwere vane NSCLC yekurapa adjuvant neTecentriq.
Kupona kusina chirwere (DFS) ndiyo yaive yakakosha mhedzisiro chiyero, sezvakatemwa nemuongorori mune yekutanga efficacy analysis population (n=476) yevarwere vane nhanho II-IIIA NSCLC ine PD-L1 kutaura pa1% yemabundu maseru. PD-L1 1% TC). Muruoko rweatezolizumab, yepakati DFS haina kusvika (95 muzana CI: 36.1, NE) ichienzaniswa nemwedzi 35.3 (95 muzana CI: 29.0, NE) muBSC ruoko (HR 0.66; 95 muzana CI: 0.50, 0.88; p= 0.004).
Iyo DFS HR yaive 0.43 mune yakagara yakatsanangurwa yechipiri subgroup kuongororwa kwevarwere vane PD-L1 TC 50% nhanho II-IIIA NSCLC (95 muzana CI: 0.27, 0.68). Iyo DFS HR yaive 0.87 muongororo yeboka diki yevarwere vane PD-L1 TC 1-49 muzana nhanho II-IIIA NSCLC (95 muzana CI: 0.60, 1.26).
Kuwedzera aspartate aminotransferase, blood creatinine, uye alanine aminotransferase, pamwe ne hyperkalemia, rash, chikosoro, hypothyroidism, pyrexia, kuneta / asthenia, kurwadziwa kwemusculoskeletal, peripheral neuropathy, arthralgia, uye pruritus, ndiyo yakajairika (gumi kubva muzana) maitiro asina kunaka. varwere vanogamuchira atezolizumab, kusanganisira ma laboratory abnormalities.
Nekuda kwechiratidzo ichi, iyo yakakurudzirwa atezolizumab dose ndeye 840 mg mavhiki maviri ega ega, 1200 mg masvondo matatu ega ega, kana 1680 mg masvondo mana ega ega kweanosvika gore.
