A randomized, open-label, comparative study of simvastatin plus diet versus diet alone on angiographic retardation of coronary atherosclerosis in adult Japanese patients: Japanese utilization of simvastatin therapy (JUST) study

2004 ◽  
Vol 26 (6) ◽  
pp. 878-888 ◽  
Author(s):  
Kyoichi Mizuno ◽  
Haruo Nakamura ◽  
Yasuo Ohashi ◽  
Tsuneo Kaburagi ◽  
Akira Kitabatake ◽  
...  
Keyword(s):  
Comparative Study ◽  
Coronary Atherosclerosis ◽  
Japanese Patients ◽  
Open Label ◽  
Simvastatin Therapy ◽  
Diet Versus

scholarly journals ATIM-07. EFFICACY AND SAFETY OF NIVOLUMAB IN PATIENTS WITH FIRST RECURRENCE OF GLIOBLASTOMA: A MULTICENTER, OPEN-LABEL, NON-COMPARATIVE STUDY (ONO-4538-19)

2019 ◽  
Vol 21 (Supplement_6) ◽  
pp. vi2-vi3
Author(s):  
Naoki Kagawa ◽  
Tomokazu Aoki ◽  
Kazuhiko Sugiyama ◽  
Toshihiko Wakabayashi ◽  
Yoshiki Arakawa ◽  
...  
Keyword(s):  
Comparative Study ◽  
Posterior Probability ◽  
Japanese Patients ◽  
World Health ◽  
Adverse Event Rate ◽  
Efficacy And Safety ◽  
Open Label ◽  
Who Grade ◽  
Posterior Mean ◽  
First Recurrence

Abstract BACKGROUND The anti-programmed cell death protein 1 (PD-1) immune checkpoint antibody, nivolumab, may be beneficial in patients with recurrent glioblastoma. OBJECTIVE This open-label, non-comparative study assessed the efficacy and safety of nivolumab in Japanese patients with first recurrence of glioblastoma. METHODS Patients with a first recurrence of histologically confirmed World Health Organization (WHO) Grade IV glioma, after treatment with temozolomide plus radiotherapy, received nivolumab 3 mg/kg every 2 weeks until confirmed disease progression based on Response Assessment in Neuro-Oncology (RANO) criteria or development of toxicity. The primary endpoint was 1-year overall survival rate (1y-OS) assessed using a Bayesian approach. The prespecified efficacy criteria were that the Bayesian posterior mean 1y-OS with nivolumab would be 49%, and the Bayesian posterior probability threshold for exceeding the 1y-OS of bevacizumab (34.5%) from the Japanese Phase II study (JO22506) would be 93%. RESULTS Of the 50 patients enrolled, 44 (93.5%) had recurrent malignant glioma (glioblastoma and gliosarcoma), 26 (59.1%) had measurable disease, and 4 (9.1%) received corticosteroids at baseline. The posterior mean (90% Bayesian credible intervals) 1y-OS with nivolumab was 54.35% (42.27–66.21), and the observed posterior probability of exceeding the 1y-OS of bevacizumab (34.5%, JO22506) was 99.7%. The median (90% confidence interval) overall and progression-free survival (PFS) was 13.09 months (10.38, 17.68) and 1.45 months (1.41, 1.54), respectively. One partial response was observed (objective response rate [ORR] 1/26 evaluable patients [3.8%]). The grade 3–5 treatment-related adverse event rate was 16.0%; most adverse events resolved and were manageable. CONCLUSION The 1y-OS with nivolumab monotherapy in Japanese patients was higher than that in the bevacizumab group in the JO22506 study. However, PFS and ORR were not improved compared with JO22506. The safety profile of nivolumab was consistent with that observed in other tumor types.

scholarly journals Efficacy and safety of nivolumab in Japanese patients with first recurrence of glioblastoma: an open-label, non-comparative study

2021 ◽  
Author(s):  
Tomokazu Aoki ◽  
Naoki Kagawa ◽  
Kazuhiko Sugiyama ◽  
Toshihiko Wakabayashi ◽  
Yoshiki Arakawa ◽  
...  
Keyword(s):  
Overall Survival ◽  
Survival Rate ◽  
Comparative Study ◽  
Posterior Probability ◽  
Japanese Patients ◽  
Bayesian Posterior Probability ◽  
Overall Survival Rate ◽  
Efficacy And Safety ◽  
Open Label ◽  
First Recurrence

Abstract Background An open-label, non-comparative study assessed the efficacy and safety of nivolumab in Japanese patients with first recurrence glioblastoma. Methods Patients with first recurrence of histologically confirmed World Health Organization Grade IV glioma, after treatment with temozolomide and radiotherapy, received nivolumab 3 mg/kg every 2 weeks until confirmed disease progression (Response Assessment in Neuro-Oncology criteria) or toxicity. Primary endpoint was 1-year overall survival rate assessed by Bayesian approach. The prespecified efficacy criterion was that the Bayesian posterior probability threshold for exceeding the 1-year overall survival of bevacizumab (34.5%) from the Japanese phase 2 study (JO22506) would be 93%. Results Of the 50 enrolled patients, 44 (88.0%) had recurrent malignant glioma (glioblastoma, gliosarcoma), and of these, 26 (59.1%) had at least one measurable lesion at baseline. The Bayesian posterior mean 1-year overall survival (90% Bayesian credible intervals) with nivolumab was 54.4% (42.27–66.21), and the Bayesian posterior probability of exceeding the threshold of the 1-year overall survival rate of bevacizumab (34.5%) was 99.7%. Median (90% confidence interval) overall and progression-free survival was 13.1 (10.4–17.7) and 1.5 (1.4–1.5) months, respectively. One partial response was observed (objective response rate 1/26 evaluable patients [3.8%]). Treatment-related adverse event rates were 14.0% for Grade 3–4 and 2.0% for Grade 5; most adverse events resolved and were manageable. Conclusions The 1-year overall survival with nivolumab monotherapy in Japanese patients with glioblastoma met the prespecified efficacy criterion. The safety profile of nivolumab was consistent with that observed in other tumor types. Clinical Trial Registration JapicCTI-152967.

Efficacy and safety of collagenase Clostridium histolyticum injection for Dupuytren’s contracture in non-Caucasian Japanese patients (CORD-J Study): the first clinical trial in a non-Caucasian population

2016 ◽  
Vol 42 (1) ◽  
pp. 30-38 ◽  
Author(s):  
H. Hirata ◽  
K. Tanaka ◽  
A. Sakai ◽  
R. Kakinoki ◽  
H. Ikegami ◽  
...  
Keyword(s):  
Clinical Success ◽  
Japanese Patients ◽  
Phase Iii ◽  
Dupuytren’S Contracture ◽  
Collagenase Clostridium Histolyticum ◽  
Open Label ◽  
Level Of Evidence ◽  
Dupuytren's Contracture ◽  
Clostridium Histolyticum ◽  
Corrective Effect

To assess the efficacy, safety and pharmacokinetics of 0.58 mg collagenase Clostridium histolyticum injections for the treatment of Dupuytren’s contracture in Japanese patients, we conducted a phase III, multicentre, uncontrolled, open-label clinical study in patients with Dupuytren’s contracture. Of the 77 patients, 66 achieved clinical success in the primary treated joint (86%; 95% confidence interval: 76% to 93%), confirming the efficacy of collagenase Clostridium histolyticum injections. More improvement was seen in the metacarpophalangeal joints than in the proximal interphalangeal joints (94% versus 73%). The main adverse reaction was a local reaction in the injected hand. No tendon rupture or anaphylactic reactions were seen. The concentrations of collagenase Clostridium histolyticum were below the lower limit of quantification in plasma samples at all time points. As seen in global studies in Caucasian patients, a corrective effect on Dupuytren’s contracture and good tolerance were observed in most non-Caucasian (Asian) Japanese patients. Level of Evidence: Level 3

Abstract 11885: Differential Contributions of Abdominal Visceral Fat and Epicardial Fat to Coronary Atherosclerosis in Non-Obese Japanese Patients

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Ken Harada ◽  
Takashi Kataoka ◽  
Masahiro Takeshita ◽  
Kazuhiro Harada ◽  
Ayako Kunimura ◽  
...  
Keyword(s):  
Visceral Fat ◽  
Coronary Atherosclerosis ◽  
Japanese Patients ◽  
Coronary Plaque ◽  
Epicardial Fat ◽  
Systemic Effects ◽  
Visceral Fat Area ◽  
Coronary Syndrome ◽  
Abdominal Visceral Fat ◽  
Noncalcified Plaque

Introduction: Epicardial fat is a source of adipocytokines that have both paracrine and systemic effects and is implicated in coronary atherosclerosis. The relation between epicardial fat volume (EFV) and circulating adipocytokine levels has remained unknown, however. Objectives: We assessed the relation between EFV and both plasma adipocytokine concentrations and coronary atherosclerotic plaque. Methods: Consecutive Japanese patients suspected of having coronary artery disease (n = 216) were examined. Individuals with acute coronary syndrome or with inadequate CT imaging were excluded. A total of 164 patients (65 ± 10 years; 70% men; BMI, 23.8 ± 3.6 kg/m2) was enrolled. Plasma levels of adiponectin, interleukin-6 (IL-6), plasminogen activator inhibitor-1 (PAI-1), and vascular endothelial growth factor (VEGF) were measured. The characteristics of coronary plaque, abdominal visceral fat area, and EFV were determined by 64-slice CT. Results: EFV was greater in subjects with noncalcified plaque than in those with no plaque or with calcified plaque (126 ± 39 vs. 98 ± 34 and 97 ± 45 mL, respectively; P = 0.010). EFV was significantly correlated with BMI, plasma triglyceride concentration, and the triglyceride/HDL-cholesterol ratio (r = 0.51, 0.19, and 0.20, respectively) but not with plasma adipocytokine levels, whereas plasma adiponectin and IL-6 levels were significantly correlated (r = -0.49 and 0.20, respectively) with visceral fat area, in patients with coronary plaque. Conclusions: Patients with noncalcified plaque had increased EFV but their plasma adipocytokine levels had not increased. Adipocytokines in plasma may be derived mainly from abdominal visceral fat, whereas epicardial fat may promote coronary atherosclerosis directly through a paracrine mechanism rather than by systemic effects. In conclusion, abdominal visceral fat and epicardial fat may thus contribute to coronary atherosclerosis by distinct mechanisms in nonobese individuals.

Sign in / Sign up

Export Citation Format

Share Document