Three‐year follow‐up results from phase II studies of nivolumab in Japanese patients with previously treated advanced non‐small cell lung cancer: Pooled analysis of ONO‐4538‐05 and ONO‐4538‐06 studies
| العنوان: | Three‐year follow‐up results from phase II studies of nivolumab in Japanese patients with previously treated advanced non‐small cell lung cancer: Pooled analysis of ONO‐4538‐05 and ONO‐4538‐06 studies |
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| المؤلفون: | Koichi Goto, Mitsuhiro Takenoyama, Koji Takeda, Shinji Atagi, Hidehito Horinouchi, M. Nishio, Tomohide Tamura, Naoyuki Nogami, Kazuhiko Nakagawa, Tomonori Hirashima, Hideo Saka, Naoki Sumiyoshi, Hiroshi Isobe, Hiroshi Sakai, Miyako Satouchi, Toyoaki Hida, Toshiaki Takahashi, Hiroshi Tanaka, Koichi Minato, Makoto Maemondo, Nobuyuki Katakami |
| المصدر: | Cancer Medicine Cancer Medicine, Vol 8, Iss 11, Pp 5183-5193 (2019) |
| بيانات النشر: | John Wiley and Sons Inc., 2019. |
| سنة النشر: | 2019 |
| مصطلحات موضوعية: | 0301 basic medicine, Male, Cancer Research, Lung Neoplasms, non-small cell lung cancer (NSCLC), Phases of clinical research, Kaplan-Meier Estimate, Gastroenterology, 0302 clinical medicine, Antineoplastic Agents, Immunological, Japan, Carcinoma, Non-Small-Cell Lung, Molecular Targeted Therapy, Neoplasm Metastasis, Original Research, Aged, 80 and over, Standard treatment, Middle Aged, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Treatment Outcome, Oncology, Docetaxel, 030220 oncology & carcinogenesis, Toxicity, Female, Nivolumab, phase II study, medicine.drug, Adult, medicine.medical_specialty, lcsh:RC254-282, 03 medical and health sciences, Clinical Trials, Phase II as Topic, Internal medicine, medicine, Biomarkers, Tumor, non‐small cell lung cancer (NSCLC), Humans, Radiology, Nuclear Medicine and imaging, Lung cancer, programmed cell death 1 ligand 1 (PD‐L1), Aged, Neoplasm Staging, nivolumab, business.industry, Clinical Cancer Research, medicine.disease, Discontinuation, 030104 developmental biology, programmed cell death 1 receptor (PD‐1), business |
| الوصف: | Background Nivolumab is a programmed cell death 1 (PD‐1) receptor inhibitor antibody that enhances immune system antitumor activity. It is associated with longer overall survival (OS) than the standard treatment of docetaxel in patients with previously treated advanced squamous (SQ) and non‐squamous (non‐SQ) non‐small cell lung cancer (NSCLC). We previously conducted two phase II studies of nivolumab in Japanese patients with SQ (ONO‐4538‐05) and non‐SQ (ONO‐4538‐06) NSCLC, showing overall response rates (ORRs) (95% CI) of 25.7% (14.2‐42.1) and 22.4% (14.5‐32.9), respectively, with acceptable toxicity. In this analysis, we more precisely estimated the long‐term safety and efficacy in patients with SQ and non‐SQ NSCLC by pooling data from these two trials. Methods SQ (N = 35) and non‐SQ (N = 76) NSCLC patients received nivolumab (3 mg/kg, every 2 weeks) until progression or discontinuation. OS was estimated using the Kaplan–Meier method. A pooled analysis of SQ and non‐SQ patients was also performed. Results In SQ NSCLC patients, the median OS (95% CI) was 16.3 months (12.4‐25.2), and the estimated 1‐year, 2‐year, and 3‐year survival rates were 71.4% (53.4‐83.5), 37.1% (21.6‐52.7), and 20.0% (8.8‐34.4), respectively. In non‐SQ NSCLC patients, median OS was 17.1 months (13.3‐23.0), and the estimated 1‐, 2‐, and 3‐year survival rates were 68.0% (56.2‐77.3), 37.4% (26.5‐48.1), and 31.9% (21.7‐42.5), respectively. When SQ NSCLC and non‐SQ NSCLC data were pooled, the median OS was 17.1 months (14.2‐20.6), and the estimated 1‐, 2‐, and 3‐year survival rates were 69.1% (59.6‐76.8), 37.3% (28.3‐46.2), and 28.1% (20.0‐36.7), respectively. Twenty (76.9%) of 26 responders lived for 3 or more years. Nivolumab was well tolerated and no new safety signals were found. Conclusion Treatment with nivolumab improved long‐term survival and was well tolerated in patients with SQ and non‐SQ NSCLC. Trial registration JapicCTI‐132072; JapicCTI‐132073. |
| اللغة: | English |
| تدمد: | 2045-7634 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8d0254674afd607d2a94e714630a3d09Test http://europepmc.org/articles/PMC6718542Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....8d0254674afd607d2a94e714630a3d09 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 20457634 |
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