We held an interest group session at the 16th Annual Conference of the Japanese Primary Care Association to share best practices for diagnostic excellence in primary care. In addition to physicians, pharmacists and a medical clerk participated in the session. Participants provided examples of good practices for patient engagement and interprofessional collaboration during group discussion, which included themes such as "sharing diagnostic information," "safety netting to address diagnostic uncertainty," and "feedback about diagnostic errors."

Objective: This study analyzed the efficacy of add-on atezolizumab to standard first-line bevacizumab-containing therapy in 56 Japanese patients with metastatic and recurrent cervical cancer treated across 8 sites under the Japanese Gynecologic Oncology Group between October 2018 and August 2021 in the BEATcc trial. Methods: Patients were randomized to standard arm (standard therapy: cisplatin 50 mg/m 2or carboplatin area under the curve of 5, paclitaxel 175 mg/m 2 , and bevacizumab 15 mg/kg) or experimental arm (standard therapy with atezolizumab 1,200 mg). Results: Of 56 patients, 30 were in experimental arm vs. 26, standard arm (age: 53.2±12.9 vs.54.7±12.2 years). Median progression-free survival was 15.8 months (95% confidence interval [CI]=10.4–26.1) in experimental arm vs. 11.1 months (8.4–16.5) in standard arm (hazard ratio [HR]=0.51; 95% CI=0.26–1.01). Median overall survival was 34.1 months (23.2–38.6) in the experimental arm vs. 31.6 months (16.4–36.5), standard arm (HR=0.53; 95% CI=0.23–1.21). Objective: response rate was 86.7% in experimental arm vs. 84.6%, standard arm. Complete response and partial response, respectively, were 23.3% and 63.3% in experimental arm and 26.9% and 57.7% in standard arm. Grade ≥3 adverse events occurred in 80.0%, experimental arm and 88.5%, standard arm. Gastrointestinal/genitourinary fistula incidence was lower in Japanese patients (1 patient receiving atezolizumab), likely due to stricter inclusion criteria. Conclusion Overall, add-on atezolizumab enhances the efficacy of bevacizumab and chemotherapy in Japanese patients as those in overall BEATcc population and could be considered a new first-line treatment option for metastatic, persistent, or recurrent cervical cancer in Japan.

Objective: This multi-center retrospective study aimed to clarify the characteristics, diagnostic accuracy, treatment outcomes, and prognostic factors of uterine serous carcinoma (USC) in Japanese women. Methods: The medical records of 193 patients who were treated between 2006 and 2008 at 24 participating institutions in the Japanese Clinical Oncology Group were examined, and pathological slides of 188 patients were re-checked through central pathology review (CPR), hematoxylin-eosin staining, and immunohistochemistry. Results: USC was confirmed in 144 of the 188 (76.6%) patients using CPR, and only 50% were correctly diagnosed preoperatively. Forty-three patients were diagnosed with non-serous carcinoma, whereas one patient had metastasis from another organ. The average age was 65.7 years, and 19% of patients had a history of other cancers. The incidence of stage III–IV disease was 52.8%, and lymph node metastasis was found in 28.5% of patients. Extrauterine spread and distant metastasis occurred in 39% and 14% of patients, respectively. The 2-year overall survival and progression-free survival (PFS) rates were 56% and 42%, respectively. The PFS of patients with stage I and II who underwent complete staging surgery was 92.3%, and that of those without lymph node dissection or omentectomy was 33.3%. Patients with USC had a significantly worse prognosis than 43 patients with non-serous carcinoma. Conclusion USC in Japanese women has characteristics different from those of endometrioid carcinoma, worse prognosis, and is difficult to diagnose preoperatively. Complete surgical staging is necessary even for early-stage disease. Additionally, new adjuvant treatment strategies, including molecular targeted therapy, should be explored.

Background: The anti-programmed death 1 (PD-1) antibody has led to durable clinical responses in a wide variety of human tumors. We have previously developed the caninized anti-canine PD-1 antibody (ca-4F12-E6) and evaluated its therapeutic properties in dogs with advance-staged oral malignant melanoma (OMM), however, their therapeutic effects on other types of canine tumors remain unclear. Objective: The present clinical study was carried out to evaluate the safety profile and clinical efficacy of ca-4F12-E6 in dogs with advanced solid tumors except for OMM. Methods: Thirty-eight dogs with non-OMM solid tumors were enrolled prospectively and treated with ca-4F12-E6 at 3 mg/kg every 2 weeks of each 10-week treatment cycle. Adverse events (AEs) and treatment efficacy were graded based on the criteria established by the Veterinary Cooperative Oncology Group. Results: One dog was withdrawn, and thirty-seven dogs were evaluated for the safety and efficacy of ca-4F12-E6. Treatment-related AEs of any grade occurred in 13 out of 37 cases (35.1%).Two dogs with sterile nodular panniculitis and one with myasthenia gravis and hypothyroidism were suspected of immune-related AEs. In 30 out of 37 dogs that had target tumor lesions, the overall response and clinical benefit rates were 6.9% and 27.6%, respectively. The median progression-free survival and overall survival time were 70 days and 215 days, respectively. Conclusions The present study demonstrated that ca-4F12-E6 was well-tolerated in nonOMM dogs, with a small number of cases showing objective responses. This provides evidence supporting large-scale clinical trials of anti-PD-1 antibody therapy in dogs.

This document reports the results of a questionnaire survey conducted among pharmaceutical companies that are members of the Japan Pharmaceutical Manufacturers Association as part of a collaborative research project within the AMED Research on Regulatory Science of Pharmaceuticals and Medical Devices ‘Research for the promotion of the utilization of real-world evidence in the pharmaceutical regulatory system and the harmonization of international regulations, and for the proposal of an ideal system in Japan’ (Principal Investigator： Harumasa Nakamura, National Center of Neurology and Psychiatry). This survey is the first domestic attempt to clarify the current state of development and utilization of data for companion applications (CPs) in pharmaceuticals. It is expected that the widespread development and use of pharmaceutical CPs will enhance the collection of patient-reported outcomes (PROs), which in turn will foster the utilization of real-world data (RWD) under pharmaceutical regulations. In anticipation that the results of this survey will contribute to this promotion, we are publishing the entire questionnaire results in this report.

This document reports the results of a questionnaire survey conducted among pharmaceutical companies that are members of the Japan Pharmaceutical Manufacturers Association as part of a collaborative research project within the AMED Research on Regulatory Science of Pharmaceuticals and Medical Devices ‘Research for the promotion of the utilization of real-world evidence in the pharmaceutical regulatory system and the harmonization of international regulations, and for the proposal of an ideal system in Japan’ (Principal Investigator： Harumasa Nakamura, National Center of Neurology and Psychiatry). This survey is the first domestic attempt to clarify the current state of development and utilization of data for companion applications (CPs) in pharmaceuticals. It is expected that the widespread development and use of pharmaceutical CPs will enhance the collection of patient-reported outcomes (PROs), which in turn will foster the utilization of real-world data (RWD) under pharmaceutical regulations. In anticipation that the results of this survey will contribute to this promotion, we are publishing the entire questionnaire results in this report.

A 77-year-old woman underwent endovascular abdominal aortic repair (EVAR) for an abdominal aortic aneurysm (AAA)．Five years after surgery, she visited the hospital with the chief complaint of a fever. Enhanced computed tomography (CT) showed enlargement of the AAA around the stent-graft and a mass, which was suspected to be an abscess, outside the aneurysm. A blood test revealed a high level of inflammatory response. The patient was diagnosed with infectious AAA. She received antibiotics; however, the inflammatory response did not completely improve. A second CT scan revealed that the suspected abscess had a spreading tendency. The patient was referred to our hospital for a highly suspected stent-graft infection. We performed Y-graft replacement using a rifampicin-immersed graft, and as much as possible of the wall around the aortic aneurysm was removed. The inflammatory response improved rapidly after the operation, and the patient was discharged 15 days later. According to the results of a pathological examination, a diagnosis of xanthogranulomatous inflammation and fibrosis was made. Here, we report a rare case of xanthogranulomatous inflammation of the aortic aneurysm wall after EVAR.

Objective: Histological verification of epithelioid cell granuloma is important in diagnosing sarcoidosis; tissue sampling is a worldwide requirement. In 2006, to reduce medical expenses and avoid invasive procedures, diagnostic criteria without histological verification were permitted by the Japanese government. In 2015, new diagnostic criteria, allowed clinical diagnoses based on only respiratory, ocular, and cardiac systems with at least a two-system involvement, increasing the need to sample tissue from clinically unevaluable organs in suspected sarcoidosis. This study aimed to compare the characteristics of patients who were diagnosed with sarcoidosis according to the 2006 and 2015 criteria.Materials and Methods: Using the 2015 version, we re-evaluated the characteristics of 264 patients with diagnosed or suspected sarcoidosis according to the 2006 criteria, at Jichi Medical University Hospital between 2004 and 2012 (clinical diagnosis, 84; histological diagnosis, 117; suspected sarcoidosis 63).Results: Thirty-nine patients were diagnosed with suspected sarcoidosis due to the absence of at least a two-system involvement; two patients had insufficient laboratory data suggestive of sarcoidosis. Six patients moved from suspected sarcoidosis to a histological diagnosis because of a greater leniency in the criteria for supportive findings. The 2015 diagnostic criteria excluded patients with organ involvement without a requirement for systemic steroids from the clinical diagnosis group. A case of schwannoma, erroneously placed in the clinical diagnosis group by the 2006 criteria, was reclassified according to the 2015 criteria.Conclusion: The 2015 version is preferable for clinically diagnosing sarcoidosis, even without histological specimens, and provides guidance for indications for systemic treatment.

BACKGROUND: Estimates of daily sodium (Na) and potassium (K) excretion were explicitly biased when using equations for adults. We aimed to develop equations to estimate them using overnight urine from Japanese children and adolescents. METHODS: The subjects comprised 70 students aged 10.49-15.76 years: validation group, n = 34; and verification group, n = 36. Each subject performed two operations of overnight spot urine (U RESULTS: In validation, we formulated Na excretion (mg d CONCLUSION We obtained validated equations to estimate daily Na and K excretion with accessible variables such as Na, K, and Cr concentrations of overnight urine, body height and weight, and age for children and adolescents. When using the obtained equations, caution should be paid to small but definite biases and measurement errors.
Adolescent ; Child ; Creatinine/urine* ; Female ; Humans ; Japan ; Male ; Potassium/urine* ; Sodium/urine*

PURPOSE: The difficulty of femoral preparation with supine-position hip hemi-arthroplasty (HA) often leads to intra-operative fractures (IOFs). We aimed to clarify the incidence and types of IOFs in HA for hip fractures performed in the supine and lateral positions. MATERIALS AND METHODS: We retrospectively investigated cases of HA for acute femoral neck fractures from June 2013 to May 2018. We examined the incidence and types of IOFs according to different approaches. We defined supine-position in HA as the supine and hip-hyperextended (over-range) femoral preparation position, and lateral position as the lateral and hip-flexed femoral preparation position. We used a short tapered wedged stem. RESULTS: Supine-position HA was used in 46 patients (23.7%) and lateral-position HA in 148 patients (76.3%). IOFs in supine-position HA occurred in 8 patients (17.4%) and included five Vancouver AGT and three Vancouver B2 fractures. IOFs in lateral-position HA occurred in 3 patients (2.0%) and included one Vancouver AGT and two Vancouver B fractures. Supine-position HA was a risk factor for IOFs (adjusted odds ratio, 9.71; 95% confidence interval, 2.37–39.8; P < 0.01) CONCLUSION: Supine-position in HA is an IOF risk factor and significantly increases the incidence of great trochanter fractures of Vancouver type A.
Arthroplasty, Replacement, Hip ; Femoral Neck Fractures ; Femur ; Hemiarthroplasty ; Hip Fractures ; Hip ; Humans ; Incidence ; Minimally Invasive Surgical Procedures ; Odds Ratio ; Periprosthetic Fractures ; Retrospective Studies ; Risk Factors