Multicentre phase II study of nivolumab in Japanese patients with advanced or recurrent non-squamous non-small cell lung cancer.
Multicentre phase II study of nivolumab in Japanese patients with advanced or recurrent non-squamous non-small cell lung cancer.
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Nivolumab多中心II期研究对日本晚期或复发性非小细胞肺癌的日本患者。
DOI：
10.1136/esmoopen-2016-000108
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发表时间：
2016
期刊：
影响因子：
7.3
通讯作者：
Tamura T
中科院分区：
文献类型：
--
作者：
Nishio M;Hida T;Atagi S;Sakai H;Nakagawa K;Takahashi T;Nogami N;Saka H;Takenoyama M;Maemondo M;Ohe Y;Nokihara H;Hirashima T;Tanaka H;Fujita S;Takeda K;Goto K;Satouchi M;Isobe H;Minato K;Sumiyoshi N;Tamura T
Nivolumab是一种全人源IgG4程序性细胞死亡1免疫检查点抑制剂单克隆抗体，获批用于治疗非小细胞肺癌（NSCLC）。本研究的目的是评价nivolumab在日本晚期或复发性非鳞状NSCLC患者中的安全性和疗效。在这项多中心II期研究中，在含铂化疗后进展的晚期或复发性非鳞状NSCLC患者接受nivolumab 3 mg/kg静脉给药，每2周一次，直至观察到疾病进展或不可接受的毒性。 主要终点是独立放射学审查委员会（IRC）评估的总缓解率（ORR），次要终点包括ORR（研究者评估）、无进展生存期（PFS）、总生存期（OS）、缓解持续时间、至缓解时间、最佳总缓解和安全性。在日本的19家研究中心入组了76例患者。ORR（IRC评估）为22.4%（95%CI 14.5%至32.9%）。中位PFS和OS分别为2.8个月（95% CI 1.4 - 3.4）和17.1个月（95% CI 13.3 - 23.0）。 1年OS率为68.0%（95% CI 56.2%-77.3%）。 当前/既往吸烟者对治疗的反应比非吸烟者更好（ORR 29.1% vs 4.8%）。表皮生长因子受体（EGFR）突变野生型/未知患者的ORR高于EGFR突变阳性患者（ORR 28.6% vs 5.0%）和程序性细胞死亡配体-1（PD-L1）表达可能与更高的ORR、更长的PFS和OS相关。17例患者报告了3级或更高级别的治疗相关不良事件;这些事件通过适当的治疗（包括类固醇治疗或nivolumab停药）消退或正在消退。纳武利尤单抗耐受性良好，在含铂化疗后进展的日本非鳞状NSCLC患者中显示出临床疗效，尤其是在有吸烟史、野生型/未知EGFR突变状态或阳性PD-L1表达的患者中。JapicCTI-132073。
Nivolumab is a fully human IgG4 programmed cell death 1 immune checkpoint inhibitor monoclonal antibody approved for the treatment of non-small cell lung cancer (NSCLC). The aim of this study was to evaluate the safety and efficacy of nivolumab in Japanese patients with advanced or recurrent non-squamous NSCLC. In this multicentre phase II study, patients with advanced or recurrent non-squamous NSCLC, which had progressed after platinum-containing chemotherapy, were treated with nivolumab 3 mg/kg, intravenously every 2 weeks until progressive disease or unacceptable toxicity was observed. The primary end point was independent radiology review committee (IRC) assessed overall response rate (ORR) and the secondary endpoints included ORR (investigator assessed), progression-free survival (PFS), overall survival (OS), duration of response, time to response, best overall response, and safety. 76 patients were enrolled across 19 sites in Japan. The ORR (IRC assessed) was 22.4% (95% CI 14.5% to 32.9%). The median PFS and OS were 2.8 months (95% CI 1.4 to 3.4) and 17.1 months (95% CI 13.3 to 23.0), respectively. The OS rate at 1 year was 68.0% (95% CI 56.2% to 77.3%). Current/former smokers were more responsive to treatment than non-smokers (ORR 29.1% vs 4.8%). Patients with epidermal growth factor receptor (EGFR) mutation wild type/unknown showed higher ORR compared with EGFR mutation-positive patients (ORR 28.6% vs 5.0%) and programmed cell death ligand-1 (PD-L1) expression was likely associated with higher ORR, longer PFS and OS. Treatment-related adverse events of grade 3 or higher were reported in 17 patients; these events resolved or were resolving with appropriate treatment including steroid therapy or discontinuation of nivolumab. Nivolumab was well tolerated and showed clinical efficacy in Japanese patients with non-squamous NSCLC progressed after platinum-containing chemotherapy, especially in those with a history of smoking, wild type/unknown EGFR mutation status or positive PD-L1 expression. JapicCTI-132073.
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DOI：
10.1038/nrc3239
发表时间：
2012-03-22
期刊：
Nature reviews. Cancer
影响因子：
--
作者：
Pardoll DM
通讯作者：
Pardoll DM
影响因子：
3.8
作者：
Pallis, Athanasios G.;Agelaki, Sophia;Georgoulias, Vassilis
通讯作者：
Georgoulias, Vassilis
影响因子：
50.5
作者：
Yu, H. A.;Arcila, M. E.;Riely, G. J.
通讯作者：
Riely, G. J.
DOI：
10.1097/jto.0b013e318206a221
发表时间：
2011-02
期刊：
Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer
影响因子：
--
作者：
Travis WD;Brambilla E;Noguchi M;Nicholson AG;Geisinger KR;Yatabe Y;Beer DG;Powell CA;Riely GJ;Van Schil PE;Garg K;Austin JH;Asamura H;Rusch VW;Hirsch FR;Scagliotti G;Mitsudomi T;Huber RM;Ishikawa Y;Jett J;Sanchez-Cespedes M;Sculier JP;Takahashi T;Tsuboi M;Vansteenkiste J;Wistuba I;Yang PC;Aberle D;Brambilla C;Flieder D;Franklin W;Gazdar A;Gould M;Hasleton P;Henderson D;Johnson B;Johnson D;Kerr K;Kuriyama K;Lee JS;Miller VA;Petersen I;Roggli V;Rosell R;Saijo N;Thunnissen E;Tsao M;Yankelewitz D
通讯作者：
Yankelewitz D
影响因子：
64.5
作者：
Govindan R;Ding L;Griffith M;Subramanian J;Dees ND;Kanchi KL;Maher CA;Fulton R;Fulton L;Wallis J;Chen K;Walker J;McDonald S;Bose R;Ornitz D;Xiong D;You M;Dooling DJ;Watson M;Mardis ER;Wilson RK
通讯作者：
Wilson RK