医学
卡那努马布
多西紫杉醇
肿瘤科
安慰剂
肺癌
危险系数
内科学
外科
癌症
置信区间
病理
疾病
替代医学
阿纳基纳
作者
Luís Paz-Ares,Yasushi Goto,Wan‐Teck Lim,Balázs Halmos,Byoung Chul Cho,Manuel Cobo,J.L. González-Larriba,Caicun Zhou,Ingel Demedts,Akin Atmaca,Sofia Baka,Bijoyesh Mookerjee,Socorro Portella,Zewen Zhu,Jincheng Wu,David Demanse,Bharani Dharan,Martin Reck
出处
期刊:Lung Cancer
[Elsevier]
日期:2024-01-16
卷期号:189: 107451-107451
被引量:6
标识
DOI:10.1016/j.lungcan.2023.107451
摘要
Abstract
Objectives
Canakinumab, an interleukin-1 beta inhibitor, previously showed reduced lung cancer incidence and mortality (CANTOS). Here, we compare the efficacy/safety of canakinumab versus placebo in patients with advanced non-small cell lung cancer (NSCLC) who had progressed after platinum-based doublet chemotherapy (PDC) and immunotherapy. Materials and methods
CANOPY-2, a randomized, double-blind, phase 3 trial, enrolled adult patients with stage IIIB/IV NSCLC, without EGFR or ALK alterations, who had received one prior PDC regimen and one prior programmed death-1/programmed death-ligand 1 inhibitor and experienced subsequent disease progression. Patients were randomized to canakinumab plus docetaxel or placebo plus docetaxel. Results
A total of 237 patients were randomly allocated: 120 (51 %) to canakinumab and 117 (49 %) to placebo, stratified by histology and prior lines of therapy. Three patients in the placebo arm did not receive study treatment. The trial did not meet its primary endpoint of overall survival: median 10.6 months (95 % confidence interval [CI], 8.2–12.4) for the canakinumab arm and 11.3 months (95 % CI, 8.5–13.8) for the placebo arm (hazard ratio, 1.06 [95 % CI, 0.76–1.48]; one-sided P-value = 0.633). AEs (any grade) were reported in 95 % of patients in the canakinumab group and in 98 % of patients in the placebo group. Grade 3–4 AEs were experienced by 62 % and 64 % of patients in the canakinumab and placebo groups, respectively, and grade 5 AEs were experienced by 8 % and 5 %. Prespecified, post-hoc subgroup analyses showed that patients with undetected circulating tumor DNA (ctDNA) and/or lower levels (< 10 mg/L) of C-reactive protein (CRP) achieved longer progression-free and overall survival than those with detected ctDNA or higher (≥ 10 mg/L) CRP levels. There was no association with treatment arm. Conclusion
Adding canakinumab to docetaxel did not provide additional benefit for patients with advanced NSCLC who had progressed after PDC and immunotherapy. Clinical registration: NCT03626545.
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