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.

Many post-treatment cancer patients complain of persistent fatigue, which is known to have a significant impact on activities of daily living, quality of life, and reinstatement. We report a case of a 37-year-old man with acute myeloid leukemia (AML) who was able to return to work by performing High-Intensity Interval Training (HIIT) after the remission. The diagnosis of AML was made and the treatment started in January X, and the patient reached remission and discharged in June. However, he developed herpes zoster and was unable to return to his job. The patient was referred to our hospital for rehabilitation treatment in December X. The rehabilitation treatment included 40-min HIIT twice a week and commuting practice, as well as gradual support for return-to-work. Cardiopulmonary function improved from 19.2 to 25.7 mL/min/kg of oxygen uptake at anaerobic metabolic threshold, lower limb muscle strength improved from 0.47/0.48 to 0.60/0.55 kgf/kg of knee extension muscle strength ratio (right/left), physical function improved from 14 to 24 times in 30-second chair stand test, Cancer Fatigue Scale improved from 46 to 25 points, and the patient was able to work full time in May X＋1. HIIT improved cardiopulmonary function, muscle strength, physical function, and fatigue, and enabled the patient to return to work. Even after remission, some patients have difficulty returning to work. The results suggest that appropriate follow-up, exercise guidance, and rehabilitation therapy are necessary even after treatment.

This report showed a case of temporomandibular joint (TMJ) ankylosis suspected to be associated with ankylosing spondylitis based on the observation of bony ankylosis of the cervical spine on computed tomography (CT) images. A 53-year-old man presented with a chief complaint of difficulty in opening his mouth. His medical history indicated that in his 20 s, he became aware of the difficulty in moving his neck. CT revealed marked osteoarthritic changes in the right mandibular condyle, suggesting fibrotic TMJ ankylosis. In addition, bony ankylosis of the cervical vertebral body and facet joints from the axis (C2) to C5 in continuity was observed. CT of the entire spine also showed bony deformity of the sacroiliac joints and bony ankylosis. Based on these findings, ankylosing spondylitis was suspected. The possibility of an ankylosing spondylitis complication should be considered in cases of TMJ ankylosis if bony ankylosis of the cervical spine is observed.

Many post-treatment cancer patients complain of persistent fatigue, which is known to have a significant impact on activities of daily living, quality of life, and reinstatement. We report a case of a 37-year-old man with acute myeloid leukemia (AML) who was able to return to work by performing High-Intensity Interval Training (HIIT) after the remission. The diagnosis of AML was made and the treatment started in January X, and the patient reached remission and discharged in June. However, he developed herpes zoster and was unable to return to his job. The patient was referred to our hospital for rehabilitation treatment in December X. The rehabilitation treatment included 40-min HIIT twice a week and commuting practice, as well as gradual support for return-to-work. Cardiopulmonary function improved from 19.2 to 25.7 mL/min/kg of oxygen uptake at anaerobic metabolic threshold, lower limb muscle strength improved from 0.47/0.48 to 0.60/0.55 kgf/kg of knee extension muscle strength ratio (right/left), physical function improved from 14 to 24 times in 30-second chair stand test, Cancer Fatigue Scale improved from 46 to 25 points, and the patient was able to work full time in May X＋1. HIIT improved cardiopulmonary function, muscle strength, physical function, and fatigue, and enabled the patient to return to work. Even after remission, some patients have difficulty returning to work. The results suggest that appropriate follow-up, exercise guidance, and rehabilitation therapy are necessary even after treatment.

Background: and Purpose To assess the long-term outcomes of intracranial dural arteriovenous fistula (DAVF) treated with stereotactic radiosurgery (SRS) alone or embolization and SRS (Emb-SRS) and to develop a grading system for predicting DAVF obliteration. Methods: This multi-institutional retrospective study included 200 patients with DAVF treated with SRS or Emb-SRS. We investigated the long-term obliteration rate and obliteration-associated factors. We developed a new grading system to estimate the obliteration rate. Additionally, we compared the outcomes of SRS and Emb-SRS by using propensity score matching. Results: The 3- and 4-year obliteration rates were 66.3% and 78.8%, respectively. The post-SRS hemorrhage rate was 2%. In the matched cohort, the SRS and Emb-SRS groups did not differ in the rates of obliteration (P=0.54) or post-SRS hemorrhage (P=0.50). In multivariable analysis, DAVF location and cortical venous reflux (CVR) were independently associated with obliteration. The new grading system assigned 2, 1, and 0 points to DAVFs in the anterior skull base or middle fossa, DAVFs with CVR or DAVFs in the superior sagittal sinus or tentorium, and DAVFs without these factors, respectively. Using the total points, patients were stratified into the highest (0 points), intermediate (1 point), or lowest (≥2 points) obliteration rate groups that exhibited 4-year obliteration rates of 94.4%, 71.3%, and 60.4%, respectively (P<0.01). Conclusions SRS-based therapy achieved DAVF obliteration in more than three-quarters of the patients at 4 years of age. Our grading system can stratify the obliteration rate and may guide physicians in treatment selection.

Background and Objectives: The influence of pre-intervention coronary physiologic status on outcomes post percutaneous coronary intervention (PCI) is not well known. We sought to investigate the prognostic implications of pre-PCI fractional flow reserve (FFR) combined with post-PCI FFR. Methods: A total of 1,479 PCI patients with pre-and post-PCI FFR data were analyzed. The patients were classified according to the median values of pre-PCI FFR (0.71) and post-PCI FFR (0.88). The primary outcome was target vessel failure (TVF) at 2 years. Results: The risk of TVF was higher in the low pre-PCI FFR group than in the high pre-PCI FFR group (hazard ratio, 1.82; 95% confidence interval, 1.15–2.87; p=0.011). In 4 group comparisons, the cumulative incidences of TVF at 2 years were 3.8%, 4.1%, 4.8%, and 10.2% in the high pre-/high post-, low pre-/high post-, high pre-/low post-, and low pre-/low post-PCI FFR groups, respectively. The risk of TVF was the highest in the low pre-/low post-PCI FFR group among the groups (p values for comparisons <0.05). In addition, the high pre-/low post-PCI FFR group presented a comparable risk of TVF with the high post-PCI FFR groups (p values for comparison >0.05). When the prognostic value of the post-PCI FFR was evaluated according to the pre-PCI FFR, the risk of TVF significantly decreased with an increase in postPCI FFR in the low pre-PCI FFR group, but not in the high pre-PCI FFR group. Conclusions Pre-PCI FFR was associated with clinical outcomes after PCI, and the prognostic value of post-PCI FFR differed according to the pre-PCI FFR.

Background/Aims: The Japan Gastroenterological Endoscopy Society (JGES) has published guidelines for gastroenterological endoscopy in patients undergoing antithrombotic treatment. These guidelines classify endoscopic ultrasound-guided biliary drainage (EUS-BD) as a high-risk procedure. Nevertheless, the bleeding risk of EUS-BD in patients undergoing antithrombotic therapy is uncertain. Therefore, this study aimed to assess the bleeding risk in patients undergoing antithrombotic therapy. Methods: This single-center retrospective study included 220 consecutive patients who underwent EUS-BD between January 2013 and December 2018. We managed the withdrawal and continuation of antithrombotic agents according to the JGES guidelines. We compared the bleeding event rates among patients who received and those who did not receive antithrombotic agents. Results: A total of 18 patients (8.1%) received antithrombotic agents and 202 patients (91.8%) did not. Three patients experienced bleeding events, with an overall bleeding event rate of 1.3% (3/220): one patient was in the antithrombotic group (5.5%) and two patients were in the non-antithrombotic group (0.9%) (p=0.10). All cases were moderate. The sole thromboembolic event (0.4%) was a cerebral infarction in a patient in the non-antithrombotic group. Conclusions The rate of EUS-BD-related bleeding events was low. Even in patients receiving antithrombotic therapy, the bleeding event rates were not significantly different from those in patients not receiving antithrombotic therapy.

Background/Aims: The Japan Gastroenterological Endoscopy Society (JGES) has published guidelines for gastroenterological endoscopy in patients undergoing antithrombotic treatment. These guidelines classify endoscopic ultrasound-guided biliary drainage (EUS-BD) as a high-risk procedure. Nevertheless, the bleeding risk of EUS-BD in patients undergoing antithrombotic therapy is uncertain. Therefore, this study aimed to assess the bleeding risk in patients undergoing antithrombotic therapy. Methods: This single-center retrospective study included 220 consecutive patients who underwent EUS-BD between January 2013 and December 2018. We managed the withdrawal and continuation of antithrombotic agents according to the JGES guidelines. We compared the bleeding event rates among patients who received and those who did not receive antithrombotic agents. Results: A total of 18 patients (8.1%) received antithrombotic agents and 202 patients (91.8%) did not. Three patients experienced bleeding events, with an overall bleeding event rate of 1.3% (3/220): one patient was in the antithrombotic group (5.5%) and two patients were in the non-antithrombotic group (0.9%) (p=0.10). All cases were moderate. The sole thromboembolic event (0.4%) was a cerebral infarction in a patient in the non-antithrombotic group. Conclusions The rate of EUS-BD-related bleeding events was low. Even in patients receiving antithrombotic therapy, the bleeding event rates were not significantly different from those in patients not receiving antithrombotic therapy.

Background and Objectives: Recent guideline recommends evaluation using of coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) in patients with functionally insignificant stenosis. We evaluated clinical implications of CFR and IMR in patients with high fractional flow reserve (FFR) and deferred revascularization. Methods: A total of 867 patients (1,152 vessels) consigned to deferred revascularization who underwent comprehensive physiologic assessments were enrolled. Patients with high FFR (>0.80) were categorized by CFR (≤2) and IMR (≥23 U). Clinical outcome was assessed by patient-oriented composite outcome (POCO), a composite of any death, myocardial infarction (MI), and revascularization at 5 years. Results: Patients with low CFR (≤2) showed significantly greater risk of POCO than those with high CFR (>2) in both high-FFR (p=0.024) and low-FFR (p=0.034) groups. In patients with high FFR, those with low CFR and high IMR (overt microvascular disease) displayed the greatest risk of POCO overall (p=0.015), surpassing those with high CFR and low IMR (HR, 2.873; 95% CI, 1.476–5.594; p=0.002) and showing significantly greater risk of cardiac death or MI (HR, 5.662; 95% CI, 1.984–16.154; p=0.001). Overt microvascular disease was independently associated with POCO in the high-FFR population (HR, 2.282; 95% CI, 1.176–4.429; p=0.015). Conclusion Among patients with deferred revascularization, those with low CFR showed significantly greater risk of POCO than those with high CFR, regardless of FFR. In patients with high FFR, those with overt microvascular disease showed significantly greater risk of POCO and cardiac death or MI at 5-year, compared with the others.