Wednesday, 19 November 2025

ESMO Publishes First-Ever Guidance on Validation Requirements for AI-Based Biomarkers in Oncology

 The European Society for Medical Oncology (ESMO) has released the Basic Requirements for AI-Based Biomarkers in Oncology (EBAI) framework, "the first comprehensive guidance for the safe, trustworthy and effective integration of AI-derived biomarkers in cancer care."  The framework provides guidance for developers, clinicians, regulators and healthcare institutions on means of integrating digital technologies in cancer care.  

To view the complete framework, click here

Source mentioned: 

Wednesday, 12 November 2025

ESMO launches first congress on artificial intelligence and digital oncology: a milestone in shaping the future of cancer care

The European Society for Medical Oncology (ESMO) recently launched the inaugural Congress on Artificial Intelligence and Digital Oncology, taking place in Berlin this week, November 12-14, 2025.  With over 1100 participants scheduled to attend, the conference program will include discussions of: 

  • Multimodal AI for clinical decision support, showcasing applications in molecular tumour boards and real-world data integration.
  • AI-based biomarkers for precision oncology, featuring discussions on validation frameworks and predictive modelling, including the announcement of the imminent publication of the ESMO Basic Requirements for AI-based Biomarkers in Oncology (EBAI) framework
  • Generative AI and large language models, with keynote lectures featuring speakers from Google DeepMind and Harvard Medical School.
  • Digital health in practice, exploring wearable technologies, remote monitoring, decentralised trials.
  • Ethics, regulation, and patient perspectives, addressing trust, explainability and the societal implications of AI in oncology.

To learn more about this conference, click here

Friday, 7 November 2025

Rucaparib monotherapy provides long-term benefit as first-line maintenance for patients with advanced ovarian cancer with and without HRD

 Results of ATHENA-MONO/GOG-3020/ENGOT-ov45, a phase III trial investigating rucaparib as a monotherapy in first-line maintenance treatment for advanced ovarian cancer patients, who presented in poster format at the recent ESMO (European Society of Medical Oncology) conference in Berlin, Germany. The study concluded that "sustained long-term improvement with rucaparib was observed in all subgroups examined regardless of HRD or risk status, with 29% of patients in the rucaparib group remaining progressing free at 5 years." 

To read more about this study, click here

Sources mentioned: 

Thursday, 30 October 2025

Antitumour activity of patritumab deruxtecan in heavily pretreated patients with active brain metastases of breast cancer and NSCLC

 Results from TUXEDO-3, a prospective multicentre open-label single-arm multicohort phase II study were recently published on The Lancet Oncology.  TUXEDO-3 evaluated patritumab deruxtecan in 3 patient cohorts: 1. patients with metastatic breast cancer with untreated or progressing brain metastases after local treatment"; 2. "patients with advanced non-small cell lung cancer with untreated or progressing brain metastases after local treatment" 3. "patients with treatment-naive leptomeningeal disease (LMD) or LMD progressing after radiotherapy from any advanced solid tumour."   

To read more about the TUXEDO-3 study, click here

Sources mentioned: 

Thursday, 23 October 2025

Rethinking the limits of tissue-agnostic cancer therapy

A recent editorial published in the ESMO Daily Reporter raises questions about the impact of precision medicine in personalized cancer care, considering that "patients are still largely treated according to the primary organ where their cancer originates."  Tumour-agnostic agents, drugs approved if cancer cells cause gene or protein changes, no matter where in the body the cancer originated, calls for physicians and patients to engage in precision medicine, "a first step toward a common understanding...in which tissue-agnostic development should be preferred to conventional trials."  

Click here to learn more. 



Thursday, 16 October 2025

Thymic health linked to cancer patients’ response to immunotherapy

A recent international study focused on immune checkpoint inhibitor treatment has shown that higher thymic health was associated with a 35% lower risk of cancer progression in a group of 1200 non-small cell lung cancer patients.    While further validation of this finding is required, thymic health "could serve as a non-invasive biomarker of adaptive immune competence in a range of different cancers." 

To learn more about this study, click here

Source mentioned: 

Abstract 108O - ‘Thymic health is associated with immunotherapy outcomes in patients with cancer ‘, presented by Dr Simon Bernatz during Proffered Paper session 1: Basic science & Translational research on Saturday, 18 October, from 10:15 to 11:45 (CEST) in Hall 5.2 (Nuremberg Auditorium)  

Wednesday, 8 October 2025

Increased risk of haematologic malignancies among children and adolescents exposed to radiation from medical imaging

 Findings from Risk of Pediatric and Adolescent Cancer Associated with Medical Imaging (RIC) a cohort study of 3 700 000 children from Canada and the U.S. found a "significant dose-response relation between cumulative radiation dose to bone marrow and haematologic malignancies risk." The RIC study further found that susceptibility of children to radiation-induced cancer is high due to longer life expectancy compared to adults.  In addition, a European EPI-CT study indicates a "50% higher risk among children undergoing two or three CT scans than among those undergoing one scan." 

To read more about this study, click here

Source mentioned: 

Wednesday, 1 October 2025

Study presents an AI-guided approach to target cancer antigens

 A recent study published in Science provides proof-of-concept that "generative artificial intelligence can offer a valid alternative approach to design precise, functional, and adaptable peptide binders capable of redirecting T cell responses against cancer antigens".  While the authors are optimistic regarding AI-guided methods, they do caution that further investigation is required to determine long-term impact on immune cell function. 

To learn more about this study, click here

Source mentioned: 

Johansen KH, Wolff DS, Scapolo B, Fernández-Quintero ML, Risager Christensen C, Loeffler JR, Rivera-de-Torre E, Overath MD, Kjærgaard Munk K, Morell O, Viuff MC, Lacunza I, Damm Englund AT, Due M, Gharpure A, Forli S, Rodriguez Pardo C, Tamhane T, Qingjie Andersen E, Haldrup Björnsson K, Fernandes JS, Voss LF, Thumtecho S, Ward AB, Ormhøj M, Reker Hadrup S, Jenkins TP. De novo-designed pMHC binders facilitate T cell-mediated cytotoxicity toward cancer cells. Science. 2025 Jul 24;389(6758):380-385. doi: 10.1126/science.adv0422. Epub 2025 Jul 24. PMID: 40705893.




Wednesday, 24 September 2025

De-escalated radiotherapy after surgery in HPV-associated oropharyngeal squamous cell carcinoma

A recently published phase III trial in Lancet Oncology, lower doses of adjuvant radiotherapy plus docetaxel "were associated with reduced toxicity and need for percutaneous endoscopic gastrostomy", impacting a patient's quality of life.  Following 194 patients with stage III-IV HPV-associated oropharyngeal squamous cell carcinoma indicated grade 3 or higher toxic effect "of at least possible attribution to treatment...3 months after radiotherapy.." at 3% in the de-escalated adjuvant radiotherapy group compared to 11% in the standard of care group. 

To read more about this study, click here






Wednesday, 17 September 2025

ESMO campaigns against the use of ‘Low-Alcohol’ labelling in response to council agreement on EU’s wine package

The European Society for Medical Oncology (ESMO) in partnership with the European Alliance on Alcohol (EHAA) has issued a statement against the use of the phrase 'low alcohol' "for beverages containing more than 1.2% ABC and for transparent information on the health risks of consuming alcohol."   Alcohol consumption increases the risk of developing at least 7 types of cancer, leading the International Agency for Research on Cancer (IARC) classifying alcohol as a group one carcinogen. 

To read the complete position statement, click here. 



Wednesday, 10 September 2025

ESMO urges EU policymakers to protect the wellbeing of the oncology workforce

 The European Society for Medical Oncology (ESMO) has produced a new health workforce crisis plan, stressing "the urgent need for dedicated legislation, strategies, and resources to safeguard the sustainability of the oncology workforce."  Proposed measures to alleviate burnout, a leading work-related psychosocial risk, includes adequate staffing levels, greater control over workload, flexible hours, reduced overtime, sufficient leave entitlement, enhanced career development, job security, training opportunities, and long-term workforce retention strategies. 

Click here to read the full workforce crisis plan. 




Wednesday, 3 September 2025

Arsenic trioxide in combination with all-trans retinoic acid for the treatment of newly diagnosed patients with high-risk APL

 Results from APOLLO, a randomized phase III study, indicated that a "near-chemotherapy free treatment of arsenic trioxide in combination with all-trans retinoic acid plus low-dose idarubicin significantly improved outcomes of patients with newly diagnosed, high-risk acute promyelocytic leukaemia."  A median follow-up of 37 months indicated that 2-year event free survival was 88% in patients receiving all-trans retinoic acid and arsenic trioxide vs. 71% in patients receiving all-trans retinoic acid plus anthracycline-based chemotherapy. 

To read more about the APOLLO study, click here

Sources mentioned: 

Tuesday, 19 August 2025

Blog postings will resume in September 2025

 Dear Grey Horizon readers, 

Thank you for your continued support of this blog.  Postings will resume in September 2025.  

No survival benefit from adding adjuvant chemotherapy to endocrine therapy in older women with a genomic grade index high-risk ER-positive, HER2-negative breast cancer

Findings from ASTER 70s, a phase III randomized superiority study conducted on women 70 years or older "with a genomic grade index (GGI) high-risk oestrogen receptor (ER)-positive, HER2-negative breast cancer" identified no statistically significant effect of adding adjuvant chemotherapy to the prescribed treatment plan.  While the authors od this study admit that more evidence of genomic profiling is needed to determine "whether chemotherapy is necessary for older patents with ER-positive tumours", ASTER 70s has provided little evidence on the benefit of adjuvant chemotherapy for older breast cancer patients. 

To read more about this study, click here. 

Sources mentioned: 

Thursday, 14 August 2025

ESMO joins the European Health Alliance on Alcohol (EHAA) to reduce preventable cancer cases linked to alcohol use

The European Society for Medical Oncology (ESMO) has joined the European Health Alliance on Alcohol (EHAA).  Classified as a group 1 carcinogen by the International Agency for Research on Cancer (IARC), consumption of alcohol has been linked to liver, breast, mouth, and colorectal cancer.  As a result of joining the alliance, ESMO will collaborate with EHAA "on devising and promoting evidence-based alcohol policies aimed at preventing cancer." 

Click here to read more about the European Health Alliance on Alcohol. 




Thursday, 7 August 2025

Savolitinib plus osimertinib show a high response in EGFR-mutated NSCLC progressed on first-line osimertinib due to MET-driven resistance mechanisms

 Results of SAVANNAH, a phase II study comprised of "one of the largest datasets evaluating an oral MET tyrosine kinase inhibitor in EGFR-mutated non-small cell lung cancer" was recently reported in Annals of Oncology.   Considered to be the first study to use a novel biomarker-based patient selection strategy, results from SAVANNAH "demonstrate efficacy benefit with a chemotherapy-free, orally administered, combined EGFR and MET targeted treatment regimen." 

To learn more about the SAVANNAH study, click here

Source mentioned: 

de Marinis F, Kim TM, Bonanno L, et al. Savolitinib plus osimertinib in epidermal growth factor receptor (EGFR)-mutated advanced non-small cell lung cancer with MET overexpression and/or amplification following disease progression on osimertinib: primary results from the phase II SAVANNAH study . Annals of Oncology 2025;36(8):P920-933. DOI: https://doi.org/10.1016/j.annonc.2025.04.003

Thursday, 31 July 2025

HER2 immunohistochemistry testing may not be needed in all solid tumours

 Results from a large-scale cohort study conducted on 65 000 patients with solid tumours undergoing pan-tumour HER2 immunohistochemistry (IHC) testing has shown that "upfront HER2 IHC testing may not be required for all tumour types, especially those that are rarely positive." 

The cohort study further revealed highest HER2 IHC 3+ rates in bladder cancer (13.9%), uterine serous carcinoma (13.6%), oesophago-gastric junction cancer (12.1%), breast cancer (7.8%), gastric adenocarcinoma (6.6%), and salivary gland cancer (6.5%); additional remaining cancer types were all found to have a HER2 IHC 3+ rate of 5% or less. 

To read more about this study, click here.  

Source mentioned: 

Bryant D, Feldman R, Abdulla F, et al. A Real-World Experience in Pan-Tumor Testing for HER2 IHC in More Than 65 000 Solid Tumors . JAMA Oncol; Published online 26 June 2025. doi: 10.1001/jamaoncol.2025.1791




Wednesday, 23 July 2025

Breastfeeding patterns and relation to breast cancer outcomes after early, hormone receptor-positive breast cancer

 Findings from POSITIVE, the largest known study evaluating "breastfeeding frequency, patterns, and relation to breast cancer outcomes in women previously diagnosed with early, hormone receptor-positive breast cancer" were recently unveiled in the Journal of Clinical Oncology.  According to data reported in the POSITIVE study, breastfeeding was not shown to be associated with a higher short-term rate of breast cancer related events, news particularly relevant to women planning pregnancy and breastfeeding after receiving a breast cancer diagnosis. 

To learn more about the POSITIVE study, click here

Source mentioned: 

Peccatori FA, Niman SM, Partridge AH, et al. for the International Breast Cancer Study Group and the POSITIVE Trial Collaborators. Breastfeeding After Hormone Receptor–Positive Breast Cancer: Results From the POSITIVE Trial . JCO; Published online 9 July 2025. DOI: https://doi.org/10.1200/JCO-24-02697

Thursday, 17 July 2025

Adding retifanlimab to first-line chemotherapy for patients with advanced squamous cell anal cancer

An international, phase III study evaluating "efficacy and safety of retifanlimab in combination with standard carboplatin/paclitaxel in patients with inoperable locally advanced or metastatic squamous cell anal cancer" not receiving previous systemic chemotherapy was published in a recent issue of The Lancet.   According to findings from the study, 14% of anal cancers are metastatic at diagnosis, 40% of patients with localized squamous cell anal cancer will progress after initial chemoradiation, and patents with distant metastasis have a 36% relative survival rate over a 5-year period. 

To read more about this study, click here

Sources mentioned: 

Wednesday, 9 July 2025

Measurable residual disease adapted consolidation strategy after quadruplet induction therapy for patients with newly diagnosed multiple myeloma

 Results of the phase III MIDAS study, conducted at the Universite de Toulouse in France, with findings reported at the American Society of Clinical Oncology (ASCO) Annual Meeting, indicated that newly diagnosed multiple myeloma patients "and a postinduction measurable residual disease (MRD)-negative status...consolidation therapy with autologous stem-cell transplantation...compared with isatuximab, carfilzomib, lenalidomide, and dexamethasone...did not lead to a significant difference in percentage of patients who were MED-negative...before maintenance therapy."  Further, the authors of the study emphasized challenges of treating myeloma patients, especially with regards to implementing an effective risk-adapted therapeutic strategy. 

To read more about the MIDAS study, click here

Source mentioned: 

Wednesday, 2 July 2025

ESMO calls for oncology-specific safeguards in EU joint clinical assessments of medical and in vitro diagnostic devices in the new EU public consultation

The European Society for Medical Oncology (ESMO) has compiled a detailed response to the European Commission's public consultation draft regarding Implementing Regulation for Joint Clinical Assessments of medical and in vitro diagnostic devices.  The 4 key strategic priorities noted in the framework include systematic inclusion of oncology expertise, structured stakeholder involvement, proportional and feasible evidence requirements, and clear and consistent guidance on comparators and outcomes. 

To learn more and read the full submission, click here



Wednesday, 4 June 2025

Blog postings will resume in July 2025

 

Dear Grey Horizon readers, 

Thank you for your continued support of this blog.  Postings will resume in July 2025.  

Vepdegestrant results in longer PFS than fulvestrant in previously treated patients with ESR1-mutated, ER-positive, HER2-negative ABC

 Results from VERITAC-2, an open-label randomized phase III study conducted on "ER-positive HER2- negative advanced breast cancer patients...receiving endocrine therapy plus a CDK4/6 inhibitor" to measure progression-free survival, was reported at the 2025 ASCO Annual Meeting.  Based on findings from VERITAC-2, "vepdegestrant monotherapy showed encouraging clinical activity in patients who had received multiple previous lines of treatment for ER-positive, HER-2 negative ABC." 

To read more about VERITAC-2, click here

Sources mentioned: 

Wednesday, 28 May 2025

Supplemental breast cancer imaging techniques could lead to earlier detection of cancer in women with dense breasts

 Results from the Breast Screening - Risk Adapted Imaging for Density (BRAID) study were recently published in The Lancet.  BRAID is "the first randomized controlled trial to compare supplemental imaging of abbreviated magnetic resonance imaging (MRI), automated who breast ultrasound (ABUS), and contrast-enhanced mammography with standard mammography (standard-of-care) in women of average population risk with dense breasts and a negative screening mammogram." 

For a period of 4.5 years (October 2019 - March 2024), 9361 women aged 50-70 across the UK were recruited and randomly assigned to ether abbreviated MRI, ABUS, or contrast-enhanced mammography.   Per 1000 examinations, cancer detection rate was 17.4 for abbreviated MRI, 4.2 for ABUS, and 19.2 for contrast-enhanced mammography. 

Click here to read more about the BRAID trial. 

Sources mentioned: 

Wednesday, 21 May 2025

Patient and tumour characteristics may vary across treatment lines in a selected population of patients with mCRC included in randomised trials

 Findings from a large-scale study conducted via the Aide et Recherche en Cancerologie Digestive (ARCAD) database of patients with metastatic colorectal cancer as recently published in the Journal of Clinical Oncology (JCO). According to the study, "almost one in two patients do not receive a subsequent treatment line with second- and third-line treatment rates of 50-60% and 20-30% respectively."  In order to facilitate further research and use, ARCAD is planning to develop Score Prognostic in Oncology Digestive, an app for smartphones, tablets, and computers.  

To learn more about this study click here

Source mentioned: 

Bachet J-B, de Gramont A, Raeisi M, et al. Characteristics of Patients and Prognostic Factors Across Treatment Lines in Metastatic Colorectal Cancer: An Analysis From the Aide et Recherche en Cancérologie Digestive Database . JCO; Published online 5 May 2025. DOI: https://doi.org/10.1200/JCO-24-01968

Thursday, 15 May 2025

Sun safety declining in Canada amid rise in skin cancer cases

 A recently completed study from McGill University indicates a growing number of Canadians using less sun protection amidst increasing sun exposure time, resulting in rising cases of melanoma.  According to the study, "75% of adult Canadians reported spending at least 30 minutes in the sun...with nearly half staying out for 2 hours or more".  In addition, most of the Canadians polled admitted to irregular or no use of sunscreen, with 33% of those polled experiencing sunburn. 

To learn more about this study, click here

Source mentioned: 

Amina Moustaqim-Barrette, Hibo Rijal, Santina Conte, Mahan Maazi, Johnny Hanna, Alexandra Sarah Victoria Kelly, Alicia Belaiche, Alyson McKenna, Sandra Pelaez, François Lagacé, Ivan V Litvinov - Evaluating UV exposure and skin cancer prevention behaviours in Canada: a national population-based cross-sectional study: BMJ Public Health 2025;3:e001983.




Tuesday, 6 May 2025

InflaMix identifies CAR-T recipients with a preinfusion inflammatory profile indicative of high risk for CAR-T treatment failure

 Findings from the use of InflaMix, a predictive, point-of-care-clinical tool, designed "to identify patients at high risk of treatment failure and support informed risk-benefit discussions.." in patients with non-Hodgkin lymphoma, were recently published in Nature Medicine.  InflaMix, which requires only 1 blood test, "offers an unbiased quantitative assessment of 14 blood markers, 11 of which are routinely assayed for patients with lymphoma."  

To read more about InflaMix, click here. 

Source mentioned: 

Raj SS, Fei T, Fried S, et al. An inflammatory biomarker signature of response to CAR-T cell therapy in non-Hodgkin lymphomaNature Medicine; Published online 1 April 2025. DOI: https://doi.org/10.1038/s41591-025-03532-x

Wednesday, 23 April 2025

Potential for larger gene panels to increase the number of molecularly matched therapies in patients with advanced solid tumours

 Results of ProfiLER-2, a multicentre, prospective study comparing a hospital homemade control gene panel (CTL) to "the commercially available Foundation OneCDX (F1CDX).." was recently published in Nature Medicine.   Of the 741 patients with solid tumours screened in this study, molecular-based recommended therapies were identified with F1CDX in 175 patients and CTL in 125 patients, representing a 14.8% increase when using the F1CDX gene panel.  

To read more about this study, click here. 

Source mentioned: 

Trédan O, Pouessel D, Penel N, et al. Broad versus limited gene panels to guide treatment in patients with advanced solid tumors: a randomized controlled trialNature Medicine; Published online 7 April 2025. DOI: https://doi.org/10.1038/s41591-025-03613-x

Wednesday, 16 April 2025

Cancer mortality prediction for 2025 continues to show favourable trends in the European Union

 A recently completed study of cancer mortality rates across the European Union (EU) over the past 5 years (2020-2025) indicate a lower mortality rate of 3.5% for males and 1.2% in females, with notable decreases in breast cancer for women (9.8% less among those 50-69 years old, and 12.4% less among women 70-79 years old).  The two exceptions to this downward mortality trend were pancreatic cancer for both males and females, and bladder cancer for women.  In addition, despite enhanced tobacco control measures, rate of smoking across the EU was still report at 24%.   

To read more about this study, click here

Source mentioned: 

Santucci C, Mignozzi S, Levi F, et al. European cancer mortality predictions for the year 2025 with focus on breast cancer. Annals of Oncology;36(4):460-468.

Thursday, 10 April 2025

Adding chemotherapy to radiotherapy not associated with improved OS for patients with intermediate-risk cervical cancer

 A population-based cohort study recently published in JAMA Oncology found "no significant overall survival benefit from the addition of concomitant chemotherapy to radiotherapy in patients with intermediate-risk cervical cancer." While hysterectomy and surgical lymph node assessment is considered standard treatment for early-stage cervical cancer, nearly 60% of patients continue receiving chemoradiotherapy for intermediate-risk cases "despite the absence of clear benefit." 

To read more about this study, click here

Source mentioned: 

Agustí N, Viveros-Carreño D, Wu C-F, et al. Adjuvant Chemoradiotherapy vs Radiotherapy Alone for Patients With Intermediate-Risk Cervical Cancer. JAMA Oncology; Published online 13 March 2025. doi:10.1001/jamaoncol.2025.0146