title: Efficacy and safety of nivolumab in Japanese patients with advanced or recurrent squamous non-small cell lung cancer.
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.
  
  
  BACKGROUND
  JapicCTI-132072.
authors.affiliation: Aichi Cancer Center Hospital, Aichi, Japan.
authors.forename: Toyoaki
authors.initials: T
authors.lastname: Hida
authors.affiliation: The Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Nishio
authors.affiliation: National Hospital Organization Shikoku Cancer Center, Ehime, Japan.
authors.forename: Naoyuki
authors.initials: N
authors.lastname: Nogami
authors.affiliation: National Cancer Center Hospital, Tokyo, Japan.
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Ohe
authors.affiliation: National Cancer Center Hospital, Tokyo, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Nokihara
authors.affiliation: Saitama Cancer Center, Saitama, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Sakai
authors.affiliation: Hyogo Cancer Center, Hyogo, Japan.
authors.forename: Miyako
authors.initials: M
authors.lastname: Satouchi
authors.affiliation: Kindai University Faculty of Medicine, Osaka, Japan.
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Nakagawa
authors.affiliation: National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
authors.forename: Mitsuhiro
authors.initials: M
authors.lastname: Takenoyama
authors.affiliation: KKR Sapporo Medical Center, Sapporo, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Isobe
authors.affiliation: Institute of Biomedical Research and Innovation Hospital, Hyogo, Japan.
authors.forename: Shiro
authors.initials: S
authors.lastname: Fujita
authors.affiliation: Niigata Cancer Center Hospital, Niigata, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Tanaka
authors.affiliation: Gunma Prefectural Cancer Center, Gunma, Japan.
authors.forename: Koichi
authors.initials: K
authors.lastname: Minato
authors.affiliation: Shizuoka Cancer Center, Shizuoka, Japan.
authors.forename: Toshiaki
authors.initials: T
authors.lastname: Takahashi
authors.affiliation: Miyagi Cancer Center, Miyagi, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Maemondo
authors.affiliation: Osaka City General Hospital, Osaka, Japan.
authors.forename: Koji
authors.initials: K
authors.lastname: Takeda
authors.affiliation: National Hospital Organization Nagoya Medical Center, Aichi, Japan.
authors.forename: Hideo
authors.initials: H
authors.lastname: Saka
authors.affiliation: National Cancer Center Hospital East, Chiba, Japan.
authors.forename: Koichi
authors.initials: K
authors.lastname: Goto
authors.affiliation: National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka, Japan.
authors.forename: Shinji
authors.initials: S
authors.lastname: Atagi
authors.affiliation: Osaka Prefectural Medical Center for Respiratory and Allergic Diseases, Osaka, Japan.
authors.forename: Tomonori
authors.initials: T
authors.lastname: Hirashima
authors.affiliation: Ono Pharmaceutical Co., Ltd, Osaka, Japan.
authors.forename: Naoki
authors.initials: N
authors.lastname: Sumiyoshi
authors.affiliation: St. Luke's International Hospital, Tokyo, Japan.
authors.forename: Tomohide
authors.initials: T
authors.lastname: Tamura
mesh_terms: D000368:Aged; D000911:Antibodies, Monoclonal / Q000009:adverse effects* / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D044466:Asian People; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D000077594:Nivolumab
chemical_list: D000911:Antibodies, Monoclonal; D000970:Antineoplastic Agents; D000077594:Nivolumab
keywords: Japanese; Nivolumab; non-small cell lung cancer; programmed cell death-1; squamous cell carcinoma