医学
无容量
贝伐单抗
内科学
危险系数
卡铂
肿瘤科
肺癌
临床终点
中期分析
安慰剂
不利影响
化疗
外科
随机对照试验
置信区间
癌症
免疫疗法
病理
替代医学
顺铂
作者
Shunichi Sugawara,J.-S. Lee,Jin Hyung Kang,H.R. Kim,Naoki Inui,Toyoaki Hida,K.H. Lee,Tsukihisa Yoshida,Hiroshi Tanaka,Cheng‐Ta Yang,Makoto Nishio,Yuichiro Ohe,Tomohide Tamura,Nobuyuki Yamamoto,Chong Jen Yu,Hiroaki Akamatsu,Yoshinobu Namba,Naoki Sumiyoshi,Kazuhiko Nakagawa
标识
DOI:10.1016/j.annonc.2021.06.004
摘要
This international, randomized, double-blind phase III study (ONO-4538-52/TASUKI-52) evaluated nivolumab with bevacizumab and cytotoxic chemotherapy as first-line treatment for nonsquamous non-small-cell lung cancer (NSCLC).Between June 2017 and July 2019, this study enrolled treatment-naïve patients with stage IIIB/IV or recurrent nonsquamous NSCLC without sensitizing EGFR, ALK, or ROS1 alterations. They were randomly assigned in a 1 : 1 ratio to receive nivolumab or placebo in combination with carboplatin, paclitaxel, and bevacizumab every 3 weeks for up to six cycles, followed by nivolumab/placebo with bevacizumab until progressive disease or unacceptable toxicity. The primary endpoint was progression-free survival (PFS) assessed by an independent radiology review committee (IRRC).Overall, 550 patients from Japan, Korea, and Taiwan were randomized; of these patients, 273 and 275 received the nivolumab and placebo combinations, respectively. In the present preplanned interim analysis with a median follow up of 13.7 months, the IRRC-assessed median PFS was significantly longer in the nivolumab arm than in the placebo arm (12.1 versus 8.1 months; hazard ratio 0.56; 96.4% confidence interval 0.43-0.71; P < 0.0001). The PFS benefit was observed across all patients with any programmed death-ligand 1 (PD-L1) expression levels including PD-L1-negative patients. The IRRC-assessed objective response rates were 61.5% and 50.5% in the nivolumab and placebo arms, respectively. The incidence of treatment-related adverse events of grade 3 or 4 was comparable between the two arms; treatment-related adverse events leading to death were observed in five and four patients in the nivolumab and placebo arms, respectively.The TASUKI-52 regimen should be considered a viable new treatment strategy for treatment-naïve patients with advanced nonsquamous NSCLC.
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