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BackgroundWe evaluated clinical outcomes of region target focal therapy with high-intensity focused ultrasound (HIFU) for the localized prostate cancer (PCa) based on magnetic resonance imaging-based biopsy and systematic prostate biopsy for Asian.MethodsWe prospectively recruited patients with localized PCa, located their significant tumors using MRI-transrectal ultrasound (TRUS) elastic fusion image-guided transperineal prostate biopsy and 12-cores transperineal systematic biopsy, and focally treated these regions in which the tumors were located in the prostate using HIFU. Patients’ functional and oncological outcomes were analyzed prospectively.ResultsWe treated 90 men (median age 70 years; median PSA level 7.26 ng/ml). Catheterization was performed within 24 h after the treatment in all patients. Biochemical disease-free rate was 92.2% during 21 months follow-up when use of Phoenix ASTRO definition. In follow-up biopsy, significant cancer was detected in 8.9% of the patients in un-treated areas. Urinary functions, including international prostate symptom score (IPSS) (P < 0.0001), IPSS quality of life (QOL) (P = 0.001), overactive bladder symptom score (OABSS) (P < 0.0001), EPIC urinary domain (P < 0.0001), maximum urinary flow rate (P < 0.0001), and IIEF-5 (P = 0.001), had significantly deteriorated at 1 month after treatment, but improved to preoperative levels at 3 or 6 months. Rates of erectile dysfunction and ejaculation who had the functions were 86% and 70%, respectively, at 12 months after treatment.ConclusionsThe present treatment for Asian would have similar oncological and functional outcomes to those in previous reports. Further large studies are required to verify oncological and functional outcomes from this treatment for patients with localized PCa.

We compared the comprehensive clinical outcomes of focal therapy (FT) and robot-assisted radical prostatectomy (RARP) in patients with localized prostate cancer (PC) using a win ratio analysis. After propensity score matching, a win ratio analysis, in which the composite endpoints of failure-free survival (FFS) and the urinary domain of the Expanded Prostate Cancer Index Composite (EPIC) were analyzed, was used for the comparison of the clinical outcomes of FT and RARP for the patients with localized PC. Seventy-two patients were included in each group after propensity score matching. FFS was not significantly different between the groups ( p  = 0.5044) after 36 months of follow-up. In contrast, the score of the urinary domain of the EPIC in the FT group was significantly better than that in the RARP group ( p  < 0.0001). The win ratio of FT per RARP was 3.39 ( p  < 0.0001; 95% confidence interval 2.21–5.20), suggesting a higher comprehensive outcome in the FT group than in the RARP group during short-term follow-up in single institution. Although further randomized trial with long-term follow-up would be needed for the evaluation, the win ratio would be useful to analyze the efficacy of FT according to patient preferences comprehensively.

Aim Postoperative small bowel obstruction (SBO) is one of the major complications that is mainly caused by postoperative adhesion. Recently, the antiadhesion membrane has become popular for postoperative SBO prevention. However, its efficacy is yet to be confirmed in the gastric cancer surgery field. Here, we conducted the supplemental analysis of the randomized controlled trial JCOG1001 to investigate the efficacy of the antiadhesion membrane on SBO prevention in patients with open gastrectomy for gastric cancer. Methods Of the 1204 patients enrolled in JCOG1001, 1200 patients were included. The development of SBO of Grade ≥ IIIa according to the Clavien–Dindo classification was recorded. Univariable and multivariable analyses were performed using the Fine and Gray model to determine the risk factors for SBO. Results Fifty‐one patients developed SBO (median follow‐up duration: 5.6 years). Total gastrectomy, combined resection, and blood loss significantly increased the risk for SBO development in the univariable analysis. Large amount of blood loss was independently associated with SBO development in the multivariable analysis (hazard ratio [HR], 3.089; 95% confidence interval [CI], 1.562–6.109, p = 0.0012). Antiadhesion membrane did not reduce the risk for SBO (HR, 1.299; 95% CI 0.683–2.470; p = 0.4246). In the patients belonging to subgroup analyses who received distal and total gastrectomy, the antiadhesion membrane was not associated with the incidence of SBO. Conclusions Antiadhesion membrane did not decrease SBO occurrence rate after open gastrectomy. Therefore, the use of antiadhesion membrane would not be effective for preventing SBO in gastric cancer surgery. Antiadhesion membrane did not decrease small bowel obstruction occurrence rate after open gastrectomy. Therefore, the use of antiadhesion membrane would not be effective for preventing SBO in gastric cancer surgery.

•Duration of influenza vaccine effect in the elderly is currently unclear.•This cohort study used healthcare claims data and vaccination records.•Influenza vaccines showed moderate effectiveness in the Japanese elderly.•Vaccine effectiveness showed a trend of gradual attenuation.•Vaccine protection against incidence was maintained for 4–5 months post-vaccination. The immune response to influenza vaccination in the elderly is likely to be lower than that in young adults. Clinical protection may not persist year-round in the elderly. However, the effectiveness of influenza vaccine in the elderly has not been adequately studied, especially in terms of the duration of effectiveness. We used a linked database of healthcare administrative claims data and vaccination records maintained by the municipality of a city in Kanto region of Japan. We studied individuals who were aged 65 years or older at baseline and were followed up between April 1, 2014 to March 31, 2020. The duration of influenza vaccine effectiveness by age category was analyzed using a time-dependent piecewise Cox proportional hazard model with time-dependent vaccine status, prior season vaccination and covariates confirmed in the baseline period (age, sex, cancer, diabetes, chronic obstructive pulmonary diseases, asthma, chronic kidney diseases, and cardiovascular diseases). We identified an analysis population of 83,146 individuals, of which 7,401 (8.9%) had experienced influenza and 270 (0.32%) underwent influenza-related hospitalization. Individuals who were vaccinated during the first season (n = 47,338) were older than non-vaccinated individuals (n = 35,808) (average age, 75.8 vs. 74.1 years, respectively). The multivariable analysis showed a lower incidence of influenza in vaccinated individuals (hazard ratio [HR], 0.47; 95% confidence interval [CI], 0.43–0.51; P < 0.001), while the incidence of hospitalization for influenza did not differ significantly by vaccination status (HR, 0.79; 95% CI, 0.53–1.18; P = 0.249). Protective effectiveness against incidence was maintained for 4 or 5 months after vaccination in those aged 65–69 and 80-years, 5 months in 70–79 years. Our study identified moderate vaccine effectiveness in preventing the incidence of influenza in the Japanese elderly. Vaccine effectiveness showed a trend of gradual attenuation. Clinicians should suspect influenza infection even in those vaccinated, especially in elderly individuals who had received vaccination more than 4 or 5 months previously.

Background Most evidence of the waning of vaccine effectiveness is limited to a relatively short period after vaccination. Methods Data obtained from a linked database of healthcare administrative claims and vaccination records maintained by the municipality of a city in the Kanto region of Japan were used in this study. The study period extended from April 1, 2020, to December 31, 2022. The duration of the effectiveness of the COVID-19 vaccine was analyzed using a time-dependent piecewise Cox proportional hazard model using the age, sex and history of cancer, diabetes, chronic obstructive pulmonary disease, asthma, chronic kidney disease, and cardiovascular disease as covariates. Results Among the 174,757 eligible individuals, 14,416 (8.3%) were diagnosed with COVID-19 and 936 (0.54%) were hospitalized for COVID-19. Multivariate analysis based on the time-dependent Cox regression model with reference of non-vaccine group revealed a lower incidence of COVID-19 in the one-dose group (hazard ratio, 0.76 [95% confidence interval, 0.63–0.91]), two-dose (0.89 [0.85–0.93]), three-dose (0.80 [0.76–0.85]), four-dose (0.93 [0.88–1.00]), and five-dose (0.72 [0.62–0.84]) groups. A lower incidence of COVID-19-related hospitalization was observed in the one-dose group (0.42 [0.21–0.81]), two-dose (0.44 [0.35–0.56]), three-dose (0.38 [0.30–0.47]), four-dose (0.20 [0.14–0.28]), and five-dose (0.11 [0.014–0.86]) groups. Multivariable analyses based on the time-dependent piecewise Cox proportional hazard model with reference of non-vaccine group revealed significant preventive effects of the vaccine for 4 months for the incidence of COVID-19 and ≥ 6 months for hospitalization. Conclusions Vaccine effectiveness showed gradual attenuation with time after vaccination; however, protective effects against the incidence of COVID-19 and hospitalization were maintained for 4 months and ≥ 6 months, respectively. These results may aid in formulating routine vaccination plans after the COVID-19 pandemic.

Purpose Identifying factors associated with treatment alteration (treatment discontinuation and dose reduction) may help to attain the treatment goals for metastatic breast cancer. The value of changes in the quality of life (QOL) in predicting treatment alteration remained unclear. This study aimed to examine the relationship between changes in the QOL and treatment alteration of first-line chemotherapy for metastatic breast cancer. Methods We merged data from two randomized clinical trials in Japan, conducted from 2006 to 2017, that included patients who were diagnosed with human epidermal growth factor receptor 2-negative and endocrine treatment-resistant breast cancer, with metastatic disease at presentation or recurrence after surgery. The European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 was used to assess QOL. The association between change in time-dependent QOL (worsening by 10-point or not) and time to treatment alteration was assessed using the Cox regression models controlling for patient characteristics (age, liver metastasis, hormone status, and treatment regimen) and baseline QOL. Results Worsening physical functioning, global health status, and dyspnea were significantly associated with treatment discontinuation. Worsening role functioning, global health status, and fatigue were significantly associated with dose reduction. The threshold for defining worsening did not have a significant impact on the relationship. Conclusion Changes in QOL are associated with the probability of treatment alteration among metastatic breast cancer patients. Physical functioning, role functioning, global health status, dyspnea, and fatigue should be prioritized for symptom management in patients with metastatic breast cancer.

Background Although the standard therapy for advanced-stage hepatocellular carcinoma (HCC) is systemic chemotherapy, the combination of atezolizumab and bevacizumab (atezo + bev) with a high objective response rate may lead to conversion to resection in patients with initially unresectable HCC. This study aims to evaluate the efficacy of atezo + bev in achieving conversion surgery and prolonged progression-free survival (PFS) for initially unresectable HCC. Methods The RACB study is a prospective, single-arm, multicenter, phase II trial evaluating the efficacy of combination therapy with atezo + bev for conversion surgery in patients with technically and/or oncologically unresectable HCC. The main eligibility criteria are as follows: (1) unresectable HCC without a history of systemic chemotherapy, (2) at least one target lesion based on RECIST ver. 1.1, and (3) a Child‒Pugh score of 5–6. The definition of unresectable tumors in this study includes macroscopic vascular invasion and/or extrahepatic metastasis and massive distribution of intrahepatic tumors. Patients will be treated with atezolizumab (1200 mg/body weight) and bevacizumab (15 mg/kg) every 3 weeks. If the patient is considered resectable on radiological assessment 12 weeks after initial chemotherapy, the patient will be treated with atezolizumab monotherapy 3 weeks after combination chemotherapy followed by surgery 3 weeks after atezolizumab monotherapy. If the patient is considered unresectable, the patient will continue with atezo + bev and undergo a radiological assessment every 9 weeks until resectable or until disease progression. The primary endpoint is PFS, and the secondary endpoints are the overall response rate, overall survival, resection rate, curative resection rate, on-protocol resection rate, and ICG retention rate at 15 min after atezo + bev therapy. The assessments of safety and quality of life during the treatment course will also be evaluated. The number of patients has been set at 50 based on the threshold and the expected PFS rate at 6 months after enrollment of 40% and 60%, respectively, with a one-sided alpha error of 0.05 and power of 0.80. The enrollment and follow-up periods will be 2 and 1.5 years, respectively. Discussion This study will elucidate the efficacy of conversion surgery with atezo + bev for initially unresectable HCC. In addition, the conversion rate, safety and quality of life during the treatment course will also be demonstrated. Trial registration This study is registered in the Japan Registry of Clinical Trials (jRCTs051210148, January 7, 2022).

BackgroundLate complications following gastric cancer surgery, including postgastrectomy syndromes, are complex problems requiring a solution. Reported risk factors for developing late complications include surgery-related factors, such as the surgical approach and the extent of resection and reconstruction. However, this has not been assessed in a prospective study with a large sample size. Therefore, this study aimed to evaluate associations between surgery-related factors and the development of late complications. Data from the JCOG0912 trial were used. It compared laparoscopy-assisted distal gastrectomy (LADG) to open distal gastrectomy (ODG) in clinical stage I gastric cancer patients. MethodsThis study included 881/921 patients enrolled in the JCOG0912 trial. The incidence of late complications was compared between the ODG and the LADG arms. In addition, associations between surgery-related factors and the development of late complications were assessed by multivariable analyses using the proportional odds model to identify relevant risk factors.ResultsThere was no difference in the type or number of patients with late complications between the LADG and the ODG arms. The multivariable analysis for each late complication revealed that the Billroth-I reconstruction (vs. R-en-Y or Billroth-II) had a lower risk of cholecystitis [odds ratio (OR) 0.187, 95% confidence interval (CI) 0.039–0.905, P = 0.037] or ileus (OR 0.116, 95%CI 0.033–0.406, P < 0.001), and pylorus-preserving gastrectomy (vs. R-en-Y or Billroth-II) had a higher risk of reflux esophagitis (OR 3.348, 95% CI 1.371–8.176, P = 0.008). The surgical approach was not a risk factor for any late complications.ConclusionDifferences in surgical approaches did not constitute a risk for developing late complications after gastrectomy. Billroth-I reconstruction reduced the risk of ileus and cholecystitis, but pylorus-preserving gastrectomy carried a risk for reflux esophagitis.

Objectives This study aimed to evaluate the incidence of patient–prosthesis mismatch (PPM) and degree of left ventricular (LV) mass regression after surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) in patients with small aortic annulus (defined as annular diameter of ≤ 21 mm). Methods We retrospectively analyzed echocardiographic findings in total of 277 patients with aortic stenosis and small aortic annulus (63 underwent SAVR and 214 underwent TAVR) between October 2013 and March 2019. PPM was defined as an effective orifice area index (EOAI) ≤ 0.85 cm 2 /m 2 . LV mass regression was evaluated as percentage change in LV mass index (LVMI) from baseline to the 1-year follow-up. Results The median EOAI before discharge was slightly larger in the TAVR group than in the SAVR group (1.09 vs. 1.07 cm 2 /m 2 ; P  = 0.030). However, the incidence of PPM before discharge (9.4 vs. 12.7%; P  = 0.438) and at the 1-year follow-up (11.7 vs. 11.1%; P  = 0.901) was similar between groups. Mild or greater paravalvular leakage (PVL) after the procedure was more frequent in the TAVR group (11.7 vs. 0%; P  = 0.002). Reduction in LVMI was significantly higher in the SAVR group (19.3 vs. 6.4%; P  < 0.001). Multivariate analysis demonstrated that reduction in LVMI was positively associated with higher baseline transaortic pressure gradient ( P  < 0.001) and higher baseline LVMI ( P  < 0.001) and negatively associated with older age ( P  < 0.001) and mild or greater PVL ( P  < 0.001). Conclusions SAVR provides better LV mass regression than TAVR with a comparable rate of PPM in patients with small aortic annulus.

Abstract Introduction: The phase III REFLECT trial demonstrated that lenvatinib was superior to sorafenib in terms of progression-free survival (PFS), time to progression, and objective response rate (ORR) for patients with unresectable hepatocellular carcinoma (HCC). This study assessed the efficacy and safety of preoperative lenvatinib therapy for patients with oncologically or technically unresectable HCC. Methods: In this multicenter single-arm phase II trial, patients with advanced HCC and factors suggestive of a poor prognosis (macroscopic vascular invasion, extrahepatic metastasis, or multinodular tumors) were enrolled. Patients with these factors, even with technically resectable HCC, were defined as oncologically unresectable because of the expected poor prognosis after surgery. After 8 weeks of lenvatinib therapy, the patients were assessed for resectability, and tumor resection was performed if the tumor was considered technically resectable. The primary endpoint was the surgical resection rate. The secondary endpoints were the macroscopic curative resection rate, overall survival (OS), ORR, PFS, and the change in the indocyanine green retention rate at 15 min as measured before and after lenvatinib therapy. The trial was registered with the Japan Registry of Clinical Trials (s031190057). Results: Between July 2019 and January 2021, 49 patients (42 oncologically unresectable patients and 7 technically unresectable patients) from 11 centers were enrolled. The ORR was 37.5% based on mRECIST and 12.5% based on RECIST version 1.1. Thirty-three patients underwent surgery (surgical resection rate: 67.3%) without perioperative mortality. The surgical resection rate was 76.2% for oncologically unresectable patients and 14.3% for technically unresectable patients. The 1-year OS rate and median PFS were 75.9% and 7.2 months, respectively, with a median follow-up period of 9.3 months. Conclusions: The relatively high surgical resection rate seen in this study suggests the safety and feasibility of lenvatinib therapy followed by surgical resection for patients with oncologically or technically unresectable HCC.