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.

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 Carbon Ion Radiotherapy for Oligo-Recurrence in the Lung

2013 ◽  
Vol 2013 ◽  
pp. 1-6 ◽  
Author(s):  
Naoyoshi Yamamoto ◽  
Mio Nakajima ◽  
Hirohiko Tsujii ◽  
Tadashi Kamada
Keyword(s):  
Colorectal Cancer ◽  
Lung Cancer ◽  
Overall Survival ◽  
Survival Rate ◽  
Local Control ◽  
Local Control Rate ◽  
Carbon Ion Radiotherapy ◽  
Overall Survival Rate ◽  
Carbon Ion ◽  
Metastatic Lung

The clinical results after carbon ion radiotherapy for the metastatic lung tumors believed to be in the state of oligo-recurrence were evaluated. One hundred and sixteen lesions in 91 patients with lung cancer metastasis were treated with carbon ion radiotherapy at our institute from April 1997 to February 2011. Regarding the prescribed dose, total dose ranged between 40 gray equivalents (GyE) and 80 GyE, and fraction size ranged from 1 to 16 fractions. After a median followup period of 2.3 years (range, 0.3–13.1 years), the statistical overall survival rate and local control rate were 71.2% and 91.9% at 2 years after treatment, respectively. Treatment-related side effects were not a clinical problem. When classified by the primary organ, there were 49 cases of lung cancer, 20 cases of colorectal cancer, and 22 cases of others. The overall survival rate and local control rate for lung metastasis cases from lung cancer at 2 years after treatment were 81.5% and 92.4%, respectively, and 65.0% and 92.0% regarding lung metastasis from colorectal cancer. Carbon ion beam therapy for the metastatic lung tumors is a safe therapy, and the therapeutic effect is comparable to the outcome obtained from reported surgical resections.

PREDICTORS OF OVERALL SURVIVAL IN MEN WITH CHRONIC LYMPHOCYTIC LEUKEMIA

2021 ◽  
pp. 50-56
Author(s):  
M.V. Markovtseva ◽  
E.N. Zgural'skaya
Keyword(s):  
Overall Survival ◽  
Glomerular Filtration Rate ◽  
Survival Rate ◽  
Glomerular Filtration ◽  
Median Survival ◽  
Filtration Rate ◽  
Lymphocytic Leukemia ◽  
Overall Survival Rate ◽  
Patient Will ◽  
Actual Survival

The generally accepted staging for chronic lymphocytic leukemia (CLL) suggested by K. Rai and J. Binet allows calculating the median survival depending on the size of the tumor mass. However, in real clinical practice, the overall survival rate may differ significantly from the calculated median. Thus, the search for parameters affecting the overall survival rate of CLL patients is really relevant. The aim of the study was to assess general clinical parameters as predictors of survival in CLL patients. Materials and Methods. The authors examined 60 CLL men (stages A–C according to Binet) with known overall survival rate. Data mining was used to identify significant factors affecting the overall survival in such patients. Patients were divided into two non-overlapping classes: K1 (actual survival was less than the predicted median survival) and K2 (actual survival was more or equal to the predicted median survival). Results. The most significant differences between the classes were obtained for glomerular filtration rate. If the parameter value is more than 76.5 ml/min/1.73 m2, we can say that the patient will overcome the median survival for the corresponding CLL stage according to Binet. Otherwise, the overall survival of a CLL patient will be less than the estimated one. Conclusion. If during diagnosing glomerular filtration rate of a CLL patient is more than 76.5 ml/min/1.73 m2, it can be considered as a predictor of overcoming the median survival according to Binet. The results of the studies obtained are patented. Patent RU 2725877 C1, July 7, 2020. Keywords: overall survival in CLL patients, men, glomerular filtration rate, data mining. Общепризнанные системы стадирования хронического лимфолейкоза (ХЛЛ) К. Rai и J. Binet позволяют рассчитать медиану выживаемости пациента в зависимости от величины опухолевой массы. Однако в реальной клинической практике параметр общей выживаемости пациента может значимо отличаться от расчетной медианы. Ввиду этого поиск параметров, влияющих на показатель общей выживаемости пациентов с ХЛЛ, представляет особую актуальность. Цель исследования – оценить возможность использования общеклинических параметров в качестве предикторов выживаемости больных ХЛЛ. Материалы и методы. Ретроспективно проанализированы данные 60 мужчин с ХЛЛ стадии A–C по Binet c известной общей выживаемостью. Для выявления значимых факторов, влияющих на общую выживаемость пациентов, использовали метод интеллектуального анализа данных. Пациенты были разделены на два непересекающихся класса: K1 (фактическая выживаемость меньше прогнозируемой медианы выживаемости) и K2 (фактическая выживаемость больше или равна прогнозируемой медиане выживаемости). Результаты. Наиболее значимые различия между классами были получены по показателю скорости клубочковой фильтрации. При значении параметра более 76,5 мл/мин/1,73 м2 можно говорить о том, что пациент преодолеет расчетные данные медианы выживаемости для соответствующей стадии ХЛЛ по Binet. В противном случае общая выживаемость пациента ХЛЛ будет меньше расчетной. Выводы. Наличие у пациента с ХЛЛ на момент постановки диагноза скорости клубочковой фильтрации более 76,5 мл/мин/1,73 м2 можно рассматривать в качестве предиктора преодоления расчетного параметра медианы выживаемости по Binet. Результаты полученных исследований запатентованы. Патент RU 2725877 C1 от 7.07.2020. Ключевые слова: общая выживаемость при ХЛЛ, мужчины, скорость клубочковой фильтрации, интеллектуальный анализ данных.

scholarly journals Efficacy and safety of nivolumab in combination with ipilimumab in Japanese patients with advanced melanoma: An open-label, single-arm, multicentre phase II study

2018 ◽  
Vol 105 ◽  
pp. 114-126 ◽  
Author(s):  
Kenjiro Namikawa ◽  
Yoshio Kiyohara ◽  
Tatsuya Takenouchi ◽  
Hisashi Uhara ◽  
Hiroshi Uchi ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Study ◽  
Japanese Patients ◽  
Advanced Melanoma ◽  
Efficacy And Safety ◽  
Open Label ◽  
Multicentre Phase

Carbon Dioxide Laser Microsurgery for Early Supraglottic Carcinoma

1998 ◽  
Vol 107 (8) ◽  
pp. 680-688 ◽  
Author(s):  
Petra Ambrosch ◽  
Martina Kron ◽  
Wolfgang Steiner
Keyword(s):  
Carbon Dioxide ◽  
Overall Survival ◽  
Survival Rate ◽  
Local Control ◽  
Carbon Dioxide Laser ◽  
Local Control Rate ◽  
Overall Survival Rate ◽  
Laser Microsurgery ◽  
Supraglottic Carcinoma ◽  
Free Rate

Forty-eight untreated patients with early supraglottic carcinoma (12 patients stage I and 36 patients stage II) had primary carbon dioxide laser microsurgery between 1979 and 1994 with the intent of complete tumor removal with preservation of functionally important structures of the larynx. Ninety-six percent of the patients were treated exclusively by surgery; 4% had laser microsurgery and postoperative radiotherapy. With a median follow-up of 55 months, the 5-year local control rate with the first treatment was 100% for pT1 cases and 89% for pT2 cases. The ultimate local control rate with voice preservation, including patients successfully salvaged after a local recurrence, was 97% for pT2 carcinomas. Five (10%) patients died of tumor (TNM)–related deaths. The 3-year recurrence-free rate and 3-year overall survival rate (Kaplan-Meier) were 87% and 85%; the 5-year recurrence-free rate and 5-year overall survival rate were 83% and 76%, respectively. The results achieved with transoral laser microsurgery in early supraglottic carcinoma are comparable to those of open supraglottic laryngectomy with respect to local control and survival. The functional results are superior, since clinically relevant aspiration did not occur.

scholarly journals Efficacy and safety of secukinumab in Japanese patients with active ankylosing spondylitis: 24-week results from an open-label phase 3 study (MEASURE 2-J)

2019 ◽  
Vol 30 (1) ◽  
pp. 132-140 ◽  
Author(s):  
Mitsumasa Kishimoto ◽  
Atsuo Taniguchi ◽  
Ayako Fujishige ◽  
Shuhei Kaneko ◽  
Sibylle Haemmerle ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Japanese Patients ◽  
Efficacy And Safety ◽  
Open Label ◽  
Phase 3 ◽  
Open Label Phase

scholarly journals A Cross Sectional Study on Loco-Regional Recurrences and Overall Survival Rate among Patients with Stage II (T2N0M0) Glottis Carcinoma Treated with Chemoradiation and Surgery

2021 ◽  
Vol 8 (04) ◽  
pp. 219-223
Author(s):  
Niharika Darasani
Keyword(s):  
Overall Survival ◽  
Survival Rate ◽  
Squamous Cell ◽  
Stage Ii ◽  
Overall Survival Rate ◽  
Disease Specific Survival ◽  
Free Survival ◽  
Tertiary Teaching ◽  
Voice Preservation ◽  
Disease Specific

BACKGROUND Single modality treatment for stage I and stage II squamous cell carcinomas of glottis region gave excellent results. Since a long time these are treated either with definitive radiation therapy or surgical excision with endoscopes. There was not much difference with regard to voice preservation, local recurrence and disease-free survival period. Our aim was to study the clinical presentation and management protocol of glottis carcinoma in a tertiary hospital and observe the final outcome of stage II (T2N0M0) glottis carcinoma and specific factor for survival in patients treated with surgery, radiotherapy and concurrent chemoradiation. METHODS 43 patients of glottis carcinoma stage II (T2N0M0) attending a tertiary teaching hospital between May 2015 and April 2017 were included in the study. Demography and smoking status of subjects were recorded. Staging of the disease was according to American Joint Committee on Cancer (AJCC) Staging System 7th edition. Paraglottic space infiltration was taken as a criteria to upgrade the staging. The overall survival rate, recurrence free survival, disease specific survival rate and laryngeal function preservation rate were calculated. RESULTS Out of 43 patients, males were 90.69 % and 09.30 % were females. Male to female ratio was 10.57 : 1. Mean age was 58.62 ± 2.35 years. 67.44 % were current smokers, 27.90 % were former smokers and 02.32 % were non-smokers. The overall survival scores and disease specific survival was 100 % with 11.62 % locoregional recurrences. The voice preservation was 86.04 %. Radiotherapy was used in 72.09 %, chemoradiation in 18.60 % patients and 11.62 % patients underwent surgery. 11.62 % patients presented with locoregional recurrence during 24 months of follow up. 02.32 % patients had to undergo tracheostomy. CONCLUSIONS The overall survival scores and disease specific survival were 100 % with 11.62 % loco-regional recurrence. Voice preservation was 86.04 %. Proactive prevention rather than escalation of treatment protocol gives better prognosis. KEYWORDS Glottis, Larynx, Supra Glottis, Sub Glottis, Squamous Cell Carcinoma, Chemo Radiation and Trans Oral Laryngeal Surgeries

scholarly journals Treatments for the early stage Hepatocellular Carcinoma: Laparoscopic Liver Resection or Percutaneous Radiofrequency, How to make the decision?

Liver Cancer ◽  
2021 ◽  
Author(s):  
Jinli Zheng ◽  
Wei Xie ◽  
Yunfeng Zhu ◽  
Li Jiang
Keyword(s):  
Hepatocellular Carcinoma ◽  
Overall Survival ◽  
Survival Rate ◽  
Liver Resection ◽  
Complication Rate ◽  
Early Stage ◽  
Line Treatment ◽  
Overall Survival Rate ◽  
First Line ◽  
First Line Treatment

Hepatectomy is still as the first-line treatment for the early stage HCC, but the complication rate is higher than p-RFA and the overall survival rate is comparable in these two treatments. Therefore, the patients with small single nodular HCCs could get more benefit from p-RFA, and we need to do further research about p-RFA.

scholarly journals Decreased Expression of KPNA2 in Hepatocellular Carcinoma Infers Favorable Prognosis and High Immune Infiltrating Level

2021 ◽  
Author(s):  
kangming zhu ◽  
yvndi zhang ◽  
hui yvan ◽  
jing li
Keyword(s):  
Hepatocellular Carcinoma ◽  
Overall Survival ◽  
Logistic Regression ◽  
Survival Rate ◽  
Western Blotting ◽  
Good Prognosis ◽  
Overall Survival Rate ◽  
Pathological Stage ◽  
Down Regulation ◽  
Immune Infiltration

Abstract BackgroundLiver hepatocellular carcinoma (LIHC) is an important pathological type of liver cancer. The immune infiltration of the tumor microenvironment is negatively correlated with the overall survival rate of LIHC. At present , the role and molecular mechanism of KPNA2 in LIHC have not been elucidated, and the prognostic correlation between the two and the immune infiltration of LIHC are still unclear. Our study evaluated the role of KPNA2 in LIHC through TCGA data.MethodGene expression profiling interactive analysis (GEPIA) is used to analyze the expression of KPNA2 in LIHC. We evaluated the impact of KPNA2 on the survival of LIHC patients through the survival module. Then, We downloaded the LIHC data set from TCGA. Logistic regression was used to analyze the correlation between clinical information and KPNA2 expression. Cox regression analysis was used to analyze the clinicopathological characteristics related to the overall survival rate of TCGA patients. In addition, we used the "correlation" modules of CIBERSORT and GEPIA to explore the correlation between KPNA2 and cancer immune infiltrate. Western blotting was used to detect the expression of KPNA2.ResultUsing logistic regression for univariate analysis, increased KPNA2 expression was significantly correlated with pathological stage, tumor status, and lymph node status. In addition, multivariate analysis showed that down-regulation of KPNA2 expression, negative pathological stage and distant metastasis are independent prognostic factors for good prognosis. Specifically, CIBERSORT analysis was used to establish a negative correlation between the up-regulated expression of KPNA2 and the level of immune infiltration of B cells, NK cells, mast cells, and T cells. In addition, we confirmed this in the "Association" module of GEPIA. The expression of KPNA2 in LIHC tissues was significantly lower than that in adjacent normal tissues by western blotting.ConclusionThe down-regulation of KPNA2 expression is associated with a good prognosis and an increase in the proportion of immune cells in LIHC. These conclusions indicate that KPNA2 is related to the level of immune infiltration of LIHC and can be used as a potential prognostic biomarker of LIHC and a potential target for clinical tumor treatment.

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