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Efficacy and safetyof nivolumab inJapanese patientswith advanced orrecurrent squamousnon‐small cell lungcancer Toyoaki HidaMakoto NishioNaoyuki Nogami2017 год

Efficacy and safety of nivolumab in Japanese patients with advanced or recurrent squamous non‐small cell lung cancer
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Аннотация: 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.
Год издания: 2017
Авторы: 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, Kōichi Goto, Shinji Atagi, Tomonori Hirashima, Naoki Sumiyoshi, Tomohide Tamura
Издательство: Wiley
Источник: Cancer Science
Ключевые слова: Cancer Immunotherapy and Biomarkers, Lung Cancer Treatments and Mutations, Lung Cancer Diagnosis and Treatment
Другие ссылки: Cancer Science (PDF)
Cancer Science (HTML)
Europe PMC (PubMed Central) (PDF)
Europe PMC (PubMed Central) (HTML)
PubMed Central (HTML)
PubMed (HTML)