• Triphasic MRI evaluation of Hepatocellular Carcinoma according to ACR LI-RADS Compared with Histopathological Reports.
    1 week ago
    This study aims to evaluate the diagnostic accuracy of ACR LI-RADS 5 on Triphasic MRI for detecting hepatocellular carcinoma, using histopathology as the reference standard. This cross-sectional analytical study was conducted in the Department of Radiology and Imaging, Bangladesh Medical University (BMU), Dhaka, Bangladesh from April 2024 to September 2025. Patients with clinical, biochemical, or imaging suspicion of HCC underwent triphasic MRI and were categorized according to the ACR LI-RADS classification system. MRI findings were compared with histopathological diagnoses. Data were analyzed using SPSS version 26.0 and statistical significance was considered at p<0.05. ACR LI-RADS 5 on triphasic MRI demonstrated a sensitivity of 83.33%, specificity of 91.67%, positive predictive value of 93.75%, negative predictive value of 78.57% and overall diagnostic accuracy of 86.67% for the detection of hepatocellular carcinoma. Triphasic MRI showed high diagnostic accuracy, specificity and positive predictive value of ACR LI-RADS 5 for detecting hepatocellular carcinoma, demonstrating strong agreement with histopathological findings and supporting its role as a reliable non-invasive diagnostic tool.
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  • Association between Serum Folate Status and Cervical Intraepithelial Neoplasia.
    1 week ago
    Cervical intraepithelial neoplasia (CIN) is a premalignant lesion of cervix and if left untreated can progress to invasive cervical cancer after several years. Approximately 1.0-2.0% women have CIN II⁺ each year. Folate and vit B12 play important roles as inhibitors of human carcinogenesis in several organs. This study was done to evaluate the association of serum folate level with cervical intraepithelial neoplasia. This was a case control study conducted at colposcopy clinic of Bangladesh Medical University, Bangladesh. One hundred and twenty-two women were included in the study by purposive sampling from October 2019 to September 2020 after getting institutional review board approval. Study population were VIA positive women who were referred for colposcopy at colposcopy clinic of Bangladesh Medical University (BMU), Dhaka, Bangladesh. After getting informed consent, colposcopy and histopathological examination was done in all subjects irrespective of colposcopy result. Cases (n=61) were assigned to those who had histopathologicaly confirmed CIN. Control groups (n=61) were those who had both colposcopicaly and histopathologicaly normal cervix. Both groups were matched in relation to age, age at marriage, age at first delivery, parity and duration of OCP use. Serum folate level was measured in both cases and controls. Data were analyzed using SPSS software version 22. Continuous variables were expressed by mean±SD. Qualitative variables by percentage. Association of folate status and cervical intraepithelial neoplasia were assessed by unpaired 't' test, ANOVA test, Chi-Square test and in odds ratio with 95% CI. Cut off value for low serum folate level was obtained from ROC curve and it was <7.65 ng/ml. Among 61 cases of CIN, 55.0% were CIN I (n=34), 13.0% were CIN II (n=8) and 31.0% (n=19) were CIN III and carcinoma in situ. Statistically significant difference was found (p<0.05) in mean serum folate level between two groups. Among cases it was 9.74±3.51ng/ml and among controls 12.09±5.05 ng/ml, p=0.003s. Using multivariate logistic regression model serum folate <7.65ng/ml was found independently associated with CIN (OR 1.671 95% CI 1.16-2.40, p=0.039s). Low serum folate level was significantly associated with cervical intraepithelial neoplasia. So oral supplementation of folic acid to young adolescent girls and women of reproductive age may be considered to reduce the risk of developing CIN and subsequently cervical cancer.
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  • Intermittent Pneumatic Compression in Patients with Postmastectomy Lymphedema: A Randomized Controlled Trial.
    1 week ago
    Lymphedema as a result of curative surgery for breast cancer can lead to long term morbidity. Lymphedema following post-radical mastectomy causes family and social problem of young individual. Manual-lymphatic-drainage (MLD), IPC (Intermittent pneumatic Compression), MLB (Multi-layered-bandage) and compression sleeves are main treatment stream along with medication and modification of Activities of Daily Living (ADL). The aim of this study was to evaluate the effects of intermittent pneumatic compression (IPC) alone or in combination with exercises on upper limbs circumference and hand function. Subjects were required to have mild to moderate unilateral upper limb lymphedema acquired as a result of curative cancer surgery. The study population consisted of 21 patients with breast cancer-related lymphedema. One group received IPC for 45 minutes per session at 50-60mmHg, 5 sessions per week for 3 weeks (15 sessions in total), combined with physical exercise, and the other group received physical exercise only. Before and after arm circumference measurement done at six sites on affected limb. Hand function was assessed at six months with the DASH (Disabilities of Arm Shoulder and Hand) clinical questionnaire. Both groups exhibited a reduction in upper limb circumferences after the therapy in comparison to the initial values. The reduction reached statistical significance at most measurement levels in the group that received combined IPC and exercise. Intermittent pneumatic compression is an effective method of reducing post-mastectomy lymphedema. The exercises did not have a significant effect on function of hand.
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  • Association of Hypercalcemia with Advanced Oral Squamous Cell Carcinoma.
    1 week ago
    Squamous cell carcinoma (SCC) is the most frequent type of oral cancer in the globe. Despite breakthroughs in overall treatment modalities, survival rates of individuals with oral squamous cell carcinoma (OSCC) have not improved appreciably. One of the reasons for OSCC's poor survival rate is late diagnosis. The majority of patients arrive at the hospital in advanced stages of the disease (stage-3 and stage-4). This cross-sectional comparative study was carried out in the Department of Oral and Maxillofacial Surgery of former Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Bangladesh, from September 2022 to August 2023. And aimed to find out the association of hypercalcemia with advanced oral squamous cell carcinoma (stage-3 and stage-4). The study was comprised of 84 subjects in which 42 were selected as case group with advanced Oral Squamous Cell Carcinoma (OSCC), reporting to the Department of Oral and Maxillofacial Surgery, BSMMU; fulfilling the inclusion and exclusion criteria. The control group of subjects was consisted with 42 healthy attendants of patients after fulfilling the inclusion and exclusion criteria. All these participants were assessed clinically and their detailed history was recorded, 5 ml of intravenous blood was collected using standard aseptic conditions. These samples were centrifuged and serum was seen separated as the top transparent layer. This separated serum was used immediately for quantitative determination of serum calcium by biochemistry automated analyzer: Alinity ci. Serum calcium level was calculated and expressed in mg/dl. The collected data was sorted, tabulated and statistically analyzed. Hypercalcemia (>10.50 mg/dl) was found in 10(23.8%) patients of case group and no one in control group. The mean serum calcium level was found 9.48±0.71 mg/dl in case group and 9.07±0.56 mg/dl in control group. The difference was statistically significant (p<0.05) between two groups. The findings of the study showed that mean serum calcium levels in OSCC patients were substantially higher than in healthy people in Bangladesh.
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  • The influence of focused ultrasound in the treatment of cervical squamous intraepithelial lesion on vaginal microbiota and cervical immune microenvironment: a prospective observational study.
    1 week ago
    To observe the changes in the vaginal microbiota and cervical immune microenvironment following focused ultrasound treatment of cervical squamous intraepithelial lesions, with clinical efficacy assessed for contextual validation.

    The case group comprised 50 patients with cervical squamous intraepithelial lesions who underwent focused ultrasound treatment and completed longitudinal collection of cervical secretions at pretreatment, 1-2 weeks, and (14 ± 2) weeks post-treatment. According to the treatment response at (14 ± 2) weeks, the case group was further classified into cure (histopathologically confirmed absence of SIL, or normal cytology and colposcopy) and improvement (decreased SIL level on histopathology or cytology with corresponding colposcopy) subgroups. These patients were compared with 17 healthy individuals (the control group). Changes in the levels of DEFB1, IFN-γ, IL-1β, IL-8, IL-10, SIgA, SLPI, and the Th1/Th2 ratio were measured in cervical secretions. Meanwhile, vaginal microbiota was examined in both groups at baseline and (14 ± 2) weeks post-treatment.

    (1) Following focused ultrasound treatment, levels of DEFB1, IL-1β, IL-8, SIgA, and SLPI in cervical secretions were significantly decreased at (14 ± 2) weeks post-treatment in the cure group compared with pretreatment levels (p < 0.05). (2) Compared with pretreatment levels in the cure group, vaginal microbiota indicators-including pH, Nugent score, bacterial diversity, bacterial density, and Lactobacillus abundance-were significantly normalized at (14 ± 2) weeks post-treatment (p < 0.05).

    Focused ultrasound treatment may contribute to regression of cervical squamous intraepithelial lesions and may be associated with restoration of vaginal microbiota and cervical immune microenvironment.
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  • One-stage versus two-stage video-assisted thoracic surgery for synchronous bilateral pulmonary nodules: protocol for a prospective, multicentre, randomised controlled clinical trial in China (OTVATS-2).
    1 week ago
    With the increasing detection of synchronous bilateral pulmonary nodules in clinical practice, both one-stage and two-stage video-assisted thoracic surgery (VATS) have been widely applied. This study protocol describes the OTVATS-2 trial, which aims to compare perioperative complications and long-term outcomes between these two surgical strategies.

    A prospective, multicentre, randomised controlled clinical trial will be conducted to compare the surgical outcomes of one-stage versus two-stage VATS in patients with synchronous bilateral pulmonary nodules. A total of 256 patients will be enrolled from three academic institutions in China. This trial is expected to last for 2 years, with patient recruitment starting in July 2025. The primary outcome is perioperative complication rate within 30 days. Secondary outcomes including 5-year overall survival, 5-year disease-free survival, surgical time, blood loss, duration of chest tube, length of stay, postoperative pain scores, quality of life scores as well as anxiety and depression scores.

    This study has been approved by the Ethics Committee of China-Japan Friendship Hospital (No. 2025-KY-150) and the institutional review boards of all participating centres, including the Ethics Committees of Peking University Third Hospital and Beijing Hospital. Written informed consent will be obtained from all enrolled participants. Results of the research will be published in a peer-reviewed journal.

    ChiCTR 2500106215.
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  • Understanding the impact of perineal reconstruction after extended margin cancer surgery on longer-term quality of life, morbidity and health economic outcomes: protocol for the UK REMACS observational cohort study.
    1 week ago
    Advanced and recurrent pelvic cancers pose significant public health challenges due to their invasive nature, affecting pelvic structures like the pelvic floor, other organs and the perineum. Treatment involves chemoradiotherapy followed by extended margin cancer surgery (EMCS) to achieve cancer cure. EMCS results in an empty pelvis prone to major complications like collections, abscesses, bowel obstruction, fistulae and perineal wound breakdown. Known as the empty pelvis syndrome (EPS), this affects >50% of patients. EPS leads to poor quality of life (QoL), reduced return to function and significant financial burden to patients and healthcare services. Perineal reconstruction using myocutaneous flaps or biological meshes may mitigate these complications, but their longer-term clinical outcomes and effectiveness are not well-documented. This study addresses key unmet needs and aligns with strategic healthcare priorities.The Reconstruction after Extended Margin Cancer Surgery (REMACS) study aims to assess the effects of EMCS and perineal reconstruction on QoL, complications and health economic utilisation up to 12 months post-surgery.Objectives include:a. Providing real-world data on 12-month QoL and complications to aid shared decision-making consultations regarding reconstructive techniques post-ECMS.b. Informing clinical practice and patient expectations, improving communication and reducing regret throughout the initial stages of cancer survivorship.c. Evaluating economic impacts on patients and healthcare settings, optimising resource utilisation.d. Uncovering hidden treatment toxicities post-ECMS.

    Design: Multi-centre observational cohort study.

    236 patients undergoing EMCS with perineal reconstruction in tertiary cancer centres, ensuring diverse representation.

    Patients will complete QoL (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC-QLQ-C30), EuroQol-5 Dimension 5-Level Questionnaire (EQ-5D-5L), Locally Recurrent Rectal Cancer-QoL (LRRC-QoL)) and Decision-Regret questionnaires pre-surgery and 3, 6, 12 months post-surgery. Patient economic impact (COST, patient employment, health resource utilisation), quality-adjusted life years, incremental cost-effectiveness ratios (EQ-5D-5L) and healthcare economic impact will be recorded over 12 months after surgery. Complications (Clavien-Dindo) and pathology outcomes. 5-year survival and cancer recurrence will also be recorded as part of standard of care. Purposefully selected patients (n=30) representing different cancer types and from different geographical regions in the UK, ensuring the inclusion of different ethnic and under-represented minority backgrounds (ie, sexual and gender minorities and those from low socio-economic groups) will be interviewed at 3 and 12 months post-surgery. Patient experiences including preparedness, complex decision-making, complications, regret and hidden cancer treatment toxicities will be explored.

    EORTC-QLQ-C30 global health scores at 12 months will be compared between groups (primary outcome: flap versus mesh reconstruction). Descriptive statistics, causal inference techniques and regression modelling will be used to account for allocation bias and heterogeneity. Propensity scoring will weight cases and causal inference techniques will be used to visualise and understand confounding effects. Cost-utility economic analyses will compare reconstructive techniques. Longitudinal interview analyses will use constant comparative methods using reflexive thematic analysis.

    REMACS is approved by HRA REC (22/NE/0032). The study is funded by Penguins Against Cancer (Registered Charity Number 1159905), Bowel Research UK (BRUK SG 23019), PLANETS Cancer Charity (Registered Charity Number 1175572) and an NIHR Research for Patient Benefit Grant (NIHR207881).This study will benefit patients internationally by providing real-world outcomes to improve shared decision-making around complex consultations, informing patient expectations and clinical outcomes for QoL, complications and cost after EMCS and perineal reconstruction. Results will be disseminated to researchers, healthcare professionals, patients, carers, charities and policymakers through online platforms, media, scientific conferences and journals. This will raise awareness of late effects of cancer treatment, influence international guidelines and cancer commissioning.

    Clinical Trials.gov registration number-NCT05219058 and ISRCTN registry number-ISRCTN81241096.
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  • Single-arm, multicentre phase II trial of sintilimab plus platinum-based doublet chemotherapy followed by adaptive radiotherapy strategy for patients with unresectable stage III non-small-cell lung cancer in China: the ART-LUNG 01 study protocol.
    1 week ago
    Consolidation immunotherapy postchemoradiotherapy is standard for unresectable stage III non-small-cell lung cancer (NSCLC) per PACIFIC and GEMSTONE-301, but optimal integration with chemoradiotherapy is unclear, especially for large tumours. Induction immunotherapy before concurrent chemoradiotherapy (cCRT) may enhance tumour downstaging and immune synergy, while adaptive radiotherapy with strict lung constraints (V20 ≤20%) could reduce toxicity. This trial aims to evaluate the efficacy and safety of sintilimab with induction chemotherapy followed by adaptive radiotherapy and consolidation sintilimab in patients with unresectable stage III NSCLC.

    This prospective, multicentre, single-arm phase II trial will enrol 35 patients with histologically or cytologically confirmed unresectable stage III NSCLC, without sensitising mutations, and Eastern Cooperative Oncology Group(ECOG) performance status 0-1. Patients will receive two cycles of induction sintilimab (200 mg, day 1, every 3 weeks) plus platinum-based doublet chemotherapy, followed by definitive cCRT with adaptive radiotherapy planning strictly limiting both lung V20 ≤20%. Radiotherapy dose can be delivered in three optional regimens based on tumour volume and distribution: (1) planning gross tumour volume (PGTV) 60-66 Gy/2.0-2.2 Gy/30F with planning target volume (PTV) 54 Gy/1.8 Gy/30F; (2) PGTV 54-66 Gy/2.0-2.2 Gy/30F without PTV irradiation or (3) PGTV 50 Gy/2.0 Gy/25F without PTV irradiation. During radiotherapy, patients will receive two additional cycles of sintilimab plus chemotherapy. Consolidation sintilimab will continue for up to 1 year or until disease progression/unacceptable toxicity.

    This study was approved by the Institutional Ethics Committee of The Third Xiangya Hospital, Central South University (approval number: R25063; the approval letter is provided as online supplemental file 1). The study results will be disseminated through publication in peer-reviewed journals, presentations at national and international scientific conferences and communication to participants and the public via institutional channels and patient advocacy groups. Individual participant data will be available on reasonable request after study completion, subject to institutional and ethical approvals.

    NCT07138755.
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  • Efficacy and safety of T-DXd versus Other HER2-targeted therapies in second-line and later settings for HER2-positive metastatic breast cancer: A Bayesian network meta-analysis.
    1 week ago
    HER2-positive advanced breast cancer remains challenging after trastuzumab-based therapy because available regimens differ in survival, response, and toxicity. We compared therapies used in second-line and later settings.

    This PRISMA-NMA-compliant review was registered with PROSPERO (CRD420251244047). PubMed, Embase, Web of Science, and CENTRAL were searched through July 24, 2026. Phase II or III randomized controlled trials after trastuzumab-based therapy were eligible. Bayesian network meta-analysis summarized PFS and OS as hazard ratios and confirmed ORR and safety outcomes as odds ratios. Random-effects models were used where heterogeneity was estimable; fixed-effect Bayesian models were used for the sparse SAE and ILD/pneumonitis networks. DoR was analyzed exploratorily using a fixed-effect Bayesian normal model after prespecified conversion of arm-level summary statistics; TTP was not quantitatively synthesized when the required summary measures were unavailable or clinically non-equivalent.

    Sixteen reports representing seven independent randomized trial families and 3,339 unique randomized participants were included. Relative to T-DXd, T-DM1 had less favorable PFS (HR 3.30, 95% CrI 2.06-5.28) and OS (HR 1.52, 1.19-2.01). However, T-DXd was not represented in the second-line-only OS network or the Asia-dominant PFS/OS networks; therefore, its survival ranking reflects evidence primarily from mixed-line, non-Asia-dominant trials. T-DXd produced higher confirmed ORR than Lap-Cap (OR 7.43, 3.80-13.16), PTN-Cap (OR 3.35, 1.24-8.19), and T-DM1 (OR 6.31, 3.98-10.32). DoR showed no clear between-treatment difference in the EMILIA/NALA network, and TTP could not be quantitatively synthesized. Any-grade AE estimates did not indicate a safety advantage for T-DXd. SAE comparisons were also inconclusive: T-DM1 vs Lap-Cap OR 0.90 (0.67-1.21) and T-DXd vs T-DM1 OR 1.30 (0.87-1.93). T-DXd had higher ILD/pneumonitis odds than T-DM1 (OR 5.55, 2.79-12.16); LVD differences were unclear.

    Within the connected overall networks, T-DXd showed a favorable survival profile and the highest confirmed ORR, although its survival ranking was not estimable in the second-line-only OS or Asia-dominant survival networks. Its increased ILD/pneumonitis risk relative to T-DM1 is clinically important. Indirect survival comparisons and sparse safety networks require cautious interpretation.
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  • Efficacy and safety of immune checkpoint inhibitors combined with TKIs for recurrent or metastatic cervical cancer with PIK3CA mutation.
    1 week ago
    PIK3CA mutations are among the most common driver mutations in cervical cancer (CC), yet therapeutic strategies targeting PIK3CA mutations are still under investigation. This study aims to evaluate the efficacy and safety of immune checkpoint inhibitors (ICIs) combined with tyrosine kinase inhibitors (TKIs) in patients with PIK3CA-mutated recurrent or metastatic (R/M) CC.

    This study was based on two prospective clinical trials (ChiCTR1900023015 and the CLAP study) and retrospective data from Fujian Cancer Hospital, comparing ICIs combined with TKIs with physician's-choice Non-ICI/TKI conventional treatments in PIK3CA-mutated R/M CC. The primary endpoint was objective response rate (ORR), and secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.

    A total of 55 patients were included, with 27 in the ICIs plus TKIs treatment group and 28 in the Non-ICI/TKI conventional treatment group. The ORR in the ICIs plus TKIs group was 85.19% (95% CI, 67.52%-94.08%), significantly higher than 28.57% (95% CI, 15.25%-47.06%) in the Non-ICI/TKI conventional treatment group (P < 0.001). The PFS in the ICIs plus TKIs group was 21.03 months, significantly longer than 9.13 months in the Non-ICI/TKI conventional treatment group (HR, 0.49; 95% CI, 0.26-0.94, P = 0.033). Although the OS difference was not statistically significant (HR, 0.65; 95% CI, 0.31-1.34, P = 0.24), the ICIs plus TKIs group showed superior clinical efficacy. The incidence of hypertension (P < 0.001), rash (P = 0.004), hypothyroidism (P < 0.001), proteinuria (P = 0.010), and palmoplantar erythrodysesthesia syndrome (P = 0.023) was higher in the ICIs plus TKIs group compared to the Non-ICI/TKI conventional treatment group. The observed adverse events were generally manageable. Although grade ≥3 adverse events occurred, no grade ≥3 immune-related adverse events or treatment-related deaths were observed.

    ICIs plus TKIs demonstrated significant efficacy in treating PIK3CA-mutated R/M CC. Although there were some safety concerns, the adverse reactions were manageable, no grade ≥3 immune-related adverse events or treatment-related deaths were observed.
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