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Development of a core screening, assessment and outcome set for cancer prehabilitation: an international Delphi consensus study protocol.1 week agoA core screening, assessment and outcome set is needed in cancer prehabilitation to standardise what is measured in both research and services. Currently, there is significant variation in measures used, which limits comparability between studies and evidence synthesis. Standardising measures will improve the quality, comparability and impact of research by reducing heterogeneity between studies, minimising reporting bias, improving trial efficiency, enabling data synthesis into large datasets, supporting international collaboration and data sharing, and accelerating the implementation of best practices.
An international Delphi consensus process will be conducted involving patients, healthcare professionals and researchers to identify screening, assessment and outcomes and their corresponding measurement instruments, to be included in a core set. The study consists of three phases: (1) A scoping review to identify screening, assessment and outcomes and associated measurement instruments currently used in cancer prehabilitation. (2) At least two rounds of a modified Delphi survey to prioritise the identified screening, assessment and outcomes using a 1-9 Likert scale. Consensus will be defined across stakeholder groups using prespecified thresholds. A consensus meeting will be held if agreement is not reached. (3) Measurement instruments corresponding to each retained screening, assessment and outcome will be assessed for quality for measurement properties and feasibility. Further Delphi rounds will be conducted to reach consensus on the most appropriate measurement instrument for each core screening, assessment and outcome.
The study has ethical approval (Ref: 25/NW/0159). Findings will be disseminated through peer-reviewed publications, conference presentations, stakeholder networks and made publicly available via the Core Outcome Measures in Effectiveness Trials database.CancerAccessCare/Management -
CARE study: prospective cohort study on supportive care among paediatric oncology patients in western Kenya-a study protocol.1 week agoChildhood cancer presents significant challenges in low- and middle-income countries (LMICs), as survival rates remain substantially low. Supportive care, including nutritional support and infection prevention plus management, is crucial in improving outcomes of childhood cancer patients. To develop evidence-based interventions improving supportive care and survival, insight is needed into local prevalences of malnutrition, colonisation and infections, their association with clinical outcomes and the attitude of parents or legal guardians towards nutritional care and infection prevention. The overall aim of this prospective cohort study is to identify modifiable nutritional and infection-related determinants of clinical outcomes at 6 months in children with cancer (1-15 years of age) treated with curative intent at the Paediatric Oncology ward of the Shoe4Africa Children's Hospital at the Moi Teaching and Referral Hospital in Eldoret, Kenya.
We will conduct a prospective cohort study on 150 children aged 1-15 years who are newly diagnosed with cancer and treated with curative intent. During 6 months of follow-up, we will collect clinical data, perform nutritional assessments and monitor pathogen exposure, colonisation and infections. Parents or legal guardians will receive one questionnaire to assess attitudes towards supportive care. Six-month mortality is the primary outcome. Other outcomes include the prevalence and characteristics of malnutrition, rectal colonisation with bacterial and fungal pathogens, infections and neutropenic fever episodes. Statistical analyses will include descriptive statistics, chi-square tests, logistic regression and thematic analysis.
The Institutional Research and Ethics Committee has approved the study protocol (FAN: 0004674, protocol version 1.0). Informed consent from parents or legal guardians and assent from children ≥12 years will be obtained. Findings will be disseminated through peer-reviewed publications, presentations at academic conferences and engagement with local and national policymakers and stakeholders. Data from this study could guide the development of locally informed, evidence-based supportive care interventions, with the ultimate goal to improve overall survival for children with cancer in LMICs.CancerAccessCare/ManagementAdvocacy -
Fasting opens a metabolic window that favors anti-tumor immunity.1 week agoShort-term fasting reshapes the metabolic landscape of the tumor microenvironment, creating a transient window of altered nutrient availability that cytotoxic CD8⁺ T cells can exploit. Chen and colleagues report that intratumoral isoleucine accumulation during fasting supports T cell effector programs, enhancing responses to immune checkpoint blockade in mice and humans.CancerAccess
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Daraxonrasib in Previously Treated Advanced RAS-Mutated Pancreatic Cancer.1 week agoCurrent therapies for patients with pancreatic ductal adenocarcinoma (PDAC) provide modest benefit. Activating RAS mutations occur in more than 90% of PDAC tumors. Daraxonrasib (RMC-6236) is an oral RAS(ON) multiselective inhibitor that targets guanosine triphosphate-bound mutant and wild-type RAS.
In this phase 1-2 study, we evaluated daraxonrasib in patients with advanced solid tumors with activating RAS mutations. Patients received 10 to 400 mg of daraxonrasib orally once daily; 300 mg was selected as the phase 3 dose. The primary end point was safety. Pharmacokinetics and antitumor activity were secondary end points. This report focuses on the 168 study patients with previously treated RAS-mutated PDAC.
Among the 168 patients with PDAC who received daraxonrasib at a dose of 300 mg or less, treatment-related adverse events of any grade were reported in 96%; such events of grade 3 or higher were reported in 30%. Treatment-related adverse events that occurred in at least 10% of the patients included rash, diarrhea, nausea, stomatitis or mucositis, vomiting, and fatigue. In a subgroup of 26 patients with RAS G12 mutations who were treated with second-line daraxonrasib at a dose of 300 mg, an objective response to therapy was reported in 35% (95% confidence interval [CI], 17 to 56). The median duration of response was 8.2 months (95% CI, 3.8 to not evaluable), with median values of 8.5 months for progression-free survival and 13.1 months for overall survival. Among the 38 patients with RAS G12, G13, or Q61 mutations, 29% (95% CI, 15 to 46) had an objective response. The median duration of response was 8.2 months (95% CI, 3.8 to 8.8), with median values of 8.1 months for progression-free survival and 15.6 months for overall survival.
Daraxonrasib was associated with treatment-related adverse events of grade 3 or higher in one third of patients with previously treated RAS-mutated PDAC; antitumor activity was also reported. (Funded by Revolution Medicines; RMC-6236-001 ClinicalTrials.gov number, NCT05379985.).CancerAccessCare/ManagementAdvocacy -
[Risk factors for cervical intraepithelial lesions among beneficiaries of second-level care].1 week agoCervical cancer (CC) is a major public health problem, particularly in low- and middle-income countries. Although human papillomavirus (HPV) is the main causal agent, the relevance of various risk factors varies by context.
To identify familial, sociodemographic, behavioral, and sexual history factors associated with squamous intraepithelial lesions (SIL) in women attending the Opportunistic Cervical Cancer Screening Program in the Regional Hospital with Family Medicine Unit No. 32 in Minatitlán, Veracruz, Mexico.
An observational case-control study (1:2) was conducted in women aged 25-60 years with available cytology results. An anonymous questionnaire was applied, and data were analyzed using comparison tests and odds ratios (OR) with 95% confidence intervals (95% CI).
A total of 119 women (37 cases, 82 controls) were included. No significant differences were found between groups for age, age at first intercourse, number of pregnancies, sexual partners, contraceptive use, or smoking. A strong association was found between the presence of SIL and a history of abnormal cytology (crude OR 2916; corrected OR 1322), as well as between SIL and a family history of cervical cancer (OR 2.73). Specific sexual practices showed no association.
Some factors considered risk factors showed no association in this population. This highlights the importance of follow-up for abnormal cytology and the need for further longitudinal studies with context-sensitive approaches.CancerAccessAdvocacy -
[Infrared thermography outcomes in women with suspected breast cancer].1 week agoBreast cancer (BC) is the most common cause of death in women aged 40 to 75 years. Infrared thermography (IT) has been proposed as a noninvasive test useful in the detection of BC.
To analyze the results of IT in women with suspected BC.
An analytical, observational, longitudinal, and prospective study was conducted. Women aged ≥ 15 years with suspected BC were included, with BI-RADS (Breast Imaging Reporting and Data System) 4. Prior to the biopsy, breast temperature was measured using 2 thermographic sensors. The histopathological results of the breast biopsy were recorded and classified as inflammatory lesions, fibrocystic breast disease, premalignant lesions, and malignant lesions.
A total of 104 women were analyzed, with BI-RADS 4A (64%), 4B (26%), and 4C (10%), and 4 were eliminated due to loss to follow-up. Mean age was 47.7 ± 12.2 years. 14% of cases showed a palpable lesion, with the right breast being the most affected (56%). The most common malignant lesion was ductal carcinoma (11%). The IT cutoff point for malignant lesion ≥ 33.4 °C showed a sensitivity of 0.69, specificity of 0.63, area under the curve (AUC) = 0.65 (95% confidence intervals [95% CI] 0.45-0.79), p = 0.03; with an odds ratio (OR) = 4.16 (95% CI 1.23-14.09), p = 0.01.
The results of the IT showed moderate sensitivity and specificity for malignant lesions. The cutoff point ≥ 33.4 °C showed a 4-fold increased risk for malignancy.CancerAccessAdvocacy -
Effect of capsule invasion on recurrence and survival in axillary lymph node metastases of breast cancer.1 week agoThe aim of this study was to investigate the effect of capsule invasion on recurrence and survival in breast cancer patients with axillary lymph node metastases.
This retrospective study included 135 breast cancer patients with axillary lymph node involvement who underwent surgery between 2009 and 2018. The relationships between capsule invasion and various clinicopathological factors-including demographic parameters, tumor stage, surgical technique, histological type, number of involved lymph nodes, tumor size, estrogen receptor, progesterone receptor, human epidermal growth factor receptor 2, and Ki-67 index-were analyzed using chi-square, Kaplan-Meier, and Fisher's exact tests. Additionally, multivariate Cox regression analysis was performed to assess the independent prognostic value of capsule invasion for recurrence. A p<0.05 was considered statistically significant.
Capsular invasion was observed in 64 of 135 patients (47.4%). Recurrence occurred in six patients with capsule invasion compared to only one patient without capsule invasion. Multivariate Cox regression analysis, controlling for positive lymph node count, tumor size, grade, and receptor status, confirmed that capsule invasion was an independent predictor of recurrence [HR 3.45, 95%CI 1.12-10.65, p=0.032]. No significant association was found between tumor size and capsule invasion (p>0.05). During follow-up, 20 patients died (9 with and 11 without capsule invasion), with no significant difference in 5-year survival or mean survival time between groups (p=0.972, Kaplan-Meier analysis). Grading of capsular invasion showed a significant correlation with recurrence (p=0.026).
Although lymph node capsule invasion in breast cancer with axillary lymph node involvement does not significantly impact overall survival, it independently and significantly elevates the risk of recurrence, as demonstrated by multivariate analysis.CancerAccessAdvocacy -
[Initial clinical experience with ribociclib in advanced HR+/HER2- breast cancer in Uruguay].1 week agoRibociclib improves progression-free and overall survival (PFS and OS) in women with advanced HR+/HER2- breast cancer (BC), but real-world evidence in Uruguay is limited.
To describe the clinical characteristics, outcomes, and safety profile of women with advanced HR+/HER2- breast cancer treated with ribociclib plus hormone therapy in Uruguay.
Observational, retrospective study. Demographic and clinical variables, type of hormone therapy, treatment duration, and adverse events were analyzed.
A total of 54 patients from public and private institutions were included, with a median age of 60 years. 67% relapsed after adjuvant treatment. Bone was the most common metastatic site (72%). Ribociclib was administered as first-line treatment in 81% of cases, and combined with aromatase inhibitors in 63%. The mean OS was 41.6 months and the mean PFS was 30 months; medians were not reached. Neutropenia was the most frequent adverse event (66%), followed by gastrointestinal toxicity (nausea 33%, diarrhea 28%) and skin toxicity (16%). One death due to pulmonary embolism was recorded, and QTc prolongation was documented in 5.6% of patients. Dose reduction was required in 20%, and one patient discontinued treatment due to skin toxicity.
Ribociclib was well tolerated, with a safety profile consistent with the literature. This study provides relevant local evidence and supports its use in real-world settings. Longer follow-up is needed to more accurately assess OS and PFS outcomes.CancerAccessCare/ManagementAdvocacy -
Outcomes of Hypofractionated Radiotherapy in Patients With Geriatric Head and Neck Cancer: Role of Comprehensive Geriatric Assessment.1 week agoElderly patients with locally advanced head and neck squamous cell carcinoma (HNSCC) often present with frailty and multiple comorbidities, which reduce their tolerance to standard oncologic treatments. This study evaluates the outcomes of hypofractionated radiotherapy (RT) in frail elderly patients with HNSCC after geriatric assessment.
A prospective study was conducted among 154 elderly patients with nonmetastatic HNSCC (60 years and older) between October 2023 and October 2024. The G8 geriatric screening tool identified frail patients (G8 ≤ 14), who subsequently underwent a comprehensive geriatric assessment (CGA). Patients deemed unfit for radical treatment received hypofractionated RT. Treatment outcomes, toxicity, and survival were analyzed.
Of 154 patients, 90 (58.45%) had G8 scores ≤14, indicating the need for CGA. Among them, 53 (58.88%) were unfit for definitive therapy and received hypofractionated RT. With a median follow-up of 3 months, the median overall survival (OS) was 6.5 months. At 3 months post-treatment, 39.6% of patients were alive, whereas 60.4% had died. There is a strong relation between G8 score and survival (regression coefficient [B] = 1.969, adjusted R2 = 0.574, P < .001). With a median G8 score of 11, Kaplan-Meier analysis showed a significantly shorter median OS in patients with G8 ≤ 11 compared with those with G8 > 11 (3.66 v 11.10 months; P < .001). Among all domains of CGA, patients with normal nutritional status and low comorbidity index had significantly better OS (for Mini Nutritional Assessment, P < .001; for Charlson comorbidity index, P = .004). Treatment was well-tolerated, with minimal grade 3 toxicity.
Hypofractionated RT is a feasible option for frail elderly patients with HNSCC, improving symptom control with manageable toxicity. G8 and CGA assessments facilitate personalized treatment, emphasizing quality of life over curative intent.CancerAccessCare/ManagementAdvocacy -
Understanding the Needs and Challenges of Cancer Registry Stakeholders.1 week agoCancer registry data represent an indispensable tool for researchers and community outreach and engagement (COE) professionals seeking to understand and mitigate cancer burden in cancer center catchment areas and beyond. To provide insights into the opportunities and obstacles for innovation in the population cancer data space, we contrast the needs and challenges of three groups of stakeholders with regard to cancer registry data.
We convened a nationwide panel of 18 population cancer researchers, COE professionals, and central cancer registry officials. We performed qualitative analysis of individual interviews, survey responses, and meeting transcripts to identify the cancer registry data-related needs and challenges of each stakeholder group. We identified distinct functional categories related to registry data applications, and described points of convergence and divergence within each category across the three stakeholder groups.
We completed 8 hours of individual panelist interviews, received 16 survey responses (88.9% response rate), and conducted three meetings of working groups. All stakeholder groups agreed on the value of accurate and representative registry data. Researchers desired granular data (case-level and aggregated by small geographic levels) with more clinically relevant data fields and linked community-level access measures. COE participants valued cancer burden and social drivers of health metrics aggregated at a subcounty level as well as user-friendly data querying and visualization tools. Cancer registry officials described an imperative to comply with mandatory reporting requirements and to protect patient privacy in a setting of resource constraint that can conflict with the data use goals of researchers and COE users.
Population cancer researchers, COE professionals, and cancer registry officials understand the value of registry data, but the priorities of each are misaligned to varying degrees. Further work is needed to understand the elements of successful efforts to expand the utility and use of registry data.CancerAccessAdvocacy