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Background/aim: There are no real-world comparative data of nivolumab doses of 3 mg/kg and 240 mg/body for recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). We investigated the efficacy and safety of nivolumab in treating recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) at different doses using real-world data., Patients and Methods: R/M SCCHN patients who received nivolumab were divided into the 3 mg/kg and 240 mg/body groups and retrospectively examined for efficacy and safety., Results: A total of 199 patients (3 mg/kg and 240 mg/body, 88 and 111 patients, respectively) were included. The 3 mg/kg vs. 240 mg/body groups had similar overall response rates (15% vs. 25, p=0.15), disease control rates (46% vs. 57%, p=0.15), overall survival (9.5 months vs. 10.9 months), and progression-free survival (3.7 months vs. 3.8 months, p=0.95). The incidence of immune-related adverse events was also similar in both groups., Conclusion: In R/M SCCHN patients, nivolumab showed similar efficacy and safety at doses of 3 mg/kg and 240 mg/body., (Copyright © 2022 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background: Resting 12-lead electrocardiography is widely used for the detection of cardiac diseases. Electrocardiogram readings have been reported to be affected by aging and, therefore, can predict patient mortality., Methods: A total of 12,837 patients without structural heart disease who underwent electrocardiography at baseline were identified in the Shinken Database among those registered between 2010 and 2017 (n = 19,170). Using 438 electrocardiography parameters, predictive models for all-cause death and cardiovascular (CV) death were developed by a support vector machine (SVM) algorithm., Results: During the observation period of 320.4 days, 55 all-cause deaths and 23 CV deaths were observed. In the SVM prediction model, the mean c-statistics of 10 cross-validation models with training and testing datasets were 0.881 ± 0.027 and 0.927 ± 0.101, respectively, for all-cause death and 0.862 ± 0.029 and 0.897 ± 0.069, respectively for CV death. For both all-cause and CV death, high values of permutation importance in the ECG parameters were concentrated in the QRS complex and ST-T segment., Conclusions: Parameters acquired from 12-lead resting electrocardiography could be applied to predict the all-cause and CV deaths of patients without structural heart disease. The ECG parameters that greatly contributed to the prediction were concentrated in the QRS complex and ST-T segment.

Background: Ischemic stroke (IS) and major bleeding, which are serious adverse events in patients with atrial fibrillation (AF), could have seasonal variations, but there are few reports., Methods and results: In the Shinken Database 2004-2016 (n=22,018), 3,581 AF patients (average age, 63.5 years; 2,656 men, 74.2%; 1,388 persistent AF, 38.8%) were identified. Median CHADS 2 and HAS-BLED scores were both 1 point. Oral anticoagulants were prescribed for 2,082 (58.1%) patients (warfarin, 1,214; direct oral anticoagulants [DOACs], 868). Incidence and observation period (maximum 3 years) of IS, extracranial hemorrhage (ECH), and intracranial hemorrhage (ICH) were counted separately for the northern hemisphere seasons. During the mean follow-up period of 2.4 years, there were totals of 90 IS, 73 ECH, and 33 ICH cases. The respective incidence rates per 1,000 patient-years in spring, summer, autumn, and winter were 8.5, 8.8, 7.5, and 16.8 for IS, 7.2, 9.7, 3.8, and 13.1 for ECH, and 2.7, 1.9, 3.8, and 7.0 for ICH. The number of patients with DOACs relatively increased among those with ECH in summer., Conclusions: Significant seasonal variations were observed for IS, ECH, and ICH events in AF patients, and were consistently the highest in winter. A small peak of ECH was observed in summer, which seemed, in part, to be related to increased DOAC use.

Background: In Japan, the recent status of the mortality of atrial fibrillation (AF) patients is still unclear., Methods and Results: We used a single-hospital based cohort database in an urban city (Tokyo) in Japan, including all the new visitors from 2004 to 2009 (n=13,228). The non-adjusted death rates of AF patients for all-cause, stroke, and cardiovascular death were 1091, 97, and 727 per 100,000 patient-years, and the age-adjusted ones were 317 (95% CI, 316-318), 16 (95% CI, 16-16), and 238 (95% CI, 237-239), respectively. The age-adjusted relative risk of AF on all-cause mortality was 1.7 in the particular population., Conclusions: The present study provides the most recent data about the characteristics and the mortality of AF patients in Tokyo, thus serving as the basic information for finding problems to solve regarding Japanese AF patients., (Copyright © 2011 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.)

Thrombocytopenia related to Helicobacter pylori infection is a definitive subset of chronic immune thrombocytopenic purpura (ITP) but its long-term prognosis has not been evaluated extensively. The possibility of recurrence of thrombocytopenia after re-infection of H. pylori is another concern. We evaluated 8-year follow-up data for 11 patients with ITP related to H. pylori infection in a single institution. In 2001, patients with chronic ITP were evaluated for H. pylori infection at the Tokyo Metropolitan Komagome Hospital using ¹³C urea breath test (UBIT). Nineteen patients turned out to be positive and were treated for H. pylori infection. Platelet count 6 months after treatment revealed complete response (CR) in 10 patients and response in one patient. Eight years later, 17 of these 19 patients were re-evaluated for H. pylori infection and platelet count. Platelet counts of the 11 previous responders remained to indicate CR. Two of 13 patients re-examined by UBIT showed positive results and one of these two patients continued to keep normal platelet count. Nonetheless, the prognosis of patients who responded to eradication was excellent.

Prognosis of patients with heart failure (HF) remains unclear in Japan and should be determined in a prospective fashion. A prospective cohort of The Shinken Database comprised details on all of the new patients, including both inpatients and outpatients, who visited The Cardiovascular Institute Hospital in 2004-2005. HF patients were defined as those with symptomatic HF coexisting with structural heart diseases. Among 4,255 patients who visited our hospital, 597 patients (male/female 414/183, age 65.1 +/- 12.9 years, LVEF 56.2 +/- 18.0%) were diagnosed as presenting symptomatic HF. Ischemic heart disease was present in 305 (51.1%), valvular heart disease in 212 (35.5%), dilated cardiomyopathy in 59 (9.9%), hypertrophic cardiomyopathy in 24 (4.0%), hypertensive heart disease in 14 (2.3%), and others in 67 (11.2%). Hypertension, atrial fibrillation, and diabetes were observed in 35.3%, 27.4%, and 23.7%, respectively. During the mean follow-up period of 539 +/- 257 days, 40 deaths (5.0% per year) occurred, including 34 cardiovascular deaths (4.5% per year, NYHA class II: 1.0%, III: 11.3%, IV: 36.6% per year, respectively). The present study showed that the prognosis of Japanese patients with HF among moderate to severe severity was found to be similar to that of Western countries. Multiple Cox hazard analysis identified the presence of chronic kidney disease and NYHA class as independent predictors for cardiovascular death. This prospective cohort study identified the prevalence, prognosis, and risk factors in HF patients to provide a basis for therapeutic management in Japan.