Efficacy and safety of nivolumab in Japanese patients with advanced or recurrent squamous non-small cell lung cancer.
Efficacy and safety of nivolumab in Japanese patients with advanced or recurrent squamous non-small cell lung cancer.
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DOI：
10.1111/cas.13225
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发表时间：
2017-05
期刊：
影响因子：
5.7
通讯作者：
Tamura T
中科院分区：
文献类型：
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作者：
Hida T;Nishio M;Nogami N;Ohe Y;Nokihara H;Sakai H;Satouchi M;Nakagawa K;Takenoyama M;Isobe H;Fujita S;Tanaka H;Minato K;Takahashi T;Maemondo M;Takeda K;Saka H;Goto K;Atagi S;Hirashima T;Sumiyoshi N;Tamura T
IIIB/IV期非小细胞肺癌(NSCLC)的治疗选择有限。尼伏卢单抗是一种程序性细胞死亡-1免疫检查点抑制抗体，已被证明对治疗非小细胞肺癌有效。本研究调查了尼伏单抗在日本晚期或复发的鳞状非小细胞肺癌患者中的有效性和安全性，这些患者在含铂化疗后进展。在这项多中心II期研究中，患者接受尼伏鲁单抗(3毫克/公斤，静脉注射)治疗。每2周一次，直到出现进展性疾病或不可接受的毒性。主要终点是由独立放射学审查委员会(IRC)评估的总体缓解率(ORR)，次要终点包括研究地点评估的总缓解率(ORR)、总生存率(OS)、无进展生存率(PFS)、反应持续时间、有效时间、最佳总体反应(BOR)和安全性。这项研究包括来自日本17个地点的35名患者。IRC评估的ORR为25.7%(95%CI为14.2，42.1)，研究现场评估的ORR为20.0%(95%CI为10.0，35.9)。中位OS、中位有效时间和中位PFS分别为16.3(95%CI 12.4~25.4)、2.7(1.2~5.5)和4.2(95%CI 1.4~7.1)个月。IRC评估的BOR为部分缓解、稳定和进展，分别为25.7%、28.6%和45.7%。报告了24名患者(68.6%)与治疗相关的不良事件，其中大多数通过适当的治疗得到解决，包括类固醇治疗或停用尼伏卢单抗。尼伏单抗对日本晚期或复发的鳞状非小细胞肺癌患者有效且耐受性良好，这些患者在含铂化疗后进展。临床试验注册号：JAPICCTI-132072
Limited treatment options are available for stage IIIB/IV non‐small cell lung cancer (NSCLC). Nivolumab, a programmed cell death‐1 immune checkpoint inhibitor antibody, has been shown to be effective for the treatment of NSCLC. The present study investigated the effectiveness and safety of nivolumab in Japanese patients with advanced or recurrent squamous NSCLC that progressed after platinum‐containing chemotherapy. In this multicenter phase II study, patients were treated with nivolumab (3 mg/kg, i.v.) every 2 weeks until progressive disease or unacceptable toxicity was seen. Primary endpoint was overall response rate (ORR) assessed by independent radiology review committee (IRC) and secondary endpoints included a study site‐assessed ORR, overall survival (OS), progression‐free survival (PFS), duration of response, time to response, best overall response (BOR), and safety. The study included 35 patients from 17 sites in Japan. Patients had IRC‐assessed ORR of 25.7% (95% CI 14.2, 42.1) and the study site‐assessed ORR was 20.0% (95% CI 10.0, 35.9). Median OS, median time to response and median PFS were 16.3 (95% CI 12.4–25.4), 2.7 (range 1.2–5.5) and 4.2 (95% CI 1.4–7.1) months, respectively. The IRC‐assessed BOR was partial response, stable disease, and progressive disease for 25.7%, 28.6%, and 45.7% of patients, respectively. Treatment‐related adverse events were reported in 24 patients (68.6%), most of which resolved with appropriate treatment including steroid therapy or discontinuation of nivolumab. Nivolumab was effective and well tolerated in Japanese patients with advanced or recurrent squamous NSCLC that progressed after platinum‐containing chemotherapy. Clinical trial registration number: JapicCTI‐132072