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  • 1
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    Features and Outcomes of Histologically Proven Myocarditis With Fulminant Presentation
    Ovid Technologies (Wolters Kluwer Health) ; 2022
    In:  Circulation Vol. 146, No. 19 ( 2022-11-08), p. 1425-1433
    Details
    In: Circulation, Ovid Technologies (Wolters Kluwer Health), Vol. 146, No. 19 ( 2022-11-08), p. 1425-1433
    Abstract: Fulminant myocarditis presentation (FMP) is a rare and severe presentation of myocarditis. The natural history of FMP and its clinical features associated with poor outcomes are incompletely understood because there is a lack of generalizable evidence. Methods: This multicenter retrospective cohort study included patients hospitalized with histologically proven myocarditis who underwent catecholamine or mechanical support from 235 cardiovascular training hospitals across Japan between April 2012 and March 2017. Clinical features and the prognostic predictors of death or heart transplantation within 90 days on the basis of clinical and pathologic findings were determined using the Kaplan-Meier method, log-rank test, and Cox regression analysis. Results: This study included 344 patients with histologically proven FMP (median age, 54 years; 40% female). The median follow-up was 600 days (interquartile range, 36 to 1599 days) and the cumulative risk of death or heart transplantation at 90 days was 29% (n=98). Results from multivariable Cox regression analysis showed that older age, nonsinus rhythm, low left ventricular wall motion ( 〈 40%) on admission, and ventricular tachycardia or fibrillation on admission day were associated with worse 90-day survival. Severe histologic damage (damaged cardiomyocytes comprising ≥50% of the total cardiomyocytes) was associated with a worse 90-day prognosis in patients with lymphocytic myocarditis. Conclusions: The results from analyses of data from this multicenter registry demonstrated that patients with FMP are at a higher risk of death or heart transplantation in real-world settings. These observations inform which clinical and pathologic findings may be useful for prognostication in FMP. Registration: URL: https://www.umin.ac.jp/ctr ; Unique identifier: UMIN000039763.
    Type of Medium: Online Resource
    ISSN: 0009-7322 , 1524-4539
    URL: Article
    DOI: 10.1161/CIRCULATIONAHA.121.058869
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2022
    detail.hit.zdb_id: 1466401-X
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  • 2
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    Tumor response of FOLFOXIRI plus cetuximab versus bevacizumab in RAS wild-type metastatic colorectal cancer: The subgroup-analysis of DEEPER trial (JACCRO CC-13).
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 4_suppl ( 2022-02-01), p. 109-109
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 4_suppl ( 2022-02-01), p. 109-109
    Abstract: 109 Background: Triplet regimen, FOLFOXIRI, combined with bevacizumab (bev) or panitumumab has been shown to be superior in terms of early tumor shrinkage and depth of response (DpR) compared to doublet combinations in patients with RAS wild-type metastatic colorectal cancer (mCRC). We performed a randomized phase II study, DEEPER trial (JACCRO CC-13)[NCT02515734], to investigate the efficacy and safety of cetuximab (cet) vs. bevacizumab (bev) in combination with modified (m)-FOLFOXIRI (irinotecan 150 mg/m 2 , oxaliplatin 85 mg/m 2 , 5-FU 2400 mg/m 2 ) in previously untreated mCRC patients with RAS wild-type tumors (Tsuji A, et al. ASCO 2021). Methods: The primary endpoint was DpR during the entire course. Secondary endpoints included overall response rate (ORR), disease control rate, R0 resection rate, progression-free survival, and overall survival. A post-hoc subgroup analysis by PS, tumor sidedness, age, and location of metastases was performed to evaluate the efficacy of triplet plus cet vs. bev regimen. Results: A total of 359 patients were enrolled between July 2015 and June 2019. For the full analysis set (median age 65y, 64% male, PS0/1: 91%/9%, left/right primary: 83%/17%), 173 and 175 patients were randomly assigned to the cet and bev arms, respectively. Median DpR was 57.4% vs. 46.0% ( p = 0.001), and the ORR was 69.1% vs. 71.7% ( p = 0.60), in cet vs. bev, respectively. The subgroup analysis was present in the table. There was no significant difference in terms of ORR and R0 resection rate between groups according to PS, tumor sidedness, age, and liver metastases (LM). In patients with only LM, the R0 resection rate of cet vs. bev was 25.0% vs. 14.8% ( p = 0.21). Conclusions: The m-FOLFOXIRI plus cet showed to be significantly superior to the m-FOLFOXIRI plus bev in terms of DpR in first-line treatment for RAS wild-type mCRC. The better DpR of m-FOLFOXIRI plus cet was evident for RAS wild-type mCRC patients with left-sided tumors, LM or under 70 years old. Clinical trial information: UMIN000018217.[Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.4_suppl.109
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
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  • 3
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    Real-World Data of Trastuzumab Deruxtecan for Advanced Gastric Cancer: A Multi-Institutional Retrospective Study
    MDPI AG ; 2022
    In:  Journal of Clinical Medicine Vol. 11, No. 8 ( 2022-04-17), p. 2247-
    Details
    In: Journal of Clinical Medicine, MDPI AG, Vol. 11, No. 8 ( 2022-04-17), p. 2247-
    Abstract: Trastuzumab deruxtecan (T-DXd) has shown promising efficacy against HER2-positive advanced gastric cancer (AGC). However, data on its real-world efficacy in AGC patients are insufficient, and the predictive marker of T-DXd is unclear. In this multi-center retrospective study, we collected clinical information of 18 patients with HER2-positive AGC who received T-DXd after intolerant or refractory responses to at least two prior regimens and analyzed predictive factors. The median age was 71 years (range: 51–85), 13 men were included, and ECOG performance status (PS): 0/1/2/3 was 9/6/2/1. A total of 11 patients (61%) received prior immune checkpoint inhibitors (ICIs), 14 patients were HER2 3+, and 4 patients were HER2 2+/FISH positive. The median trastuzumab (Tmab)-free interval was 7.7 months (range: 2.8–28.6). The overall response rate was 41%, and the disease control rate was 76%. Median progression-free survival (PFS) was 3.9 months (95% CI: 2.6–6.5), and median overall survival (OS) was 6.1 months (95% CI: 3.7–9.4). PFS (6.5 vs. 2.9 months, p = 0.0292) and OS (9.2 vs. 3.7 months, p = 0.0819) were longer in patients who received prior ICIs than in those who had not. PFS (6.5 vs. 3.4 months, p = 0.0249) and OS (9.4 vs. 5.7 months, p = 0.0426) were longer in patients with an 8 month or longer Tmab-free interval. In patients with ascites, PFS (6.5 vs. 2.75 months, p = 0.0139) and OS (9.4 vs. 3.9 months, p = 0.0460) were shorter. T-DXd showed promising efficacy in HER2-positive AGC patients in a real-world setting. Pre-administration of ICIs and a sufficient Tmab-free interval may be predictive factors of T-DXd efficacy.
    Type of Medium: Online Resource
    ISSN: 2077-0383
    URL: Article
    DOI: 10.3390/jcm11082247
    Language: English
    Publisher: MDPI AG
    Publication Date: 2022
    detail.hit.zdb_id: 2662592-1
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  • 4
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    Improvement of Body Weight and Nutritional Status in Gastric Cancer Patients Enhances the Benefit of Nivolumab Therapy
    MDPI AG ; 2022
    In:  Journal of Clinical Medicine Vol. 11, No. 20 ( 2022-10-17), p. 6100-
    Details
    In: Journal of Clinical Medicine, MDPI AG, Vol. 11, No. 20 ( 2022-10-17), p. 6100-
    Abstract: Nivolumab improves overall survival (OS) in patients with advanced gastric cancer (AGC) refractory to at least two previous chemotherapy regimens. We investigated whether changes in body weight and nutrition from first-line chemotherapy to nivolumab affected its efficacy. The correlation between weight change and nutritional status up to the start of nivolumab treatment and OS and progression-free survival (PFS) after starting nivolumab treatment was determined. Nutritional status was examined using the C-reactive protein/albumin ratio (CAR). A loss in body weight (LBW) from the onset of the first treatment of 〈 4.5% led to OS prolongation and improved PFS outcomes. The median OS values in the LBW 〈 4.5% and ≥4.5% groups were 11.4 and 3.6 months, respectively. Similarly, changes in CAR from first-line chemotherapy (ΔCAR) affected OS; the ΔCAR 〈 0.01 group had a better prognosis than the ΔCAR ≥ 0.01 group. The median OS values in the ΔCAR 〈 0.01 and ≥0.01 groups were 9.4 and 4.5 months, respectively. The median OS in the group with LBW 〈 4.5% and ΔCAR 〈 0.01 was 12.9 months. LBW and deterioration of nutritional status following first-line chemotherapy are poor prognostic factors in AGC patients who received nivolumab as third- or later-line therapy. Early intervention to maintain body weight and nutritional status may improve the efficacy of immune checkpoint inhibitors.
    Type of Medium: Online Resource
    ISSN: 2077-0383
    URL: Article
    DOI: 10.3390/jcm11206100
    Language: English
    Publisher: MDPI AG
    Publication Date: 2022
    detail.hit.zdb_id: 2662592-1
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  • 5
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    A Multi-Center, Open-Label, Randomized Controlled Trial to Evaluate the Efficacy of Convalescent Plasma Therapy for Coronavirus Disease 2019: A Trial Protocol (COVIPLA-RCT)
    MDPI AG ; 2022
    In:  Life Vol. 12, No. 6 ( 2022-06-08), p. 856-
    Details
    In: Life, MDPI AG, Vol. 12, No. 6 ( 2022-06-08), p. 856-
    Abstract: Background: Coronavirus disease 2019 is a global public health concern. As of December 2020, the therapeutic agents approved for coronavirus disease 2019 in Japan were limited to two drugs: remdesivir, an antiviral drug, granted a Special Approval for Emergency on 7 May 2020, and dexamethasone, which has an anti-inflammatory effect. The aim of this study is to evaluate the efficacy of convalescent plasma collected from donors who recovered from coronavirus disease 2019. Methods: This is an open-label, randomized controlled trial comprising two groups: a convalescent plasma and a standard-of-care group. Plasma administered to patients with coronavirus disease 2019 randomized in the convalescent plasma group of this trial will be plasma that has been collected and stored in an associated study. Patients with a diagnosis of mild coronavirus disease 2019 will be included in this trial. The efficacy of convalescent plasma transfusion will be evaluated by comparing the convalescent plasma group to the standard-of-care group (without convalescent plasma transfusion) with respect to changes in the viral load and other measures. The primary endpoint will be time-weighted average changes in the SARS-CoV-2 virus load in nasopharyngeal swabs from day 0 to days 3 and 5. It is hypothesized that the intervention should result in a decrease in the viral load in the convalescent plasma group until day 5. This endpoint has been used as a change in viral load has and been used as an index of therapeutic effect in several previous studies. Discussion: The proposed trial has the potential to prevent patients with mild COVID-19 from developing a more severe illness. Several RCTs of convalescent plasma therapy have already been conducted in countries outside of Japan, but no conclusion has been reached with respect to the efficacy of convalescent plasma therapy, which is likely in part because of the heterogeneity of the types of target patients, interventions, and endpoints among trials. Actually, previous clinical trials on plasma therapy have shown inconsistent efficacy and are sometimes ineffective in COVID-19 patients with severe disease, which is due to unmeasured neutralizing antibody titer in the COVID-19 convalescent plasma. To improve this issue, in this study, we measure neutralizing activity of convalescent plasma before administration and provide the plasma with high neutralizing activity to the subjects. It is hoped that this study will further evidence to support the role of convalescent plasma therapy in COVID-19.
    Type of Medium: Online Resource
    ISSN: 2075-1729
    URL: Article
    DOI: 10.3390/life12060856
    Language: English
    Publisher: MDPI AG
    Publication Date: 2022
    detail.hit.zdb_id: 2662250-6
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  • 6
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    Residual effects of low dose of suvorexant, zolpidem, and ramelteon in healthy elderly subjects: A randomized double‐blind study
    Wiley ; 2022
    In:  Neuropsychopharmacology Reports Vol. 42, No. 3 ( 2022-09), p. 288-298
    Details
    In: Neuropsychopharmacology Reports, Wiley, Vol. 42, No. 3 ( 2022-09), p. 288-298
    Abstract: Current hypnotic agents have next‐day residual effects. The new orexin antagonist, suvorexant, has little muscle relaxation effect on the physical and cognitive function in the following morning and daytime. In this study, the effects of suvorexant, zolpidem, ramelteon and placebo in elderly subjects were evaluated. Methods Six men and eight women aged 63–75 years received a single tablet and lights were then turned off. Subjects were instructed to sleep from 23:00–6:00 with an interruption from 4:00–4:30 for evaluations. Suvorexant 10 mg, zolpidem 5 mg, ramelteon 4 mg or placebo was administered single time in a randomized, double‐blind and crossover design with a one‐week drug holiday in between each drug. Measures of objective parameters and subjective ratings were obtained every 2 h from 4:00 to 16:00. Result No subjects showed serious side effects from physical observations and vital sign checks before and after hypnotics were taken. During the first sleep period, the REM sleep time with suvorexant was especially longer than that with zolpidem. During the second sleep period, suvorexant had shorter sleep latency and longer stage2 sleep time than ramelteon and zolpidem, respectively. During the whole entire sleep, the REM sleep time with suvorexant was longer than zolpidem and placebo. For the body sway test with closed eye, the main effects of the medicines and zolpidem were significantly better than suvorexant and ramelteon. Conclusion The changes of physical and cognitive functions in healthy elderly after taking hypnotics were not remarkable. Therefore, these three hypnotics maybe appropriate for the elderly people with insomnia for single‐time low dose administration.
    Type of Medium: Online Resource
    ISSN: 2574-173X , 2574-173X
    URL: Article
    DOI: 10.1002/npr2.12262
    Language: English
    Publisher: Wiley
    Publication Date: 2022
    detail.hit.zdb_id: 2942336-3
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  • 7
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    The contribution and potential of older blood donors in Asia Pacific regions
    Wiley ; 2022
    In:  Transfusion Medicine Vol. 32, No. 1 ( 2022-02), p. 71-76
    Details
    In: Transfusion Medicine, Wiley, Vol. 32, No. 1 ( 2022-02), p. 71-76
    Abstract: To investigate the blood supply contribution of older donors in five Asia Pacific regions. Background Older people are often the largest blood user group. Thus, as the population ages blood supply needs increase. Minimum and maximum donation age criteria potentially constrain the size of the donor pool. Materials and methods Haemoglobin values and demographic frequency analytics (sex, age and blood type) were analysed on blood donors aged 60 years or more, from Hong Kong, Indonesia, Japan, Singapore and South Korea over 12 months. Results Data on  434357 donations was analysed. ABO Rh(D) frequencies of older donors matched that of national frequencies. Older donors were a disproportionately smaller proportion of the total donor pool for each country. Indonesia was the only region with no maximum age limit. Median haemoglobin for older males ranged from 14.2 to 14.8 g/dl and for females 13.1 to 13.9 g/dl. The frequency of female donors was between 15% and 33% of older donors. Older donors had higher donation frequency and lower deferral rates. Conclusion Older donors are loyal and regular donors but under‐represented in all regions studied. They could help meet future blood supply needs, especially post‐menopausal female donors. Studies including ferritin levels are needed to determine if upper age limits can be safely modified.
    Type of Medium: Online Resource
    ISSN: 0958-7578 , 1365-3148
    URL: Issue
    URL: Article
    DOI: 10.1111/tme.v32.1
    DOI: 10.1111/tme.12845
    Language: English
    Publisher: Wiley
    Publication Date: 2022
    detail.hit.zdb_id: 2010901-5
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  • 8
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    Shock Recovery With Decaying Compressive Pulses: Shock Effects in Calcite (CaCO 3 ) Around the Hugoniot Elastic Limit
    American Geophysical Union (AGU) ; 2022
    In:  Journal of Geophysical Research: Planets Vol. 127, No. 6 ( 2022-06)
    Details
    In: Journal of Geophysical Research: Planets, American Geophysical Union (AGU), Vol. 127, No. 6 ( 2022-06)
    Abstract: We present a method to efficiently investigate the shock effects in minerals in rock samples with sizes of 〉 20 mm Impact experiments with decaying compressive pulses revealed the shock effects in marble, which is a macro block of calcite (CaCO 3 ) Calcite that experiences compression of 〉 3 GPa exhibits undulatory extinction
    Type of Medium: Online Resource
    ISSN: 2169-9097 , 2169-9100
    URL: Article
    DOI: 10.1029/2021JE007133
    Language: English
    Publisher: American Geophysical Union (AGU)
    Publication Date: 2022
    detail.hit.zdb_id: 1086497-0
    detail.hit.zdb_id: 3094268-8
    detail.hit.zdb_id: 2016810-X
    SSG: 16,13
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  • 9
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    P20-2 Observational study to evaluate RAS status in ctDNA for mCRC patients with RAS mutant tumor: RASMEX study (JACCRO CC-17)
    Elsevier BV ; 2022
    In:  Annals of Oncology Vol. 33 ( 2022-07), p. S519-
    Details
    In: Annals of Oncology, Elsevier BV, Vol. 33 ( 2022-07), p. S519-
    Type of Medium: Online Resource
    ISSN: 0923-7534
    URL: Article
    DOI: 10.1016/j.annonc.2022.05.257
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2022
    detail.hit.zdb_id: 2003498-2
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  • 10
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    Prognostic impact of CEBPA bZIP domain mutation in acute myeloid leukemia
    American Society of Hematology ; 2022
    In:  Blood Advances Vol. 6, No. 1 ( 2022-01-11), p. 238-247
    Details
    In: Blood Advances, American Society of Hematology, Vol. 6, No. 1 ( 2022-01-11), p. 238-247
    Abstract: Mutations of CCAAT/enhancer–binding protein alpha (CEBPAmu) are found in 10% to 15% of de novo acute myeloid leukemia (AML) cases. Double-mutated CEBPA (CEBPAdm) is associated with a favorable prognosis; however, single-mutated CEBPA (CEBPAsm) does not seem to improve prognosis. We investigated CEBPAmu for prognosis in 1028 patients with AML, registered in the Multi-center Collaborative Program for Gene Sequencing of Japanese AML. It was found that CEBPAmu in the basic leucine zipper domain (bZIP) was strongly associated with a favorable prognosis, but CEBPAmu out of the bZIP domain was not. The presence of CEBPAmu in bZIP was a strong indicator of a higher chance of achieving complete remission (P & lt; .001), better overall survival (OS; P & lt; .001) and a lower risk of relapse (P & lt; .001). The prognostic significance of CEBPAmu in bZIP was also observed in the subgroup with CEBPAsm (all patients: OS, P = .008; the cumulative incidence of relapse, P = .063; patients aged ≤70 years and with intermediate-risk karyotype: OS, P = .008; cumulative incidence of relapse, P = .026). Multivariate analysis of 744 patients aged ≤70 years showed that CEBPAmu in bZIP was the most potent predictor of OS (hazard ratio, 0.3287; P & lt; .001). CEBPAdm was validated as a cofounding factor, which was overlapping with CEBPAmu in bZIP. In summary, these findings indicate that CEBPAmu in bZIP is a potent marker for AML prognosis. It holds potential in the refinement of treatment stratification and the development of targeted therapeutic approaches in CEBPA-mutated AML.
    Type of Medium: Online Resource
    ISSN: 2473-9529 , 2473-9537
    URL: Article
    DOI: 10.1182/bloodadvances.2021004292
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2022
    detail.hit.zdb_id: 2876449-3
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