• Vitamin D supplementation before in vitro fertilisation in women with polycystic ovary syndrome: multicentre, double blind, placebo controlled, randomised clinical trial.
    3 weeks ago
    To evaluate whether vitamin D supplementation improves live birth rates in women with polycystic ovary syndrome undergoing in vitro fertilisation.

    Multicentre, double blind, placebo controlled, randomised clinical trial.

    24 fertility centres in China.

    876 participants with polycystic ovary syndrome undergoing in vitro fertilisation.

    Participants were randomised (1:1) to receive vitamin D 4000 IU/day or placebo before in vitro fertilisation for up to 90 days until the trigger day.

    The primary outcome was live birth after the first embryo transfer. Secondary outcomes included serum 25-hydroxyvitamin D (25-OHD) levels on trigger day, pregnancy outcomes, fertility outcomes, and adverse events including severe ovarian hyperstimulation syndrome.

    Of 876 participants randomised, 865 were included in the modified intention-to-treat analysis, with 435 in the vitamin D group and 430 in the placebo group. Baseline mean serum 25-OHD levels were 16.5±7.2 and 16.1±6.7 ng/mL in the vitamin D and placebo groups, respectively. On the day of triggering, the serum 25-OHD level was significantly higher in the vitamin D group than in the placebo group (32.3±11.2 v 18.2±7.6 ng/mL, adjusted mean difference 13.6, 95% confidence interval 10.9 to 16.3). 226 (52.0%) live births occurred in the vitamin D group and 216 (50.2%) in the placebo group (adjusted risk ratio 1.03, 95% confidence interval 0.91 to 1.18). Severe ovarian hyperstimulation syndrome occurred in three and six participants in the vitamin D and placebo groups, respectively (adjusted risk difference -0.7%, 95% confidence interval -2.0% to 0.6%).

    Although vitamin D supplementation (4000 IU/day) for up to 90 days increases serum 25-OHD levels, this does not translate to improved live birth rates after the first transfer for patients with polycystic ovary syndrome.

    ClinicalTrials.gov NCT04082650.
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  • Remote Exercise Program for Patients With Metastatic Renal Cell Carcinoma Undergoing Immunotherapy: An EXIO Case Series Report.
    3 weeks ago
    Patients with metastatic renal cell carcinoma (mRCC) treated with immune checkpoint inhibitors (ICIs), alone or in combination with tyrosine kinase inhibitors (TKIs), often experience significant treatment-related adverse events, including fatigue, that can impair health-related quality of life (HRQOL). Structured exercise interventions may mitigate these symptoms, but data in mRCC are limited.

    To evaluate the feasibility and impact of a 12-week supervised remote exercise program on HRQOL, fatigue, and symptom burden in patients with mRCC receiving ICIs or ICI-TKI combinations.

    Nineteen patients with mRCC (median age 67 years; 57.9% male) participated in a 12-week home-based exercise program, supervised via telehealth. The program included aerobic, resistance, and mobility exercises delivered through weekly virtual consultations and supported by the Vedius platform. Outcomes were assessed at baseline and post intervention using the Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator (FACT-ICM), Brief Fatigue Inventory (BFI), and Edmonton Symptom Assessment System (ESAS).

    Participants demonstrated significant improvements in overall HRQOL (FACT-General mean increase, 9.8 points; P  = .001; Cohen d  = 0.8), treatment-related toxicity (ICM mean increase, 10.1 points; P  = .017), and fatigue (BFI mean decrease, 21.1 points; P  = .018; ESAS fatigue mean decrease, 5.0 points; P  = .001; Cohen d  = -1.5). Symptom burden (ESAS mean decrease, 12.3; P  = .001) and key patient-reported outcomes, including anxiety, depression, appetite loss, and sleep disturbances, also improved ( P  ≤ .02).

    A 12-week supervised remote exercise program was feasible and associated with meaningful improvements in HRQOL, fatigue, and symptom burden among patients with mRCC undergoing ICI-based therapies. These findings support the integration of structured exercise into supportive care for mRCC, highlighting the potential of remote interventions to enhance physical and emotional well-being. Future studies should confirm these results in larger randomized trials and identify the most effective program components.
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  • Tutorial for variant interrogation in tumor samples.
    3 weeks ago
    The increasing accessibility of next-generation sequencing has empowered researchers to investigate somatic mutations in cancer. The complexity of variant analysis pipelines, terminology, and tool selection remains a major barrier, especially for those new to the field or working in translational settings. To address this challenge, we present a practical framework that guides researchers through the critical steps of variant interrogation in tumor samples. This guide is broken into four phases: Planning-laying the foundation for thoughtful experimental design and a clear understanding of sequencing outputs; Gathering Resources-assembling the tools, reference data, and variant annotation sets required for analysis; Filtering and Validation-executing a systematic approach to prioritize meaningful variants; and Dissemination and Storage-ensuring findings are reproducible and accessible through transparent reporting and data sharing. Developed with an emphasis on accessibility, reproducibility, and clinical relevance, this framework equips researchers with the guidance to navigate variant analysis with confidence and rigor.
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  • Intraoperative 3D quantitative magnetic resonance imaging in paediatric brain tumour surgery.
    3 weeks ago
    • To investigate if R1 and R2 can reliably be measured using 3D quantitative MRI in an intraoperative setting when paediatric brain tumour surgery is performed. • To determine whether B1+ inhomogeneities affect R1 and R2 measurements in normal-appearing white matter and the thalamus, respectively, and how R1 and R2 measurements are affected by different coils. • To assess how the relaxation parameters of brain tissue are affected by the intraoperative setting.

    The accuracy of R1 and R2, the effect of B1+-field inhomogeneity and how the flex coil position affected R1 and R2 were evaluated, both pre- and intraoperatively during surgery. Ten patients were recruited, six girls and four boys aged 2-15 years, with varying tumour entities, all referred to surgery with intraoperative MR. The patients were scanned using a head coil preoperatively and flex coils intraoperatively. Control experiments were performed on phantoms in various positions, equivalent to the patient positions. ROIs (Regions of Interest) were positioned in areas representing normal-appearing matter. Relaxation rates R1 and R2 were calculated from 3D-quantification using an interleaved Look-Locker acquisition sequence with T2 preparation pulse (3D-QALAS) data.

    There was a significant increase of R2 in the intraoperative setting compared to the preoperative 3D-QALAS measurements. In contrast to the patient examinations, control experiments using relaxation phantoms did not demonstrate similar differences.

    Relaxometry is feasible in the intraoperative setting. The detected differences between the quantitative R2 values in tissue pre- and intraoperatively seem to be explained by the physiological conditions characterising the surgical situation.
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  • Association between cervical conization and pregnancy outcomes: A nationwide population-based cohort study.
    3 weeks ago
    Cervical conization is the standard treatment for cervical intraepithelial neoplasia. However, its effects on pregnancy outcomes remain controversial. Using data from the Korean National Health Insurance System, this population-based retrospective cohort study evaluated the relationship between cervical conization and adverse pregnancy outcomes between 2006 and 2022. Altogether, 199,826 singleton primiparous women aged 19 years or older were included, of whom 18,602 had undergone conization prior to pregnancy. The adjusted odds ratios for obstetric complications were estimated using multivariable logistic regression. Conization was associated with an elevated risk of cervical incompetence (adjusted odds ratios [aOR] 3.15; 95% confidence interval [CI] 3.01-3.30), preterm labor (aOR 1.44), preterm premature rupture of membranes (aOR 1.67), placenta previa, gestational diabetes, and intrauterine growth restriction. The subgroup analysis revealed that women who underwent both conization and cerclage had substantially higher risks of preterm labor and preterm premature rupture of membranes than did those who did not receive cerclage. The results point to a heightened obstetric risk following cervical conization, emphasizing the need for tailored prenatal care and continued prospective investigation.
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  • Patients' needs and preferences in developing Art-Based Learning in outpatient palliative cancer care: A qualitative study.
    3 weeks ago
    Art-Based Learning (ABL), an art pedagogical practice, may assist cancer patients by providing a meaningful experience through art viewing. However, little is known about what needs to be considered when developing an exhibition space for ABL in a palliative care setting. This study aimed at providing an overview of needs and preferences from a patient perspective.

    Patients were included through purposive sampling based on the following criteria: WHO performance status 0 or 1, ≥ 18 years, Dutch proficiency, and ability to come to the hospital. For the online sessions, access to the internet, a device, and a microphone were required. Patients participated in an ABL session either online or in the hospital followed by a semi-structured interview. The transcribed interviews were thematically analyzed using both deductive and inductive approaches.

    Participants (n = 13) had a positive experience with ABL either online (n = 6) or in the hospital (n = 7). The results showed the multidimensionality of the patients' needs and preferences regarding the exhibition and ABL, from preferences regarding the exhibition space and needs for accessibility both online and on-site, to personalization of ABL by the facilitator.

    Our study showed that the hospital and online museum are appropriate and accessible environments for an exhibition for ABL. A varied selection of artworks might contribute most to a meaningful experience. Furthermore, we identified the patients' need for a person-centered approach in ABL in palliative care, in which not only the facilitator, but also health care professionals play an important role.
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  • Nutritional and prognostic effects of thoracic duct obliteration during esophagectomy.
    3 weeks ago
    Thoracic duct obliteration (TDO), either ligation or resection, is performed during esophagectomy to enhance oncological radicality or manage chylothorax. However, its nutritional and oncological effects are unclear. We retrospectively analyzed patients undergoing esophagectomy for esophageal cancer at our institution between January 2016 and May 2024. We assessed laboratory parameters and computed tomography-derived body composition indices from diagnosis to 9-12 months postoperatively (15-25 months for laboratory data). We also analyzed nutritional indices, overall survival (OS), and recurrence-free survival (RFS). A total of 82 patients underwent TDO, and 313 did not (non-TDO). After propensity score matching, we included 75 TDO and 150 non-TDO patients. The TDO group achieved a higher lymph node yield, without affecting chylothorax incidence, nutritional or body composition indices, OS, RFS, or recurrence patterns between the TDO and non-TDO groups. However, analysis of neoadjuvant therapy (NAT) subgroup found more subcutaneous fat loss 3-6 months postoperatively in TDO patients (-55.35% vs. -32.93%, P = 0.002). This difference was no longer evident at 9-12 months (-42.97% vs. -42.89%, P = 0.859). Among the NAT patients, thoracic duct resection was associated with better OS and RFS than non-resection (3-year OS: 77.15% vs. 57.25%, P = 0.038; 3-year RFS: 72.41% vs. 48.08%, P = 0.049). In conclusion, TDO during esophagectomy does not compromise long-term nutritional or oncological outcomes in patients with esophageal cancer. In the NAT subgroup, transient subcutaneous fat loss was evident during the early postoperative period but was no longer apparent after a year. Survival outcomes were better among NAT patients who received thoracic duct resection.
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  • Deriving wisdom from data: The value and continued rationale for structured data in the era of artificial intelligence-driven oncology care.
    3 weeks ago
    The adoption of electronic health records (EHRs) has transformed health care, improving efficiency and chart accessibility. However, the widespread reliance on unstructured data entry and the lack of standardized documentation frameworks have resulted in significant data fragmentation across health care systems. The prevalence of unstructured data in EHRs limits their potential for clinical decision support, trial matching, real-world evidence (RWE) generation, and quality measurement. Data fragmentation in health care triggers a cascade of challenges that ultimately compromise patient care. Clinicians face an excessive documentation burden and struggle to locate critical information buried in unstructured notes. Researchers encounter difficulties in extracting reliable clinical data. EHR vendors grapple with standardizing unstructured information for interoperability, and payers are unable to process unstructured clinical data efficiently to support value-based care models. These challenges are particularly acute in oncology, where complex clinical elements like cancer staging, disease status, and treatment changes require precise, structured documentation. Emerging artificial intelligence (AI) technologies, such as large language models (LLMs) and ambient listening, offer a path to automate structured data generation while reducing the workload on providers. Here, the authors propose LLM-based workflows that balance automation with clinician verification, streamlining data entry without compromising accuracy. Realizing these benefits requires coordinated efforts among clinicians, researchers, EHR vendors, payers, and policymakers to align regulatory frameworks with AI-driven innovations. This article outlines a strategy to enhance structured data capture within EHRs, ultimately improving patient care, research, and health care efficiency.
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  • Receipt of guideline-concordant local and chemotherapy-based systemic therapy for patients with triple-negative breast cancer: 10-year survival outcomes in a multi-state population-based analysis.
    3 weeks ago
    Women diagnosed with triple-negative (ER-, PR-, HER2-) breast cancer (TNBC) have poor survival outcomes compared with other breast cancer subtypes. Yet there is little nonexperimental data on whether guideline-concordant therapy translates to better outcomes over time, or about factors associated with receipt of such guideline care. This study addresses these issues.

    Using data from the Centers for Disease Control and Prevention National Program of Cancer Registries (NPCR) augmented via medical records abstraction, the authors constructed a cohort of women diagnosed with invasive, nonmetastatic (stage I-III) TNBC in 2004 (N = 747) and followed through 2015. The date and primary cause of death were derived from the NPCR and the National Death Index. Standard-of-care treatment (as aligned with the study's timeframe) was defined as being guideline concordant (GC) for surgery, radiation therapy, and chemotherapy based on appropriate initiation, regimen, and completion. Through regression modeling, the authors examined predictors of being GC and the association of GC with 10-year survival outcomes.

    Controlling for patient, tumor, and sociodemographic factors, patients whose management was GC had significantly better all-cause survival (hazard ratio [HR], 0.59; 95% confidence interval [CI], 0.45-0.77), breast cancer-specific survival (HR, 0.60; 95% CI, 0.42-0.86), and also better non-breast cancer survival (HR, 0.63; 95% CI, 0.40-1.00), compared with those whose management was Not GC. Treatment at a Commission on Cancer-accredited facility was a significant predictor of receiving GC care (odds ratio, 1.87; 95% CI, 1.34-2.59).

    Building on this study's methodology and its findings about the effectiveness of long-standing approaches to TNBC management, additional population-based studies are urgently needed as new therapeutic approaches are being integrated into guidelines and clinical practice.
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  • Second-line chimeric antigen receptor T-cell therapy versus standard of care in relapsed or refractory large B-cell lymphoma: A systematic review and meta-analysis.
    3 weeks ago
    CD19-directed chimeric antigen receptor (CAR)-T-cell therapy has emerged as a second-line option for relapsed/refractory large B-cell lymphoma (R/R LBCL). However, its long-term benefits over standard of care (SOC) remain a matter of debate.

    A systematic review and meta-analysis was performed of three randomized controlled trials (ZUMA-7, TRANSFORM, BELINDA) and one real-world comparative study evaluating second-line CAR-T versus standard-of-care chemoimmunotherapy (±autologous stem cell transplantation) in adults with early R/R LBCL. Hazard ratios (HRs) and 95% CIs for overall survival (OS), event-free survival (EFS), and progression-free survival (PFS) were pooled. Individual patient data were reconstructed to generate pooled Kaplan-Meier survival curves. Subgroup analyses and long-term safety outcomes were also evaluated.

    A total of 1199 patients were included. Pooled analyses demonstrated a significant benefit of CAR-T over SOC in OS (HR = 0.75; 95% CI, 0.62-0.92), EFS (HR = 0.51; 95% CI, 0.33-0.78), and PFS (HR = 0.47; 95% CI, 0.39-0.58). Three-year OS and PFS estimates from reconstructed data were 53.59% and 44.08% in the CAR-T group, compared to 41.46% and 17.82% with SOC, respectively. Subgroup analyses confirmed consistent EFS across subgroups, including age, disease subtype, and relapse status. Long-term toxicities indicated more frequent hypogammaglobulinemia with CAR-T cell therapy, with no excess in secondary malignancies.

    Second-line CAR-T therapy significantly improves long-term survival and disease control in R/R LBCL, with consistent benefit across subgroups and real-world settings. These findings support early CAR-T use as a standard strategy in high-risk LBCL, while emphasizing the importance of timely delivery and long-term monitoring.
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