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Use of patient-centered versus disease-centered language in public-facing media from National Cancer Institute–designated Comprehensive Cancer Centers.
e23123 Background: Receiving a cancer diagnosis often requires emotional and informational support. The way health information is delivered shapes patients' perceptions of their care and can influence cognitive framing and behavioral responses. Online resources constitute a common initial point of contact for patients navigating the complexities of their diagnosis. Thus, language should be used intentionally to support patients’ psychological well-being. The ASCO Language of Respect guidelines and other patient advocates recommend using person-centered language (PCL) over disease-centered language (DCL) to preserve patient individuality and foster therapeutic trust. This study characterizes the frequency of PCL versus DCL within patient-facing webpages of National Cancer Institute-Designated Cancer Centers (NCI-DCCs). Methods: NCI-DCCs (n=73) were identified using the NCI’s website. To prioritize patient-facing communication, Comprehensive or Clinical Cancer Centers (n=66) were included, and Basic Laboratory Centers (n=7) were excluded. For each institution, the homepage and the webpage for four common cancer types (breast, lung, prostate, colorectal) were analyzed. Pages were classified as containing PCL, DCL, both, or neither. Descriptive statistics are reported. Results: 322 unique webpages with 66 homepages, 63 Breast, 64 Prostate, 64 Lung, and 65 Colorectal webpages across the 66 NCI-DCCs were analyzed. Frequencies for PCL, DCL, both, or neither were: Homepages 9.1%, 36.4%, 9.1%, 45.5%; Breast 36.5%, 21.9%, 33.3%, 7.9%; Prostate 34.4%, 21.9%, 18.8%, 25.0%; Lung 37.5%, 25.0%, 17.2%, 20.3%; Colorectal 23.1%, 18.5%, 24.6%, 33.8%. Homepages were the least likely to use PCL, whether alone or in combination with DCL (18.2%), most likely to use DCL exclusively (36.4%), and most likely to use neither PCL nor DCL (45.5%). In contrast, disease-specific pages had higher use of PCL, whether alone or in combination with DCL. Breast cancer showed the highest rate of any PCL (69.8%), while colorectal cancer pages had the lowest rate (47.7%). However, DCL was still commonly used amongst all disease-specific webpages. Conclusions: PCL as a language motif helps maintain a patient’s individuality, promote positive identity formation, and strengthen trust with those with perceived authority, such as healthcare providers at NCI-DCCs. The linguistic structure found on commonly visited online resources should be thoughtful to avoid damaging or harmful language such as DCL. The use of DCL and neutral language on NCI-DCC homepages and disease-specific pages is a missed opportunity to optimize a patient’s journey through their cancer diagnosis and treatment. Further research is needed to fully characterize the impact of using PCL versus DCL in the setting of treating patients with cancer.
TSY-310, a novel bispecific EGFR×ROR1 ADC: Assessment of antitumor activity in heterogeneous breast tumors through enhanced internalization and bystander cytotoxicity.
3086 Background: Epidermal growth factor receptor (EGFR) is a clinically validated target and is highly expressed in various solid tumors, including triple-negative breast cancer (TNBC). Clinical efficacy of EGFR-directed therapies in TNBC, however, is often limited by intratumoral heterogeneity, acquired resistance, and mutations conferring insensitivity to tyrosine kinase inhibitors. TSY-310 is a novel bispecific EGFR×ROR1 nanobody-Fc fusion antibody–drug conjugate (BsADC) designed to address these challenges by simultaneously targeting EGFR and receptor tyrosine kinase-like orphan receptor 1 (ROR1). TSY-310 carries an average of 3.6 molecules of monomethyl auristatin E (MMAE) via a protease-cleavable valine–citrulline linker, enabling potent and tumor-selective cytotoxicity, and induces strong tumor regression across multiple NSCLC PDX models representing a range of EGFR and ROR1 expression levels. Methods: Cytotoxicity was evaluated in cell lines with distinct EGFR/ROR1 expression profiles. Bystander killing was assessed in co-culture systems of antigen-positive and antigen-negative cells. Cellular internalization and trafficking were analyzed by immunofluorescence microscopy. In vivo efficacy and bystander activity are investigated in xenograft models with heterogeneous antigen expression. Results: TSY-310 exhibited sub-nanomolar cytotoxicity (IC 50 = 0.45 nM) against MDA-MB-468 (ROR1⁺/EGFR⁺) TNBC cells in correlation with dual receptor expression levels, and demonstrated robust bystander killing, eliminating neighboring antigen-negative A427-Luc and MDA-MB-453-Luc cells through MMAE diffusion in co-culture systems. Rapid internalization of TSY-310 was observed in dual-positive MDA-MB-468 cells within 6 hours, consistent with enhanced cytotoxic activity. In a EGFR⁺/ROR1⁺ HBCx-28 TNBC PDX model, it achieved complete and sustained tumor regressions in all treated mice (5/5) and demonstrated superior efficacy compared with the monospecific ROR1-directed ADC on a payload-equivalent basis. In vivo studies to assess bystander activity and efficacy in heterogeneous tumor models are ongoing. Conclusions: These findings highlight TSY-310 as a first-in-class bispecific ADC capable of overcoming tumor heterogeneity through dual binding and bystander killing, supporting its potential as an effective therapeutic agent for heterogeneous solid tumors such as TNBC, where existing EGFR-targeted therapies have shown limited benefit.
What do patients undergoing androgen deprivation therapy think about exercise interventions and the use of wearable activity monitors?
e17091 Background: Exercise is critical for the prevention of functional decline and maintaining overall health, especially among patients with prostate cancer (PC) undergoing androgen deprivation therapy (ADT). Despite the well-established benefits of exercise intervention, the most acceptable exercise programs for PC patients receiving ADT remain unclear. Thus, this qualitative study sought to understand patient perspectives regarding exercise preferences and barriers to inform tailoring of exercise interventions for this population. Methods: Patients undergoing ADT were recruited from two sites: a large academic medical center and a Veterans Affairs (VA) medical center and were enrolled in the DigiPRO trial (NCT04575402) which integrates 12 weeks of wearable activity monitors with patient-reported outcomes to model functional decline. As an optional sub-study, virtual semi-structured qualitative interviews were conducted with enrolled patients, exploring patient preferences for exercise interventions, perceptions of functional changes, and views on wearables using a semi-structured interview guide. Interview transcripts were analyzed using content analysis. Results: Among the 30 interviewed participants in the sub-study (Median age: 68 years, SD; 8.8), resistance and aerobic training guided by an instructor were favored, with preferences for small groups, one-on-one, or solo workouts in gym or outdoor settings. As participants reported ADT-related fatigue, muscle loss, and fluctuating energy levels, they emphasized the need for flexible pacing and recovery days, expressing the need for adaptable and personalized programming that accommodates treatment side effects. Patients reported that wearables enhanced their motivation to be active, noting that the self-monitoring encouraged exercise goal completion (such as meeting daily step count targets) and helped them counteract treatment-related lethargy. Reported additional benefits of the wearables included activity reminders, sleep and heart rate tracking, and guided breathing, which patients found useful for managing the side-effects of ADT. Conclusions: These findings support the integration of wearable activity monitors as a motivational tool to enhance adherence to future prescribed exercise regimens, improving physical function and survivorship among PC survivors on ADT. Given ADT-associated fluctuations in physical function, patient input also highlighted the benefits of instructor-guided exercise interventions, such as aerobic and resistance training, tailored to individual needs and energy levels. Clinical trial information: NCT04575402 .
<i>Bacteroides sp. DH3716P</i> and mediation of immunotherapy response in oligometastatic nasopharyngeal carcinoma via the gut–nasopharyngeal axis.
6031 Background: Predictors of benefit from gemcitabine/cisplatin (GP) plus PD-1 blockade in oligometastatic nasopharyngeal carcinoma (OM-NPC) remain limited. We investigated whether baseline gut microbiome features are linked to response through a gut–nasopharyngeal axis. Methods: We performed metagenomic sequencing on baseline fecal samples from 69 OM-NPC patients receiving GP chemotherapy combined with PD-1 blockade. β-diversity analyses (PCA, PCoA, NMDS) characterized microbiota compositional differences. LEfSe analysis identified differentially abundant taxa between responders (R) and non-responders (NR). Functional enrichment analyses (KEGG, KO, MetaCyc) determined pathway differences. Co-occurrence network analysis assessed microbiota stability. Single-cell RNA sequencing from 7 tumor specimens was analyzed using SAHMI algorithm to determine bacterial-immune cell interactions. Machine learning models built on microbiota, clinical parameters, and serum biomarkers predicted treatment response. Results: Microbiota composition differed significantly between R and NR groups. R group showed significant enrichment of Enterococcus , Megasphaera , and Streptococcus . Functional analysis revealed R group possessed enhanced short-chain fatty acid (SCFA) synthesis, glycolysis, and lipid metabolism pathways. Network analysis demonstrated R group had denser ecological networks with superior stability and functional redundancy compared to NR. At species level, Bacteroides sp. DH3716P abundance associated with response and prolonged progression-free survival (PFS). This strain highly expressed SusD/RagB family outer membrane proteins and glycoside hydrolase activities, suggesting xylan degradation pathway activation leading to host glycolysis stimulation and SCFA-mediated immune regulation. scRNA-seq analysis revealed Bacteroides predominantly infected CD8+ cells in tumor microenvironment. Bacteroides+ CD8+ T cells demonstrated enhanced IL-15 pathway activity, activated multiple immune response pathways, and increased sensitivity to ICIs. Cell-cell communication analysis indicated Bacteroides+ CD8+ T cells recruited proliferative T cell subsets through CCL5-CCR5 axis, promoting sustained CD8+ T-mediated anti-tumor immunity. Integrated machine learning models achieved high accuracy in predicting treatment response (AUC: 0.996, 95% CI: 0.989-1.000). Conclusions: Bacteroides sp. DH3716P sustains immunotherapy response in OM-NPC through enhanced SCFA production and IL-15-CCL5/CCR5 axis-mediated CD8+ T cell activation and proliferative T cell recruitment in the tumor microenvironment. Our microbiota-derived predictive model (AUC 0.996) establishes a clinically feasible strategy for microbiome-assisted personalized immunotherapy in OM-NPC.
Early operative management versus nonoperative care for cancer-associated small bowel obstruction in patients with recent peritoneal metastasis: A real-world propensity-matched analysis.
e15574 Background: Cancer-associated small bowel obstruction (SBO) is a morbid complication of advanced malignancy; malignant bowel obstruction occurs in 3–15% of cancer patients, and untreated cases have a mean survival of only 4–5 weeks. Guidelines emphasize conservative management because comparative evidence for palliative surgery remains limited. Consequently, clinicians often favor nonoperative or hospice-directed care. We evaluated the association between early operative management and short-term survival and palliative care utilization in this population. Methods: We performed a retrospective cohort study using the TriNetX global federated electronic health record network. Adults (≥18 years) with SBO and active peritoneal metastasis within 1 year before to 1 day after SBO were included; hematologic malignancies were excluded. Exposure was bowel surgery within 30 days of SBO diagnosis. Outcomes were all-cause mortality and palliative care encounter at 1, 3, and 6 months. Cohort 1 consisted of 24,076 patients who had nonoperative management. Cohort 2 consisted of 2,173 patients who had early palliative surgery. Within each time horizon, cohorts were propensity-score matched 1:1 using demographics, comorbidities, baseline laboratory values, and documented do-not-resuscitate status. Odds ratios (ORs) with 95% confidence intervals (CIs) were estimated. Results: After 1:1 propensity-score matching, each cohort included 2,063 patients. Compared with early surgery, nonoperative management was associated with higher mortality at 1 month (OR 2.24; 95% CI 1.87–2.67; p < 0.001), 3 months (OR 2.45; 95% CI 2.12–2.84; p < 0.001), and 6 months (OR 2.05; 95% CI 1.80–2.35; p < 0.001). Nonoperative management was also associated with higher palliative encounters at 1 month (OR 2.18; 95% CI 1.86–2.56; p < 0.001), 3 months (OR 1.81; 95% CI 1.57–2.09; p < 0.001), and 6 months (OR 1.86; 95% CI 1.61–2.14; p < 0.001). Conclusions: Among patients with cancer-associated SBO and recent peritoneal metastasis, early operative management was associated with improved short-term survival and fewer transitions to palliative care through 6 months. These real-world, risk-adjusted estimates suggest that peritoneal metastasis alone should not preclude surgical consideration and support individualized, multidisciplinary decision-making rather than default nonoperative or hospice-directed pathways.
Drivers of organotropism and patterns of metastatic progression in metastatic non–small cell lung cancer.
e20541 Background: The non-random distribution of metastases (mets) to distant organ sites, known as organotropism, has been observed in patients with non-small cell lung cancer (NSCLC). Most patients will develop mets in two or more organ sites, with select sites and high met burden having prognostic and predictive significance. However, mechanisms driving site-specific and widespread metastatic potential are not well understood, and real-world overall survival (rwOS) remains poor. We used a database containing real-world clinical and genomic information to characterize and evaluate the prognostic value of temporal patterns of metastatic progression on rwOS in patients with NSCLC receiving systemic therapy (ST). Methods: This retrospective study utilized the Flatiron Health-Foundation Medicine Clinico-Genomic Database of patients with metastatic NSCLC treated with first-line (1L) ST. Patient, tumor, and treatment variables were summarized descriptively and compared with chi-squared tests. rwOS was estimated via Kaplan Meier method and compared with logrank test. Bernoulli mixture models were used to cluster patients by met sites at time of metastatic diagnosis, 1L therapy start, and last follow-up. Results: Data from 18 met sites was evaluated for 11,527 patients. Common sites at diagnosis were bone (22.7%), lung (17.4%), pleura (16.6%), and brain (13.0%). 72.9% of patients developed mets in two or more organ sites, and certain initial sites were associated with the non-random distribution of secondary mets. For example, patients with initial adrenal mets were more likely to develop a secondary brain met (OR 1.43, p < 0.001) compared to another site. Two phenotypes of patients with high met burden (HMB, ≥3 sites with frequency ≥0.5) at last follow-up were identified. HMB 1 (n = 1,556, median 4 sites) had frequent brain, bone, lung, and liver mets, whereas HMB 2 (n = 545, median 5 sites) had bone, distant lymph node, adrenal, soft tissue, and liver mets. HMB 1 patients more frequently had bone or liver avid disease at 1L start, whereas HMB 2 patients often had already developed HMB by this time. HMB 1 patients had better median rwOS (11.8 months) than HMB 2 patients (10.2 months), as well as compared to patients that had a lower met burden with bone (11.6 months) or liver avid disease (9.8 months, p < 0.05). Mutations in select genes that regulate interferon-gamma response and cytoplasm organization (KIF5B, CD74, ETV6, NCOA4) were associated with HMB 1, but not HMB 2 or site-specific disease. Conclusions: Definable patterns of metastasis are associated with rwOS in NSCLC. This study is the most comprehensive evaluation of the impact of longitudinal patterns of organ-specific spread and drivers of overall metastatic potential on survival outcomes in patients with NSCLC to date. This novel framework could serve as a crucial counseling and clinical management tool when caring for patients with advanced NSCLC.
Transforming renal cell carcinoma outcomes: The paradigm shift influenced by immune checkpoint inhibitors.
e16559 Background: Renal Cell Carcinoma (RCC) is a malignancy that arises from the renal tubular epithelial cells. It has distinct sub-types with clear cell carcinoma accounting for 75%-85% of tumors. The use of immune checkpoint inhibitors (ICI) since 2015 has revolutionized the treatment of RCC. The purpose of this study is to determine the survival trends in patients with RCC before and after the introduction of ICI. Methods: 78998 cases of RCC were collected from SEER Plus Database, 17 Registries, Nov 2024 Sub (2000-2022), using the ICD Code 8312/3. A multivariate Cox regression model was used to examine the effects of independent variables including age [continuous variable], sex [reference = males], race [ref = Caucasians], stage [ref = locoregional], median household income inflation adjusted to 2023 [ref = < 100K], and treatment including surgery, chemotherapy (CTX), XRT [ref = no Tx utilized, respectively] on the survival. Dependent variables were survival (months) and an event (1 = death, 0 = censored). All analysis was conducted using GraphPad Prism 10.6.1. Results: From 2000 to 2014, with every 1-year increase in age, the hazard of death increased by 3.6% whereas in the ICI (2015 and onwards) era it was 2.5% (p < 0.0001). Females had 13% lower risk of death compared to males pre-ICI (p < 0.0001) whereas the risk was 6% less post-ICI (p 0.0027). Distant staging had 3-fold higher risk of death compared to locoregional stage pre-ICI, while it was 4.16-fold higher risk in the post ICI (2015+) (p < 0.0001). For people with income > 100K, the risk of death was 12% lower compared to income < 100K in both time periods (p < 0.0001). Risk reduction with surgery was 65% up to 2014, but it was 72% after 2015 (p < 0.0001). HR with the use of XRT was 1.5 pre-2015 (p < 0.0001) while 0.89 from 2015 onwards (p 0.0005). Chemotherapy use had no statistical significance in the pre-ICI duration but was significant with 26% lower risk in the ICI duration (p < 0.0001). Race had no significant association with survival in both eras. Conclusions: In this large population-based retrospective analysis, survival outcomes for RCC improved consistently in the ICI era, with greater relative benefits observed across age, and treatment-related variables. The seemingly reduced benefit observed in female gender with the advent of ICI is attributable to the overall improvement male mortality during the same time period. Higher hazard risk with distant stage post-2014 highlights the possibility of either worse outcomes with newer modalities or aggressive genetic mutations. Persistent socioeconomic hazard disparities highlight the need for equitable access to evolving oncologic treatments for better outcomes. These findings suggest that advances in systemic therapy have translated into a measurable population-level survival benefit and underscore the importance of continued efforts to optimize care and address disparities in the modern era.
Real-time breath volatile organic compound analysis for detection of newly diagnosed, treatment naïve non-small cell lung cancer: A pilot study.
e22525 Background: Non-small cell lung cancer (NSCLC) is highly lethal as most cases are late stage at diagnosis. Screening efforts with computed tomography aimed at reducing NSCLC mortality is limited to specific sub-populations with limited implementation globally. Thus, rapid scalable screening tools to detect NSCLC continue to be an unmet need. Detection and analysis of volatile organic compounds (VOCs) from exhaled breath with proton transfer reaction-time-of-flight mass spectrometry (PTR-MS) is real-time, non-invasive, and highly sensitive. With the hypothesis that PTR-MS analytics of exhaled VOC can discriminate between patients with lung cancer and healthy volunteers, we performed a pilot study to identify and define a unique exhaled-breath VOC signature representative of newly diagnosed, treatment-naïve NSCLC. Methods: A single-centre, prospective, pilot study was conducted. Treatment-naïve patients with newly diagnosed, histologically confirmed NSCLC of any stage were recruited and the control group comprised age, sex, and smoking history matched healthy volunteers with no known malignancy. Exhaled-breath VOC profiles were analysed with PTR-MS testing. A proprietary machine learning algorithm was employed to analyse breath samples to identify a VOC signature that could distinguish between patients with newly diagnosed, treatment naïve NSCLC and healthy controls. Results: 185 newly diagnosed treatment naïve lung cancer patients were recruited over 18 months with over 500 distinct VOC measured in each breath. Amongst these VOC, 20 were identified that differed significantly in concentration within breath of patients with lung cancer compared to breath of healthy controls. To make a 20 VOC multiplex predictive biomarker for lung cancer, a random forest model with 10-fold cross validation was adopted to build the classifier. The optimised VOC signature distinguished patients with newly diagnosed treatment naïve NSCLC from healthy controls with an area under the curve of 0.9 and 0.87 in the training and validation sets respectively with corresponding sensitivity and specificity of 93% and 86% in the training set, and 89% and 85% in the validation set. Conclusions: This study represents the largest known cohort of newly diagnosed, treatment naïve NSCLC patients with exhaled-breath VOC samples. A high-performance VOC signature unique to newly diagnosed NSCLC was identified. The high sensitivity and specificity demonstrated provides a strong signal for the feasibility of breath-based screening for NSCLC. Further large-scale external validation is ongoing to test the utility of exhaled-breath VOC as a real-time, point-of-care non-invasive screening tool for NSCLC.
Adjuvant chemotherapy (CT) benefit in invasive lobular carcinoma (ILC) by Oncotype DX Recurrence Score and menopausal status.
540 Background: The benefit of adjuvant CT in early-stage hormone receptor–positive (HR+) and HER2-negative (HER2–) ILC remains uncertain. The predictive utility of the Oncotype DX Recurrence Score (RS), widely used to guide CT decisions in HR+/HER2 BC, remains debated in ILC. To address these gaps, we analyzed the impact of adjuvant CT on overall survival (OS) across RS categories and by menopausal status. Methods: We queried the National Cancer Database for patients (pts) with early-stage HR+/HER2– ILC who had surgery between 2010 and 2021. Pts were grouped by receipt of adjuvant CT (CT+ vs CT–). Analyses were stratified by RS (low 0–15, intermediate 16–25, high ≥26) and menopausal status, using age (<50 vs ≥50 years) as a proxy. Overlap propensity score weighting (OPSW) balanced baseline covariates (race, ethnicity, comorbidities, clinical T and N stage, grade and radiation and hormone therapies), and OPSW Cox models assessed the association between time-varying adjuvant CT and OS. Results: Among 141,949 pts with ILC, 19.6% received adjuvant CT. The CT+ cohort was younger (median age 59 vs 67 years) and more often pre-menopausal (21.8 vs 9%), and had high grade tumors (8.7 vs 3.3%), advanced T stage (T2: 39.4 vs 21.8%; T3: 14.9 vs 3.4%), node-positive (N1-3: 22 vs 3.2%) disease and more frequently received radiation (74.6 vs 56.5%) and hormone therapy (93.3 vs 87.5%), all p<0.001. RS testing was available in 38% of pts; CT+ cohort more often had high (9.2 vs 1.2%) or unknown RS (75.4 vs 57.9%), p<0.001. In the high RS group, CT was associated with improved 5-year (93.3 vs 90.5%) and 10-year OS (79.4 vs 71.7%) and lower mortality (adjusted hazard ratio (aHR) 0.69, p <0.001) (Table 1). Among postmenopausal pts, the survival benefit with CT was greatest in pts with high RS (10-year OS: 78.6 vs 69.2%; aHR 0.65, 95% CI 0.52–0.82, p=0.0003). No OS benefit was observed in low (aHR= 1.16, p= 0.31) or intermediate (aHR= 1.07, p= 0.39) RS groups. Among premenopausal pts, CT benefit was limited to the intermediate RS group (10-year OS: 94.9 vs 91.3%; aHR 0.57, 95% CI 0.33–1.00, p=0.049); no benefit was observed in low (aHR= 1.11, p= 0.77) or high (aHR= 1.50, p= 0.55) RS. Conclusions: In early-stage HR+/HER2– ILC, RS has limited clinical utility. Adjuvant CT benefit was restricted to pts with high RS, predominantly in postmenopausal pts, while RS did not reliably predict benefit in premenopausal pts. No OS benefit was seen in low RS disease, supporting a selective, biology-driven approach to CT use in ILC. CT decisions in pts with unknown RS appear largely driven by clinicopathologic factors. 10-year survival analysis of ILC patients based on CT receipt and RS. RS group OS (%, 95% CI) CT + OS (%, 95% CI) CT - aHR (95% CI) Reference: CT- p-value Low 87.6 (84.6-90.6) 88.9 (88.0-89.9) 1.13 (0.87-1.47) 0.36 Intermediate 86.2 (84.4-88.1) 86.5 (85.3-87.7) 1.02 (0.87-1.20) 0.78 High 79.4 (76.4-82.5) 71.7 (66.9-76.8) 0.69 (0.55-0.87) <0.01
BNT326-01: A Phase 1b/2 trial of BNT326/YL202 (HER3 ADC) as monotherapy and in combination with pumitamig (anti-PD-L1 × VEGF bsAb) in patients with advanced solid tumors.
TPS3160 Background: BNT326/YL202 is an investigational ADC composed of an anti-HER3 IgG1 monoclonal antibody conjugated to ~8 molecules of a novel topoisomerase I inhibitor payload via a tripeptide linker. HER3 is frequently overexpressed in various solid tumors, particularly in relapsed or refractory tumors, making it an attractive therapeutic target. Increasing evidence suggests that ADCs may enhance the efficacy of immunotherapeutic agents. It is hypothesized that combining BNT326 with immunotherapy including pumitamig, an investigational anti-PD-L1 x VEGF-A bispecific antibody, could lead to better patient outcomes than administering either drug alone. Targeting angiogenesis may facilitate ADC penetration, which in turn could stimulate tumor immunity and increase sensitivity to PD-L1 inhibition. Preclinical in vivo models testing the combination of pumitamig with BNT326 showed superior tumor growth inhibition compared to each treatment alone (Hamilton E, AACR 2025, #648). Methods: This global Phase 1b/2, open-label, adaptive two-part multicohort trial (NCT07070232) will evaluate safety, efficacy, optimal dose and pharmacokinetics of BNT326 in selected indications, both as monotherapy (Part 1) and in combination with pumitamig (Part 2) in patients (≥18y, ECOG PS 0 or 1) with histologically or cytologically confirmed solid tumors that are advanced and/or have relapsed/progressed after prior therapy. Both parts will start enrolling patients independently of each other. In Part 1, patients in Cohorts 1A-C will be randomized to one of two dose levels of BNT326 based on doses derived from the ongoing monotherapy trials (YL202-INT-101-01 [NCT05653752] and YL202-CN-201-01 [NCT06107686], whereas Cohorts 1D, 1E, and 1G receive dose level 2 of BNT326. 1A: cutaneous melanoma 2L+; 1B: NSCLC 2L+, negative for actionable oncogenic alterations; 1C: EGFRm NSCLC 2L+; 1D: rare melanoma; 1E: other advanced solid tumors; 1F: drug-drug interaction cohort, dose defined in randomization cohorts 1A - 1C; and 1G: cervical cancer 2L+. In Part 2, patients in Cohorts 2A and 2B will receive two dose levels of BNT326 in combination with pumitamig. Patients in Cohorts 2D and 2E will receive two dose levels of BNT326 with pumitamig and dose level 2 of BNT326 as monotherapy. Patients in Cohort 2F receive one combination dose level. 2A: cutaneous melanoma 2L+; 2B: HER2-negative breast cancer 2L+/1L; 2C (optional, not open): cutaneous melanoma 1L+; 2D: gastric/gastroesophageal junction cancer 2L+; 2E: colorectal cancer 2L+; and 2F: cervical cancer 2L+. Primary endpoints are safety, overall response rate, and pharmacokinetics for cohort 1F. Enrollment for all cohorts is ongoing globally. Clinical trial information: NCT07070232 .
Albumin–bilirubin index as a determinant of short- and long-term outcomes after locoregional therapy for hepatocellular carcinoma: A real-world propensity-matched analysis.
e16304 Background: Hepatic reserve is a critical determinant of outcomes in hepatocellular carcinoma (HCC), yet traditional scoring systems such as MELD are frequently unavailable or underpowered in real-world datasets. The albumin–bilirubin index (ALBI) is a validated, objective measure of liver function derived from routine laboratory values and has emerged as a pragmatic alternative for risk stratification. However, the impact of ALBI on longitudinal outcomes following locoregional therapy (LRT) for HCC in routine clinical practice remains incompletely characterized. Methods: We performed a retrospective cohort study using TriNetX to identify adults with HCC treated with locoregional therapies (transarterial chemoembolization, yttrium-90 radioembolization, stereotactic body radiation therapy, or thermal ablation). Hepatic reserve was assessed using an albumin–bilirubin–based definition with labs within 30 days pre-therapy. Low ALBI (preserved function) was defined as albumin ≥3.5 g/dL and bilirubin ≤2.0 mg/dL, and high ALBI (impaired function) as albumin < 3.5 g/dL or bilirubin > 2.0 mg/dL. Propensity score matching (1:1) balanced demographics and comorbidities. Outcomes at 6 months, 1, 3, and 5 years included mortality, hepatic failure, ascites, portal hypertension, and esophageal varices. RD, RR, OR, and HR with 95% CIs were reported. Results: After matching, 509 patients were included in each ALBI group. High ALBI was consistently associated with significantly worse outcomes across all time points. Overall mortality was higher in the high-ALBI group at 6 months (19.6% vs 8.7%), 1 year (31.0% vs 13.9%), 3 years (51.0% vs 28.3%), and 5 years (57.1% vs 35.6%). Corresponding hazard ratios for mortality ranged from 2.32 to 2.65 across time points (all p < 0.05). High ALBI was also associated with substantially increased risks of hepatic failure (5-year RD 23.9%, HR 3.29), ascites (5-year RD 18.5%, HR 2.50), and esophageal varices (5-year RD 8.5%, HR 2.60). These associations persisted from early through long-term follow-up, demonstrating durable prognostic separation by ALBI status. Conclusions: In this large, real-world cohort of HCC patients undergoing locoregional therapy, impaired hepatic reserve as defined by a high albumin–bilirubin index was strongly and consistently associated with worse short- and long-term survival and higher rates of hepatic decompensation. An albumin–bilirubin–based ALBI classification represents a pragmatic and clinically meaningful tool for risk stratification when MELD is unavailable and may inform treatment selection, prognostication, and post-therapy surveillance in routine clinical practice.
Application of PET RANO 1.0 criteria and associations with outcome in <i>IDH-</i> mutant gliomas: A retrospective cohort study.
2075 Background: Amino acid PET is increasingly used to guide clinical decisions in glioma. For standardized response assessment, PET RANO 1.0 criteria have been formulated, but are primarily consensus-based and lack validation in molecular subgroups of diffuse gliomas. Methods: In this retrospective cohort study, patients with newly diagnosed or recurrent IDH -mutant glioma and at least two O-(2-[ 18 F]-fluoroethyl)-L-tyrosine ([ 18 F]FET) PET scans in 02/2013 - 08/2025 were included. PET was evaluated using PET RANO 1.0 criteria based on maximum and mean tumor-to-background ratios (TBR max /TBR mean ) and PET volume. Intervention-free survival (IFS) was used as endpoint. Results: Overall, 219 patients (110 [50.2%] oligodendroglioma, 106 [48.4%] astrocytoma, 3 with unknown 1p/19q status; 115 [52.5%] CNS WHO 2, 80 [36.5%] CNS WHO 3, 23 [10.5%] CNS WHO 4, 1 grading inconclusive) with 251 lesions were included. Median age at first PET was 45 years (range: 21-75), and 117 (53.4%) patients were male. In total, 220 treatment lines (173 [78.6%] first line treatment; 47 [21.4%] recurrence/progression) were followed, of which 135 (61.4%) involved radiotherapy and/or systemic treatment, and 85 (38.6%) observation. Median time between PET scans was 6.7 months (2.4-11.8). In first-line treatment at baseline, PET-based measurable disease was seen in 126/173 (72.8%), non-measurable in 38/173 (22.0%) and no measurable disease in 9/173 (5.2%). PET-based complete remission (PET-CR) was observed in 7/173 (4.0%), partial remission (PET-PR) in 32/173 (18.5%), stable disease (PET-SD) in 74/173 (42.8%), and progressive disease (PET-PD) in 60/173 (34.7%) patients. The primary driver of PET-PD was an increase in PET volume alone (27/60, 45.0%) or in combination with an increase in TBR max /TBR mean (19/60, 31.7%), followed by new measurable disease in 14/60 (23.3%) patients. In astrocytoma, IFS was shorter in patients with PET-PD (median: 10.0 months; 95%CI: 8.3-32.6) compared to PET-SD/-PR/-CR (33.0 months; 95%CI: 22.0-52.1; p = 0.043). Similar differences were seen in oligodendroglioma (PET-PD: 16.0 months; 95%CI: 11.7-63.3; vs. PET-SD/-PR/-CR: 34.5 months; 95%CI: 24.3-57.0; p = 0.036). At treatment for recurrence, baseline PET showed measurable disease in 37/47 (78.7%) and non-measurable disease in 10/47 (21.3%) patients. PET-CR was seen in 3/47 (6.4%), PET-PR in 16/47 (34.0%), PET-SD in 24/47 (51.1%) and PET-PD in 4/47 (8.5%) patients, with numerical differences in IFS (p = 0.16) according to PET response in recurrent disease. In both first-line treatment and recurrence, measurable disease at baseline was not associated with PET response (p > 0.05). Conclusions: Response assessment based on PET RANO 1.0 criteria is associated with outcome in IDH- mutant glioma. Further analyses considering MRI-based response assessment are ongoing for further validation of PET-based clinical trial endpoints.
B cell responses in recurrent respiratory papillomatosis patients treated with DNA immunotherapy INO-3107.
2549 Background: Recurrent respiratory papillomatosis (RRP) is a chronic, debilitating disease of the airway primarily caused by infection with human papillomavirus (HPV) types 6 and/or 11 and characterized by recurrent, benign tumor growth with potential for malignant transformation. Current standard of care consists of repeated surgical removal of papillomas, which can lead to lasting airway damage and impaired vocal function. Thus, a non-surgical approach to treat RRP is paramount. Previously, we described T cell responses associated with an overall clinical response rate of 81% (26/32) to INO-3107, a DNA immunotherapy designed to generate T cells capable of targeting HPV-infected cells, in adult RRP patients during a Phase 1/2 trial (NCT04398433). Here, we describe B cell responses in these patients. Methods: INO-3107 was administered during study weeks 0, 3, 6 and 9. Peripheral blood mononuclear cells (PBMCs) were obtained at screening/day 0, weeks 6, 9, 11, 26 and 52. Formalin-fixed, paraffin-embedded papilloma tissue was obtained prior to INO-3107 treatment (Scr) and at the end of the 52-week study (EOS). Both PBMCs and tissue were subjected to RNA and BCR sequencing, which additionally underwent single sample gene set enrichment analysis and CloneTrack analysis, respectively. Clinical response was defined as any reduction in frequency of RRP surgical interventions in the 52 weeks following dose 1 of INO-3107 (Y1) compared to the 52 weeks prior. Results: Following INO-3107 treatment, 85% (23/27) of patients exhibited B cell expansion in PBMCs that was sustained through Y1 for responders, which in contrast began to contract at week 26 for non-responders. Enrichment of B cell signatures, inclusive of total, naïve, memory, and plasma B cells, in papilloma tissue increased significantly by EOS in responders compared to non-responders. Increases in tissue BCR clone counts from Scr to EOS correlated significantly with clinical response during Y1. BCR sequences detected in tissue taken at EOS displayed a low degree of overlap with those detected at Scr. Newly detected BCR sequences in EOS tissue were present in PBMCs prior to EOS. Some of these B cell clones were detectable in PBMCs and papilloma tissue only after INO-3107 treatment. Conclusions: B cell immunogenicity may play a role in mediating clinical responses to DNA immunotherapy INO-3107 for the treatment of RRP. INO-3107 treatment induced expansion and emergence of B cells in the blood of RRP patients, which trafficked to and infiltrated papilloma tissue by EOS as evidenced by increased B cell enrichment and clone counts. These immune responses were associated with improved clinical outcomes. These results suggest that INO-3107 engages B cells equipped with the potential to promote activation of T cell responses described previously (doi: 10.1038/s41467-025-56729-6) and that they may play a role in long-term immunity against RRP. Clinical trial information: NCT04398433 .
Impact of a patient-facing app to address surgical oncology patients’ social determinants of health: Preliminary results of a phase II clinical trial.
1570 Background: Unmet Social Determinants of Health (SDH) needs, including housing, transportation, food insecurity, utilities, and social support, are associated with adverse outcomes in cancer care, including delays in treatment, missed appointments, and hospital readmissions. Few interventions have been rigorously evaluated to address these SDH needs in surgical oncology populations. We conducted a Phase II randomized controlled trial to evaluate whether a patient-facing mobile application (Carealth), integrated with a follow-up resource referral platform (findhelp.org), could improve clinical and process outcomes compared to a “sham” app that included an attention-control (static CDC site). Methods: We enrolled adult patients with cancer (or suspected cancer) scheduled for surgery at three large U.S. centers. Participants were randomized to Carealth (intervention) or sham (control). We assessed 30-day readmission after surgery, distribution of where resources were sought among interventions clients (among those with baseline needs), time from consultation to surgery, and missed/rescheduled visits within 90 days. Analyses used descriptive statistics, Fisher’s exact tests and crude odds ratios for readmission, Kaplan–Meier/log-rank methods for time to surgery, and proportional odds models for missed visits, under an intention-to-treat framework. Results: Of 585 patients screened, 161 were randomized (81 intervention, 80 control). Baseline characteristics were well balanced, with 17% reporting at least one SDH need at baseline. App uptake was 80% overall. Thirty-day readmissions were rare and similar between groups, occurring in 5 of 80 patientsOR 1.64, p = 0.72). Median time to surgery was 45 days in the intervention group vs 49 days in controls (log-rank p = 0.42). Missed/rescheduled visits within 90 days did not differ (proportional OR 1.28, p = 0.79). Among participants with SDH needs, multiple resource pathways were used, including counselor or patient navigator services, community or online resources, and the Carealth app; a subset reported partial or complete resolution of needs through the app. Conclusions: In this Phase II trial, an SDH-focused patient-facing app achieved outcomes comparable to standard-of-care navigation with respect to readmissions, time to surgery, and appointment adherence. While underpowered for rare clinical events, the intervention demonstrated high uptake and sustained patient engagement, supporting its potential role as a scalable, low-resource adjunct to existing support and navigation services. Larger trials enriched for patients with unmet SDH needs are warranted to assess clinical and health-system impact. Clinical trial information: NCT06688513 .
Vepdegestrant, a proteolysis targeting chimera (PROTAC) estrogen receptor (ER) degrader, plus abemaciclib (ABE) in ER+/human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (ABC): TACTIVE-U phase 1b/2 results.
1067 Background: Substudy A of the open-label, phase 1b/2 TACTIVE-U umbrella study is evaluating vepdegestrant, an oral PROTAC ER degrader, in combination with ABE for treatment of ER+/HER2− ABC (NCT05548127). Here, we report results for all patients (pts) in phases 1b and 2 treated with vepdegestrant (200 mg orally once daily) plus ABE (150 mg orally twice daily). Methods: Eligible pts were adults (age ≥18 years) with ER+/HER2− ABC who had received 1–2 prior lines of therapy in the ABC setting; 1 prior cyclin-dependent kinase 4/6 inhibitor (CDK4/6i)-based regimen (in any setting) was required. The primary endpoint of phase 1b was dose-limiting toxicities during the first cycle. The primary endpoint of phase 2 was objective response rate (ORR); secondary endpoints included clinical benefit rate (CBR), progression-free survival (PFS), safety, and pharmacokinetics (PK). Results: As of October 10, 2025, 37 female pts (median age, 59 years [range, 38–84]; 20 pts [54.1%] had ESR1 -mutated [ ESR1 m] tumors) received vepdegestrant plus ABE in phases 1b and 2, with 26 pts treated for ≥5 28-day cycles; 10 remain on treatment. All pts received prior CDK4/6i (ribociclib, 48.6%; palbociclib, 43.2%; ABE, 8.1%) in any setting; prior treatments in the metastatic setting included aromatase inhibitors (64.9%), fulvestrant (35.1%), and chemotherapy (21.6%). Among pts with measurable disease at baseline, the ORR was 30.6% (95% CI, 18.0–46.9) in all pts and 45.0% (95% CI, 25.8–65.8) in pts with ESR1 m tumors. The CBR was 59.5% (95% CI, 43.5–73.7) in all pts and 65.0% (95% CI, 43.3–81.9) in pts with ESR1 m tumors. Median PFS was 7.2 months (95% CI, 5.5–16.5) in all pts and 10.9 months (95% CI, 5.5–not estimable) in pts with ESR1 m tumors. Five pts (13.5%) discontinued treatment due to treatment-emergent adverse events (TEAEs). TEAEs led to dose reduction of vepdegestrant in 6 pts (16.2%) and dose reduction of ABE in 19 pts (51.4%). Treatment-related adverse events of any grade that occurred in ≥20% of pts were diarrhea (73.0% [grade 1/2, 70.3%; grade 3/4, 2.7%]), fatigue (54.1% [grade 1/2, 40.5%; grade 3/4, 13.5%]), neutropenia (54.1% [grade 1/2, 21.6%; grade 3/4, 32.4%]), nausea (35.1% [grade 1/2, 32.4%; grade 3/4, 2.7%]), anemia (32.4% [grade 1/2, 29.7%; grade 3/4, 2.7%]), vomiting (24.3% [grade 1/2, 21.6%; grade 3/4, 2.7%]), and decreased appetite (21.6% [grade 1/2, 18.9%; grade 3/4, 2.7%]). There were no grade 5 TEAEs. PK data showed that vepdegestrant was associated with a modest 22% increase in exposure of ABE and its active metabolites, indicating no significant drug-drug interaction. Conclusions: In this phase 1b/2 study of pts with ER+/HER2− ABC, vepdegestrant plus ABE demonstrated antitumor activity and a safety profile that was generally consistent with the known profiles of each agent. Clinical trial information: NCT05548127 .
Phase 2 basket trial of precision TIL therapy for immunotherapy-resistant advanced cancers.
2505 Background: Adoptive cell therapy (ACT) using unselected autologous tumor-infiltrating lymphocytes (TIL) has demonstrated clinical activity in metastatic cutaneous melanoma, an immunotherapy-sensitive cancer with high tumor mutational burden (TMB). However, we recently demonstrated in metastatic uveal melanoma, a prototypic low-TMB, immunotherapy-resistant cancer, that efficacy of TIL ACT requires infusion of TIL with measurable anti-tumor reactivity. Thus, to extend TIL ACT to additional immunotherapy-resistant cancers, we developed TILScore , a pan-cancer in situ transcriptomic biomarker designed to preoperatively identify metastases enriched with clinically active TIL. Here we report initial results from a pilot phase 2 TIL therapy trial prospectively evaluating TILScore as a precision biomarker for immunotherapy-resistant cancers. Methods: This single-center phase 2 trial (NCT03935893) enrolled patients with treatment-refractory, locally advanced, recurrent, or metastatic cancers into ten histology-defined cohorts. After a feasibility run-in, metastases with core biopsy TILScore > 0.248 were selected for TIL harvest and manufacturing. Patients received non-myeloablative lymphodepletion (NMA-LD) with cyclophosphamide and fludarabine, followed by infusion of TIL and high-dose interleukin-2. The primary endpoint was cohort-specific objective response rate (ORR) by RECIST v1.1 using a Bayesian basket design targeting ORR > 20% as evidence of promising activity. Results: As of 1/17/2026, 19 patients received TIL therapy. Tumor types included pancreatic adenocarcinoma (PDAC, n = 7), leiomyosarcoma (n = 3), peritoneal mesothelioma (PeM, n = 2), and single cases each of non–small cell lung cancer, cervical squamous cell carcinoma (SCC), nasopharyngeal SCC, and melanoma subtypes (cutaneous, acral, mucosal, unknown origin). All had progression after frontline therapy, with a median of 5 prior metastatic treatments; 58% had received checkpoint blockade. Liver metastases were the most common TIL source (37%), followed by lung and soft tissue (32% each). Infusion products contained a median of 5.36E10 TIL with an even mix of CD4 and CD8 cells. Adverse events were consistent with NMA-LD and interleukin-2; no grade 5 events occurred. Among 18 evaluable patients, ORR was 33% (6/18) with cohort specific responses in PDAC (50%, 3/6: 1 CR, 2 PR), PeM (100%, 2/2: 1 CR, 1 PR), and melanoma of unknown origin (100%, 1/1: 1 CR). TILScore predicted clinical response with an area under the receiving operating characteristic curve of 0.806 (P = 0.041). Conclusions: TILScore -guided selection of metastases for TIL manufacturing is feasible and enables consistent generation of clinically active TIL in patients with immunotherapy-resistant cancers. Promising clinical activity in PDAC and PeM supports evaluation of this biomarker-driven TIL ACT approach in larger, histology-specific cohorts. Clinical trial information: NCT03935893 .
Trends and disparities in mortality from malignant neoplasms of male genital organs in the United States, 1999–2023.
11134 Background: Genital malignant neoplasms remain an important cause of mortality among males living in the United States. Tumor progression and organ-specific compromise contribute to increased risk and disease severity. Although recent data show overall declines in mortality over time, disparities persist, highlighting the need to analyze and interpret trends across demographic and geographic factors. Methods: The mortality data from the CDC WONDER underlying cause of death files for men aged ≥25 years were used to analyze age-adjusted and crude mortality rates (AAMRs and CMRs) per 100,000 for male genital neoplasms (ICD-10 Codes: C60-C63.9), stratified by year, gender, race/ethnicity, place of death, and geography. Joinpoint regression was used to estimate average annual percent change (AAPC) and annual percent change (APC) with 95% confidence intervals (CIs). Statistical significance was defined as p<0.05. Results: From 1999 to 2023, a total of 765,516 deaths were reported among patients of male genital malignant neoplasms, with most occurring at the decedent’s home. The overall AAMR decreased from 18.29 in 1999 to 12.51 in 2023 (AAPC: -1.55; 95% CI: -1.71 to -1.39; p<0.001), with the most significant decline observed between 1999–2013 (APC: -2.73; p<0.001). Men aged 65 years and older experienced the greatest annual decline (-2.50%; p<0.001), but had the highest CMR (63.84), whereas mortality among men aged 25–44 years increased notably between 2013–2023 (APC: 3.65; p<0.001). The highest AAMR was observed among non-Hispanic (NH) Blacks (26.98), while the lowest AAMR was noted among NH Asians (6.30). Geographic disparities were evident, with the West having the highest AAMR (14.48) and the Northeast having the lowest (13.02). Non-metropolitan areas showed a higher AAMR (14.94 vs 13.79) and a slightly steeper decline in mortality than non-metropolitan areas (AAPC: -1.81 vs -1.80). At the state level, the District of Columbia ranked the highest, placed in the top 90th percentile, between 1999 and 2023. Conclusions: Despite a significant decline in mortality related to malignant neoplasms of male genitals over the past two decades, disparities persist, especially among older men, NH Black individuals, those living in non-metropolitan areas, and the West region. This underscores the need for targeted prevention, early detection, and equitable integrated care. Average annual percent change (AAPC) of age-adjusted mortality rates for male genital malignant neoplasms in the United States, 1999 to 2023. Variable Deaths AAPC (95%CI) Overall (Male) 765,516 -1.55 (-1.71 to -1.39) Non-metropolitan areas 126,009 -1.80 (-2.05 to -1.55) Metropolitan areas 537,718 -1.81 (-2.00 to -1.62)
GEMINI-BREAST: Evaluating minimal residual disease (MRD) through longitudinal circulating tumor DNA (ctDNA) profiling in breast malignancies.
TPS649 Background: While advancements in early-stage breast cancer (ESBC) treatment have improved survival, disease recurrence and therapeutic resistance remain significant challenges. Current biomarkers guide initial treatment, yet novel diagnostics are required to improve risk stratification and recurrence prediction. Circulating tumor DNA (ctDNA) offers a non-invasive method for detecting minimal residual disease (MRD), potentially enabling the identification of molecular relapse before radiographic progression. However, deeper validation of ctDNA kinetics across the treatment continuum is needed to inform precision oncology strategies in ESBC. Additionally, the logistical complexity of tissue-dependent assays presents a barrier to scalability. In order to address these gaps, the purpose of the GEMINI-BREAST study is to evaluate a methylation-based, tissue-free ctDNA assay (Tempus xM) and integrate this with comprehensive clinical and multi-omic data to determine prognostic utility for invasive disease-free survival (iDFS) and long term outcomes in patients with ESBC. Methods: GEMINI-BREAST (NCT07211178) is a prospective, non-interventional, multi-center study enrolling up to 900 participants with ESBC treated with curative intent. Eligible patients enroll into one of three analytical cohorts (n ~ 300 each): Cohort 1 enrolls pre-neoadjuvant therapy (high-risk HR+/HER2- [Stage II-III], HER2+ [Stage II-III], or TNBC [Stage I-III]); Cohort 2 enrolls post-surgery/pre-adjuvant therapy (same subtypes, no evidence of disease); and Cohort 3 enrolls long-term survivors (high-risk HR+/HER2- [Stage II-III], ≥ 5 years since diagnosis). Longitudinal blood samples for ctDNA analysis and archival tissue for NGS are collected at standard-of-care intervals, including, as applicable: pre-neoadjuvant, neoadjuvant on-treatment (weeks 3, 6, 12) and post-treatment, post-surgical/pre-adjuvant, adjuvant on-treatment (every 3 months), end of definitive therapy, surveillance for up to 5 years (every 3-6 months for Cohorts 1/2; every 6-12 months for Cohort 3), and at progression/recurrence. The primary objective is to evaluate the association between ctDNA dynamics (Cohort 1) or MRD status (Cohort 2/3) and iDFS, with secondary endpoints assessing overall survival, lead time to recurrence, and the predictive value of ctDNA clearance for pathological complete response. Recruitment is currently ongoing at U.S. sites. Clinical trial information: NCT07211178 .
Integrated data platform: Backbone of cancer research office.
e13653 Background: The management of research portfolio and workflow is crucial for every research entity in a cancer center. It ensures efficiency and quality of study startup (SSU), subject accrual, regulatory compliance, quality assurance, etc. A Clinical Trial Management System (CTMS) would help with research administration. However, for research with resource constraints, it can be difficult and expensive. In this poster, we present a budget-friendly, in-house integrated data platform to improve data integrity, centralize data storage, and automate performance tracking that has been applied in our center. Methods: We built the platform using Microsoft (MS) SQL Server, MS Access and Tableau through the following steps. First, we discussed with team leaders to determine data elements required for research portfolio tracking. Second, we designed and built a relational database in MS SQL server, including entity tables and reference tables. Third, we cleaned up historical data that was previously stored in various Excel files and transferred them into the newly built database. Fourth, based on fields in entity tables, we created different forms in MS Access as data entry interface. Lastly, we developed SQL queries to extract data, and visualized results in Tableau dashboard suite to address distinct needs. Results: Database and data entry interface were built in 2021. First set of dashboards were launched in 2022, including accruals and studies overview, active studies list, SSU timeline, iRIS directory and Protocol Evaluation and Monitoring Committee (PEMC) Review. In the following years, we kept adding new functions to the existing tools. In 2024, Quality Assurance (QA) tracker was implemented. At the end of 2025, this platform had managed 324 studies (69% therapeutic), 4097 accruals (9% therapeutic), 378 QA records (29% reviews have findings), 56 PEMC meetings (167 protocols reviewed), and 150 Institutional Review Board (IRB) continuing reviews. This platform received positive feedback across teams and leadership regarding improved efficiency and quality of research administration. Conclusions: For a research office with limited resources and lacking CTMS, this platform is a cost-effective, sustainable and replicable solution. Due to flexibility of the system, different modules can be added on as our demands expand. Centralized data storage and performance tracking improves transparency and provides a more comprehensive insight into research portfolio.
EUnetCCC.
e13617 Background: Cancer is the second leading cause of death in Europe and the primary cause of mortality among individuals under 65 years of age. Despite major advances in oncology, substantial disparities persist across European countries in access to high-quality cancer care, early diagnosis, innovative treatments, and clinical research. Addressing these inequities requires system-level models of care that integrate clinical excellence, research, education, and sustainability. In response, the European Commission launched Europe’s Beating Cancer Plan, under which the European Network of Comprehensive Cancer Centres (EUnetCCC) was established to transform cancer care delivery across Europe. Methods: EUnetCCC is a Joint Action funded by the EU4Health Programme, coordinated by the French National Cancer Institute, involving all 27 European Union Member States and four associated countries. The initiative is structured into nine Work Packages addressing governance, certification, sustainability, quality improvement, research integration, and the implementation of Comprehensive Cancer Networks. A standardized certification framework for Comprehensive Cancer Centres (CCCs) was developed to promote harmonized quality standards, multidisciplinary care, integration of research and clinical practice, and cross-border collaboration. Results: EUnetCCC currently includes 163 partner institutions from 31 countries and aims to ensure that by 2028, at least 90% of eligible cancer patients in Europe will have access to high-quality comprehensive cancer care through a network of at least 100 certified CCCs, with at least one CCC in each Member State. The model facilitates equitable access to quality-assured diagnostics, innovative therapies, clinical trials, and professional training, while strengthening capacity in less-resourced regions. Cross-border collaboration within the network supports patient mobility, shared expertise, and improved care delivery for complex cancer cases. Conclusions: EUnetCCC represents a scalable, system-level model for cancer care delivery that integrates quality, equity, and innovation across diverse healthcare systems. By harmonizing standards and embedding research into routine care, EUnetCCC addresses structural disparities and provides a transferable framework for improving quality and outcomes in cancer care globally.