Association of financial toxicity with quality of life in testicular cancer survivors.

OBJECTIVES: Most testicular cancer (TC) survivors have long-term survival. However, the association between financial toxicity (FT), which is an economic side effect of cancer treatment, and the quality of life (QOL) of TC survivors is still unclear. Thus, the impact of FT on the QOL of TC survivors was examined in a multi-institutional cross-sectional study. METHODS: We recruited TC survivors from eight high-volume institutions in Japan between January 2018 and March 2019. A total of 562 participants completed the EORTC QLQ-C30, EORTC QLQ-TC26 and the questionnaires on demographics, including annual income. Financial difficulty in the EORTC QLQ-C30 and low income were used to assess financial distress (FD) and financial burden (FB), respectively. FT was defined as FD and FB. The QOL scores were compared, and a multivariate logistic regression analysis for FT was performed. RESULTS: With severe FD, TC survivors had more treatment side effects, physical limitations, and anxiety concerning employment and future. The TC survivors who reported low income were worried about their jobs and the future. The QOL of the survivors with FT exhibited high impairment, except for sexual activity. In particular, the TC survivors with FT were physically limited and anxious concerning the future. The multivariate logistic regression analysis revealed that four or more chemotherapy cycles were substantial risk factors for FT (4 cycles, odds ratio (OR) = 4.17; ≥5 cycles, OR = 6.96). CONCLUSIONS: TC survivors who received multi-cycle chemotherapy were prone to experience FT, resulting in a decline in their health-related QOL.

[Promotion of Diversity in the Academic Field of Urology : Analysis of 10,000 Articles Published in Acta Urologica Japonica during a 65-Year Period].

Gender equality is one of the most important issues in the promotion of diversity. The participation status of female urologists in academic activities has not been clarified. In the present study, we analyzed a total of 10,288 articles published by 58,914 authors in Acta Urologica Japonica since the first issue in 1955 to the present. The author's gender was determined by an application program interface for gender estimation in combination with independent manual confirmation by two researchers. The increasing rate (⊿person/⊿year) of female authors was as low as 0.067 in 1955-79, but increased to 0.400 in 1980-2000 and 0.814 in 2001-20. Over the time periods, the annual total numbers of female authors (person/year) showed an increasing trend from 3.2 in 1955-79 to 16.3 in 1980-2000 and 26.0 in 2001-20. The numbers of female author individuals, the ratio of female authors to all authors and the ratio of publications by female first author to all publications also showed similar trends. These results suggest that gender equality is becoming more prevalent in the academic field of urology. The methods and data of this study are considered to be useful for the promotion of gender equality in the academic field of urology for the future.

Current status of systemic chemotherapy for octogenarians with advanced urothelial cancer in Japan: a Japanese multi-institutional study (CURE study).

BACKGROUND: The standard regimen of systemic chemotherapy for patients with advanced urothelial cancer (UC) changed from methotrexate, vinblastine, adriamycin, and cisplatin (MVAC) to gemcitabine and cisplatin (GC) in 2008 when the use of gemcitabine for UC began to be reimbursed by public health insurance in Japan. We examined its influence on the chemotherapy trend in elderly patients aged ≥80 years. METHODS: Among 345 patients included in our previous multicenter retrospective cohort study (chemotherapy for urothelial carcinoma: renal function and efficacy study; CURE study), the outcome of 30 patients aged ≥80 years was reviewed before and after 2008 and compared with 315 young patients. RESULTS: There were only 7 (4.6 %) elderly individuals among all registered patients before 2008, whereas the number increased to 23 (12 %) after 2008. Before 2008, only one elderly patient received MVAC, while GC (whose rate was similar to the rate in young patients) was administered to 13 patients (56.5 %) after 2008. The chemotherapeutic effect and overall survival (OS) rate was not significantly different between young and elderly patients. In the elderly treated with the GC regimen, the renal impairment rate after the first cycle was significantly higher, and the presence of distant metastases and renal impairment were independent prognostic factors in a multivariate analysis. CONCLUSION: Since GC was approved as the standard regimen for first-line chemotherapy in UC, selected elderly patients have been able to safely receive systemic chemotherapy like young patients. The clinical response rate and OS rate were similar to the young, but we need to monitor changes in renal function more closely in the elderly treated with GC.

[Socioeconomic advantages of longer screening intervals for men with low prostate-specific antigen levels in prostate cancer mass screening].

In prostate specific antigen (PSA) -based prostate cancer mass screening, the optimal re-screening interval is still in question, although guidelines suggest that a prolonged interval would be safe and cost-saving. We examined the socioeconomic feasibility of prolonged re-screening interval based on individual baseline PSA values. Markov decision-analytic models of prostate cancer screening were established for cost-effectiveness comparison of prolonged re-screening in men with low (≦1 ng/ml) PSA level (meta-interval strategy) and annual re-screening in every participant (control strategy). Effectiveness and socioeconomic feasibility were evaluated according to quality-adjusted life years (QALYs) and incremental cost-effectiveness ratio (ICER ; Δcost per ΔQALY), respectively. As a result, outcomes including cancer detection rates and stage shift suggested that these models well recapitulated actual prostate cancer mass screening. The meta-interval strategy was more cost-effective than the control strategy. The ICER for the control strategy with respect to the meta-interval strategy exceeded US$62, 000/QALY through the sensitivity analyses for every assumption. The meta-interval strategy was more effective and less expensive if the trade-off of impaired clinical outcomes caused by delayed detection was small. In conclusion, our models suggest that the meta-interval strategy is more cost-effective than annual screening. It can be even more effective if the interval is determined appropriately such that cancer can be detected within the therapeutic window.

Electrocardiographic assessment of incident atrial fibrillation in hemodialysis patients.

The prevalence and incidence of atrial fibrillation in hemodialysis patients have recently increased, but there are few evident predictors of incident atrial fibrillation in hemodialysis patients. The purpose of this study was to determine whether electrocardiographic findings can predict the development of atrial fibrillation in hemodialysis patients. A cohort of 299 patients (age, 63.1 ± 14.0 years; men, 59.2%; duration of hemodialysis, 80.3 ± 77.7 months) on hemodialysis therapy in December 2004 was included. To determine the incidence of atrial fibrillation, electrocardiographic findings were checked regularly every 1-3 months through December 2009. To detect paroxysmal atrial fibrillation, we examined electrocardiograms any time a patient had cardiac symptoms. Cox proportional hazard analysis was used to determine independent variables for the onset of atrial fibrillation. At the time of enrollment, 37 patients had pre-existing atrial fibrillation, for a prevalence rate of 12.4%. On the other hand, newly developed atrial fibrillation during the 5-year follow-up was determined in 45 patients, for an incidence rate of 4.37/100 patient-years. In multivariate analysis, age (hazard ratio, 1.04; 95% confidence interval, 1.01 to 1.07) and the presence of a P-terminal force >0.04 mm/s as an electrocardiographic finding (hazard ratio, 4.89; 95% confidence interval, 2.54 to 9.90) were independently associated with new-onset atrial fibrillation. The prevalence and incidence rates of atrial fibrillation are high in maintenance hemodialysis patients. Age and the presence of a P-terminal force >0.04 mm/s as an electrocardiographic finding may predict new-onset atrial fibrillation in these patients.

[Assessment of clinical usefulness of Eviprostat for benign prostatic hyperplasia--comparison of Eviprostat tablet with a formulation containing two-times more active ingredients].

We compared the usefulness of Eviprostat tablet, a therapeutic agent for benign prostatic hyperplasia (BPH), and EVI-F tablet, a new formulation of Eviprostat containing two times more active ingredients (Chimaphila umbellata extract, Populus tremula extract, Pulsatilla pratensis extract, Equisetum arvense extract and purified wheat germ oil) and consequently designed to reduce the number of tablets per dose by half. In this study, patients with BPH were randomly assigned to either Eviprostat group (6 tabs/day) or EVI-F group (3 tabs/day) using the envelope method. The clinical efficacy of these two drugs were evaluated by the International Prostate Symptom Score (IPSS) and QOL score at the end of the treatment period, and their safety was evaluated by the incidence of side effects. Based on the clinical study guidelines for dysuria, the change in the IPSS total score and QOL score were comparable to the previously reported data for other treatment agents for BPH, and these indices showed gradual improvement with the treatment period. Both treatments were well tolerated. The clinical usefulness of the monotherapy with EVI-F tablet or Eviprostat tablet was reasonably demonstrated in this study. Furthermore, both treatments reduced nocturia, which has an impact on the QOL of patients with BPH.

Impact of improvement in specificity of primary screening test on total cost of prostate cancer mass screening.

OBJECTIVES: Improvement in the specificity of primary screening tests, without significant cost elevation of the assay, provides cost savings in prostate cancer screening programs by reducing unnecessary secondary screening procedures. The purpose of this study was to evaluate the economic impact of improvement in the specificity of primary screening tests and to estimate the socially acceptable cost elevation for improved specificity. METHODS: A decision-analytic model was designed to evaluate the total costs of prostate cancer mass screening according to the changes in the specificity and the cost of the primary screening test. All assumed factors were tested by three-way sensitivity analyses incorporating cost and specificity. RESULTS: The base case analysis showed that a 1% improvement in the specificity of the primary screening test provides a $1.19 cost reduction per participant. Sensitivity analyses showed that an acceptable cost elevation for a 1% improvement in the specificity ranged from 0.68 to 2.90 $/% with respect to changes in several factors in the screening program. CONCLUSIONS: The specificity and cost of the primary screening test has a significant economical impact on prostate cancer mass screening. For each screening program, it should be taken into consideration whether the cost of the new test deserves the specificity.

[A multi-center prospective study for antibiotic prophylaxis to prevent perioperative infections in urologic surgery].

In order to assess the ability of our protocol for antibiotic prophylaxis to prevent perioperative infections in urologic surgery, 1,353 operations of open and laparoscopic urologic surgery conducted in 21 hospitals between September 2002 and August 2003 were subjected to analyses. We classified surgical procedures into four categories by invasiveness and contamination levels: Category A; clean less invasive surgery, Category B; clean invasive or clean-contaminated surgery, Category C; surgery with urinary tract diversion using the intestine. Prophylactic antibiotics were administrated intravenously according to our protocol, such as Category A; first or second generation cephems or penicillins on the operative day only, Category B; first and second generation cephems or penicillins for 3 days, and Category C; first, second or third generation cephems or penicillins for 4 days. The wound conditions and general conditions were evaluated in terms of the surgical site infection (SSI) as well as remote infection (RI) up to postoperative day (POD) 30. The SSI rate highest (23.3%) for surgery with intestinal urinary diversion, followed by 10.0% for surgery for lower urinary tract, 8.9% for nephroureterctomy, and 6.0% for radical prostatectomy. The SSI rates in clean surgery including open and laparoscopic nephrectomy/adrenalectomy were 0.7 and 1.4%, respectively. In SSIs, gram-positive cocci such as methicillin-resistant Staphylococcus aureus (58.8%) or Enterobacter faecalis (26.5%) were the most common pathogen. Similarly, the RI rate was the highest (35.2%) for surgery using intestinal urinary diversion, followed by 16.7% for surgery for lower urinary tract, 11.4% for nephroureterctomy, and 7.6% for radical prostatectomy, while RI rates for clean surgery were less than 5%. RIs most frequently reported were urinary tract infections (2.6%) where Pseudomonas aeruginosa (20.3%) and Enterobacter faecalis (15.3%) were the major causative microorganisms. Parameters such as age, obesity, nutritional status (low proteinemia), diabetes mellitus, lung disease, duration of operation, and blood loss volume were recognized as risk factors for SSI or RI in several operative procedures. Postoperative body temperatures, peripheral white blood counts, C reactive protein (CRP) levels in POD 3 were much higher than those in POD 2 in cases suffering from perioperative infections, especially suggesting that CRP could be a predictable marker for perioperative infections.

Assessment of a protocol for prophylactic antibiotics to prevent perioperative infection in urological surgery: a preliminary study.

BACKGROUND: The aim of the present study was to assess the usability and efficacy of our new protocol of prophylactic antibiotic use to prevent perioperative infection in urological surgery. METHODS: We prospectively investigated 339 cases of typical urological surgery in our department between April 2001 and March 2002 (group I). We classified surgical procedures into four categories by invasiveness and contamination levels: category A, clean less invasive or endoscopic surgery; category B, clean invasive or clean contaminated surgery; category C, urinary tract diversion using the intestine; and category D, infected surgery. Antibiotics were administrated intravenously according to our protocol: category A, first or second generation cephems or penicillins during the operative day only; category B, first and second generation cephems or penicillins for 3 days; and category C, second or third generation cephems for 4 days. Category D was excluded from the analysis. To judge perioperative infections, the wound condition and general conditions were evaluated in terms of the surgical site infection (SSI) as well as remote infection (RI) up to postoperative day (POD) 14. We retrospectively reviewed 308 patients who underwent urological surgery between April 2000 and March 2001 (group II) as reference cases that were administered antibiotics without any restriction. RESULTS: Perioperative infection rates (SSI + RI) in group I and group II were 25 of 339 (7.4%) and 35 of 308 (11.4%), respectively. Surgical site infection rates of categories A, B, and C in group I were 1.8%, 7.6%, and 30.0%, respectively, while those in group II were 2.0%, 7.4%, and 46.2%, respectively. There was no significant difference in infection rates in terms of RI and SSI between group I and group II. The amounts, as well as the prices, for intravenously administrated antibiotics and oral antibiotics decreased to approximately half and one-fifth, respectively. CONCLUSION: Our protocol effectively decreased the amount of antibiotics used without increasing perioperative infection rates. Thus, our protocol of prophylactic antibiotic therapy would be recommended as an appropriate method for preventing perioperative infection in urological surgery.

[Translation and adaptation of the UCLA prostate cancer index for use in Japan].

PURPOSE: To translate the UCLA Prostate Cancer Index (UCLA PCI), which is designed to measure Quality of Life (QOL) of patients with prostate cancer, and to adapt it as needed for use in Japan. METHODS: We translated the original English version into a preliminary Japanese version in a multi-stage procedure according to established guidelines. Then, we tested the preliminary Japanese version on 6 patients with prostate cancer, and we revised the Japanese version based on the findings of the pilot test. RESULTS: The back-translation of the preliminary Japanese version was reviewed by its original developer, and some wordings were revised. In the pilot testing, the average time required to complete the questionnaire was 5.5 minutes. Four of the 20 items frequently had missing data (> 15%). This is believed to have been due to inappropriate wording of the response choices, which were revised accordingly. CONCLUSION: We conducted translation and cross-cultural adaptation of the Japanese version of UCLA PCI. Pilot testing proved to be useful in refining items and response choices.

Follow-up of clinical stage I testicular cancer patients: cost and risk benefit considerations.

BACKGROUND: Regardless of the way it is managed, a high cure rate has been achieved for recurrent low-stage testicular cancer. Achieving a balance between survival and the patient's inconvenience and expense during follow-up, has therefore become an important issue. METHODS: Prognoses and recurrence patterns were investigated in 39 patients with stage I non-seminomatous germ cell tumor of the testis (NSGCT), and 82 patients with stage I seminomatous germ cell tumor of the testis (SGCT), who underwent high orchiectomy between 1970 and 1997 at our institution. We considered the cost benefits and the risks by reviewing our results together with other reported results. RESULTS: Patients with clinical stage I NSGCT under surveillance showed no progression later than 4 years after orchiectomy. The ability to detect progression using chest X-ray alone appeared very low. There was no infradiaphragmatic recurrence after adjuvant radiotherapy for patients with stage I SGCT. Only two of 204 patients showed progression, which included eight of our patients who underwent two cycles of adjuvant carboplatin therapy. CONCLUSIONS: Four years of intensive follow-up is probably sufficient for patients with stage I NSGCT under surveillance, and routine chest X-rays may be required only during the first year of surveillance. The benefit of using adjuvant radiotherapy for patients with stage I SGCT is that we could remove abdominal and pelvic CT scans from the routine follow-up protocol. Randomized trials will clarify whether the adjuvant carboplatin therapy is less toxic, provides better prognosis and is more cost-effective than adjuvant radiotherapy.

In vivo assessment of adenoviral vector-mediated gene expression of dopamine D(2) receptors in the rat striatum by positron emission tomography.

For functional assessment of gene therapy in experimental animals, in vivo assessment of transferred genes will provide a major advance over an in vitro analysis which must be done post-hoc. In the current study we conducted positron emission tomography (PET) analysis in rats following injection of the adenoviral vector encoding the cDNA for the rat dopamine D(2) receptors (D(2)R) (AdCMV.DopD(2)R) into rat brain to provide a quantitative evaluation of D(2)R overexpression. Quantitative measurements as well as images by PET and ex vivo autoradiography demonstrated the significant increase of D(2)R binding of [(11)C]raclopride, a specific D(2)R radioligand, in the AdCMV.DopD(2)R-injected rat striatum 2 or 3 days after vector injection. Longitudinal in vivo assessment of the gene expression by PET demonstrated decreased binding of [(11)C]raclopride with time, which was in agreement with the observation in a cross-sectional autoradiographic study. The results of the current study demonstrate that PET can be used for longitudinal in vivo assessment of D(2)R expression mediated by adenoviral vector in rat brain.