Performance Status Research Articles

Comparison of masticatory performance and oral hygiene status using cream-type denture adhesives and home liners: A cross-sectional study using propensity-score matching.

Differences in the effects of cream-type denture adhesives and home liners remain unclear. This cross-sectional study aimed to clarify the differences in the oral-hygiene status and masticatory performance between participants using cream-type denture adhesives and those using home liners. Masticatory performance with and without cream-type denture adhesives and home liners was evaluated using colour-changeable chewing gum. Oral hygiene was assessed using the tongue coating index (TCI). Propensity-score matching was performed using oral moisture, presence of palatal or mandibular protuberances, type of residual ridge, denture type (complete or partial denture), and denture retention as background factors. Wilcoxon signed-rank test was used to examine the differences in masticatory performance with and without cream-type denture adhesives and home liners and differences in masticatory performance and TCI between the cream-type denture adhesive and home-liner groups. This study included 38 and 40 cream-type adhesive and home-liner users, respectively, and 17 pairs were obtained after propensity-score matching. The Wilcoxon signed-rank tests showed that masticatory performance was significantly different with and without the use of home liners, and higher values were obtained with the use of home-liners. However, the cream-type denture adhesive and home-liner groups showed no significant differences in terms of the change in masticatory performance with the use of them. Furthermore, Wilcoxon signed-rank tests showed that TCI values were significantly high in the cream-type adhesive group. The findings in this study suggest that home liners improve masticatory performance and that participants regularly using cream-type denture adhesives have poorer oral hygiene.

Automatic cleaning suggestion adapting to real-time soiling status of solar farms

Solar farms are subject to various environmental factors that can affect their performance and output. One of the major factors is soiling. Consequently, it is essential to monitor and mitigate the effects of soiling on solar panels to ensure optimal performance and maximum profitability of a solar farm. In this paper, we present a novel cleaning intervention strategy that adapts to the present solar panel performance status to detect cleaning requirements for maximizing profit. This algorithm works with onsite insolation and panel data to give live feedback on cleaning requirements. Moreover, unlike other models in the literature, this method does not require historical or a priori insolation, weather, or soiling data. We have comprehensively tested the algorithm through experiment and simulation under various conditions (i.e., seasonal rain, few annual rainfall or sandstorms, unpredictable dust accumulation). The results show that the adaptive cleaning algorithm, even with no historical insolation or soiling information, outperforms optimal periodic cleaning strategies in terms of net revenue. The adaptive cleaning suggestion system shows significant advantages especially in locations with high variability in weather and soiling conditions. The algorithm is also suitable for practical deployment in solar farms near industrial or construction zones where sudden dust accumulation can occur. Our adaptive model will maximize profit in such unpredictable soiling scenarios, while in comparison, it is not even possible to utilize historical information-based cleaning cycle model in such cases.

The role of surgery in recurrent local cerebral metastases: a multi-institutional retrospective analysis.

Local recurrent brain metastases are defined as lesions that recur in the brain at the same site after a previous local therapy. In patients already submitted to surgery, a second operation may be potentially challenging due to scar formation, infiltration of cerebral vessels or eloquent brain areas and local effect of previous radiotherapy. The aim of this study is to retrospectively review the results and complications of a second surgical treatment in a series of local recurrent lesions and to review the literature on this topic. 37 patients submitted to surgery for a local, histologically confirmed, recurrent brain metastases between 2000 and 2022 were retrospectively analyzed with respect to the following parameters: age, histology, anatomic location, time to recurrence, previous radiotherapy, size of recurrent tumors, preoperative and postoperative Karnofsky Performance Status(KPS) score, recursive partitioning analysis (RPA) class and graded prognostic assessment (GPA) score, surgery-related complications and the presence of further cerebral metastases. Overall survival (OS) was calculated using the Kaplan-Meier method. A multivariate Cox proportional hazard model was developed using stepwise regression (forwards selection) with predictive variables that were significant in the univariate analyses. A significant improvement of post-operative KPS status was obtained after second surgery. At multivariate analysis better results in terms of OS were achieved in patients with a pre-operative KPS ≥ 70 and in patients who had received radiotherapy after the initial surgery. No significant postoperative complications related to previous treatments were observed. Surgical resection of local recurrent brain metastases may improve patients ́ neurologic conditions allowing more time for systemic therapies to act with a low incidence of surgery-related morbidity and mortality. However, careful patient selection with a fair pre-operative clinical status seems mandatory to achieve the best post-operative results, since uniform treatment-paradigms cannot be established yet, due to the highly heterogeneous patient cohort.

Outcomes following off-site remote systemic cancer therapy administration.

The Veterans Affairs Nebraska Western Iowa Health Care System (VA-NWIHCS) uses teleoncology and remote systemic cancer therapy services to expand care to veterans in rural Nebraska via remote sites in Lincoln and Grand Island. This study compares clinical outcomes in patients receiving care at these remote sites to those at the primary site in Omaha. Data were retrospectively reviewed for 151 patients who received first-line systemic therapy at VA sites in Omaha, Lincoln, or Grand Island between January 1, 2018, and December 31, 2020. This included patient demographics, malignancy type and stage, survival, systemic therapy received, treatment intent and toxicities, missed or delayed cycles, and frequency of hospitalizations or emergency department visits. SAS version 9.4 was used for analysis. The study population included 108 patients who received their systemic therapy in Omaha, whereas 43 received therapy at the remote sites. The demographic of both populations was predominantly male with a median age of 69 years and Eastern Cooperative Oncology Group Performance Status of 0 to 1. The two groups were comparable in terms of comorbidities. Both populations had a similar distribution of cancer types, proportion of patients with stage IV disease, and treatment with curative intent. There was no difference in 1- and 2-year survival, systemic therapy-related toxicity classification and prevalence, number of delayed/missed cycles, and hospitalization/emergency department visits. Evaluated outcomes in patients treated in Omaha versus remote sites via teleoncology under the same providers were similar. Effective oncology care, including systemic therapy, can be provided via teleoncology, and this model can help mitigate issues with access to care.

Promise and challenges of traditional Chinese medicine, specifically Calculus bovis, in liver cancer treatment

Liver cancer, one of the most common malignancies worldwide, ranks sixth in incidence and third in mortality. Liver cancer treatment options are diverse, including surgical resection, liver transplantation, percutaneous ablation, transarterial chemoembolization, radiotherapy, chemotherapy, targeted therapy, immunotherapy, and traditional Chinese medicine (TCM). A multidisciplinary team (MDT) is essential to customize treatment plans based on tumor staging, liver function, and performance status (PS), ensuring individualized patient care. Treatment decisions require a MDT to tailor strategies based on tumor staging, liver function, and PS, ensuring personalized care. The approval of new first-line and second-line drugs and the establishment of standard treatments based on immune checkpoint inhibitors have significantly expanded treatment options for advanced liver cancer, improving overall prognosis. However, many patients do not respond effectively to these treatments and ultimately succumb to the disease. Modern oncology treatments, while extending patient survival, often come with severe side effects, resistance, and damage to the body, negatively impacting quality of life. Huang et al 's study published at World Journal of Gastroenterology rigorously validates the anticancer properties of Calculus bovis , enhancing our understanding of TCM and contributing to new liver cancer treatment strategies. For over 5000 years, TCM has been used in East Asian countries like China to treat various diseases, including liver conditions. Analysis of real-world clinical data suggests that for patients with advanced-stage tumors lacking effective treatments, integrated TCM therapies could provide significant breakthroughs.

Performance variables and nutritional status analysis from Moroccan professional and adolescent football players during the competition period: a descriptive study

IntroductionNutrition plays an integral role in optimizing football players’ performance during training sessions and matches and maintaining their overall health throughout the season. This study aimed to evaluate how well the dietary practices of professional and adolescent football players in Morocco during the competitive period met international macronutrient recommendations, and to explore the relationship between their nutritional status and aerobic performance, as measured by the Yo-Yo IRL1 test.MethodsA total of 277 footballers from Morocco's professional league, “Botola-Pro”, were monitored over a seven-day (training microcycle) during the competitive period. The dietary intake was assessed through self-reported methods and 24-hour recalls. Relevant body composition was measured with bioelectrical impedance (BI), and aerobic performance was evaluated using the Yo-Yo IR test.ResultsThe results indicated significant variations in performance and nutritional status across different categories and age groups. The nutritional status of the players didn't match the UEFA recommendations (p < 0.001). We found that higher intake levels of carbohydrates and proteins were positively correlated with the total distance covered by the players (p < 0.001, r = 0.63, R2 = 0.4 for carbohydrates; p < 0.001, r = 0.59, R2 = 0.35 for proteins). Conversely, a higher proportion of energy derived from fats in the diet was negatively correlated with the distance covered (p < 0.001, r = −0.64, R2 = 0.41).ConclusionThese findings suggest that optimizing carbohydrates and protein intake while managing fat consumption is crucial for enhancing sporting performance. This information is essential for tailoring training programs and nutritional regimens based on the competition level.

Spontaneous recovery of postsurgical progressive cervical spine kyphosis following intramedullary spinal cord tumor resection in a 4-year-old boy: illustrative case.

Postsurgical kyphosis is relatively common in children who have undergone resection of intramedullary spinal cord tumors. Progressive kyphosis almost always requires instrumentation and fusion surgery, which can delay or interfere with adjuvant oncological treatments and can deleteriously impact the long-term performance status of the patient. Here, the authors report a case of near-complete spontaneous recovery (i.e., without spinal fusion surgery) of postsurgical progressive cervical spine kyphosis following intramedullary spinal cord tumor resection and discuss the potential factors that may have contributed to this positive outcome. This case serves as a reminder that spontaneous recovery from postsurgical progressive cervical spine kyphosis can occur and that some patients (i.e., those without neurological deficits) can be monitored closely, with a watch-and-wait approach, before subjecting them to additional surgical risks, delays in other treatments, and potential morbidity. https://thejns.org/doi/10.3171/CASE24187.

Efficacy and safety of pembrolizumab in patients with advanced urothelial carcinoma deemed potentially ineligible for platinum-containing chemotherapy: Post hoc analysis of KEYNOTE-052 and LEAP-011.

First-line pembrolizumab monotherapy is a standard of care for platinum-ineligible patients with advanced urothelial carcinoma (UC). No global standardized definition of platinum ineligibility exists. This study aimed to evaluate the efficacy and safety of pembrolizumab monotherapy in patients with UC who met various criteria for platinum ineligibility. Patients from KEYNOTE-052 and LEAP-011 deemed potentially platinum ineligible were pooled for this post hoc exploratory analysis as follows: group 1: Eastern Cooperative Oncology Group performance status (ECOG PS) 2; group 2: ECOG PS 2 and age ≥80 years, renal dysfunction, or visceral disease; and group 3: any two other factors regardless of ECOG PS. Patients received pembrolizumab 200 mg intravenously every 3 weeks. End points included objective response rate (ORR), progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors, version 1.1, by blinded independent central review, overall survival (OS), and safety. A total of 612 patients treated with pembrolizumab from KEYNOTE-052 (n=370) and LEAP-011 (n=242) were included; the median (range) follow-up was 56.3 months (51.2-65.3 months) and 12.8 months (0.2-25.1 months), respectively. For group 1, ORR was 26.2%, median PFS was 2.7 months, and median OS was 10.1 months. For group 2, ORR ranged from 23.5% to 33.3%, median PFS ranged from 2.1 to 4.4 months, and median OS ranged from 9.1 to 10.1 months. For group 3, ORR ranged from 25.7% to 27.9%, median PFS ranged from 2.1 to 2.8 months, and median OS ranged from 9.0 to 10.6 months. Treatment-related adverse event rates were consistent across groups. Frontline pembrolizumab has consistent antitumor activity and safety in patients with advanced UC categorized as potentially ineligible for platinum-based chemotherapy, regardless of the variable definitions of platinum ineligibility used.

Impact of Karnofsky performance status on outcomes of patients with severe alcohol-associated hepatitis: a propensity-matched analysis.

Severity scores, including the model for end-stage liver disease (MELD) and discriminant function score, guide the treatment of patients with severe alcohol-associated hepatitis (AH). We aimed to investigate the impact of functional status on outcomes of patients with AH. Medically managed patients (n = 133) with AH from 1 January 2019 to 31 December 2022 were included in this prospective study. The objectives were to compare the long-term survival, recompensation rates, corticosteroid response, incidence of infections, hepatic encephalopathy (HE) and acute kidney injury (AKI) among propensity score-matched patients with good Karnofsky performance status (KPS) (score ≥50) and poor KPS (score <50) using Kaplan-Meier analysis. Twenty-five patients with good KPS were matched with 25 patients with poor KPS and followed up for a median duration of 10 (0.5-33) months. Survival was 76% (19/25; 95% confidence interval (CI), 54.9-90.6) in patients with good KPS compared to 42.3% (11/25; 95% CI, 23.4-63.1) patients with poor KPS (P = 0.001) at 10 months. The recompensation rate was higher in the good KPS group than in the poor KPS group (68% vs 44%; P = 0.04). A higher proportion of patients in the good KPS group (78.9%) than in the poor KPS group (42.8%; P = 0.03) responded to corticosteroids. Survival was lower among non-responders in the poor KPS group (0% vs 75%; P = 0.01). The proportion of patients who developed infection (36% vs 28%; P = 0.051), HE (36% vs 12%; P = 0.01) and AKI (60% vs 16%; P < 0.001) was higher in patients with poor KPS than in good KPS. KPS is an important determinant of outcomes in patients with AH, including survival, recompensation, response to corticosteroids and complications.

Matching-adjusted indirect comparison of Acalabrutinib versus Ibrutinib in relapsed/refractory mantle cell lymphoma

ABSTRACT Objective In the absence of head-to-head clinical trials, matching-adjusted indirect comparison (MAIC) was used to compare 2 Bruton tyrosine kinase inhibitors (BTKis) approved for the treatment of relapsed/refractory (R/R) mantle cell lymphoma (MCL). This analysis compares the efficacy and safety of acalabrutinib versus ibrutinib using a more mature dataset than a previously published MAIC. Methods Individual patient data from 122 patients treated with acalabrutinib in a phase 2 study were weighted to match aggregate baseline characteristics of patients pooled from 3 separate trials of ibrutinib. Patients were matched on Eastern Cooperative Oncology Group performance status, simplified Mantle Cell Lymphoma International Prognostic Index, lactate dehydrogenase, prior lines of therapy, tumor burden, and blastoid histology. Outcomes assessed included progression-free survival (PFS), overall survival (OS), and adverse events. Results After matching, differences in PFS between acalabrutinib (median 17.8 months) and ibrutinib (median 12.8 months) were not statistically significant (hazard ratio [HR], 0.92; 95% confidence interval [CI], 0.74–1.15; P = 0.48). Similarly, after matching, OS differences between acalabrutinib (median 36.5 months) and ibrutinib (median 27.9 months) did not reach statistical significance (HR, 0.87; 95% CI, 0.64–1.17; P = 0.35). Acalabrutinib was associated with an improved safety profile compared with ibrutinib, with statistically significantly lower rates of grade ≥3 atrial fibrillation and thrombocytopenia. Conclusions This comparison of 2 BTKis used in the treatment of R/R MCL showed that PFS and OS risk was not statistically different between the treatments; however, acalabrutinib had an improved safety profile compared with ibrutinib.

Factors associated with mortality and evaluation of clinical risk scores among cancer patients admitted with post-chemotherapy infection in Uganda: a prospective cohort study

Abstract Background Little is known about outcomes from cancer chemotherapy-associated infections in sub-Saharan Africa. Accordingly, among cancer patients admitted with post-chemotherapy infection in Mbarara, Uganda, we aimed to determine 1) the 30-day case fatality rate, 2) factors associated with mortality, and 3) clinical risk score performance. Methods We enrolled participants aged 18 years or older if they 1) received cancer chemotherapy within the past 30 days, 2) were admitted to the oncology ward, and 3) were prescribed intravenous antibiotics. We used Cox proportional hazards regression to determine predictors of 30-day mortality and calculated the area under the receiver operating characteristic curve (AUC) for each clinical risk score. Results Among 150 participants, 67 (45%) were female and the median (IQR) age was 56 (43-66) years. Esophageal cancer (18%) and pneumonia (42%) were the most common malignancy and infection, respectively. Death by 30 days occurred in 63 (42%) participants. qSOFA ≥2 (adjusted hazard ratio [aHR] 2.51, 95% confidence interval [CI] 1.42-4.44, p=0.001), and UVA score &amp;gt;4 (aHR 2.13, 95% CI 1.08-4.18, p=0.03) were independently associated with 30-day mortality. An ECOG score ≥3 was similarly independently associated with 30-day mortality in the qSOFA and UVA models. The AUCs for qSOFA and UVA were 0.70 (95% CI 0.63-0.79) and 0.72 (95% CI 0.64-0.80), respectively. Conclusions In participants with post-chemotherapy infection in Mbarara, Uganda, the case fatality rate was high. ECOG, qSOFA, and UVA scores were associated with 30-day mortality.

Prognostic Value of Sarcopenia in Elderly Patients with Metastatic Non-Small-Cell Lung Cancer Undergoing Radiotherapy

Background: Sarcopenia, a syndrome characterized by age-related loss of muscle mass and function, lacks universally accepted diagnostic criteria, particularly for its role as a prognostic factor in elderly patients with non-small-cell lung cancer (NSCLC). This study aimed to evaluate the prognostic significance of sarcopenia, assessed by psoas muscle size on baseline CT scans, in patients over 70 years of age with metastatic NSCLC. Methods: We retrospectively analyzed 85 elderly patients undergoing palliative radiation therapy between August 2022 and July 2024. Using morphometric analysis of psoas size, we investigated its correlation with overall survival (OS) and progression-free survival (PFS). Results: Our results showed that decreased psoas size was significantly associated with shorter OS and PFS, with median OS of 10 months and PFS of 4 months in sarcopenic patients compared to longer survival times in non-sarcopenic patients. Median survival of non-sarcopenic vs. sarcopenic patients was 21 ± 7 months (muscle area &gt; median) versus 5 ± 2.3 months (muscle area &lt; median). Multivariate analysis confirmed that psoas size, along with ECOG performance status and treatment of primary NSCLC, was a significant predictor of survival. Discussion: These findings suggest that psoas muscle size is a valuable prognostic marker for elderly NSCLC patients, potentially guiding treatment decisions and patient management. Further research is needed to validate these results and refine prognostic models for this population.

Real-world treatment patterns, biomarker testing, and clinical outcomes of metastatic non-small cell lung cancer patients in the immunotherapy era

BackgroundTreatment for first-line (1L) metastatic non-small cell cancer (mNSCLC) changed with the introduction of immunotherapy. We describe treatment utilization and clinical outcomes in a real-world mNSCLC cohort in a 2.7-million-member state-mandated health provider.MethodsNewly diagnosed mNSCLC patients initiating systemic anti-cancer treatment (January 2017–December 2020) were identified from the National Cancer Registry. Real-world time on treatment (rwToT) was defined as the length of time between the first and last administration date of treatment. Real-world overall survival (rwOS) was estimated using Kaplan–Meier analysis. Outcomes were assessed at a minimum of 6 months’ follow-up (cutoff: 30 June 2021).ResultsAmong 843 patients, 85% had adenocarcinoma (NSQ) and 15% had squamous cell carcinoma (SQ) histology: of these, 43% and 26% were women, median age was 67 and 69 years, and 55% and 48% had 0–1 ECOG performance status, respectively (missing: 27% and 30%, respectively). Median follow-up for the entire cohort was 27.1 months (95% CI: 24.7–29.6). NSQ patients with no known EGFR/ALK/ROS1 aberrations received PD-1 inhibitor monotherapy (PDM) (N = 147) or combination (PDC) (N = 194) or platinum-based chemotherapy (PBC, N = 133). Median rwToT was 4.5 (95% CI: 3.5–7.6), 5.2 (95% CI: 4.6–7.6), and 2.3 (95% CI: 2.1–3.0) months, respectively; for the subgroup of patients with ECOG PS 0–1, rwToT was 9.4 (95% CI: 5.0–20.8), 7.1 (95% CI: 5.0–10.1), and 2.9 (95% CI: 2.2–4.1) months, respectively. Median rwOS from 1L was 12.5 (95% CI: 9.9–17.9), 14.8 (95% CI: 10.5–19.4), and 9.1 (95% CI: 7.1–11.5) months; for the subgroup of patients with ECOG PS 0–1, median rwOS was 25.1 [95% CI: 14.9–not reached (NR)], 17.6 (95% CI: 14.3–NR), and 11.3 (95% CI: 9.2–21.3) months, respectively. For ECOG PS 0–1 and PD-L1 ≥50% patients, median rwOS was 25.1 months (95% CI: 13.9–NR) and NR for PDM and PDC, respectively. For ECOG PS 0–1 and PD-L1 &amp;lt;50% patients, median rwOS was 14.3 (95% CI: 10.1–NR) and 11.2 (95% CI: 9.1–21.3) months for PDC and PBC, respectively.ConclusionOur real-world data support the benefit of single-agent PD-1 inhibitor monotherapy for patients with PD-L1 high expression or PD-1 inhibitor combination for all patients diagnosed with mNSCLC with no known EGFR/ALK/ROS1 aberrations, initiating 1L treatment.

Twelve-year experience of pineal region meningiomas: long-term outcomes of maximal safe resection.

The purpose of this research was to summarize the clinical and prognostic features of pineal region meningiomas, evaluate treatment strategies and long-term prognoses, and improve the management of pineal region meningiomas. We retrospectively studied the data of 37 patients who received surgical resection for pineal region meningiomas at West China Hospital of Sichuan University from 2009 to 2021. Adjuvant gamma knife radiosurgery (GKRS) was conducted according to the extent of resection (EOR). Progression-free survival (PFS), Karnofsky performance status (KPS) scores and recovery of neurological function were adopted to assess a comprehensive management strategy for pineal region meningiomas. The most common symptom was headache associated with intracranial hypertension (75.7%). The occipital transtentorial approach (40.5%) and supracerebellar infratentorial approach (29.7%) were performed in most cases. Gross total resection (GTR) was achieved in 27 patients (73.0%) and the remaining patients were treated with subtotal resection (STR) combined with postoperative GKRS. With a mean follow-up period of 87.0 months, the progression rate was 10.0%, the 5-year PFS rate was 92.9%, and the ΔKPS was 16.3. Multivariate analysis revealed that the STR + GKRS and supracerebellar infratentorial approach were beneficial to the recovery of quality of life of patients. Pineal region meningiomas are sporadic but challenging. It is necessary to select the most appropriate surgical approach, EOR, and hydrocephalus treatment strategy for patients with pineal region meningiomas. Maximal safe resection to protect neurovascular function combined with postoperative GKRS can significantly improve the quality of life of patients.

A novel scoring system proposal to guide surgical treatment indications for high grade gliomas in elderly patients: DAK-75.

High-grade gliomas are the most prevalent neurooncological desease in adults, their incidence increases with age, peaking in the seventh decade. This paper aims to address how to select patients for surgical resection by identifying pre-surgical predictors of 12-month mortality in newly diagnosed HGG patients aged ≥ 75years. A prognostic score will be proposed to guide surgical decisions based on expected survival. Retrospective observational single-center cohort study was carried out at the "Città della Salute e della Scienza-Molinette" University Hospital in Turin, Italy. All consecutive patients aged ≥ 75years newly diagnosed with HGG were included, regardless of whether they underwent surgical resection. Clinical, radiological, histological and molecular data were collected.Variables potentially available at the time of diagnosis were considered to develop a multivariable logistic regression predictive model, with 12-months overall survival as the dependent variable. 102 patients aged 75years or older received a new diagnosis of high-grade glioma, of whom 68 underwent surgical resection. Patients undergoing surgery were slightly younger (76.9 vs 79.0years, p = 0.007) and had better performance status (median KPS 80 vs 70). Most tumors undergoing surgery were localized in cortical or subcortical non-motor areas (p < 0.001) and less frequently deep-seated (p = 0.023) or multifocal (p < 0.001). A predictive model, the DAK-75 score, was developed: the AUROC of the final model was 0.822 (95% CI 0.741-0.902). The score includes clinical presentation, tumor location, and KPS, ranging from 0 to 20, categorizing risk scores into low-risk and high-risk groups (< or > 8). Higher scores corresponded to fewer surgical patients and higher one-year mortality rates (92.2% vs 47.1%, p < 0.001). DAK-75 score may represent a valuable tool in the decision-making process for neurosurgical intervention in elderly patients diagnosed with HGG. Further studies are needed to externally and prospectively validate the scoring system.

Phase II clinical trial assessing the efficacy of enzalutamide in advanced non-resectable granulosa cell ovarian tumors: The GREKO III study (GETHI2016–01)

BackgroundGranulosa cell ovarian tumors (GCT) are orphan disease with limited treatments. Hormone therapy is a potential treatment, due to the overexpression of hormone receptors in most tumors. This study explores the activity of the antiandrogen, enzalutamide, in metastatic cases. MethodsWe designed a phase II clinical trial under the Spanish Collaborative Group for Transversal Oncology and Rare and Orphan Tumors (GETTHI). Eligible participants were adult women with advanced GCT. Primary endpoint was objective response rate. Secondary endpoints included clinical benefit rate, progression-free survival, overall survival, and safety profile. Patients received enzalutamide 160 mg once daily. ResultsFrom April 2018 to March 2020, eighteen patients were screened, and sixteen were included across nine institutions. Median age was 56.4 years (range 45–71), and most were Caucasian (14 cases), one Arabian and one Latin. ECOG performance status was zero in 13 cases (81 %) and one in three (19 %). Six patients (38 %) had previously received hormone therapy as adjuvant treatment or for advanced disease, and 15 (94 %) chemotherapy. Median time from metastasis to study entry was 96 months (range 4.5–198).No objective response was observed, but the clinical benefit rate reached 68.8 % (95 % CI [46 %–91.5 %]). Median progression-free survival was 3.8 months (95 % CI [1.36–6.14]). Median overall survival was not reached, with a median follow-up of 6 months (range 2.2–19).At the time of database closure, 14 patients had discontinued treatment, 13 due to disease progression and one by personal choice. Two deaths attributed to disease progression were recorded.Five grade 3 adverse events were reported, with only one (asthenia) deemed related to the therapy. ConclusionsAlthough enzalutamide demonstrated modest activity in GCT, durable stabilization was observed in some cases.Trial Registration:ClinicalTrials.gov Identifier: NCT03464201

Impact of Residual Vein Venous Thrombosis in Consecutive Patients with Cancer-Associated Thrombosis Treated with Tinzaparin—A Cohort Study

Background: The role of residual venous thrombosis (RVT) as a risk factor for recurrent venous thromboembolism (VTE) in patients with cancer-associated thrombosis (CAT) remains controversial. Methods: We conducted a cohort study on consecutive patients with CAT treated with tinzaparin recruited between 2007 and 2022. Primary outcome: RVT. Secondary outcomes: identification of variables associated with RVT and the role of RVT in VTE recurrences or clinically relevant bleeding (CRB). Results: Among 511 patients with CAT (age 64.1 years ± 13.4 years; 53.5% males) followed for 17.6 months (p25–75: 7.9–34), 35.8% (n = 183) presented RVT (at 6 months, 55.5%). Variables identified as being associated with RVT were ECOG performance status &gt; 1, metastasis, and cancer location. Within 5 years, there were 57 CRB (11.2%; 95% CI: 8.6–14.2) and 67 VTE recurrences (13.1%, 95%CI: 10.3–16.4). Competing risk analysis identified that RVT at 6 months was associated with VTE recurrence within 5 years (sub-hazard ratio: 2.1; 95% CI: 1.2–3.7; p = 0.006), but not with CRB. Multivariate analysis confirmed that RVT at 6 months (HR: 2.1; 95% CI: 1.2–3.7) and metastases (HR: 1.7; 95% CI: 1.1–2.9) were associated with VTE recurrence within 5 years. Conclusions: RVT is high in patients with CAT. The presence of RVT at 6 months was associated with an increased risk of recurrent VTE over 5 years.

The associations between mathematical skills, cognitive performance, and language background in elementary school children. a two-year follow-up study

ABSTRACT Early mathematical skills contribute to later school performance and socio-economic status. Working memory is related to mathematical skills, but spatial and language skills have independent effects on separate areas of mathematical skills such as solving word problems or arithmetic skills. In this study, 9- to 10-year-old children's (N = 57) cognitive and mathematical skills were assessed three times over 2 years. Spatial reasoning was associated with performance in solving word problems and working memory with performance in the arithmetic test. Regarding word problems, girls outperformed boys. Also, the second-language learners performed similarly to the native speakers in the beginning and in the end of the third grade, but worse in the end of the fourth grade. The results suggest that the students’ inadequate mastery of the school language may lead to underachievement in mathematics, implying that further efforts should be invested in supporting their language learning.

Environmental Enrichment and Health Outcomes Among Low-Grade Glioma Brain Tumor Survivors.

BACKGROUND: Brain tumor survivors who received radiotherapy (RT) are at a disproportionately increased risk of accelerated aging and symptom burden. We aim to examine the association between environmental enrichment (EE) and health outcomes among low-grade glioma survivors who received brain RT. METHODS: The study used a cross-sectional cohort design, enrolling participants approximately 5 years from diagnosis. The construct of EE consisted of social network, physical activity, employment status, and financial stability. Berkman-Syme Social Network Index, International Physical Activity Questionnaire, Vocational Index Scale, and a Socioeconomic Questionnaire were used to measure the construct of EE. Health outcome measures included the Montreal Cognitive Assessment, Symbol Digit Modality Test, clinical brain magnetic resonance images (pre-RT, approximately 2-3 years after RT, and approximately 5 years after RT), Karnofsky Performance Status Scale, and the MD Anderson Symptom Inventory Brain Tumor Module. Ordinal logistic regression estimated the association between levels of EE and health outcomes. RESULTS: Thirty-nine participants completed the study and experienced varying levels of EE. The median age was 44 years old, ranging from 26 to 78 years old. Nineteen individuals were diagnosed with oligodendroglioma, and 18 were diagnosed with astrocytoma. Thirteen participants had low EE, 17 had moderate EE, and 9 had high EE. Although not statistically significant, we observed patterns of increasing health outcomes (Montreal Cognitive Assessment, Symbol Digit Modality Test, and Karnofsky Performance Status Scale) related to increasing levels of EE. CONCLUSION: This study is an initial exploration into the role of EE in health outcomes and survivorship programs for persons with glioma. Future research should assess EE before treatment or at the time of diagnosis and be longitudinal to accurately ascertain the association between EE and health outcomes. Comprehensive neuro-oncology survivorship programs structured to facilitate EE may reduce symptom burden, promote neuroplasticity, and improve cognitive and functional outcomes after brain radiation.

HLX07 alone or combined with serplulimab, cisplatin and 5-fluorouracil for advanced esophageal squamous cell carcinoma: A phase 2 study.

The combination of anti-PD-1 antibody serplulimab and chemotherapy is considered standard first-line therapy for advanced esophageal squamous cell carcinoma (ESCC), but few later-line treatments are available. Here we evaluated the therapeutic efficacy of the recombinant, humanized anti-EGFR antibody HLX07 when used alone or together with serplulimab and chemotherapy against advanced ESCC. This open-label, non-randomized, two-cohort, phase 2 trial involved patients 18-75 years old with histologically or cytologically confirmed locally advanced, unresectable, or metastatic ESCC, and an Eastern Cooperative Oncology Group performance status of 0-1. Patients who had failed first-line immuno-chemotherapy or at least two lines of other systemic therapy received HLX07 monotherapy intravenously at a dose of 1,000 mg once every 2 weeks (Q2W). Patients with no prior systemic therapy received HLX07 (1,000 mg, day 1) and serplulimab (200 mg, day 1) intravenously Q2W for up to 2 years, concurrently with cisplatin (50 mg/m2, day 1) for up to 8 cycles and 5-fluorouracil (1,200 mg/m2, days 1-2) for up to 12 cycles intravenously Q2W. The primary endpoints were progression-free survival (PFS) and objective response rate (ORR). Overall, 50 patients were enrolled. In the HLX07 monotherapy group, ORR was 15.0% (3/20), and the median PFS was 1.5 months (95% confidence interval [CI], 1.3 to 3.7). The median duration of response was not reached, and the rate of patients showing an objective response lasting at least 6 months was 66.7% (95% CI, 5.4 to 94.5). Two (10.0%, 2/20) patients experienced grade 3-4 treatment-related adverse events (TRAEs), including hypomagnesemia, hypocalcemia, and fatigue. No patient experienced grade 5 TRAEs. In the HLX07 combination group, the ORR was 60.0% (18/30), and the median PFS was 7.8 months (95% CI, 3.3 to 9.1). Fourteen (46.7%, 14/30) patients experienced grade 3-4 TRAEs, and one (3.3%, 1/30) patient died due to serplulimab-related pneumonitis. HLX07 monotherapy and its combination with serplulimab and chemotherapy showed manageable toxicity and promising antitumor activity in patients with recurrent or metastatic ESCC. Randomized controlled trials are warranted to further establish the safety and efficacy of HLX07 against ESCC. This trial was registered at Clinicaltrials.gov (NCT05221658).