A Combined Index Using the Mini-Mental State Examination and Lawton Index to Discriminate Between Clinical Dementia Rating Scores of 0.5 and 1: A Development and Validation Study.

Objective: To develop a combined index using cognitive function and instrumental activities of daily living (IADL) to discriminate between Clinical Dementia Rating (CDR) scores of 0.5 and 1 in the clinical setting, and to investigate its optimal cutoff values and internal and external validities.Methods: We included outpatients aged 65-89 years with CDR scores of 0.5 or 1. The optimal cutoff values and internal validity were verified using Japanese memory clinic-based datasets between September 2010 and October 2021 [National Center for Geriatrics and Gerontology (NCGG) datasets]. Cognitive function and IADL were assessed using the Mini-Mental State Examination (MMSE) and Lawton Index (LI), respectively. The optimal cutoff values were defined using the Youden Index. To verify internal validity, sensitivity and specificity were calculated using stratified 5-fold cross-validation. To verify external validity, sensitivity and specificity of the optimal cutoff values were assessed in the Organized Registration for the Assessment of dementia on Nationwide General consortium toward Effective treatment (ORANGE) Registry dataset between July 2015 and March 2022, which has multicenter clinical data.Results: A total of 800 (mean age, 77.53 years; men, 50.1%) and 1494 (mean age, 77.97 years; men, 43.3%) participants comprised the NCGG and ORANGE Registry datasets, respectively. The optimum cutoff values for men and women were determined as MMSE < 25 and LI < 5 and MMSE < 25 and LI < 8, respectively; such a combined index showed good discriminative performance in internal (sensitivity/specificity: men, 92.50/73.52; women, 88.57/65.65) and external validities (men, 81.43/77.62; women, 77.64/74.67).Conclusion: The index developed is useful in discriminating between CDR scores of 0.5 and 1 and should be applicable to various settings, such as memory clinics and clinical research.

Association between abdominal adiposity and cognitive decline in older adults: a 10-year community-based study.

OBJECTIVES: This study aimed to investigate the association between abdominal adiposity and change in cognitive function in community-dwelling older adults. DESIGN, SETTING, AND PARTICIPANTS: This longitudinal study included older adults aged ≥60 years without cognitive impairment who participated in the National Institute for Longevity Sciences - Longitudinal Study of Aging. MEASUREMENTS: Cognitive function was evaluated biennially using the Mini-Mental State Examination (MMSE) over 10 years. Waist circumference (WC) was measured at the naval level, and subcutaneous fat area (SFA) and visceral fat area (VFA) were assessed using baseline computed tomography scans. WC, SFA, and VFA areas were stratified into sex-adjusted tertiles. A linear mixed model was applied separately for men and women. RESULTS: This study included 873 older adults. In men, the groups with the highest levels of WC, SFA, and VFA exhibited a greater decline in MMSE score than the groups with the lowest levels (ß [95% confidence interval]: WC, -0.12 [-0.23 to -0.01]; SFA, -0.13 [-0.24 to -0.02]; VFA, -0.11 [-0.22 to -0.01]). In women, the group with the highest level of WC and SFA showed a greater decline in MMSE score than the group with the lowest level (WC, -0.12 [-0.25 to -0.01]; SFA, -0.18 [-0.30 to -0.06]), but VFA was not associated with cognitive decline. CONCLUSION: Higher WC, SFA, and VFA in men and higher WC and SFA in women were identified as risk factors for cognitive decline in later life, suggesting that abdominal adiposity involved in cognitive decline may differ according to sex.

Claims-based Frailty Index in Japanese Older Adults: A Cohort Study Using LIFE Study Data.

BACKGROUND: We aimed to assess whether the United States-developed Claims-based Frailty Index (CFI) can be implemented in Japanese older adults using claims data. METHODS: We used the monthly claims data and certification of long-term care (LTC) insurance data of residents from 12 municipalities from April 2014 to March 2019. The 12 months from first recording was defined as the "baseline period," and the time thereafter as the "follow-up period". Participants aged ≥65 years were included, and those with no certified LTC insurance or who died at baseline were excluded. New certification of LTC insurance and all-cause mortality during the follow-up period were defined as outcome events. CFI categorization consisted of three steps including: 1) using 12 months deficit-accumulation approach that assigned different weights to each of the 52 items; 2) the accumulated score to derive the CFI; and 3) categorizing the CFI as "robust" (<0.15), "prefrail" (0.15-0.24), and "frail" (≥0.25). Kaplan-Meier survival curves and Cox proportional hazard models were used to determine the association between CFI and outcomes. Hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated. RESULTS: There were 519,941 participants in total. After adjusting for covariates, the severe CFI category had a high risk of certification of LTC insurance (prefrail: HR 1.33; 95% CI, 1.27-1.39 and frail: HR 1.60; 95% CI, 1.53-1.68) and all-cause mortality (prefrail: HR 1.44; 95% CI, 1.29-1.60 and frail: HR 1.84; 95% CI, 1.66-2.05). CONCLUSION: This study suggests that CFI can be implemented in Japanese claims data to predict the certification of LTC insurance and mortality.

Pneumococcal vaccination coverage and vaccination-related factors among older adults in Japan: LIFE Study.

PURPOSE: To investigate individual and environmental vaccination-related factors among the older adults in Japan, using administrative data. METHODS: We conducted a cohort study and included people who reached the relevant age (≥65 years) for routine pneumococcal vaccination of older adults between April 2015 and March 2020. Monthly data of residents in the two municipalities from April 2014 to March 2020 and vaccination records from April 2015 to March 2020 were used. We defined five cohorts according to the year in which routine vaccinations were available. Each cohort was followed for a total of two years, with the first year being the "baseline period" and second year being the "vaccine follow-up period." Pneumococcal vaccination data was extracted from vaccination records at "first dose." Age, sex, socioeconomic status, comorbidities, hospital visit history, hospitalization history, Specific Health Check-ups participation, and information on contracted hospitals for pneumococcal vaccination were used as covariates. A multivariate logistic regression model was used to investigate the relationship between pneumococcal vaccination and vaccination-related factors. Odds ratios (OR) and 95 % confidence intervals (95 % CI) were calculated. RESULTS: Analysis included 17,991 patients. Vaccination coverage was 33.6 % for all subjects. Multivariate analysis found the following as significant vaccination-related factors: female (OR: 1.18, 95 % CI: 1.11-1.26), not low income (1.76, 1.17-2.76), hospital visits: ≥once/month (1.27, 1.19-1.35), and Specific Health Check-ups participation (2.10, 1.95-2.27). No significant results were found for hospitals that contracted pneumococcal vaccination. CONCLUSIONS: Individual factors, such as sex and Specific Health Check-ups participation, were found to be important factors affecting pneumococcal vaccination among older adults in Japan. Environmental factors, such as the characteristics of residential areas, should be evaluated in further investigations.

Effect of Bone Metastasis Cancer Board on Spinal Surgery Outcomes: A Retrospective Study.

Background and Objectives: Bone metastasis cancer boards (BMCBs) focusing on the management of bone metastases have been gathering much attention. However, the association of BMCBs with spinal surgery in patients with spinal metastases remains unclear. In this retrospective single-center observational study, we aimed to clarify the effect of a BMCB on spinal metastasis treatment. Materials and Methods: We reviewed consecutive cases of posterior decompression and/or instrumentation surgery for metastatic spinal tumors from 2008 to 2019. The BMCB involved a team of specialists in orthopedics, rehabilitation medicine, radiation oncology, radiology, palliative supportive care, oncology, and hematology. We compared demographics, eastern cooperative oncology group performance status (ECOGPS), Barthel index (BI), number of overall versus emergency surgeries, and primary tumors between patients before (2008-2012) and after (2013-2019) BMCB establishment. Results: A total of 226 patients including 33 patients before BMCB started were enrolled; lung cancer was the most common primary tumor. After BMCB establishment, the mean patient age was 5 years older (p = 0.028), the mean operating time was 34 min shorter (p = 0.025), the mean hospital stay was 34.5 days shorter (p < 0.001), and the mean BI before surgery was 12 points higher (p = 0.049) than before. Moreover, the mean number of surgeries per year increased more than fourfold to 27.6 per year (p < 0.01) and emergency surgery rates decreased from 48.5% to 29.0% (p = 0.041). Patients with an unknown primary tumor before surgery decreased from 24.2% to 9.3% (p = 0.033). Postoperative deterioration rates from 1 to 6 months after surgery of ECOGPS and BI after BMCB started were lower than before (p = 0.045 and p = 0.027, respectively). Conclusion: The BMCB decreased the emergency surgery and unknown primary tumor rate despite an increase in the overall number of spinal surgeries. The BMCB also contributed to shorter operation times, shorter hospital stays, and lower postoperative deterioration rates of ECOGPS and BI.

Analysis of post-extraction bleeding in patients taking antithrombotic therapy using data from the longevity improvement and fair evidence study.

BACKGROUND: Several studies have investigated post-extraction bleeding in patients on antithrombotic therapy, but most included a small sample size. OBJECTIVE: This study aimed to analyse post-extraction bleeding in patients on antithrombotic therapy using data from a large database. MATERIALS AND METHODS: Claims data of National Health Insurance and Late-Stage Elderly Healthcare System enrollees who underwent tooth extraction between October 2014 and March 2019 (n = 107 767) in a large multiregional cohort study (Longevity Improvement and Fair Evidence study) were included. Antithrombotic therapy was determined based on the drug codes used at the time of tooth extraction (classified into six groups: no antithrombotic, single antiplatelet, dual antiplatelet, Direct Oral Anticoagulant, warfarin and combined antiplatelet and anticoagulant therapies). The outcome was defined as the presence of "post-extraction bleeding" as a receipt disease name in the same month as tooth extraction. To examine the association between antithrombotic therapy and post-extraction bleeding in detail, multiple logistic regression analysis was performed with post-extraction bleeding as the objective variable; each antithrombotic therapy as the explanatory variable; and age, sex and comorbidities as adjustment variables. RESULTS: Antithrombotic therapy was administered in 14 343 patients (13.3%), and post-extraction bleeding was observed in 419 patients (0.4%). The rate of post-extraction bleeding was significantly lower in the no antithrombotic therapy and single antiplatelet groups than that in the other groups (odds ratio: 2.00-9.02). CONCLUSION: The frequency of post-extraction bleeding is high in patients on anticoagulation or dual antithrombotic therapy. Therefore, careful preparation before extraction is necessary in these patients.

Clinical Characteristics and Surgical Outcomes of Metastatic Spine Tumors in the Very Elderly: A Prospective Cohort Study in a Super-Aged Society.

The number of advanced-age patients with spinal metastases is rising. This study was performed to clarify the characteristics and surgical outcomes of spinal metastases in advanced-age patients. We prospectively analyzed 216 patients with spinal metastases from 2015 to 2020 and divided them into three age groups: <70 years (n = 119), 70-79 years (n = 73), and ≥80 years (n = 24). Although there were no significant intergroup differences in preoperative characteristics and surgery-related factors except for age, patients aged ≥80 years tended to have a worse performance status (PS), Barthel index, and EuroQol-5 dimension (EQ-5D) before and after surgery than the other two groups. Although the median PS, mean Barthel index and mean EQ-5D greatly improved postoperatively in each group, the median PS and mean Barthel index at 6 months and the mean EQ-5D at 1 month postoperatively were significantly poorer in the ≥80-year group than the 70-79-year group. The rates of postoperative complications and re-deterioration of the EQ-5D were significantly higher in the oldest group than in the other two groups. Although surgery for spinal metastases improved the PS, Barthel index, and EQ-5D regardless of age, clinicians should be aware of the poorer outcomes and higher complication rates in advanced-age patients.

Context of walking and loneliness among community-dwelling older adults: a cross-sectional study.

BACKGROUND: Older adults are more likely to experience loneliness than younger people. Moreover, greater loneliness in older adults is associated with poor mental health and increased risk of cardiovascular disease and mortality. Physical activity is an effective intervention for reducing loneliness among older adults. Among physical activities, walking is suitable for older adults, because it is easy and safe to incorporate into daily life. We hypothesized that the association between walking and loneliness depends on the presence of others and the number of people present. The aim of this study is to investigate the association between the context of walking (the number of walkers) and loneliness among community-dwelling older adults. METHODS: This cross-sectional study included 173 community-dwelling older adults aged 65 or older. Context of walking was classified as non-walking, walking alone (days of walking alone > days of walking with someone), and walking with someone (days of walking alone ≤ days of walking with someone). Loneliness was measured using the Japanese version of the University of California Los Angeles Loneliness Scale. A linear regression model was used to investigate the relationship between context of walking and loneliness, adjusted for age, sex, living situation, social participation, and physical activity excluding walking. RESULTS: Data from 171 community-dwelling older adults (mean age = 78.0 years, 59.6% women) were analyzed. After adjustment, walking with someone was associated with lower loneliness than non-walking (adjusted ß: -0.51, 95% confidence interval: -1.00, -0.01). CONCLUSIONS: The study's findings suggest that walking with a companion may effectively prevent or reduce loneliness among older adults.

Association between locomotive syndrome and anemia among community-dwelling older adults.

AIM: To investigate the association between locomotive syndrome and anemia among community-dwelling older adults. METHODS: This cross-sectional study was conducted at specific health checkup centers in Japan between 2019 and 2020. We sent a questionnaire to older adults aged ≥65 years who participated in health checkups. A total of 2507 community-dwelling older adults were included in this study (mean age = 72.3 years, 51.4% women). Locomotive syndrome was measured using a 25-question Geriatric Locomotive Function Scale with a score range of 0-100, and was defined as ≥16 points. Anemia was defined using World Health Organization criteria, as a hemoglobin concentration of <13.0 g/dL in men and <12.0 g/dL in women. Logistic regression analyses were performed to investigate the association between locomotive syndrome and anemia, adjusted for age, sex, body mass index, depression symptoms, self-reported comorbidities (cancer, rheumatoid arthritis, knee osteoarthritis, fractures, and spinal disease), hypertension, and renal function. RESULTS: Of all the participants, 11.6% had locomotive syndrome and 12.8% had anemia. Even after adjustment, a relationship between locomotive syndrome and anemia was observed (adjusted odds ratio = 1.9, 95% confidence interval = 1.3-2.7). CONCLUSIONS: Community-dwelling older adults with anemia had a significantly higher prevalence of locomotive syndrome than those without. This finding suggests that older adults with anemia are at risk of locomotive syndrome, and appropriate measures should be taken for prevention. Geriatr Gerontol Int 2023; 23: 426-429.

Impact of postoperative physical activity on the development of pneumonia in the subacute phase after esophagectomy in patients with esophageal cancer: A retrospective cohort study.

PURPOSE: Physical activity is important to improve recovery following surgery. This study investigated the impact of physical activity on the development of pneumonia after radical esophagectomy in patients with thoracic esophageal cancer in the subacute phase from postoperative day 11 to hospital discharge. METHODS: This retrospective cohort study included 83 patients who underwent radical esophagectomy for esophageal cancer between 2016 and 2022. Physical activity was measured using an activity tracker, and the average number of steps between postoperative days 8 and 10 was examined. The primary outcome was pneumonia (Clavien-Dindo classification 2 or higher) developing between postoperative day 11 and hospital discharge. We used the receiver operating characteristic (ROC) curve analysis to calculate the optimal cutoff value of physical activity that can predict the development of pneumonia and define low physical activity. We used logistic regression analysis to investigate the impact of low physical activity on postoperative pneumonia. RESULTS: Pneumonia developed in 10 patients (12.0%) during the observation period. The optimal cutoff value of physical activity for predicting pneumonia was 1494 steps per day (sensitivity: 60.0%, specificity: 89.0%, area under the curve: 0.743). In multivariate analysis, low physical activity was an independent predictor of incident pneumonia [odds ratio: 12.10, 95% confidence interval: 2.21-65.90, p = 0.004], with adjustment for age, gastric tube reconstruction route, and postoperative recurrent nerve palsy. CONCLUSIONS: Physical activity following radical esophagectomy in patients with thoracic esophageal cancer was an independent predictor of the development of pneumonia in the subacute phase after radical esophagectomy.

Rehabilitation effects in idiopathic normal pressure hydrocephalus: a randomized controlled trial.

BACKGROUND: Gait-balance disturbances are core symptoms of idiopathic normal pressure hydrocephalus (iNPH). However, the rehabilitation effects of cerebrospinal fluid (CSF) shunting along with other treatment or no further treatment (natural course [NC]) for iNPH are unknown. OBJECTIVES: This study evaluated whether dynamic equilibrium gait training (DEGT) can improve gait-balance functions after CSF shunting of patients with iNPH compared to standard exercise (SE) and NC. Furthermore, it investigated the incidence of falls. METHODS: A total of 70 patients with iNPH who underwent CSF shunting were randomly assigned to 6 weeks of DEGT (n = 23), 6 weeks of SE (n = 23), or NC (n = 24). Evaluation was performed at baseline (preoperatively) and at 1 week, 7 weeks (postintervention), and 6 months postoperatively (follow-up). Outcomes were measured using the functional gait assessment (FGA), 10-m walk test, timed up-and-go test, life-space assessment (LSA), and fall incidence. RESULTS: A total of 65 participants completed the study. During the intention-to-treat analysis, the DEGT group demonstrated significant recovery of gait-balance functions according to only the FGA at postintervention and follow-up compared to the SE and NC groups; however, recovery of the SE group did not differ from that of the NC group. The DEGT group had a significantly lower fall incidence than the other groups at follow-up. Significantly better LSA results were observed for all groups at follow-up compared to baseline; however, no difference in LSA results were observed between groups. CONCLUSIONS: DEGT in addtion to CSF shunting can facilitate the recovery of gait-balance function and reduce the fall incidence of iNPH patients.

Outcomes of palliative surgery for bone metastasis of metastatic renal cell carcinoma in the era of targeted therapy.

INTRODUCTION: The introduction of tyrosine kinase inhibitors has revolutionized treatment strategies for metastatic renal cell carcinoma (RCC) and has improved survival rates. The number of patients with bone metastases from RCC requiring surgery will increase as survival rates improve. However, there is insufficient evidence to standardize the treatment of bone metastases after the introduction of targeted therapy for metastatic RCC. We aimed to determine the outcomes of palliative surgical treatment of bone metastases in the extremities of patients with metastatic RCC. MATERIALS AND METHODS: We retrospectively reviewed 26 lesions from 17 patients who underwent surgery for extremity and acetabular bone metastases and were treated with targeted therapies for advanced RCC between 2008 and 2020. The median follow-up duration was 19 months (range, 4-76). We assessed the patients' activities of daily living, quality of life, and pain and analyzed their postoperative values relative to preoperative values. Postoperative overall survival (OS), local progression-free survival (LPFS), and the factors affecting them were evaluated using the Kaplan-Meier method and log-rank test. RESULTS: The 5-year OS and LPFS rates were 39.5% and 65.6%, respectively. The factors affecting OS were sex, Katagiri score, visceral metastases, and preoperative targeted therapy, while the factors affecting LPFS were pathologic fractures and surgical technique. CONCLUSION: In this study, the postoperative outcomes of palliative surgery for bone metastases from metastatic RCC were good. We suggest that systemic treatment should be prioritized over local control for advanced bone metastasis in RCC and surgery before pathological fracture should be performed for local control.

Dynamic gait stability in patients with idiopathic normal pressure hydrocephalus with high and low fall-risk.

BACKGROUND: This study aimed to investigate whether dynamic gait stability differs between idiopathic normal-pressure hydrocephalus with high- and low-fall-risk. METHODS: Participants comprised 40 idiopathic normal-pressure hydrocephalus patients and 23 healthy-controls. Idiopathic normal-pressure hydrocephalus patients were divided into those with high-fall-risk (n = 20) and low-fall-risk (n = 20) groups using the cut-off score of ≤14/30 for fall-risk on the Functional Gait Assessment. Dynamic stability during gait was assessed by three-dimensional motion analysis. Dynamic stability was defined as the ability to maintain an extrapolated center of mass within the base of support at heel contact, with the distance between the two defined as the margin of stability. Conscious motor control was assessed by the Movement-Specific Reinvestment Scale. FINDINGS: Anteroposterior and mediolateral margin of stabilities were significantly larger in both idiopathic normal-pressure hydrocephalus groups than in healthy-controls. The mediolateral margin of stability was significantly higher in the high-fall-risk group than in the low-fall-risk group; whereas, the anteroposterior margin of stability did not differ between idiopathic normal-pressure hydrocephalus groups. The Movement-Specific Reinvestment Scale was significantly higher in the high-fall-risk group than in the low-fall-risk group. INTERPRETATION: Idiopathic normal-pressure hydrocephalus patients with have high forward and lateral dynamic stability during gait regardless of their fall-risk. In particular, idiopathic normal-pressure hydrocephalus patients with high-fall-risk may consciously maintain lateral dynamic stability to a greater extent than those with low-fall-risk. These findings highlight a conscious motor control component in the pathological gait of idiopathic normal-pressure hydrocephalus, and provide clues for rehabilitation and fall prevention strategies in idiopathic normal-pressure hydrocephalus patients.

Identification and characterization of slow­cycling cells in Ewing sarcoma.

Ewing sarcoma (ES) is an aggressive primary malignant bone tumor that predominantly affects children and young adults. Multimodal treatment approaches have markedly improved the survival of patients with localized ES. However, local recurrence and distant metastasis following curative therapies remain a main concern for patients with ES. Recent studies have suggested that slow­cycling cells (SCCs) are associated with tumor progression, local recurrence and distant metastasis in various types of cancers. According to the results of these studies, it was hypothesized that SCCs may play a critical role in tumor progression, chemoresistance and local/distal recurrence in patients with ES. The present study applied a label­retaining system using carboxyfluorescein diacetate succinimidyl ester (CFSE) to identify and isolate SCCs in ES cell lines. In addition, the properties of SCCs, including sphere formation ability, cell cycle distribution and chemoresistance, in comparison with non­SCCs were investigated. RNA sequencing also revealed several upregulated genes in SCCs as compared with non­SCCs; the identified genes not only inhibited cell cycle progression, but also promoted the malignant properties of SCCs. On the whole, the present study successfully identified SCCs in ES cells through a label­retaining system using CFSE. Moreover, to the best of our knowledge, the present study is the first to describe the characteristic properties of SCCs in ES. The findings of this study, if confirmed, may prove to be useful in elucidating the underlying molecular mechanisms and identifying effective therapeutic targets for ES.

Mediolateral Postural Control during Gait in Parkinson's Disease.

Objectives: Balance in the mediolateral direction is usually maintained in patients with early-stage Parkinson's disease (PD), but not in moderate-stage PD as revealed by the Tandem Gait Test. Although mediolateral postural control in PD patients remains controversial, previous studies have shown that the Tandem Gait Test may predict the risk of future falls in patients with PD. This study aimed to clarify postural control differences among PD patients with and without mediolateral balance impairments (MLBI: mediolateral balance impairments, nMLBI: non-mediolateral balance impairments, respectively) and healthy controls (HCs). Methods: We recruited 40 PD patients and 20 HCs. According to the Tandem Gait Test score, PD patients were divided into MLBI and nMLBI groups. Primary outcome measures were the ambulatory movement trajectory amplitude of the center of mass and its coefficient of variation (CV) during gait. Results: Mediolateral movement trajectory amplitudes and CV were not significantly different between the nMLBI group and HCs, whereas the mediolateral movement trajectory amplitude in the MLBI group was significantly higher than that in the nMLBI group. Moreover, the CV of the mediolateral movement trajectory amplitude in the MLBI group was significantly lower than that in the nMLBI group. The mediolateral movement trajectory amplitude was significantly correlated with the fall score. Conclusions: The current results suggest that PD patients with mediolateral balance impairments showed mediolateral postural sway during gait compared with PD patients without mediolateral balance impairments. It is necessary to focus on the instabilities in the mediolateral direction to avoid falls in PD patients.

Perioperative Adriamycin plus ifosfamide vs. gemcitabine plus docetaxel for high-risk soft tissue sarcomas: randomised, phase II/III study JCOG1306.

BACKGROUND: This randomised phase II/III trial aimed to determine whether perioperative chemotherapy with gemcitabine plus docetaxel (GD) is non-inferior to the standard Adriamycin plus ifosfamide (AI) in terms of overall survival (OS) in patients with soft tissue sarcoma (STS). METHODS: Patients with localised high-risk STS in the extremities or trunk were randomised to receive AI or GD. The treatments were repeated for three preoperative and two postoperative courses. The primary endpoint was OS. RESULTS: Among 143 enrolled patients who received AI (70 patients) compared to GD (73 patients), the estimated 3-year OS was 91.4% for AI and 79.2% for GD (hazard ratio 2.55, 95% confidence interval: 0.80-8.14, P = 0.78), exceeding the prespecified non-inferiority margin in the second interim analysis. The estimated 3-year progression-free survival was 79.1% for AI and 59.1% for GD. The most common Grade 3-4 adverse events in the preoperative period were neutropenia (88.4%), anaemia (49.3%), and febrile neutropenia (36.2%) for AI and neutropenia (79.5%) and febrile neutropenia (17.8%) for GD. CONCLUSIONS: Although GD had relatively mild toxicity, the regimen-as administered in this study-should not be considered a standard treatment of perioperative chemotherapy for high-risk STS in the extremities and trunk. CLINICAL TRIAL REGISTRATION: jRCTs031180003.

Clinical Outcomes and Prognostic Factors in Soft Tissue Sarcoma Patients After Unplanned Excision.

Purpose: Soft tissue sarcomas (STSs) constitute a group of rare, heterogeneous tumors representing approximately 1% of all cancers. Owing to the rarity and pathological diversity of the disease, unplanned excision (UE) has often been performed for STS, resulting in an unfavorable prognosis. This study aimed to clarify clinical outcomes and prognostic factors in STS patients who underwent UE. Patients and Methods: In a retrospective review of the medical records of patients with STS who underwent surgery at our institution between 1999 and 2015, patients were enrolled to either a UE group or a planned excision (PE) group. An analysis was then conducted to identify factors associated with prognosis after UE. Results: Of 134 patients undergoing surgery for STS, 110 were enrolled to the PE group and 24 to the UE group. The median size of the primary tumor was significantly smaller, and more lesions were located in the superficial layer in the UE group than in the PE group. In addition, plastic reconstruction after additional radical resection was required significantly more often in the UE group than in the PE group. No significant difference in overall survival, local recurrence-free survival, or disease-free survival (DFS) between the UE and PE groups was observed; however, metastasis-free survival was significantly better in the UE group. In the UE group, poorer DFS was associated with older age (≥61 years) and a larger primary tumor (≥2.9 cm). Conclusion: A prognosis similar to that in patients undergoing PE could be achieved by appropriate additional surgeries in patients initially undergoing UE. However, UE for STS should be avoided, especially in older patients and those with a larger primary tumor.

Clinical Outcome of Patients with Pelvic and Retroperitoneal Bone and Soft Tissue Sarcoma: A Retrospective Multicenter Study in Japan.

This study aimed to retrospectively analyze the clinical outcomes of patients with pelvic and retroperitoneal bone and soft tissue sarcoma (BSTS). Overall, 187 patients with BSTS in the pelvis and retroperitoneal region treated at 19 specialized sarcoma centers in Japan were included. The prognostic factors related to overall survival (OS), local control (LC), and progression-free survival (PFS) were evaluated. The 3-year OS and LC rates in the 187 patients were 71.7% and 79.1%, respectively. The 3-year PFS in 166 patients without any distant metastases at the time of primary tumor diagnosis was 48.6%. Osteosarcoma showed significantly worse OS and PFS than other sarcomas of the pelvis and retroperitoneum. In the univariate analyses, larger primary tumor size, soft tissue tumor, distant metastasis at the time of primary tumor diagnosis, P2 location, chemotherapy, and osteosarcoma were poor prognostic factors correlated with OS. Larger primary tumor size, higher age, soft tissue tumor, chemotherapy, and osteosarcoma were poor prognostic factors correlated with PFS in patients without any metastasis at the initial presentation. Larger primary tumor size was the only poor prognostic factor correlation with LC. This study has clarified the epidemiology and prognosis of patients with pelvic and retroperitoneal BSTS in Japan.

A randomized phase III trial of denosumab before curettage for giant cell tumor of bone. JCOG1610.

OBJECTIVES: The aim of JCOG1610 (randomized controlled phase III trial) was to confirm the superiority of preoperative denosumab to curettage with adjuvant local therapy for patients with giant cell tumor of bone without possible post-operative large bone defect. METHODS: The primary endpoint was relapse-free survival and the total sample size was set at 106 patients. Patient accrual began in October 2017. However, the accrual was terminated in December 2020 due to a recommendation from the Data and Safety Monitoring Committee because of poor patient accrual. Now, we report the descriptive results obtained in this study. RESULTS: A total of 18 patients had been registered from 13 Japanese institutions at the time of termination on December 2020. Eleven patients were assigned to Arm A (curettage and adjuvant local therapy) and 7 to Arm B (preoperative denosumab, curettage and adjuvant local therapy). Median follow-up period was 1.6 (range: 0.5-2.8) years. Protocol treatment was completed in all but one patient in Arm A who had a pathological fracture before surgery. All patients in Arm B were treated with five courses of preoperative denosumab. Relapse-free survival proportions in Arm A and B were 90.0% (95% confidence interval: 47.3-98.5) and 100% (100-100) at 1 year, and 60.0% (19.0-85.5) and 62.5% (14.2-89.3) at 2 years, respectively [hazard ratio (95% confidence interval): 1.51 (0.24-9.41)]. CONCLUSION: In terms of relapse-free survival, the superiority of preoperative denosumab was not observed in patients with giant cell tumor of bone without possible post-operative large bone defect.