Assessing patient risk, benefit and outcomes in drug development: an observational study of regorafenib clinical trials.

Objective: Our objective of this study was to analyse all oncological clinical trials using regorafenib to create a complete risk/benefit profile for the drug.

Background: Creating a novel chemotherapy is costly both in time and capital spent for drug manufacturers. To regenerate what they've spent, drug manufacturers may attempt to repurpose their medications for new indications via clinical trials.

Cancer incidence and competing mortality risk following 15 presenting symptoms in primary care: a population-based cohort study using electronic healthcare records.

Objectives: Assessment of age, sex and smoking-specific risk of cancer diagnosis and non-cancer mortality following primary care consultation for 15 new-onset symptoms.

Methods And Analysis: Data on patients aged 30-99 in 2007-2017 were extracted from a UK primary care database (CPRD Gold), comprising a randomly selected reference group and a symptomatic cohort of patients presenting with one of 15 new onset symptoms (abdominal pain, abdominal bloating, rectal bleed, change in bowel habit, dyspepsia, dysphagia, dyspnoea, haemoptysis, haematuria, fatigue, night sweats, weight loss, jaundice, breast lump and post-menopausal bleed).Time-to-event models were used to estimate outcome-specific hazards for site-specific cancer diagnosis and non-cancer mortality and to estimate cumulative incidence up to 12 months following index consultation.

Tale of two zones: investigating the clinical outcomes and research gaps in peripheral and transition zone prostate cancer through a systematic review and meta-analysis.

Objective: To assess pathological characteristics, clinical features and outcomes of patients diagnosed with peripheral zone (PZ) and transition zone (TZ) prostate cancer after prostatectomy.

Methods And Analysis: We systematically reviewed PubMed, EMBASE and MEDLINE. Primary endpoints were biochemical relapse-free survival (bRFS) and distant metastases rate; secondary endpoints included clinical and pathological features.

Assessing the rates of false-positive ovarian cancer screenings and surgical interventions associated with screening tools: a systematic review.

Objective: Early detection of ovarian cancer can improve patient outcomes; however, screening tests can yield false-positive results, leading to unnecessary surgical interventions. This systematic review explores the prevalence of false-positive ovarian cancer screenings and subsequent unnecessary surgical interventions.

Methods And Analysis: Five databases were searched in March 2023 and again in March 2024, encompassing primary literature published between 2003 and 2024.

Artificial intelligence across oncology specialties: current applications and emerging tools.

Oncology is becoming increasingly personalised through advancements in precision in diagnostics and therapeutics, with more and more data available on both ends to create individualised plans. The depth and breadth of data are outpacing our natural ability to interpret it. Artificial intelligence (AI) provides a solution to ingest and digest this data deluge to improve detection, prediction and skill development.

Baseline tumour vessel perfusion as a non-invasive predictive biomarker for immune checkpoint therapy in non-small-cell lung cancer.

Objective: Current biomarkers for predicting immunotherapy response in non-small-cell lung cancer (NSCLC) are derived from invasive procedures with limited predictive accuracy. Thus, identifying a non-invasive predictive biomarker would improve patient stratification and precision immunotherapy.

Methods And Analysis: In this retrospective multicohort study, the discovery cohort included 205 NSCLC patients screened from ORIENT-11 and an external validation (EV) cohort included 99 real-world NSCLC patients.

Accuracy of screening tests for cervical precancer in women living with HIV in low-resource settings: a paired prospective study in Lusaka, Zambia.

Objective: This study aimed to provide evidence to improve cervical screening for women living with HIV (WLHIV). We assessed the accuracy of screening tests that can be used in low-resource settings and give results at the same visit.

Methods And Analysis: We conducted a paired, prospective study among consecutive eligible WLHIV, aged 18-65 years, receiving cervical cancer screening at one hospital in Lusaka, Zambia.

Cancer burden across the South Asian Association for Regional Cooperation in 2022.

Objective: The objective of this study is to present a cross-sectional analysis of cancer burden in the South Asian Association for Regional Cooperation (SAARC) region and explain unique characteristics of its cancer burden as compared with the rest of the world.

Methods And Analysis: Using publicly available data from the Global Cancer Observatory (GCO) and the World Bank, we collected cancer statistics and population statistics for Afghanistan, Bangladesh, Bhutan, India, the Maldives, Nepal, Pakistan, and Sri Lanka from 2017 to 2022.

Results: The number of newly diagnosed cases in the region was 1 846 963, representing 9.

Bedside implications of the use of surrogate endpoints in solid and haematological cancers: implications for our reliance on PFS, DFS, ORR, MRD and more.

Clinical endpoints, such as overall survival, directly measure relevant outcomes. Surrogate endpoints, in contrast, are intermediate, stand-in measures of various tumour-related metrics and include tumour growth, tumour shrinkage, blood results, etc. Surrogates may be a time point measurement, that is, tumour shrinkage at some point (eg, response rate) or biomarker-assessed disease status, measured at given time points (eg, circulating tumour DNA, ctDNA).

Health-related quality of life outcomes reporting associated with FDA approvals in haematology and oncology.

Objective: Health-related quality of life (HRQoL) outcomes are important in making clinical and policy decisions. This study aimed to examine the HRQoL reporting in cancer drug trials leading to Food and Drug Administration (FDA) approvals.

Methods And Analysis: This retrospective cohort study analysed HRQoL data for trials leading to FDA approvals between July 2015 and May 2020.

Characterisation of clinical response and transcriptional profiling of proliferating CD8 T cells in the blood of cancer patients after PD-1 monotherapy or combination therapy.

Objective: Immune checkpoint inhibitors (ICI) that block the programmed cell death 1 (PD-1) pathway have shown promise with limited benefit. We and others have shown in small patient cohorts that an early proliferative CD8 T-cell response in the blood may be predictive of clinical response. However, these studies lack detailed analyses and comparisons between monotherapy and combination therapies.

Novel machine learning algorithm in risk prediction model for pan-cancer risk: application in a large prospective cohort.

Objective: To develop and validate machine-learning models that predict the risk of pan-cancer incidence using demographic, questionnaire and routine health check-up data in a large Asian population.

Methods And Analysis: This study is a prospective cohort study including 433 549 participants from the prospective MJ cohort including a male cohort (n=208 599) and a female cohort (n=224 950).

Results: During an 8-year median follow-up, 5143 cancers occurred in males and 4764 in females.

Association between neutrophil-to-eosinophil ratio and efficacy outcomes with avelumab plus axitinib or sunitinib in patients with advanced renal cell carcinoma: post hoc analyses from the JAVELIN Renal 101 trial.

Objective: We report post hoc analyses of efficacy with first-line avelumab plus axitinib or sunitinib according to baseline neutrophil-to-eosinophil ratio (NER) in patients with advanced renal cell carcinoma (aRCC) from the JAVELIN Renal 101 phase 3 trial.

Methods And Analysis: Progression-free survival (PFS), overall survival (OS) and objective response per baseline NER were analysed in the overall population and in patients with programmed death ligand 1 (PD-L1+) tumours. Multivariable Cox regression analyses to assess the effect of NER after adjustment for other baseline variables were conducted.

First-in-human phase 1 study of the arginase inhibitor INCB001158 alone or combined with pembrolizumab in patients with advanced or metastatic solid tumours.

Objective: The arginase inhibitor INCB001158 was evaluated for safety (primary endpoint) in locally advanced or metastatic solid tumours; pharmacokinetics, pharmacodynamics and efficacy were also assessed.

Methods And Analysis: In this non-randomised, open-label, three-part phase 1 study, INCB001158 was orally administered two times per day as monotherapy or in combination with intravenous pembrolizumab 200 mg every 3 weeks. Dose expansion was conducted in tumour-type cohorts (with or without prior anti-PD-1/PD-L1 (programmed death protein 1/programmed death ligand 1) therapy).

Pharmacological class effects of anticancer drugs: opportunities for decreasing healthcare spending.

In the field of general medicine, class effects, or therapeutic interchangeability, have been declared for several families of drugs including statins, calcium channel blockers and ACE inhibitors. The existence of such class effects enables healthcare payers to negotiate for substantially lower drug prices, thereby reducing financial toxicity, both at an individual and societal levels. Until now, the existence of class effects in oncology has been considered rare.

Novel proteomics-based plasma test for early detection of multiple cancers in the general population.

Objective: Early detection of cancer is crucial for reducing the global burden of cancer, but effective screening tests for many cancers do not exist. This study aimed to develop a novel proteome-based multi-cancer screening test that can detect early-stage cancers with high accuracy.

Methods And Analysis: We collected plasma samples from 440 individuals, healthy and diagnosed with 18 early-stage solid tumours.

Prospective evaluation of artificial intelligence (AI) applications for use in cancer pathways following diagnosis: a systematic review.

The role of artificial intelligence (AI) in cancer care has evolved in the face of ageing population, workforce shortages and technological advancement. Despite recent uptake in AI research and adoption, the extent to which it improves quality, efficiency and equity of care beyond cancer diagnostics is uncertain to date. Henceforth, the objective of our systematic review is to assess the clinical readiness and deployability of AI through evaluation of prospective studies of AI in cancer care following diagnosis.

Challenges faced by women oncologists in Africa: a mixed methods study.

Objective: Recent studies have identified challenges facing women oncologists in Western contexts. However, similar studies in Africa have yet to be conducted. This study sought to determine the most common and substantial challenges faced by women oncologists in Africa and identify potential solutions.

Postprogression therapy and confounding for the estimated treatment effect on overall survival in phase III oncology trials.

Objective: Estimations of the treatment effect on overall survival (OS) may be influenced by post-progression therapies (PPTs). It is unclear how often OS analyses account for PPT effects. The purpose of this cross-sectional analysis was to determine the prevalence of OS analyses accounting for PPT effects in phase III oncology trials.

Machine learning based on blood test biomarkers predicts fast progression in advanced NSCLC patients treated with immunotherapy.

Objective: Fast progression (FP) represents a desperate situation for advanced non-small cell lung cancer (NSCLC) patients undergoing immune checkpoint inhibitor therapy. We aimed to develop a predictive framework based on machine learning (ML) methods to identify FP in advanced NSCLC patients using blood test biomarkers.

Methods And Analysis: We extracted data of 1546 atezolizumab-treated patients from four multicentre clinical trials.

Preconsultation compassion video to reduce anxiety among patients referred to a cancer centre: a randomised control trial.

Objective: Anxiety is common among patients attending an initial oncology consultation. The objective of this trial was to test if an enhanced compassion video emailed to patients prior to their initial oncology consultation reduces anxiety compared with being sent an information-only introduction video.

Methods And Analysis: We conducted a randomised control trial at a single university-based cancer centre between May 2021 and October 2023.

Preclinical study and parallel phase II trial evaluating antisense STAT3 oligonucleotide and checkpoint blockade for advanced pancreatic, non-small cell lung cancer and mismatch repair-deficient colorectal cancer.

Objective: To evaluate signal transducer and activator of transcription 3 (STAT3) inhibition we conducted a co-clinical trial testing danvatirsen, a STAT3 antisense oligonucleotide (ASO) and checkpoint inhibition in conjunction with preclinical experiments.

Methods And Analysis: Orthotopically implanted pancreatic cancer (pancreatic adenocarcinoma (PDAC)) was treated with STAT3 ASO with immune checkpoint inhibition. Tumour infiltrating immune cell populations were characterised via flow cytometry.