Efficacy and safety of nivolumab in Japanese patients with advanced or recurrent squamous non-small cell lung cancer

Toyoaki Hida, Makoto Nishio, Naoyuki Nogami, Yuichiro Ohe, Hiroshi Nokihara, Hiroshi Sakai, Miyako Satouchi, Kazuhiko Nakagawa, Mitsuhiro Takenoyama, Hiroshi Isobe, Shiro Fujita, Hiroshi Tanaka, Koichi Minato, Toshiaki Takahashi, Makoto Maemondo, Koji Takeda, Hideo Saka, Koichi Goto, Shinji Atagi, Tomonori HirashimaNaoki Sumiyoshi, Tomohide Tamura

Research output: Contribution to journalArticlepeer-review

58 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)1000-1006
Number of pages7
JournalCancer science
Volume108
Issue number5
DOIs
Publication statusPublished - 05-2017
Externally publishedYes

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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