Expert Review Of Anticancer Therapy[JOURNAL]
Sun
200 papers
Mirdametinib in symptomatic neurofibromatosis type 1 plexiform neurofibromas.
Phillips KA, Schiff D
Expert Rev Anticancer Ther · 2026 Mar · PMID 41816962 · Publisher ↗
INTRODUCTION: Neurofibromatosis type 1 (NF1) is a rare genetic disorder frequently complicated by plexiform neurofibromas (PNs) - benign but often morbid tumors associated with pain, disfigurement, and functional impairm...
INTRODUCTION: Neurofibromatosis type 1 (NF1) is a rare genetic disorder frequently complicated by plexiform neurofibromas (PNs) - benign but often morbid tumors associated with pain, disfigurement, and functional impairment. Mitogen-activated protein kinase (MEK) inhibitors have emerged as an approach for the management of NF1-PNs. AREAS COVERED: This review summarizes the pharmacology, mechanism of action, preclinical rationale, and clinical development of mirdametinib, a selective MEK1/2 inhibitor approved for the treatment of symptomatic, inoperable NF1-PNs in children and adults. We review key pharmacokinetic and pharmacodynamic properties, preclinical data supporting MAPK/ERK pathway inhibition, and outcomes from mirdametinib clinical trials. Emphasis is placed on efficacy outcomes, patient-reported benefits, durability of response, safety profile, and regulatory milestones. Emerging evidence from indirect treatment comparisons and early combination strategies is also discussed to contextualize mirdametinib within the evolving therapeutic landscape. EXPERT OPINION: Mirdametinib represents a meaningful advance in the management of NF1-PNs, offering durable tumor volume reduction, improvements in pain and quality of life, and a manageable safety profile across age groups. While head-to-head comparisons with other MEK inhibitors are lacking, available evidence suggests a favorable balance of efficacy and tolerability that may support its use as a first-line systemic option in appropriately selected patients.
Machine learning-based prognostic prediction for cutaneous malignant melanoma patient survival.
Wang Y, Liu J, Wu H … +1 more , Zhai H
Expert Rev Anticancer Ther · 2026 Jul · PMID 41804614 · Publisher ↗
BACKGROUND: Cutaneous malignant melanoma (CMM) is a highly malignant tumor that necessitates early diagnosis and precise survival prediction. The development of accurate prognostic models is essential for improving patie...
BACKGROUND: Cutaneous malignant melanoma (CMM) is a highly malignant tumor that necessitates early diagnosis and precise survival prediction. The development of accurate prognostic models is essential for improving patient survival. RESEARCH DESIGN AND METHODS: This retrospective study analyzed data from 5979 CMM patients in the SEER database (2004-2015), with external validation using the TCGA dataset. Patients were randomly allocated to training and testing sets in a 7:3 ratio. The SMOTE+DeepSurv (DeepSmote) model was compared against seven models, including DeepSurv, XGBoost, Logistic Regression (LR), Support Vector Machine (SVM), Random Forest (RF), K-Nearest Neighbors (KNN), and Decision Tree (DT). Model performance was evaluated using Area Under the Curve (AUC), accuracy, precision, recall, and F1-score. RESULTS: The DeepSmote model demonstrated superior prognostic performance across both SEER and TCGA datasets. On the SEER test set, it achieved an AUC of 0.96, accuracy of 0.95, and F1-score of 0.95 for 1-year prediction. This strong performance was maintained in the external TCGA cohort (AUC: 0.91, accuracy: 0.88, F1-score: 0.87), and consistent superiority was observed for 3- and 5-year predictions, confirming its robustness and generalizability. CONCLUSION: DeepSmote provides an accurate, generalizable prognostic tool for CMM survival prediction, outperforming other models across multiple datasets and evaluation metrics.
Harnessing the power of artificial intelligence for clinical trials in cancer.
Sonmez G, Yazarkan Y, Sahin TK … +1 more , Guven DC
Expert Rev Anticancer Ther · 2026 Jun · PMID 41797434 · Publisher ↗
INTRODUCTION: Cancer research has become increasingly data-intensive, with digital pathology, imaging, and genomic sequencing generating vast, heterogeneous datasets. Artificial intelligence (AI) now plays a growing role...
INTRODUCTION: Cancer research has become increasingly data-intensive, with digital pathology, imaging, and genomic sequencing generating vast, heterogeneous datasets. Artificial intelligence (AI) now plays a growing role across the oncology continuum, offering tools to interpret complex data, streamline workflows, and enhance clinical decision-making. In the context of clinical trials, AI is emerging as a catalyst for more efficient, inclusive, and data-driven research. AREAS COVERED: This review summarizes how AI, encompassing foundational machine learning (ML) models alongside advanced deep learning (DL) and large language model (LLM) systems, is being applied across the oncology trial lifecycle - from design and recruitment to data management and outcome assessment. Tools such as Trial Pathfinder, TrialGPT, and PRISM demonstrate the ability to emulate trial criteria, accelerate patient matching, and improve eligibility accuracy. The review also highlights key challenges related to algorithmic bias, explainability, accountability, and evolving regulatory oversight by the FDA and EMA. EXPERT OPINION: AI is transitioning from conceptual promise to operational utility in oncology clinical research. As regulatory frameworks mature, harmonizing innovation with patient protection will be essential. When responsibly implemented, AI can bridge the gap between research and real-world care, transforming oncology trials into faster, fairer, and more reliable engines of discovery.
Learning from late-stage trial failures in higher-risk myelodysplastic syndromes: towards adaptive and biomarker-enriched designs.
Zeidan AM, Aakko S, Stahl M … +7 more , Bewersdorf JP, Bono P, Huttunen T, Jalkanen J, Louramo E, Nimba A, Williamson J
Expert Rev Anticancer Ther · 2026 May · PMID 41762737 · Publisher ↗
INTRODUCTION: Higher-risk myelodysplastic syndromes (HR-MDS) remain an area of high unmet need in which multiple randomized late-stage trials have failed to improve outcomes beyond hypomethylating agent monotherapy, desp...
INTRODUCTION: Higher-risk myelodysplastic syndromes (HR-MDS) remain an area of high unmet need in which multiple randomized late-stage trials have failed to improve outcomes beyond hypomethylating agent monotherapy, despite encouraging early-phase signals. AREAS COVERED: Key randomized late-stage HR-MDS trials that failed to meet primary endpoints are evaluated for recurring design and interpretive challenges. Key themes include endpoint limitations, optimistic effect-size assumptions, underpowering for modest but clinically meaningful hazard ratios, and signal dilution from biological and operational heterogeneity. We discuss adaptive methodologies applicable to HR-MDS to improve trial efficiency and preserve statistical integrity. Regulatory perspectives including contemporary guidance and emerging international principles for confirmatory adaptive trials are considered. Randomized Phase 2/3 HR‑MDS trials and relevant literature were identified through searches of PubMed, ClinicalTrials.gov, and major conference proceedings (2010-2025). EXPERT OPINION: Many new HR-MDS therapies are likely to deliver incremental survival gains rather than large overall survival improvements, particularly given an apparent survival plateau around 2 years. Future confirmatory programs should, therefore, plan for incremental improvements, prespecify handling of transplantation and post-protocol therapies, and integrate molecular stratification/enrichment to reduce variance. Adaptive designs should be used to stop futile programs earlier and to expand adequately powered trials when emerging data support clinically meaningful benefit.
The role of PSMA PET/CT imaging in identifying low-risk prostate cancer candidates for active surveillance after biopsy.
Kabasakal L, Kaya G
Expert Rev Anticancer Ther · 2026 Mar · PMID 41762043 · Publisher ↗
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The pricing barrier: cost-effectiveness of Glofitamab for relapsed/refractory DLBCL in China beyond threshold and value-based pricing strategy considerations.
Lin S, Wang X, Yang L … +4 more , Luo S, Huang X, Weng X, Xu X
Expert Rev Anticancer Ther · 2026 Feb · PMID 41733310 · Publisher ↗
BACKGROUND: To assess the cost-effectiveness of Glofitamab plus Gemcitabine and Oxaliplatin (Glofit-GemOx) versus Rituximab plus Gemcitabine and Oxaliplatin for treating relapsed/refractory diffuse large B-cell lymphoma...
BACKGROUND: To assess the cost-effectiveness of Glofitamab plus Gemcitabine and Oxaliplatin (Glofit-GemOx) versus Rituximab plus Gemcitabine and Oxaliplatin for treating relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) in China. RESEARCH DESIGN AND METHODS: A partitioned survival model utilized data from the phase 3 STARGLO trial, extrapolating progression-free survival and overall survival via parametric distributions. Costs and utilities were derived from Chinese databases and literature, covering drug expenses, adverse event management, and subsequent therapies. Incremental cost-effectiveness ratios (ICERs) were assessed against a willingness-to-pay (WTP) threshold of $40,343 per quality-adjusted life year (QALY). Sensitivity and budgetary impact analyses were conducted. RESULTS: Glofit-GemOx yielded an additional 1.47 QALYs (2.64 vs. 1.17) at an incremental cost of $92,765, resulting in an ICER of $63,379/QALY, exceeding the WTP threshold. Key drivers included Glofitamab's price and utility parameters. Probabilistic sensitivity analysis showed a 14.5% probability of cost-effectiveness at the threshold. A 30% price reduction would be required to achieve cost-effectiveness. The five-year budget impact analysis projected sustained and substantial incremental costs associated with Glofit-GemOx. CONCLUSIONS: Although Glofit-GemOx offers significant survival benefits, it is not cost-effective in China at current prices. Price reductions or insurance coverage could improve accessibility, supporting the need for value-based pricing strategies.
The clinical utility of molecular residual disease testing in early-stage breast cancer.
Micha JP, Bohart R, Goldstein BH
Expert Rev Anticancer Ther · 2026 Feb · PMID 41670648 · Publisher ↗
INTRODUCTION: Breast cancer is the most commonly-diagnosed malignancy among women. Currently, radiologic imaging is indicated for defined surveillance periods and to assess or corroborate patient symptomatology. More rec...
INTRODUCTION: Breast cancer is the most commonly-diagnosed malignancy among women. Currently, radiologic imaging is indicated for defined surveillance periods and to assess or corroborate patient symptomatology. More recently, the advent of circulating tumor DNA (ctDNA) assays has conferred a potential enhancement in disease monitoring via the evaluation of molecular residual disease (MRD). AREAS COVERED: Studies have shown that MRD testing reportedly eventuates in a lead-time predictive benefit in diagnosing progressive disease compared to traditional assessment. In particular, the Signatera test has compelling advantages compared to many of the available MRD tests, especially given the reported clinical data with MRD testing in early-stage breast cancer. In the current review, we recount the results from several studies on the topic of MRD testing in the treatment and surveillance of breast cancer. EXPERT OPINION: MRD testing in early-stage breast cancer theoretically confers a significant clinical benefit with adjuvant therapy and during patient surveillance. However, there are concerns with the potential for aggressive or prolonged treatment, not to mention the specific approach to managing patients who are ctDNA positive but remain asymptomatic.
Immune checkpoint inhibitors in urothelial carcinoma: a practical framework for patient selection, toxicity management, response assessment, and treatment sequencing.
Al Armashi AR, Gong J, Barata P … +3 more , Brown J, Garcia J, Sheng I
Expert Rev Anticancer Ther · 2026 Feb · PMID 41660943 · Publisher ↗
INTRODUCTION: Managing urothelial carcinoma with immune checkpoint inhibitors requires addressing issues beyond clinical outcomes. Implementation difficulties affect most patients, predictive biomarkers show limited util...
INTRODUCTION: Managing urothelial carcinoma with immune checkpoint inhibitors requires addressing issues beyond clinical outcomes. Implementation difficulties affect most patients, predictive biomarkers show limited utility, and treatment discontinuation from toxicity remains problematic. AREAS COVERED: This article integrates clinical trials, systematic reviews, health-system evaluations, and guidelines from 2016 to 2025. We detail limitations of programmed death-ligand 1 (PD-L1) expression, panel-based tumor mutational burden (TMB), clinic-ready toxicity pathways, immune-appropriate response criteria (iRECIST), pseudoprogression, hyperprogression, post-ICI sequencing (FGFR3 alterations, enfortumab vedotin-based therapy, chemotherapy, trials), and delivery models (navigation, electronic patient-reported outcomes, telemedicine, payment structures). EXPERT OPINION: Optimizing systemic frameworks for immunotherapy care requires careful evaluation of functional status, protocols for immune-related adverse events management, standardization for assessments of clinical responses, and ensuring equitable access to care. ctDNA and AI-assisted radiomics are promising adjuncts to clinical care, but still require multi-center prospective validation before adoption into routine practice.
Integrating liquid biopsies in non-small cell lung cancer diagnosis and management: opportunities and challenges.
Lim JU, Oya Y, Fu R … +3 more , Sooi K, Ang YLE, Soo RA
Expert Rev Anticancer Ther · 2026 Feb · PMID 41656166 · Publisher ↗
INTRODUCTION: Liquid biopsy has emerged as an important approach to capture tumor-derived material from blood and other body fluids, offering a minimally invasive window into cancer biology. In non - small cell lung canc...
INTRODUCTION: Liquid biopsy has emerged as an important approach to capture tumor-derived material from blood and other body fluids, offering a minimally invasive window into cancer biology. In non - small cell lung cancer (NSCLC), it enables comprehensive molecular profiling that informs patient management, from guiding therapy choices to monitoring disease status and assessing minimal residual disease (MRD). AREAS COVERED: Its main advantages over tissue biopsy lie in being noninvasive, capable of reflecting tumor heterogeneity and real-time biological changes. These strengths allow liquid biopsy to be applied at different clinical timepoints, including diagnosis, treatment decision-making, evaluation during therapy, detection of resistance, and surveillance for recurrence. Although circulating tumor DNA (ctDNA) remains the most established analyte, the scope is broadening to include circulating RNAs, circulating tumor cells, exosomes, DNA methylation signatures, and tumor-educated platelets, each providing complementary insights. A literature search of PubMed, EMBASE, and Web of Science was conducted without restrictions, supplemented by screening reference lists and major oncology conference abstracts. EXPERT OPINION: While significant progress has been made integrating liquid biopsies in NSCLC, challenges persist, encompassing issues of standardization, cost, and clinical integration.
The evolving survival landscape in advanced non-small cell lung cancer: an interrupted time series analysis.
Ji J, Li T, Li Z … +3 more , Zhou J, Qin F, Teng M
Expert Rev Anticancer Ther · 2026 Feb · PMID 41641745 · Publisher ↗
BACKGROUND: Treatment of advanced non-small cell lung cancer (NSCLC) has shifted from chemotherapy to targeted therapy and immunotherapy. We aimed to evaluate the effects of these novel therapies on advanced NSCLC in rea...
BACKGROUND: Treatment of advanced non-small cell lung cancer (NSCLC) has shifted from chemotherapy to targeted therapy and immunotherapy. We aimed to evaluate the effects of these novel therapies on advanced NSCLC in real-world setting. RESEARCH DESIGN AND METHODS: We conducted a retrospective cohort study using the SEER database of patients with advanced NSCLC receiving systemic therapy. Patients were stratified into three periods: chemotherapy (1992-2002), targeted therapy (2003-2014), and immunotherapy (2015-2022). We used interrupted time series analysis to evaluate changes in overall survival rate and cancer-specific survival rate (CSSR). RESULTS: The analysis included 32,899 patients. Compared to chemotherapy (11.9 months), median overall survival was significantly longer with targeted therapy (19.3 months) and immunotherapy (27.4 months). The 3-year CSSR increased by 0.36% and 0.89% per year following targeted therapy and immunotherapy, respectively. Adenocarcinoma showed sustained improvement in 3-year CSSR after targeted therapy (0.52% per year) and immunotherapy (0.83% per year), while squamous cell carcinoma showed no significant change. Most subgroups showed continuous survival improvement after immunotherapy. CONCLUSION: The introduction of targeted therapy and immunotherapy has produced significant survival improvement in adenocarcinoma, with the most pronounced benefits with immunotherapy. Treatment efficacy varies across subgroups highlighting the need for further investigation to optimize personalized therapy.
The role of zongertinib, a highly selective tyrosine kinase inhibitor, in targeting -mutant NSCLC: a bench-to-bedside review.
Heymach JV, Popat S, Smit EF … +6 more , Christopoulos P, Planchard D, Yoshida T, Zugazagoitia J, Yu Y, Wilding B
Expert Rev Anticancer Ther · 2026 Jul · PMID 41640088 · Publisher ↗
INTRODUCTION: HER2 is mutated in 2-4% of non-small cell lung cancers (NSCLC) and is associated with poor prognosis. Tyrosine kinase inhibitors (TKIs) targeting HER2 have historically been hampered by insufficient efficac...
INTRODUCTION: HER2 is mutated in 2-4% of non-small cell lung cancers (NSCLC) and is associated with poor prognosis. Tyrosine kinase inhibitors (TKIs) targeting HER2 have historically been hampered by insufficient efficacy against exon 20 insertion mutations and lack of specificity, resulting in off-target adverse events. Zongertinib is an oral, irreversible HER2-selective TKI that spares wild-type EGFR, thereby minimizing associated toxicities. Zongertinib was recently approved in the United States (accelerated), China (conditional), and Japan for patients with previously treated advanced -mutant NSCLC. AREAS COVERED: This article outlines the discovery and clinical development of zongertinib that led to these approvals. We discuss the first-in-human Beamion LUNG-1 trial (NCT04886804), in which zongertinib demonstrated encouraging and durable activity, with a manageable safety profile, in patients with -mutant advanced NSCLC. Finally, we summarize ongoing clinical trials of zongertinib, including its assessment as first-line treatment for advanced -mutant NSCLC. EXPERT OPINION: Zongertinib is the first oral TKI approved for -mutant NSCLC and will provide patients with a convenient, tolerable and effective treatment option in an area of significant unmet need. Next steps include its potential transition to a first-line setting, identification of additional indications, and development of novel combination regimens.
An evaluation of pembrolizumab with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for HER2 positive gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1).
Seguchi K, Kawazoe A, Nakayama I … +1 more , Shitara K
Expert Rev Anticancer Ther · 2026 Feb · PMID 41640060 · Publisher ↗
INTRODUCTION: Despite the introduction of several novel agents, survival for patients with metastatic gastric or gastroesophageal junction adenocarcinoma remains limited. In human epidermal growth factor receptor 2 (HER-...
INTRODUCTION: Despite the introduction of several novel agents, survival for patients with metastatic gastric or gastroesophageal junction adenocarcinoma remains limited. In human epidermal growth factor receptor 2 (HER-2) positive disease, pembrolizumab plus trastuzumab and fluoropyrimidine- and platinum-based chemotherapy has recently demonstrated a survival benefit, particularly in tumors expressing programmed death-ligand 1 (PD-L1) with a combined positive score (CPS) ≥1 in the phase III KEYNOTE-811 trial. AREAS COVERED: This review summarizes the evolution of HER2-directed therapies in gastric cancer and focuses on the efficacy and safety of pembrolizumab in combination with trastuzumab and chemotherapy. We highlight the mechanistic rationale for dual HER2 and PD-1 blockade, pivotal trial evidence, and other novel HER2-directed therapies currently under active clinical evaluation in the first-line setting. A literature search was conducted using PubMed and ClinicalTrials.gov. EXPERT OPINION: Pembrolizumab plus trastuzumab and chemotherapy has established a new first-line standard of care for patients with HER2-positive, PD-L1 CPS ≥1 metastatic gastric or gastroesophageal junction adenocarcinoma. Nonetheless, primary and acquired resistance driven by HER2 heterogeneity, immune evasion, and dynamic molecular evolution remain major challenges. Next-generation HER2-targeted therapies, including bispecific antibodies, novel antibody - drug conjugates, and dual HER2 antibodies will be crucial to further improve outcomes in this population.
Body composition and physical activity as predictors of immune-related adverse events in patients undergoing cancer immunotherapy: a systematic review.
De Nys L, Güney G, Grootjans FIJ … +2 more , Maes YKM, Adriaenssens N
Expert Rev Anticancer Ther · 2026 Jul · PMID 41627877 · Publisher ↗
INTRODUCTION: Host factors may affect immune-related adverse events (irAE) during immune checkpoint inhibitor (ICI) therapy. We systematically reviewed studies on body composition (BMI, CT/DXA-defined sarcopenia, sarcope...
INTRODUCTION: Host factors may affect immune-related adverse events (irAE) during immune checkpoint inhibitor (ICI) therapy. We systematically reviewed studies on body composition (BMI, CT/DXA-defined sarcopenia, sarcopenic obesity) and physical activity (PA) in relation to irAE incidence and severity in ICI-treated adults. METHODS: PubMed, Embase, Scopus, and Web of Science were searched from inception to 15 December 2024. Eligible studies assessed baseline body composition and/or PA in relation to irAE. Risk of bias was evaluated using the NIH tool and QUIPS. Findings were synthesized using structured narrative methods. RESULTS: Seven studies (2,590 patients) were included. Two large cohorts found overweight/obese patients had higher odds of any-grade irAE (OR = 1.4-1.5); one disease-specific cohort found no association. One CT-based study showed higher irAE risk with sarcopenia (OR = 2.64) and more with sarcopenic obesity (OR = 5.50). Two studies on PA were conflicting: one found higher PA reduced severe irAE risk (OR = 0.19), another found no association. CONCLUSIONS: Body composition and PA may help predict irAE in ICI-treated patients. Evidence is low to very low certainty: overweight/obesity may increase toxicity risk, higher PA may lower risk, and evidence for sarcopenia is limited. Standardized prospective studies are needed to confirm these associations. PROTOCOL REGISTRATION: https://www.crd.york.ac.uk/PROSPERO identifier is CRD420251084119.
Use of Razoxane as a radiosensitizer for the treatment of soft tissue sarcomas.
Rothman J
Expert Rev Anticancer Ther · 2026 Jul · PMID 41581093 · Publisher ↗
INTRODUCTION: Razoxane, discovered in the 1960s, was evaluated as a topoisomerase II inhibitor to treat cancer. Cancer therapeutic models of the mid-1900's were based on the following three assumptions: treatment agents...
INTRODUCTION: Razoxane, discovered in the 1960s, was evaluated as a topoisomerase II inhibitor to treat cancer. Cancer therapeutic models of the mid-1900's were based on the following three assumptions: treatment agents should demonstrate activity as a single agent, should reduce tumor size, or could exacerbate tumor hypoxia. Razoxane fulfilled none of these requirements. AREAS COVERED: Although well-tolerated, safe, and approved for cancer treatment, Razoxane lacks the cell-killing activity exhibited by other agents and was a commercial failure. It blocks the cell cycle at G2/M boundary, leading to cell cycle synchrony where radiation and chemotherapeutics are most effective. Daughter chromatid separation is inhibited; metaphase clefts do not form; and cells continue to synthesize DNA and become polyploidal, polynucleate, and hypertrophic, demonstrating a senescent phenotype where weakened cells are removed. Cell proliferation halts, allowing neovasculature to mature with structured endothelial lining and reduced sinusoids, thus eliminating a major route by which tumor cells enter the bloodstream and metastasize. EXPERT OPINION: Blockade of the cell cycle at G2/M maximizes DNA alteration in response to therapy; improved oxygenation enhances the generation of reactive oxygen species during polytherapy; and increased vascularity facilitates synergy with radiation and chemotherapy by improving drug delivery.
Impact of health-related social needs on mortality risk in cancer survivors: evidence from 1999-2018 NHANES.
Xu P, Niu Z, Xu D … +2 more , Ding Y, Zhang Z
Expert Rev Anticancer Ther · 2026 Jul · PMID 41581082 · Publisher ↗
BACKGROUND: Cancer survivors experience disproportionate burdens of health-related social needs (HRSNs), yet the mortality implications of cumulative HRSN burden remain poorly characterized. RESEARCH DESIGN AND METHODS:...
BACKGROUND: Cancer survivors experience disproportionate burdens of health-related social needs (HRSNs), yet the mortality implications of cumulative HRSN burden remain poorly characterized. RESEARCH DESIGN AND METHODS: We analyzed 3643 adult cancer survivors from the 1999-2018 National Health and Nutrition Examination Survey. HRSNs burden was assessed based on eight indicators. Cox proportional hazard models were applied to estimate the associations between cumulative number of unmet HRSNs and all-cause, cardiovascular disease (CVD), and cancer mortality, reporting hazard ratios (HRs) and 95% confidence intervals (CIs). RESULTS: Over a median 85-month follow-up, 1304 (24.99%) participants died, including 433 from cancer and 334 from CVD. Compared to those with 0-1 unmet HRSN, HRs (95% CIs) for participants with 6-8 unmet HRSNs were 4.01 (2.89-5.58) for all-cause mortality, 2.34 (1.08-5.06) for CVD mortality, and 4.00 (2.41-6.64) for cancer mortality. Restricted cubic spline curves found no evidence of non-linear relationships between unmet HRSNs count and all-cause, CVD, and cancer mortality. Associations between HRSN burden and all-cause and cancer mortality were more pronounced in participants under 60 years of age. CONCLUSION: Cumulative HRSN burden is associated with mortality risk among cancer survivors, particularly younger adults. Routine HRSNs assessment should be integrated into survivorship care to identify high-risk patients.
From fecal microbiota transplants to targeted intervention for improvement of immune checkpoint inhibition therapy: how far down the road are we?
Kleinhans M, Lissen A, Hewitson L … +1 more , Rijkers GT
Expert Rev Anticancer Ther · 2026 Jul · PMID 41575201 · Publisher ↗
INTRODUCTION: The outcome of immune checkpoint inhibition (ICI) therapy of cancer appears to be influenced by the gut microbiota composition of the patient. Microbiome-based therapy by fecal microbiota transplantation (F...
INTRODUCTION: The outcome of immune checkpoint inhibition (ICI) therapy of cancer appears to be influenced by the gut microbiota composition of the patient. Microbiome-based therapy by fecal microbiota transplantation (FMT) appears to improve the outcome of ICI therapy. The ideal composition of the microbiota as well as treatment schedule are not yet established. AREAS COVERED: The most recently published studies are reviewed, as well as the study designs of registered clinical trials which are ongoing. The effect of pretreatment of patients with antibiotics, aimed to improve engraftment of the transplant, is evaluated. EXPERT OPINION: The optimal treatment schedule would be to start with FMT, followed by ICI, implying FMT should be given to ICI naive patients. Rather than donor derived FMT, defined consortia of microbiota could be preferred.
Management of tenosynovial giant cell tumor: approved and investigational therapies.
Conway AP, Lim A, Schulte BC … +1 more , Agulnik M
Expert Rev Anticancer Ther · 2026 Jul · PMID 41557367 · Publisher ↗
INTRODUCTION: Tenosynovial giant cell tumor (TGCT) is a rare, benign neoplasm driven by overexpression of colony-stimulating factor 1 (CSF-1), which recruits CSF-1 receptor (CSF-1 R)-bearing macrophages and other inflamm...
INTRODUCTION: Tenosynovial giant cell tumor (TGCT) is a rare, benign neoplasm driven by overexpression of colony-stimulating factor 1 (CSF-1), which recruits CSF-1 receptor (CSF-1 R)-bearing macrophages and other inflammatory cells to promote tumor formation. While surgery remains the first-line treatment for TGCT, many patients experience unresectable or recurrent disease with high morbidity, highlighting the need for effective systemic treatments. AREAS COVERED: This review summarizes the molecular pathogenesis, diagnostic approach, and evolving systemic treatment landscape for TGCT, with a focus on treatments directed at CSF-1/CSF-1 R inhibition. Relevant literature published between 2005 and 2025 was identified through PubMed searches and manual review of reference lists. Clinical efficacy and safety data for approved and investigational CSF-1/CSF-1 R inhibitors, including pexidartinib, vimseltinib, and emerging agents, are discussed. EXPERT OPINION: Pexidartinib and vimseltinib demonstrate comparable efficacy in TGCT with objective response rates (ORR) of 39% and 40%, respectively, at week 25 of treatment; however, vimseltinib offers improved hepatic safety and tolerability, supporting its use as the preferred first-line systemic therapy. Emerging agents, including pimicotinib and emactuzumab, show potential for higher response rates and favorable safety profiles and may further reshape the TGCT treatment paradigm pending phase 3 trial results.
Regulatory landscape for CAR-T therapy development in the Brazilian context.
Mesquita FP, Maia MS, Souza PFN … +3 more , Carvalho LEM, de Barros Carlos LM, Duarte FB
Expert Rev Anticancer Ther · 2026 Jul · PMID 41552935 · Publisher ↗
INTRODUCTION: Chimeric antigen receptor T (CAR-T) therapy represents a significant advance in the treatment of hematologic malignancies, yet its global implementation remains limited by regulatory, logistical, and manufa...
INTRODUCTION: Chimeric antigen receptor T (CAR-T) therapy represents a significant advance in the treatment of hematologic malignancies, yet its global implementation remains limited by regulatory, logistical, and manufacturing challenges. Understanding differences among international regulatory frameworks is essential for expanding safe and equitable access, particularly in emerging academic programs. AREAS COVERED: This review examines the regulatory pathways, manufacturing requirements, and quality standards governing CAR-T therapies in Brazil, comparing them with those in the United States and the European Union. A focused literature search encompassed peer-reviewed articles, institutional guidelines, and regulatory documents from 2016 to 2025. Key elements assessed include GMP expectations, analytical method validation, biosafety considerations, and infrastructure requirements. The analysis also explores expanded-access mechanisms and summarizes clinical experiences that have used these pathways in the real world. EXPERT OPINION: Despite structural differences, all jurisdictions converge on core principles emphasizing product quality, long-term safety, and traceability. However, Brazil faces unique multi-agency coordination requirements and infrastructural constraints that may delay national deployment. Global evidence indicates that strengthening GMP facilities, analytical validation strategies, and harmonized regulatory processes, particularly for academic and point-of-care manufacturing, will be crucial to broaden access and sustain innovation in CAR-T therapies.
An evaluation of taletrectinib for the treatment of ROS1+ non-small cell lung cancer.
Samaeekia R, Arter Z, Nagasaka M
Expert Rev Anticancer Ther · 2026 Jan · PMID 41548253 · Full text
INTRODUCTION: ROS1 fusion - positive non-small cell lung cancer (NSCLC) represents a rare but clinically important subset, occurring in 1-2% of patients and often associated with younger, never-smoker populations. Curren...
INTRODUCTION: ROS1 fusion - positive non-small cell lung cancer (NSCLC) represents a rare but clinically important subset, occurring in 1-2% of patients and often associated with younger, never-smoker populations. Current first-generation tyrosine kinase inhibitors (TKIs) such as crizotinib and entrectinib provide meaningful benefit but are limited by poor central nervous system (CNS) penetration and the development of resistance mutations, particularly G2032R. AREAS COVERED: This review evaluates the development, pharmacologic properties, and clinical outcomes of taletrectinib, a next-generation ROS1 inhibitor recently approved by the FDA. Taletrectinib demonstrated high objective response rates in both TKI-naïve (88.8%) and TKI-pretreated (55.8%) patients, including robust intracranial activity and efficacy against the G2032R mutation. The safety profile is favorable, with predominantly low-grade gastrointestinal and hepatic adverse events and minimal neurologic toxicity. EXPERT OPINION: Taletrectinib addresses major limitations of earlier ROS1 inhibitors by combining systemic potency, CNS activity, and tolerability. While its approval represents a significant advance for ROS1+ NSCLC, challenges remain, including resistance mechanisms such as L2086F, limited global access, and the absence of phase III confirmatory trials. Ongoing research into sequencing strategies, resistance profiling, and novel combination regimens will be essential to optimize patient outcomes.
Artificial intelligence in bladder cancer management: a narrative review of diagnostic and surgical advances and current limitations.
Salzano G, Digiacomo A, Dello Stritto G … +7 more , Orsini A, De Archangelis R, Cicchetti R, Lannutti P, Ferretti S, Schips L, Marchioni M
Expert Rev Anticancer Ther · 2026 Jul · PMID 41545941 · Publisher ↗
INTRODUCTION: Bladder cancer (BC) is associated with high recurrence and progression rates that require intensive surveillance. In this context, Artificial Intelligence (AI) offers promising tools to enhance diagnostic,...
INTRODUCTION: Bladder cancer (BC) is associated with high recurrence and progression rates that require intensive surveillance. In this context, Artificial Intelligence (AI) offers promising tools to enhance diagnostic, prognostic, and surgical pathways. AREAS COVERED: This narrative review critically examines the current state of AI applications across the bladder cancer care focusing on diagnostic, prognostic and surgical domains. A comprehensive literature search was conducted to identify relevant studies. Key topics include radiomics in computed tomography (CT) and magnetic resonance imaging (MRI), radiogenomics, pathomics and AI-assisted cystoscopy. Furthermore, the role of AI in preoperative planning, intraoperative navigation and surgical training is discussed highlighting its integration in robotic and endoscopic procedures. EXPERT OPINION: AI is rapidly redefining bladder cancer management through multimodal data integration and predictive modeling. While current evidence demonstrates high diagnostic and prognostic performance, clinical implementation remains limited by heterogeneity, lack of standardization and insufficient external validation. Future efforts should prioritize prospective validation, explainability and integration into clinical workflows to realize AI's full potential in personalized uro-oncology.
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