Objective: DUO-E/GOG-3041/ENGOT-EN10 (NCT04269200) demonstrated statistically significant and clinically meaningful progression-free survival (PFS) improvement with durvalumab plus carboplatin/paclitaxel, followed by durvalumab with or without olaparib, vs. carboplatin/paclitaxel alone (intention-to-treat [ITT] population) in patients with newly diagnosed advanced or recurrent endometrial cancer. We evaluated efficacy and safety in the Japan subset of DUO-E. Methods: Patients with newly diagnosed International Federation of Gynecology and Obstetrics stage III/IV or recurrent endometrial cancer were randomized 1:1:1 to control arm (carboplatin/paclitaxel + durvalumab placebo [6 cycles] followed by durvalumab placebo + olaparib placebo), durvalumab arm (carboplatin/paclitaxel + durvalumab [1,120 mg every 3 weeks] [6 cycles] followed by durvalumab [1,500 mg every 4 weeks] + olaparib placebo), or durvalumab + olaparib arm (carboplatin/paclitaxel + durvalumab [6 cycles] followed by durvalumab + olaparib [300 mg twice a day]). Dual primary endpoints were investigatorassessed PFS for durvalumab and durvalumab + olaparib arms vs. control. This prespecified exploratory analysis evaluated PFS and safety in the Japan subset. Results: In the Japan subset (n=88) PFS favored durvalumab (hazard ratio=0.61, 95% confidence interval [CI]=0.32–1.12) and durvalumab + olaparib (0.44, 95% CI=0.22–0.85) vs. control; median PFS was 9.9 and 15.1 vs. 9.5 months, and the 18-month PFS rate was 37.0% and 42.1% vs. 22.2%, respectively. The safety profile in the Japan subset was generally consistent with the full safety analysis set and the established profiles of the individual agents. Conclusion Efficacy and safety in the Japan subset were generally consistent with outcomes in the DUO-E ITT population. This Japanese subset analysis of DUO-E supports carboplatin/ paclitaxel + durvalumab followed by durvalumab with or without olaparib as new treatment options in patients with advanced or recurrent endometrial cancer and is the first to report on these regimens in Japanese patients alone.

Double drainage sites from a common venous confluence of the pulmonary veins of a mixed total anomalous pulmonary venous connection is a rare condition that is called a “double connection.” There have been very few reports of reoperation for minor drainage of a double connection. A 28-year-old male with double connection type (Ia: major drainage + IIa: minor drainage) mixed total anomalous pulmonary venous connection (TAPVC) was referred to our institution. He had undergone TAPVC type Ia (major drainage) repair at the age of 1 year. Postoperative enhanced computed tomography showed residual TAPVC IIa (minor drainage) at the age of 15 years. Therefore, the definitive diagnosis was double connection-type mixed TAPVC. Residual shunt gradually increased, and cardiac catheterization revealed an increased pulmonary blood flow/systemic blood flow ratio. Echocardiography showed enlarged shunt vessel and mild tricuspid regurgitation. Catheter intervention was considered too risky and, therefore, we performed patch closure of the residual shunt through a right atriotomy. The postoperative course was uneventful, and follow-up computed tomography showed shrinkage of the shunt vessel without any thromboembolic events.

Objective: Lenvatinib is an oral multitarget tyrosine kinase inhibitor (mTKI) and is recommended for patients with advanced hepatocellular carcinoma (HCC) with Child-Pugh A liver function, who are not amenable to surgical resection, locoregional treatment, or transcatheter arterial chemoembolization. Hepatogastric fistula is a rare complication with a poor prognosis in patients with HCC. Previous reports on fistula formation during mTKI therapy for HCC were all associated with sorafenib. Here, we report the first case of recurrent hepatogastric fistula during lenvatinib therapy for advanced HCC managed using an over-the-scope clip (OTSC).Patient: We present the case of a 73-year-old man with alcoholic liver cirrhosis who was treated for multiple HCC for 7 years. HCC was treated using repetitive transcatheter arterial chemoembolization, radiofrequency ablation, and sorafenib. Owing to disease progression, lenvatinib treatment was started. During lenvatinib treatment, recurrent hepatogastric fistulas developed. An OTSC was useful for fistula closure and prevention of recurrence.Results: The major cause of fistula formation is considered to be the direct invasion of HCC; however, HCC treatment might also be a contributing factor in our case. In addition, OTSC was useful for fistula closure.Conclusion: Clinicians should be aware of the fatal complications during HCC treatment.

Neoadjuvant chemotherapyeoadjuvant chemoradiotherapy (NAC/NACRT) can be performed in patients with pancreatic cancer to improve survival. We aimed to clarify the clinical outcomes of biliary drainage with a metal stent (MS) or a plastic stent (PS) during NAC/NACRT. Between October 2013 and April 2016, 96 patients with pancreatic cancer were registered for NAC/NACRT. Of these, 29 patients who underwent biliary drainage with MS or PS before NAC/NACRT and a subsequent pancreatoduodenectomy were retrospectively analyzed with regard to patient characteristics, preoperative recurrent biliary obstruction rate, NAC/NACRT delay or discontinuation rate, and operative characteristics. The median age of the patients was 67 years. NAC and NACRT were performed in 14 and 15 patients, respectively, and MS and PS were used in 17 and 12 patients, respectively. Recurrent biliary obstruction occurred in 6% and 83% of the patients in the MS and PS groups, respectively (p<0.001). NAC/NACRT delay was observed in 35% and 50% of the patients in the MS and PS groups, respectively (p=0.680). NAC/NACRT discontinuation was observed in 12% and 17% of the patients in the MS and PS groups, respectively (p=1.000). The operative time in the MS group tended to be longer than that in the PS group (625 minutes vs 497 minutes, p=0.051), and the operative blood loss volumes and postoperative adverse event rates were not different between the two groups. MS was better than PS from the viewpoint of preventing recurrent biliary obstruction, although MS was similar to PS with regards to perioperative outcomes.

Objectives: Bony impingement of the proximal femur on the pelvis is an important factor for dislocation after total hip arthroplasty (THA). We evaluated bony impingement after THA using the rotation matrix derived from postoperative computed tomography (CT) images.
Patients and Methods: One hundred and seven hip joints were subjected to primary THA via a posterolateral approach. We used the rotation matrix derived from CT images to calculate internal rotation (IR) limit prior to bony impingement, and compared this limit with the intraoperative limit.
Results: The average calculated IR limit was 63 degrees (range: 30 to 85 degrees). The average intraoperative IR limit was 49 degrees (range: 20 to 70 degrees). The correlation between the intraoperative IR limit (Y) and the calculated IR limit (X) was expressed as Y=8.9+0.66X (R=0.73; p < 0.0001).
Conclusions: We could show a patient´s safe range of motion prior to bony impingement, and this will be a good indicator for dislocation not occurring during postoperative rehabilitation.

OBJECTIVESThe aim of this study was to determine whether the serum nitrite plus nitrate (NO( x )) level correlates with biomarkers that are known components of the metabolic syndrome (MetS).

METHODSSerum NO( x ) levels were measured using a commercial kit in 608 Japanese men and women between the ages of 39 and 85 years. Multivariate adjustments for age, smoking status, alcohol consumption and exercise were made in the analysis of covariance (ANCOVA). The components of the metabolic syndrome were defined based on the following criteria: body mass index (BMI) >/=25.0 kg/m(2), glycated hemoglobin (HbA1c) >/=5.6%, systolic blood pressure >/=130 mmHg or diastolic blood pressure >/=85 mmHg, high-density lipoprotein-cholesterol (HDL-C) /=1.69 mmol/l.

RESULTSThe logarithmically transformed age-adjusted serum NO( x ) (lnNO( x )) value was significantly higher in the low HDL-C group (1.76 +/- 0.05 mumol/l; p < 0.05) than MetS component groups (1.65 +/- 0.01 mumol/l) in men, but no difference was found in women. The means of serum lnNO( x ) after multivariate adjustment were 1.64, 1.65, 1.64, 1.66, and 1.81 mumol/l for 0, 1, 2, 3, and 4-5 MetS components for all subjects, respectively. The results of ANCOVA confirmed that the serum lnNO( x ) level was significantly correlated with the clustering of MetS components in both men and women (p < 0.0001 for trend).

CONCLUSIONOur results suggest that an increase in the clustering of MetS components was associated with the increase in serum NO levels in our general population.

OBJECTIVESWe determined the relationship between abdominal circumference and the concentration of nitric oxide (NO), an endothelial cell product known to play an important role in the regulation of vascular tone and thrombocyte activations.

METHODSSubjects were 177 men and 339 women aged 40 or over who were free from a history of diabetes or malignancy. Analysis of covariance was applied to examine the gender-specific and smoking-status-specific associations of abdominal fat volume measured as waist circumference, waist-hip ratio, and waist-to-stature ratio, with serum NO level represented by the concentration of NO metabolites (NOx; nitrate plus nitrite).

RESULTSAlthough men showed no statistical association between abdominal fat accumulation and NOx concentration, abdominal adiposity seemed to inversely affect the serum NOx concentration of never- and current-smoking women.

CONCLUSIONOur results suggest that a reduction in NO bioactivity occurs with abdominal fat accumulation in women. The underlying biological mechanism might involve adipocytokines secreted from visceral fat, but is yet to be elucidated.