Promoting health and productivity management in small companies through outreach-based public-private partnership: the Yokohama Linkworker Project.

Introduction: With health promotion initiatives in small companies lagging behind those in larger corporations, strengthening health and productivity management in small companies through innovative strategies is an urgent priority. We hypothesized that an outreach strategy involving a public-private partnership would be beneficial for this purpose. The present study examines the implementation of a public-private partnership strategy in Yokohama City, Japan, assessing its impact on health and productivity management in small enterprises, focusing on implementation outcomes. Methods: As part of the Yokohama Linkworker Project (Y-Link Project), this study describes and examines a public-private partnership program in Yokohama City, Japan, involving the city's government and a private life insurance company. Trained insurance sales representatives served as "Linkworkers" for the program, reaching out to small enterprises in the city. These Linkworkers provided tailored support to these companies, assisting them with obtaining the "Yokohama Health and Productivity Management Certification" issued by the City of Yokohama authorities and collaborating with external entities to offer health promotion programs for employees. Program interventions took place from August to September 2020. The RE-AIM framework was utilized to evaluate the Project. Data were extracted from Linkworkers' activity records, certification records, the Linkworker survey, and follow-up surveys with participating companies at 6- and 18- months post-interventions. Results: Within 2 months, 71 Linkworkers visited 500 companies (50% were small firms, <50 employees). Among them, 224 (45%) enterprises received certifications, contributing to an increased regional certification rate. Linkworker-assisted companies tended to be significantly smaller in size. The odds ratios of implementing workplace health promotion programs in certified firms, compared to non-certified firms, were 4.09 (95% CI: 1.79-9.35) at 6 months and 2.31 (95% CI: 1.04-5.11) at 18 months. For small firms, the odds ratios were 6.87 (95% CI: 1.74-27.06) at 6 months and 3.42 (95% CI: 1.17-10.03) at 18 months. The certification retention rate at 24 months was 60%, irrespective of company size. Linkworkers perceived the outreach strategy as having a positive impact on their primary operations. Conclusion: The Y-Link Project's outreach strategy enhanced health and productivity management in small enterprises in Yokohama City, enabling long-term health promotion programs addressing program availability disparities related to company size.

Phase 1 study of darolutamide (ODM-201): a new-generation androgen receptor antagonist, in Japanese patients with metastatic castration-resistant prostate cancer.

PURPOSE: This trial assessed the safety, pharmacokinetics, and efficacy of darolutamide (ODM-201), a new-generation nonsteroidal androgen receptor antagonist, in Japanese patients with metastatic castration-resistant prostate cancer (mCRPC). METHODS: In this open-label, nonrandomized, two-cohort, dose-escalating phase 1 study, Japanese patients with mCRPC were enrolled after a screening period. In the single-dose period (≈1 week), darolutamide was administered at 300 mg (Cohort 1) or 600 mg (Cohort 2) on day -5 (fasting state) and day -2 (fed condition). In the subsequent multiple-dose period (fed condition), patients received darolutamide 300 mg twice daily (Cohort 1) or 600 mg twice daily (Cohort 2) for 12 weeks. Primary endpoints: evaluate safety and pharmacokinetics of darolutamide. RESULTS: Of 12 patients enrolled, 9 received darolutamide (Cohort 1, n = 3; Cohort 2, n = 6). All 9 patients experienced ≥1 treatment-emergent adverse event (TEAE; majority Grade 1/2). Incidence of drug-related TEAEs (DR-TEAEs) was 44% (all grades; n = 4); most common DR-TEAE was decreased appetite (22%), and 1 serious DR-TEAE (Grade 3 nausea) was observed. No Grade ≥4 DR-TEAEs or new safety signals were observed. C max and AUC (0-t last) were dose-dependent; pharmacokinetics of each dose appeared to be linear over time. Prostate-specific antigen response was observed in 11% (1/9) of patients. Compared with fasting status, geometric mean C max increased 2.5-fold after 300 mg and 2.8-fold after 600 mg; geometric mean AUC (0-t last) increased 2.5-fold after both doses under fed conditions. CONCLUSIONS: Darolutamide was well tolerated at the examined doses in Japanese patients with mCRPC, without differences in safety and pharmacokinetics relative to Western patients.

Safety and efficacy of radium-223 dichloride in Japanese patients with castration-resistant prostate cancer and bone metastases.

BACKGROUND: Radiation therapy with radium-223 dichloride improves overall survival, reduces symptomatic skeletal events in Caucasian patients with castration-resistant prostate cancer (CRPC) and bone metastases, and is well tolerated. We report here the results of the first efficacy and safety study of radium-223 dichloride in a Japanese population. METHODS: In this open-label, uncontrolled, non-randomized, phase I trial, radium-223 dichloride was given to Japanese patients with CRPC and ≥2 bone metastases in 4-week cycles. The patients were divided into three cohorts, with cohort 1 and the expansion cohort receiving injections of radium-223 dichloride [55 kBq/kg body weight (BW)] every 4 weeks (Q4W) for up to six injections, and cohort 2 receiving an initial single radium-223 dichloride injection of 110 kBq/kg BW followed by up to five injections of 55 kBq/kg BW Q4W. Safety was determined via adverse event (AE) reporting, and biochemical bone markers were assessed for treatment efficacy. RESULTS: In total 19 patients received at least one dose of radium-223 dichloride and 18 patients experienced at least one treatment-emergent AE (TEAE) of which the most common were anemia, thrombocytopenia, and lymphocytopenia. Serious AEs were reported in three patients but none were drug-related. In the patients of cohort 1 + expansion cohort (55 kBq/kg BW Q4W treatment; n = 16), prostate-specific antigen levels remained stable or slightly increased while the bone alkaline phosphatase (ALP) level significantly decreased. The response rates of bone ALP (≥30 and ≥50% reductions) were 81.8 and 36.4% at week 12, and 81.3 and 50.0% at the end of treatment. CONCLUSIONS: Radium-223 dichloride was well tolerated in these Japanese patients and, at a dose of 55 kBq/kg BW, efficacy on biomarkers was as expected. The outcomes in Japanese patients were consistent with those reported in other non-Japanese populations. TRIAL REGISTRATION: ClinicalTrials.gov record NCT01565746.

Evaluation of the impact of a flowchart-type leaflet for cancer inpatients.

OBJECTIVES: This study aimed to evaluate the benefits of an interactive and visual flowchart-type leaflet for head and neck cancer inpatients who received induction chemotherapy, docetaxel, cisplatin, and 5-fluorourasil (DCF), or docetaxel, cisplatin, and S-1 (DCS) from September 2009 to April 2012. The flowchart-type leaflet group used a flowchart-type leaflet during chemotherapy, while the non-flowchart-type leaflet group did not. METHODS: A retrospective cohort study was performed using patient records. The endpoints of this study were to determine the following: the number of emergency hospital admissions/visits, incidence of Grade 2 or higher non-haematological adverse drug reactions, nonadherence to treatment, and the number of telephone calls from subjects. RESULTS: A total of 109 subjects were identified as follows: 49 in the flowchart-type leaflet group (139 chemotherapy sessions) and 60 in the non-flowchart-type leaflet group (163 chemotherapy sessions). No significant differences were observed in age, performance status, or chemotherapy regimen. The incidence of emergency hospital admissions was significantly lower in the flowchart-type leaflet than in the non-flowchart-type leaflet group (1% vs 10%, p < 0.01). No difference was seen between groups (12% vs 19%, p = 0.1) in the nonadherence rate of supportive medication for adverse drug reactions. Telephone call rates were significantly higher in the flowchart-type leaflet (16%, 30 calls) than in the non-flowchart-type leaflet group (7%, 11 calls) in each chemotherapy regimen. Of the 30 calls from patients in the FCL group, 24 (80%) were made to the hospital, compared with only 5 (45%) of the 11 calls from patients in the non-flowchart-type leaflet group. CONCLUSIONS: Our results suggest that the flowchart-type leaflet can reduce nonadherence and improve patient judgment during chemotherapy, leading to a decrease in emergency hospital admissions.

Treatment strategy for superficial pharyngeal squamous cell carcinoma synchronously combined with esophageal cancer.

BACKGROUND: Esophageal squamous cell carcinoma (ESCC) is often synchronously accompanied by pharyngeal squamous cell carcinoma (PSCC). However, treatment strategies for these synchronous cancers have not been established. AIM: To evaluate retrospectively the effects of both chemoradiotherapy (CRT) targeted for invasive ESCC on synchronous superficial PSCC and additional endoscopic resection (ER) for PSCC. PATIENTS AND METHODS: Screening endoscopy in the pharynx was performed in newly diagnosed ESCC patients. CRT combined with 5-fluorouracil (5-FU) and cisplatin (CDDP) was administered to all patients. The effect on superficial PSCC was only evaluated for 5-FU-CDDP chemotherapy that excluded the pharynx from the radiation field. When PSCC was remnant or recurrent in patients evaluated at complete response (CR) of ESCC, ER was performed on the PSCC. RESULTS: Fourteen cases of superficial PSCC (4.0%) were detected in 348 ESCC patients. Three PSCC reached CR in 8 ESCC-CR patients, while all 3 lesions recurred. No treatment response was found in the remaining 11 PSCC. As a second treatment, ER for 8 PSCC was completed in the 8 ESCC-CR patients, with one complication due to pneumonia. CONCLUSIONS: Standard 5-FU-CDDP CRT targeted for invasive ESCC did not demonstrate a sufficient efficacy for superficial PSCC, while ER even for PSCC after chemotherapy was curative.

QOL after head and neck reconstruction: evaluation of Japanese patients using SF-36 and GOHAI.

OBJECTIVE: To evaluate the health-related quality of life (HRQOL) of Japanese patients with head and neck cancer after treatment. STUDY DESIGN: Cross-sectional, descriptive study. PATIENTS AND METHODS: Twenty-nine patients who underwent resection and reconstruction of the head and neck cancer between September 2001 and January 2008 at the National Hospital Organization Tokyo Medical Center completed the Short Form 36 (generic QOL measure) and the General Oral Health Assessment Index (oral-specific QOL measure). RESULTS: The generic QOL of the patients was relatively maintained while oral-specific QOL was impaired compared to the Japanese norms. The patients with musculo-cutaneous flaps and 1y or longer after operation reported significantly lower QOL. CONCLUSION: This is a unique study on Japanese patients with relatively longer time after operation. Further evaluation with increased number of cases and disease-specific QOL scale is required to better understand the QOL of the patients.

[Hyponatremia with cisplatin administration in head and neck cancer patients].

Hyponatremia is one of the most common electrolyte disorders encountered in clinical practice of medical anticancer treatment. Cisplatin (CDDP) is a well-known chemotherapeutic agent that associates with hyponatremia. We retrospectively studied clinical features of hyponatremia CDDP administration. The incidence of hyponatremia at the first administration was 64. 1%. The significant risk factors of hyponatremia are body weight less than 60 kg, creatinin clearance less than 60mL/min, and sodium depletion and intake loss due to treatment-induced anorexia, nausea, vomiting and diarrhea. The mechanism of hyponatremia induced by CDDP is thought to be mainly renal salt wasting, and sometimes the syndrome of inappropriate secretion of antidiuretic hormone(SIADH).