Safety evaluation of immune-cell therapy for malignant tumor in the Cancer Immune-cell Therapy Evaluation Group (CITEG).

BACKGROUND AIMS: With the aim of strengthening the scientific evidence of immune-cell therapy for cancer and further examining its safety, in October 2015, our hospital jointly established the Cancer Immune-Cell Therapy Evaluation Group (CITEG) with 39 medical facilities nationwide. METHODS: Medical information, such as patients' background characteristics, clinical efficacy and therapeutic cell types obtained from each facility, has been accumulated, analyzed and evaluated by CITEG. In this prospective study, we analyzed the adverse events associated with immune-cell therapy until the end of September 2022, and we presented our interim safety evaluation. RESULTS: A total of 3839 patients with malignant tumor were treated with immune-cell therapy, with a median age of 64 years (range, 13-97 years) and a male-to-female ratio of 1:1.08 (1846:1993). Most patients' performance status was 0 or 1 (86.8%) at the first visit, and 3234 cases (84.2%) were advanced or recurrent cases, which accounted for the majority. The total number of administrations reported in CITEG was 31890, of which 960 (3.0%) showed adverse events. The numbers of adverse events caused by treatment were 363 (1.8%) of 19661 administrations of αßT cell therapy, 9 of 845 administrations of γδT-cell therapy (1.1%) and 10 of 626 administrations of natural killer cell therapy (1.6%). The number of adverse events caused by dendritic cell (DC) vaccine therapy was 578 of 10748 administrations (5.4%), which was significantly larger than those for other treatments. Multivariate analysis revealed that αßT cell therapy had a significantly greater risk of adverse events at performance status 1 or higher, and patients younger than 64 years, women or adjuvant immune-cell therapy had a greater risk of adverse events in DC vaccine therapy. Injection-site reactions were the most frequently reported adverse events, with 449 events, the majority of which were associated with DC vaccine therapy. Among all other adverse events, fever (228 events), fatigue (141 events) and itching (131 events) were frequently reported. In contrast, three patients had adverse events (fever, abdominal pain and interstitial pneumonia) that required hospitalization, although they were weakly related to this therapy; rather, it was considered to be the effect of treatment for the primary disease. CONCLUSIONS: Immune-cell therapy for cancer was considered to be a safe treatment without serious adverse events.

Measuring system for an attitude angle of a denture using an Inertial Measurement Unit.

PURPOSE: The aim of this study was to assemble and verify a measuring system for 3-D movements (attitude angle) of the denture during function. METHODS: For the calibration test, the sensor was fixed at the center of the rotary table. Operation and stopping of the rotary table were repeated 8 times, and the direction of rotation was reversed in the middle. The amount of rotation was 1.2 and 2.4°. As a pilot clinical trial, the attitude angles of three upper complete dentures during tapping were measured by this system. RESULTS: The attitude angles calculated by this system reduced by 3-4%. Pitch and roll of Subject III were significantly larger than Subjects I and II (P<0.001), but yaw of Subject: III was significantly smaller than Subject: II (P<0.01) during tapping. Pitch and yaw of "good" was significantly smaller than "average" in the stability of the dentures (P<0.001). But roll of "average" was significantly smaller than "good" (P<0.05). Pitch and yaw of "B" was significantly smaller than "C" in the type of maxillary ridge (P<0.001). But roll of "C" was significantly smaller than "B" (P<0.05). CONCLUSIONS: The measurement accuracy of this system was equivalent to that of 3-D motion capture system by four infrared TV cameras. The measuring system using the IMU is reliable and easy to analyze the attitude angle of the denture during function. It may serve a diagnostic appliance to evaluate the quality of the denture.

Screening test for silent aspiration at the bedside.

Many screening tests for dysphagia can be given at bedside. However, they cannot accurately screen for silent aspiration (SA). We studied the usefulness of a cough test to screen for SA and combined it with the modified water swallowing test (MWST) to make an accurate screening system. Patients suspected of dysphagia (N = 204) were administered a cough test and underwent videofluorography (VF) or videoendoscopy (VE). Sensitivity of the cough test for detection of SA was 0.87 with specificity of 0.89. Of these 204 patients, 107 were also administered the MWST. Fifty-five were evaluated as normal by the screening system, 49 of whom were evaluated as normal by VF or VE. Sixteen were evaluated as "SA suspected" by the screening system; seven of them were normal, and seven were evaluated as having SA by VF or VE. Nineteen were evaluated as aspirating with cough, 14 of whom had aspiration with cough as shown by VF or VE. Seventeen were evaluated as having SA, 15 of whom had SA shown by VF or VE. The cough test was useful in screening for SA. Moreover, a screening system that included MWST and a cough test could accurately distinguish between the healthy who were safe in swallowing and SA patients who were unsafe.

Cranial computed tomography associated with development of functional dependence in a community-based elderly population.

OBJECTIVE: To investigate whether changes at computed tomography (CT) imaging in the ageing brain are associated with future risks for functional dependence. SUBJECTS: 160 residents aged 69 years and older at the cranial CT and were independently living in a rural community in Hokkaido, Japan. METHODS: Cranial CT was performed between 1991 and 1993, graded for ventricular enlargement, sulcal enlargement, white matter change, and small infarction. Functional status was reassessed in 1998 in each participant. Multiple logistic regression analysis was performed to estimate the association of CT changes in the ageing brain with development of functional dependence over six years. RESULTS: Functional dependence was found in 19 residents at the second survey. After adjusting for age, sex, medical conditions, and cognitive functioning, small infarction and ventricular enlargement were significantly associated with development of functional dependence (adjusted odds ratio = 9.27 and 4.62). CONCLUSIONS: After controlling for age, the age-related changes on cranial CT have significant association on development of functional dependence.