Hida Toyoaki, Nishio Makoto, Nogami Naoyuki, Ohe Yuichiro, Nokihara Hiroshi, Sakai Hiroshi, Satouchi Miyako, Nakagawa Kazuhiko, Takenoyama Mitsuhiro, Isobe Hiroshi, Fujita Shiro, Tanaka Hiroshi, Minato Koichi, Takahashi Toshiaki, Maemondo Makoto, Takeda Koji, Saka Hideo, Goto Koichi, Atagi Shinji, Hirashima Tomonori, Sumiyoshi Naoki, Tamura Tomohide
Aichi Cancer Center Hospital, Aichi, Japan.
The Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
Cancer Sci. 2017 May;108(5):1000-1006. doi: 10.1111/cas.13225. Epub 2017 Apr 26.
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.
JapicCTI-132072.
对于ⅢB/Ⅳ期非小细胞肺癌（NSCLC），可用的治疗方案有限。纳武单抗是一种程序性细胞死亡蛋白1免疫检查点抑制剂抗体，已被证明对NSCLC治疗有效。本研究调查了纳武单抗在铂类化疗后进展的日本晚期或复发性鳞状NSCLC患者中的有效性和安全性。在这项多中心Ⅱ期研究中，患者每2周接受一次纳武单抗（3mg/kg，静脉注射）治疗，直至出现疾病进展或不可接受的毒性。主要终点是由独立放射学审查委员会（IRC）评估的总缓解率（ORR），次要终点包括研究地点评估的ORR、总生存期（OS）、无进展生存期（PFS）、缓解持续时间、缓解时间、最佳总体缓解（BOR）和安全性。该研究纳入了来自日本17个地点的35例患者。患者经IRC评估的ORR为25.7%（95%CI 14.2，42.1），研究地点评估的ORR为20.0%（95%CI 10.0，35.9）。中位OS、中位缓解时间和中位PFS分别为16.3（95%CI 12.4 - 25.4）、2.7（范围1.2 - 5.5）和4.2（95%CI 1.4 - 7.1）个月。经IRC评估，分别有25.7%、28.6%和45.7%的患者的BOR为部分缓解、疾病稳定和疾病进展。24例患者（68.6%）报告了与治疗相关的不良事件，其中大多数通过包括类固醇治疗或停用纳武单抗在内的适当治疗得到缓解。纳武单抗在铂类化疗后进展的日本晚期或复发性鳞状NSCLC患者中有效且耐受性良好。
JapicCTI - 132072。
