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.

Prior to the current pandemic caused by Coronavirus disease 2019 (COVID-19), there was a worldwide pandemic of H1N1 subtype influenza during 1918-1920. One of the most notable records of treatment in Japan is the story of Hiroaki Kimura in Tokyo. He used a formula including saikatsugekito and no patients died. The case was a 31-year-old woman testing positive for COVID-19 was treated with kakkonto (ge-gen-tang) and shosaikotokakikyosekko as an approximate prescription for saikatsugekito for one week from the first day of follow-up at the hotel. On the first day of treatment, the patient had severe headache, decreased oxygen saturation, increased heart rate and shortness of breath at rest as well as during physical activity, and the next day, smell and taste disorders appeared. However, by the time she left the hotel, these symptoms almost completely disappeared. This suggests the efficacy of combination of kakkonto and shosaikotokakikyosekko. Since COVID-19 often presents with symptoms of the interior organs from the early stage of the disease, combination of kakkonto and shosaikotokakikyosekko is considered to be one of the options of Kampo treatment for COVID-19.

We report a case of aortic arch replacement and extraanatomic bypass from a branched graft to both bifemoral arteries in a patient with aortic dissection complicated by ischemia in the lower extremities. A 61-year-old woman was found to have thrombosed type II aortic dissection by enhanced computed tomography (CT). Because she had no clinical symptoms, we chose conservative pharmacotherapy. A year later, she suddenly felt severe back pain and dyspnea. CT demonstrated type IIIb aortic dissection. She developed lower extremity ischemia because the true lumen in the abdominal aorta was severely compressed by the false lumen. Two weeks after onset, we planned a bilateral axillo-femoral bypass because the right lower limb ischemia had worsened, with severe pain. However, CT showed ascending aortic dissection. Hence, emergency graft replacement of aortic arch was required. A T-shaped graft was anastomosed to the bilateral femoral arteries, and was used as a delivery line during cardiopulmonary bypass. Although distal anastomosis of the arch was constructed only to the true lumen, leg ischemia persisted. Therefore, the T-shaped graft was connected to the branched graft used for antegrade systemic perfusion. We used INVOS as an indicator of intraoperative lower limb ischemia, which was useful for judging whether or not revascularization of lower extremity was achieved. After the operation, the bypass graft was patent, and ischemia in the lower extremities disappeared.

Background: Time series analysis is suitable for investigations of relatively direct and short-term effects of exposures on outcomes. In environmental epidemiology studies, this method has been one of the standard approaches to assess impacts of environmental factors on acute non-infectious diseases (e.g. cardiovascular deaths), with conventionally generalized linear or additive models (GLM and GAM). However, the same analysis practices are often observed with infectious diseases despite of the substantial differences from non-infectious diseases that may result in analytical challenges. Methods: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, systematic review was conducted to elucidate important issues in assessing the associations between environmental factors and infectious diseases using time series analysis with GLM and GAM. Published studies on the associations between weather factors and malaria, cholera, dengue, and influenza were targeted. Findings: Our review raised issues regarding the estimation of susceptible population and exposure lag times, the adequacy of seasonal adjustments, the presence of strong autocorrelations, and the lack of a smaller observation time unit of outcomes (i.e. daily data). These concerns may be attributable to features specific to infectious diseases, such as transmission among individuals and complicated causal mechanisms. Conclusion: The consequence of not taking adequate measures to address these issues is distortion of the appropriate risk quantifications of exposures factors. Future studies should pay careful attention to details and examine alternative models or methods that improve studies using time series regression analysis for environmental determinants of infectious diseases.

Background: Time series analysis is suitable forinvestigations of relatively direct and short-term effects of exposures on outcomes.In environmental epidemiology studies, this method has been one of the standardapproaches to assess impacts of environmental factors on acute non-infectious diseases(e.g. cardiovascular deaths), with conventionally generalized linear or additivemodels (GLM and GAM). However, the same manner of practices of this method is observedwith infectious diseases despite of the substantial differences fromnon-infectious diseases which may result in analytical challenges. Methods: Following Preferred ReportingItems for Systematic Reviews and Meta-Analyses guideline, systematic review wasconducted to elucidate important issues in assessing the associations betweenenvironmental factors and infectious diseases using time series analysis withGLM or GAM. Published studies in relation to associations between weatherfactors, and malaria, cholera, dengue, or influenza were targeted. Findings: Issues regarding theestimation of susceptible population and exposure lag times, adequacy ofseasonal adjustments, the presence of strong autocorrelations, and a lack of smallerobservation time unit of outcomes (i.e. daily data) were raised from our review.These concerns may be attributed to the features specific to infectious diseases,such as transmissions among individuals and complicated causal mechanisms. Conclusion: The consequence of not takingadequate measures to address these issues is distortion of the appropriate riskquantifications of exposures factors. The future studies are required careful attentionsto details, and recommended to examine alternative models or methods thatimprove studies with time series regression analysis for environmental determinantsof infectious diseases.

Miriplatin is a novel lipophilic platinum complex that was developed to treat hepatocellular carcinoma (HCC). Although HCC patients frequently have coexisting chronic renal failure, little prospective data are available regarding the clinical toxicity of chemotherapeutic agents used to treat HCC patients with chronic renal failure. In a phase II study, the plasma concentration of total platinum in patients who received miriplatin was very low, and no severe renal toxicity caused by miriplatin injection was reported. Here, we present three cases of HCC with stage 4 chronic renal failure who received transcatheter arterial chemotherapy with miriplatin. All cases were male, ages 72, 84, and 83 years, and had serum creatinine levels of 2.3, 1.6, and 1.9 mg/dL, respectively. Their estimated glomerular filtration rates were 21.9, 20.3, and 22.2 mL/min, respectively. All cases were treated for unresectable HCC with transcatheter arterial chemotherapy with miriplatin. No serious adverse events were observed, and serum creatinine levels did not elevate, even in the patient who experienced renal failure caused by cisplatin administration. These results might suggest that transcatheter arterial chemotherapy with miriplatin can be safely used in HCC patients with chronic renal failure.
Carcinoma, Hepatocellular ; Cisplatin ; Creatinine ; Glomerular Filtration Rate ; Humans ; Kidney Failure, Chronic ; Male ; Organoplatinum Compounds ; Plasma ; Platinum ; Renal Insufficiency

  The patient was a woman in her 80s, who was referred to the palliative care team in our hospital for pain due to bone metastases from lung cancer. Although gabapentin and ifenprodil tartrate were administrated in addition to opioids and loxoprofen sodium, and the dose of opioids was increased, pain was not relieved remarkably. A switch from gabapentin to pregabalin brought remarkable pain relief. Before the internal use of pregabalin, the patient was often seen lyiing in bed because of pain. However, by pregabalin, she began to walk, pushing her wheelchair and smile often. Her ability to perform the basic activities of daily living was improved. The switch from gabapentin to pregabalin was one effective option when an analgesic adjuvant for cancer pain was chosen.

A patient with uterine cervical cancer underwent radical operation and radiotherapy in 1956 and subsequently began to suffer from impaired bowel movements. For the next 40 years, a large amount of cathartics was used to induce defecation, a urination was induced by applying abdominal pressure, but a large volume of urine remained. In this patient, the effects of acupuncture treatment were evaluated using the vesical residual urine volume as measured by abdominal ultrasonography. After acupuncture treatment, defecation became easily, and the amount of cathartics could be reduced. Simultaneously, spontaneous urination became possible, and residual urine disappeared.

From 1985 through 1994, 12 consecutive patients with Taussig-Bing anomaly underwent an arterial switch. Age at operation varied from 8 to 42 months (mean 21 months). Coarctation of the aorta was present in 6 patients (including 4 with hypoplasia of the aortic arch), interruption of the aortic arch in one, straddling mitral valve in one and subaortic stenosis in two. The relationship of the great arteries was D-transposition in 11 patients (oblique in 6 and anteroposterior in 5) and side-by-side in one. Eleven patients had previous palliative surgery. Pulmonary artery banding was done in 11 patients, Blalock-Hanlon in 3, carotid flap aortoplasty in 3, subclavian flap aortoplasty in 2, extended aortic arch anastomosis in 2 and ligation of PDA in 1. The Lecompte maneuver was adopted in all but one patient with side-by-side great vessels. Intraventricular reconstruction was done through the right ventricle in 11 patients and through the right atrium in one who underwent one-stage repair. There was one early death, which was related to thrombosis of the superior mesenteric artery. One patient with side-by-side great vessels died at home 6 months after the arterial switch operation. The suspected cause of death was myocardial infarction due to compression of the left coronary artery by the pulmonary artery. In the follow-up of 10 patients ranging from 1.8 to 9.4 years (average 6.3 years), one required reoperation for pulmonary stenosis. We conclude that two-staged arterial switch operation of Taussig-Bing anomaly with D-transposition can be performed with low mortality, but there seems to be some risk of the compression of the left coronary artery in the original Jatene method for Taussig-Bing anomaly with side-by-side great vessels.

A 5-year-old boy with tricuspid atresia who underwent the Björk procedure died due to right atrial thrombus and left pulmonary embolus 37 days after operation. It is suggested that thromboembolism may be a frequent complication after the Björk procedure due to the turbulent blood flow at the right atrio-ventricular anastomosis and also due to congestive blood flow. Anticoagulation therapy seems to be essential for postoperative management.