Comparison of Intravenous Acetaminophen and Intravenous Patient-Controlled Analgesia Fentanyl after Total Hip Arthroplasty: A Multicenter Randomized Controlled Trial.

BACKGROUND: Opioids often need to be discontinued because they cause nausea, whereas the administration of intravenous acetaminophen (APAP) causes less nausea and vomiting. This study aimed to compare the effects of fentanyl-based intravenous patient-controlled analgesia (IV-PCA) and intravenous APAP on pain and nausea after total hip arthroplasty (THA). METHODS: We prospectively investigated primary THA patients who underwent the anterolateral supine approach at four centers between October 2021 and October 2022. The patients (n = 178) were divided randomly into IV-PCA (n = 88) and APAP groups (n = 90). Rest pain, motion pain, and nausea were assessed using NRS scores. RESULTS: Compared with the APAP group, the IV-PCA group experienced significantly greater resting pain and nausea on postoperative day 1. A correlation was found between preoperative and postoperative pain. Postoperative nausea at 8 h was significantly correlated with pain at rest at 4 h (r = 0.193), 8 h (r = 0.194), day 1 (r = 0.245), and day 2 (r = 0.188) after surgery. Early postoperative pain and nausea correlated with subsequent pain and nausea. CONCLUSIONS: Intravenous APAP is associated with less pain and nausea and is superior to IV-PCA.

Relationship between the Hip Abductor Muscles and Abduction Strength in Patients with Hip Osteoarthritis.

This study aimed to determine which muscle the gluteus maximus, gluteus medius, gluteus minimus (Gmin), or tensor fasciae latae (TFL) contributes most to hip abduction strength and to identify effective sites for cross-sectional area (CSA) Gmin and TFL measurement in hip osteoarthritis (OAhip) patients. Twenty-eight patients with OAhip were included. The muscle CSA and volume were determined using magnetic resonance imaging. Peak isometric strength was determined using hand-held dynamometry. Muscle volumes were normalized to the total muscle volume of hip abductors. Multiple regression analysis was performed. The difference between the CSA of Gmin and TFL was calculated, and correlations with volume and muscle strength were determined. Gmin volume was related to abductor muscle strength (p=0.042). The peak CSA of the Gmin correlated with muscle volume and strength. The CSA of the TFL correlated with volume, with no difference between the CSA of the most protruding part of the lesser trochanter and peak CSA. Gmin volume was strongly related to abductor muscle strength. Peak CSA is a useful parameter for assessing the CSA of the Gmin among patients with OAhip. The CSA of the TFL should be measured at the most protruding part of the lesser trochanter.

Lethal ventricular arrhythmia due to entrectinib-induced Brugada syndrome: a case report and literature review.

Entrectinib, a multikinase inhibitor of ROS1 and tropomyosin receptor kinases, is recommended to treat ROS1-positive metastatic non-small cell lung cancer (NSCLC). In a previous study, entrectinib-related cardiotoxicity occurred in 2% of patients; however, lethal arrhythmias remain understudied. We encountered a case of fatal arrhythmia due to drug-induced Brugada syndrome caused by entrectinib. An 81-year-old Japanese male with lung adenocarcinoma harboring ROS1-fusion gene was treated with entrectinib. The patient developed lethal arrhythmias three days after drug initiation, including ventricular tachycardia with Brugada-like electrocardiogram changes. Echocardiography and coronary angiography revealed no evidence of acute coronary syndrome or myocarditis. Following the termination of entrectinib, the electrocardiogram abnormality improved within 12 days. Hence, paying special attention to and monitoring electrocardiogram changes is necessary. In addition, it is also necessary to consider early therapeutic interventions and discontinuation of the drug in cases of drug-induced Brugada syndrome.

Analysis of Phase Angle and Balance and Gait Functions in Pre-Frail Individuals: A Cross-Sectional Observational Study.

We measured the muscle mass and phase angle of each body part to evaluate the relationship between balance and gait functions in individuals with a pre-frailty status. This cross-sectional observational study determined the skeletal muscle mass-to-body weight ratio and phase angles of 21 control (robust) and 29 pre-frail subjects. Their Brief-Balance Evaluation Systems Test, Timed Up-and-Go (TUG) test, Life-Space Assessment, and Modified Fall Efficacy Scale scores plus the relationship between muscle mass, phase angle, and motor function were evaluated. In the pre-frailty group (three males, 26 females, aged 75.58±7.60 years), significant correlations were noted between the Brief-Balance Evaluation Systems Test score and lower-limb (r=0.614) and wholebody (r=0.557) phase angles, and between the TUG test score and lower-limb muscle mass-to-body weight ratio (r=-0.616), lower-limb phase angle (r=-0.616), and whole-body phase angle (r=-0.527). Evaluating the phase angle of the lower extremities of pre-frail patients and intervening accordingly may help clinicians maintain and improve these patients' balance and gait functions.

Sense of Coherence as a Mediator in the Association Between Empathy and Moods in Healthcare Professionals: The Moderating Effect of Age.

While empathy is considered a critical determinant of the quality of medical care, growing evidence suggests it may be associated with both one's own positive and negative moods among healthcare professionals. Meanwhile, sense of coherence (SOC) plays an essential role in the improvement of both psychological and physical health. Reportedly, individual SOC reaches full stability after around age 30. The aim of this study was first to evaluate the mediatory role of SOC on the association between empathy and individual moods among 114 healthcare professionals in a general hospital, and then to examine the moderating effect of age on this association. Participants completed a range of self-report demographic questionnaires, Empathy Process Scale (EPS), the 13-item Antonovsky's SOC, and Profile of Mood States (POMS). Findings showed that SOC mediated the relations between empathy (EPS) and both POMS-Vigor (POMS-V: self-vigor mood) and POMS-Depression (POMS-D: self-depression mood). Notably, moderated mediation analysis revealed that there was a significant interaction (age × SOC) on self-vigor mood (POMS-V) in healthcare professionals. The indirect effect of empathy (EPS) on self-vigor mood (POMS-V) through SOC was significant at over mean age "32.83." Although there was no significant interaction with age regarding the indirect effect of empathy (EPS) on self-depression mood (POMS-D), in the sub-category level analysis of empathy (EPS), we found a significant interaction item [age × empathy for other's negative affect (EPS-N)] on SOC. This indirect effect was also significant at over mean age "32.83." Taken, together, the current study highlighted the significant mediator of SOC on that empathy amplifies self-vigor mood and attenuates self-depression mood as a protective factor among the Japanese healthcare professionals. Some components of these processes may depend on the moderating role of age, indicating that we may need to consider the SOC development with age for more effective empathy performance interventions among healthcare professionals.

Impact of chronological age on efficacy and safety of fluoropyrimidine plus bevacizumab in older non-frail patients with metastatic colorectal cancer: a combined analysis of individual data from two phase II studies of patients aged >75 years.

OBJECTIVE: Many clinical trials for older patients with metastatic colorectal cancer have been conducted, and fluoropyrimidine and bevacizumab are standard treatments. However, the relationship between age and the efficacy and safety of this treatment is unclear in older metastatic colorectal cancer patients. METHODS: Individual data from two phase II studies on older (≥75 years), non-frail patients with metastatic colorectal cancer treated with uracil-tegafur/leucovorin or S-1 combined with bevacizumab were collected. Patient characteristics were evaluated with multiple regression analyses for survival outcomes, using the Cox proportional hazard model and linear regression analyses for the worst grade of adverse events. RESULTS: We enrolled 102 patients with a median age of 80 years (range, 75-88 years). Of the 70 patients who died, seven (10%) died of causes unrelated to disease or treatment. The study treatment was discontinued due to adverse events in 19 patients (18.6%), with 63% aged ≥85 years. The adverse event that most commonly resulted in treatment discontinuation was grade 2 fatigue (21%). Chronological age was not associated with progression-free survival (Hazard ratio, 1.03; P = 0.40) or overall survival (Hazard ratio, 1.02; P = 0.65). Age was weakly associated with non-hematologic adverse events (regression coefficient [R], 0.27; P = 0.007), especially fatigue (R, 0.23; P = 0.02) and nausea (R, 0.19; P = 0.06), but not with hematologic (R, 0.05; P = 0.43) or bevacizumab-related (R, -0.06; P = 0.56) adverse events. CONCLUSIONS: The efficacy of fluoropyrimidine plus bevacizumab was age-independent in patients with metastatic colorectal cancer aged ≥75 years, and attention should be paid to non-hematologic adverse events as age increases.

Fat embolism syndrome in a patient with a right undisplaced femoral neck fracture.

Fat embolism syndrome (FES) is a rare condition characterised by the classic triad of respiratory distress, neurologic symptoms and petechial rash. Here, we encountered a case of FES in a patient with an asymptomatic right undisplaced femoral neck fracture (Garden Stage II). FES was diagnosed based on the Gurd and Willson's diagnostic criteria and brain magnetic resonance imaging features. To the best of our knowledge, this is the first case of FES in a patient with an undisplaced femoral neck fracture. This study highlights the importance of considering the possibility of FES even in patients with undisplaced femoral neck fractures.

Three-year outcomes of a randomized phase III trial comparing adjuvant chemotherapy with S-1 plus docetaxel versus S-1 alone in stage III gastric cancer: JACCRO GC-07.

PURPOSE: The second planned interim analysis (median follow-up 12.5 months) in a phase III trial of postoperative adjuvant chemotherapy for stage III gastric cancer revealed significant improvement in relapse-free survival (RFS) for S-1 plus docetaxel over S-1 alone. Although enrollment was terminated on the recommendation of the independent data and safety monitoring committee, we continued follow-up and herein report on 3-year RFS, the primary endpoint. PATIENTS AND METHODS: Patients with histologically confirmed stage III gastric cancer who underwent gastrectomy with D2 lymphadenectomy were randomly assigned to receive adjuvant chemotherapy with either S-1 plus docetaxel or S-1 alone. In the S-1 plus docetaxel group, S-1 was given orally for 2 weeks followed by 1 week of rest for seven courses, and docetaxel was given intravenously on day 1 of the second to seventh courses. The combination therapy was followed by S-1 monotherapy for up to 1 year. RESULTS: The 3-year RFS rate of the S-1 plus docetaxel group was 67.7%. This was significantly superior to that of 57.4% in the S-1 group (hazard ratio [HR] 0.715, 95% CI 0.587-0.871, P = 0.0008). This translated into a significant benefit in the 3-year overall survival (OS) rate in the S-1 plus docetaxel group (77.7% versus 71.2%, HR 0.742, 95% CI 0.596-0.925, P = 0.0076). CONCLUSION: On 3-year follow-up data, postoperative adjuvant therapy with S-1 plus docetaxel was confirmed to improve both RFS and OS and can be recommended as a standard of care for patients with stage III gastric cancer treated by D2 dissection.

Cancer-related FGFR2 overexpression and gene amplification in Japanese patients with gastric cancer.

OBJECTIVE: Fibroblast growth factor receptor 2 (FGFR2) has been proposed as a novel druggable target in unresectable gastric cancer. FGFR2 alteration has been reported as associated with poor prognosis even in patients with gastric cancer who received systemic chemotherapy. This study aimed to evaluate the frequency of FGFR2 overexpression and gene amplification in clinical specimens from Japanese patients with recurrent or unresectable gastric cancer. METHODS: This observational study enrolled patients who were histologically or cytologically confirmed with unresectable HER2-negative or unknown gastric or gastroesophageal junctional adenocarcinoma treated with at least one previous chemotherapy. FGFR2 overexpression and gene amplification in the specimens were evaluated by immunohistochemical staining and fluorescence in situ hybridization methods, respectively. RESULTS: In a total of 173 eligible cases, FGFR2 immunohistochemistry score was evaluated as 0, 1, 2, 3 and 4 for 20, 80, 35, 28 and 10 cases, respectively. In 151 evaluable cases with FGFR2 immunohistochemistry scores of 1-4, FGFR2 copy number expressed as fluorescence in situ hybridization signals were detected as <4, ≥4 < 10 and ≥10 copies for 123, 16 and 12 cases, respectively. FGFR2 copy number showed an increasing tendency along with higher FGFR2 immunohistochemistry scores in the corresponding specimen. The response rate and time to treatment failure for first line chemotherapy did not have any obvious relationship to FGFR2 immunohistochemistry score and FGFR2 copy number. CONCLUSIONS: Although FGFR2 overexpression and gene amplification were shown in Japanese patients with unresectable gastric cancer, these alterations did not impact the effects of cytotoxic agents as first line chemotherapy.

The protective effect of tight-fitting powered air-purifying respirators during chest compressions.

BACKGROUND: Airborne personal protective equipment is required for healthcare workers when performing aerosol-generating procedures on patients with infectious diseases. Chest compressions, one of the main components of cardiopulmonary resuscitation, require intense and dynamic movements of the upper body. We aimed to investigate the protective effect of tight-fitting powered air-purifying respirators (PAPRs) during chest compressions. METHODS: This single-center simulation study was performed from February 2021 to March 2021. The simulated workplace protection factor (SWPF) is the concentration ratio of ambient particles and particles inside the PAPR mask; this value indicates the level of protection provided by a respirator when subjected to a simulated work environment. Participants performed continuous chest compressions three times for 2 min each time, with a 4-min break between each session. We measured the SWPF of the tight-fitting PAPR during chest compression in real-time mode. The primary outcome was the ratio of any failure of protection (SWPF <500) during the chest compression sessions. RESULTS: Fifty-four participants completed the simulation. Overall, 78% (n = 42) of the participants failed (the measured SWPF value was less than 500) at least one of the three sessions of chest compressions. The median value and interquartile range of the SWPF was 4304 (685-16,191). There were no reports of slipping down of the respirator or mechanical failure during chest compressions. CONCLUSIONS: Although the median SWPF value was high during chest compressions, the tight-fitting PAPR did not provide adequate protection.

Appropriate sites for the measurement of the cross-sectional area of the gluteus maximus and the gluteus medius muscles in patients with hip osteoarthritis.

PURPOSE: To evaluate the relationship between the volume, cross-sectional area, and peak isometric muscle strength of the gluteus maximus and gluteus medius muscles in patients with hip osteoarthritis, and to use this information to identify effective sites for measurement of the cross-sectional area of these muscles. METHODS: Twenty-four patients with hip osteoarthritis were included. The muscle cross-sectional area and volume were calculated from magnetic resonance images. The cross-sectional area was calculated at three levels: the inferior point of the sacroiliac joint, just above the femoral head, and at the greatest muscle diameter. Peak isometric strength was assessed using hand-held dynamometry, using the extension and external rotation for the gluteus maximus and abduction and internal rotation for the gluteus medius. Measured outcomes were compared between the two muscles, and the association between muscle volume, cross-sectional area, and peak isometric muscle strength was evaluated using Pearson's correlation. RESULTS: Volume was correlated with the cross-sectional area in the gluteus maximus (r ≥ 0.707) and with the cross-sectional area (r ≥ 0.637) and peak isometric strength (r ≥ 0.477) in the gluteus medius. There was no difference between the cross-sectional area measured at the greatest muscle diameter and just above the femoral head (p = 0.503) for the gluteus maximus and at the inferior point of the sacroiliac joint (p = 0.651) for the gluteus medius. CONCLUSION: The cross-sectional area, when used to calculate the muscle volume, should be evaluated just above the femoral head for the gluteus maximus and at the inferior point of the sacroiliac joint for the gluteus medius.

Three-dimensional Evaluation of Abnormal Gait in Patients with Hip Osteoarthritis.

Indexes for objectively evaluating abnormal gait in hip osteoarthritis (OA) patients and determining effective interventions are unclear. We analyzed the abnormal gait of hip OA patients by focusing on movements of the trunk and pelvis to establish an effective evaluation index for each direction of motion. We studied 28 patients with secondary hip OA due to developmental dysplasia of the hip and 16 controls. The trunk and pelvic movements during gait were measured in the medial-lateral (x), vertical (y), and back-and-forth (z) directions by a triaxial angular accelerometer. Gait speed, steps, step length, muscle strength, range of motion, and timed up-and-go (TUG) test performance were measured. We determined the correlations between physical function and the index of abnormal gait in the hip OA patients. Movements other than trunk and pelvic motions in the y-direction indicated abnormal gait in the patients. Significant correlations were found between abnormal gait and range of motions (extension, internal rotation), TUG score, stride length, and steps. The TUG test, stride length and steps were important for evaluating abnormal gait in hip OA patients. Individual interventions for each movement direction are required.

Relative bradycardia as a clinical feature in patients with coronavirus disease 2019 (COVID-19): A report of two cases.

We treated two patients with COVID-19 pneumonia requiring mechanical ventilation. Case 1 was a 73-year-old Japanese man. Computed tomography (CT) revealed ground-glass opacities in both lungs. He had severe respiratory failure with a partial pressure of oxygen in arterial blood/fraction of inspiratory oxygen ratio (P/F ratio) of 203. Electrocardiogram showed a heart rate (HR) of 56 beats/min, slight ST depression in leads II, III, and aVF, and mild saddle-back type ST elevation in leads V1 and V2. High-sensitivity cardiac troponin T (cTnT) level was slightly elevated. Despite a high fever and hypoxemia, his HR remained within 50-70 beats/min. Case 2 was a 52-year-old Japanese woman. CT revealed ground-glass opacities in the lower left lung. Electrocardiogram showed a HR of only 81 beats/min, despite a body temperature of 39.2 °C, slight ST depression in leads V4, V5, V6, and a prominent U wave in multiple leads. She had an elevated cTnT and a P/F ratio of 165. Despite a high fever and hypoxemia, her HR remained within 50-70 beats/min. Both patients had a poor compensatory increase in their HR, despite their critical status. Relative bradycardia could be a cardiovascular complication and is an important clinical finding in patients with COVID-19. .

Phase II study of S-1 on alternate days plus bevacizumab in patients aged ≥ 75 years with metastatic colorectal cancer (J-SAVER).

BACKGROUND: Alternate-day administration of S-1 is thought to reduce toxicities. This phase II study evaluated S-1 on alternate days combined with bevacizumab as first-line treatment for elderly patients with metastatic colorectal cancer. PATIENTS AND METHODS: Eligible patients had histologically proven colorectal adenocarcinoma, measurable metastatic lesions, age ≥ 75 years, Eastern Cooperative Oncology Group performance status ≤ 1, no previous chemotherapy, and refused oxaliplatin- or irinotecan-containing regimens. Patients received 40 mg, 50 mg, or 60 mg (body surface area ≤ 1.25 m2, > 1.25 to ≤ 1.50 m2, or > 1.50 m2, respectively) of S-1 twice orally on Sunday, Monday, Wednesday, and Friday every week. Bevacizumab (7.5 mg/kg) was administered every 3 weeks. The primary endpoint was progression-free survival. RESULTS: Of 54 enrolled patients, 50 patients were evaluated for efficacy and 53 for safety. The median age was 79 years (range 75-88 years). The median progression-free survival was 8.1 months (95% confidence interval (CI) 6.7-9.5 months). The median overall survival was 23.1 months (95% CI 17.4-28.8 months). The response rate was 44% (95% CI 30.2-57.8%), and the disease control rate was 88% (95% CI 79.0-97.0%). Grade 3 or higher hematologic, non-hematologic, and bevacizumab-related adverse events occurred in 9%, 11%, and 25% of patients, respectively. The most common grade 3 and 4 treatment-related adverse events were hypertension (11%), nausea (6%), fatigue (6%), anemia (6%), and proteinuria (6%). Only 6 patients discontinued treatment due to adverse events. CONCLUSION: S-1 on alternate days combined with bevacizumab showed better tolerability and comparable survival compared with the results of similar studies.

Randomized Controlled Trial Comparing the Effects of Vonoprazan Plus Rebamipide and Esomeprazole Plus Rebamipide on Gastric Ulcer Healing Induced by Endoscopic Submucosal Dissection.

Objective Gastric endoscopic submucosal dissection (ESD) is currently a standard procedure, and proton pump inhibitors (PPIs) are most commonly used to treat post-ESD ulcers. Vonoprazan, a potassium-competitive acid blocker (P-CAB), reportedly inhibits gastric acid secretions more effectively than PPIs. Combination therapy of a PPI plus rebamipide is effective for treating larger ulcers. Our goal was to evaluate the effects of vonoprazan plus rebamipide compared to esomeprazole plus rebamipide for the treatment of post-ESD ulcers. Methods First, vonoprazan plus rebamipide (V group) or esomeprazole plus rebamipide (E group) was orally administered to subjects for eight weeks. We then evaluated the ulcer healing process at four and eight weeks after the procedure using a gastric ulcer stage system and by measuring the ulcer size. Patients A total of 84 patients who underwent ESD for gastric neoplasms between September 2015 and December 2017 in Tsuchiura Kyodo General Hospital were included in this randomized controlled trial. Results The ulcer scar rates at week 4 in the V group (n=43) and E groups (n=39) were 20.9% and 15.4%, while those at week 8 were 90.7% and 92.3%, respectively. The ulcer reduction rates at week 4 in the V and E groups were 94.6% and 93.8%, and those at week 8 were 99.7% and 99.3%, respectively. The ulcer scar rates and reduction rates were not significantly different between the two groups. Conclusion Combination therapy consisting of vonoprazan plus rebamipide was not superior to that of esomeprazole plus rebamipide for post-ESD ulcer healing (UMIN000019516).

Investigation on the measurement sites of the cross-sectional areas of the gluteus maximus and gluteus medius.

PURPOSES: To verify the relationship between muscle volume and muscular strength of different cross-sectional areas (CSAs) of the gluteus maximus and medius, and to clarify the effective evaluation index. METHODS: Twenty healthy adults were enrolled in this cross-sectional study. Magnetic resonance images were evaluated, and CSAs of the gluteus maximus and medius were calculated. Calculation sites were the peak CSA, lowest end of the sacroiliac joint CSA, and just above the femoral head CSA. Muscle volume and muscular strength were measured. The correlation between muscular CSA, muscle volume, and muscular strength was verified using Pearson's correlation coefficient (p < 0.05). One-way analysis of variance and the Tukey-Kramer test were used to verify differences in each CSA (p < 0.05). RESULTS: A significantly positive correlation was found between muscular CSA, muscle volume, and muscular strength of both muscles (p < 0.05). For the gluteus maximus, the muscular CSA calculated just above the femoral head showed a significantly larger value than that calculated at the lowest end of the sacroiliac joint (p < 0.05). For the gluteus medius, the peak CSA and muscular CSA calculated at the lowest end of the sacroiliac joint were significantly larger than that calculated just above the femoral head (p < 0.05). CONCLUSIONS: The maximum CSA of the gluteus maximus was found just above the femoral head and that of the gluteus medius was near the lowest end of the sacroiliac joint; hence, CSAs should be calculated at these sites. The CSA reflected muscle volume and strength.

Sex- and age-specific differences in femoral head coverage and acetabular morphology among healthy subjects-derivation of normal ranges and thresholds for abnormality.

OBJECTIVE: We aimed to clarify sex- and age-specific differences in three-dimensional and anatomic characteristics of femoral head coverage and acetabular morphology in healthy subjects. MATERIALS AND METHODS: The study included 120 healthy subjects (57 male, 63 female), stratified into groups according to age and sex. We used computed tomography data to measure various anatomic alignment parameters describing femoral head coverage and acetabular morphology. RESULTS: The lateral sector angle in the coronal plane, anterior sector angle in the sagittal plane, and posterior sector angles in the axial plane, which characterize femoral head coverage, did not differ significantly between males and females. However, the Sharp angle in the coronal plane and acetabular anteversion in both the sagittal and axial planes were significantly larger in females than in males. Overall, the age-specific trends were similar between male and female subjects. Specifically, for both males and females, the values for parameters of femoral head coverage were significantly lower in younger subjects (<50 years) than in older subjects (≥50 years); the only exception was the posterior sector angle among females; regarding acetabular morphology, younger subjects showed significantly higher values for the acetabular roof obliquity and Sharp angle, but no difference between younger and older subjects was noted regarding acetabular anteversion in the sagittal or axial plane. CONCLUSION: Our data regarding sex- and age-specific differences and estimated normal ranges for parameters characterizing femoral head coverage and acetabular morphology among healthy subjects can be used to predict normal hip morphology.

Effects of esomeprazole on the healing process of post-endoscopic submucosal dissection gastric ulcers: a single arm, prospective trial.

Objectives: Gastric endoscopic submucosal dissection (ESD) is currently a standard procedure. ESD enables en-bloc resection of large lesions, while inducing larger artificial ulcers to a greater extent than conventional procedures. Several studies have reported that proton pump inhibitors (PPIs) prevent delayed bleeding and expedite the artificial ulcer healing process. Esomeprazole, an S-isomer of omeprazole, is reportedly one of strongest inhibitors of gastric acid secretion. Previous studies have examined the effectiveness of esomeprazole. Our goal was to verify the effects of esomeprazole on artificial ulcers in a prospective study. Methods: A total of 185 patients underwent ESD for gastric neoplasms at our hospital between January 2013 and June 2015. Among these 185 patients, 49 post-ESD scar lesions were included in this prospective trial. First, 20 mg esomeprazole was orally administered to all subjects before and after the procedure. We then evaluated the delayed bleeding rate and ulcer scarring rates at 4 weeks and 8 weeks after the procedure by using a gastric ulcer stage system. Results: There was one case of delayed bleeding (2.0%). Regardless of Helicobacter pylori infection status, ulcer scarring rates at weeks 4 and 8 were respectively 28.6% (14/49) and 98% (48/49). Conclusions: Our results suggest that oral administration of esomeprazole alone may be sufficient for prompt healing of artificial gastric ulcers induced by ESD (UMIN000009367).

Uracil-Tegafur and Oral Leucovorin Combined With Bevacizumab in Elderly Patients (Aged ≥ 75 Years) With Metastatic Colorectal Cancer: A Multicenter, Phase II Trial (Joint Study of Bevacizumab, Oral Leucovorin, and Uracil-Tegafur in Elderly Patients [J-BLUE] Study).

BACKGROUND: We previously reported that uracil-tegafur with oral leucovorin (UFT/LV) treatment for elderly patients (aged ≥ 75 years) was well-tolerated in a phase II study. In the present study, the efficacy and safety of a modified (1-week shorter administration period) UFT/LV schedule combined with bevacizumab for a similar population are reported. PATIENTS AND METHODS: The present study was a single-arm, open-label, multicenter, cooperative group clinical trial. The key eligibility criteria included age ≥ 75 years, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, first-line chemotherapy, measurable lesions, and preserved organ function. Patients received UFT 300 mg/m(2)/d and LV 75 mg/d on days 1 to 21 and intravenous bevacizumab 5 mg/kg on days 1 and 15. Treatment was repeated every 28 days. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were the objective response rate (ORR), overall survival (OS), and safety. RESULTS: Of the 55 patients enrolled from 15 Japanese institutions, 52 eligible patients were evaluated. Their median age was 80 years (range, 75-87 years), and 73% had an ECOG performance status of 0. The median PFS was 8.2 months (95% confidence interval [CI], 6.2-10 months). The ORR was 40% (95% CI, 27%-55%). The median OS was 23 months (95% CI, 12-33 months). The most common grade 3 and 4 treatment-related adverse events were hypertension (12%), fatigue (8%), anemia (8%), nausea (6%), and diarrhea (6%). Treatment-related death occurred in 2 patients. CONCLUSION: UFT/LV (3 weeks of therapy and 1 week without) combined with biweekly bevacizumab is a tolerable and effective treatment option for elderly patients (aged ≥ 75 years) with metastatic colorectal cancer.

A trial of improvement of immunity in cancer patients by laughter therapy.

PURPOSE: The study was on the impact of laughter therapy on immunological improvement of patients with gastrointestinal cancer undergoing surgery and chemotherapy. MATERIALS & METHOD: Immunological measurements were performed in 41 cases with patients aged 68.9 years suffering from gastric or colorectal cancer. Intervention using Laughter Therapy was applied to 12 out of the 25 patients subjected to laproscopic surgery and 12 out of 19 patients subjected to chemotherapy. RESULTS: Immunity of patients within the control group who had surgery decreased. Immunity of patients within the control group who had chemotherapy decreased. With intervention of Laughter Therapy, the immunity of patients with surgery had either decreased or was the same. However, with intervention of Laughter Therapy using the Smile-Sun Method, the immunity of chemotherapy patients increased, notably in patients with colorectal cancer. The improvement of immunity within the control group was 0 out of 7. CONCLUSION: Patients with advanced cancer have lower immunity which is further decreased with surgery or chemotherapy. Chemotherapy patients who undertook the Laughter Therapy using the Smile-Sun Methodology during treatment in the hospital showed significantly higher immunity levels. The results of this study indicate that patients with gastrointestinal cancer, who undergo laparoscopic surgery or chemotherapy for stomach or colorectal cancer, benefit from a formal program of psychotherapeutic support during the in-patient hospital stay in terms of immunological improvement.