Open AccessEfficacy and safety of nivolumab in Japanese patients with advanced or recurrent squamous non‐small cell lung cancer
Author(s) -
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
Publication year - 2017
Publication title -
cancer science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.035
H-Index - 141
eISSN - 1349-7006
pISSN - 1347-9032
DOI - 10.1111/cas.13225
Subject(s) - nivolumab , medicine , discontinuation , response evaluation criteria in solid tumors , clinical endpoint , lung cancer , progressive disease , adverse effect , oncology , chemotherapy , phases of clinical research , progression free survival , cancer , surgery , gastroenterology , immunotherapy , clinical trial
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: Japic CTI ‐132072