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NCORP Symptom Science Portfolio analysis (2014-2025).
e24054 Background: Symptom science research constitutes the largest share of the Division of Cancer Prevention’s portfolio at the National Cancer Institute (NCI), supported through its flagship program, the National Cancer Institute Community Oncology Research Program (NCORP) as well as investigator-initiated grants. The purpose of this portfolio analysis was to describe the breadth of the symptom science portfolio, assess gaps and highlight opportunities for growth. Methods: We searched the NIH database for studies conducted through the NCORP Network between 2014 and 2024. We also queried the NIH iSearch database for grants funded by NIH between 2015 and 2024, using a keyword search, and screened results to select studies that characterize, prevent, measure, or treat cancer related symptoms. We also categorized each study based on the priority areas that were established by the Symptom Science and Quality of Life (SxQOL) Steering Committee in 2015. These research priorities were established considering clinical need, defined mechanistic hypotheses, sufficient preliminary data to warrant larger longitudinal, prospective, cohort studies and availability of interventions that were ready for large phase II and phase III randomized clinical trials. Results: Between 2014 and 2024, NCORP conducted 80 symptom science studies, the majority of which were phase II or III trials. 36 studies addressed one or more priority areas. 26 of these studies were categorized as meeting the first-tier SxQOL priorities, including 10 cancer related cognitive impairment (CRCI), 7 chemotherapy -induced peripheral neuropathy (CIPN), 5 cardiotoxicity, 1 fatigue, and 3 cancer-specific pain. Among the grant portfolio, 228 individual grants (33 conducted through NCORP) included endpoints related to top-tier symptom priorities. Fatigue was the symptom most represented in these trials, followed by cancer pain. Among completed studies, 15 demonstrated a significant intervention effect on a top tier symptom. Conclusions: Our analysis demonstrated that only a subset of studies addressed symptom science priority areas. However, the first-tier priorities of CRCI and CIPN account for our largest number of NCORP studies and the largest number of grants in the portfolio, suggesting the priorities drove research through both mechanisms. Significant gaps remain in priority areas. Targeted portfolio analyses in each area are essential to explore specific gaps and move research through the pipeline to intervention studies both through the grant portfolio and NCORP.
Barriers and facilitators to teleoncology care delivery for cognitively impaired older cancer patients: Clinician perspectives.
e13710 Background: Telehealth has improved access to care and is increasingly used in oncology. However, its expansion has outpaced evidence on how to deliver effective care to older cancer patients with cognitive impairment (CI). Our objective was to understand barriers and facilitators to delivering teleoncology care to cancer patients with CI from the perspective of clinicians. Methods: We conducted semi-structured interviews with clinicians at San Francisco VA Oncology Clinic from September-December 2025. Clinicians were asked to reflect on challenges with teleoncology care in general and for patients with diagnosed or suspected CI. Interviews were guided by the Consolidated Framework for Implementation Research and covered experiences across the following domains: 1) physical (e.g. exam), 2) decisional (e.g. medical decision-making), 3) emotional (e.g. rapport, emotional support), 4) technological/structural (e.g. audio quality, telehealth infrastructure). Study team members analyzed transcripts using rapid qualitative analysis. Results: We interviewed 10 clinicians with expertise spanning solid and hematologic malignancies. On average, clinicians reported 48% in-person, 25% video, and 27% phone visits. Clinicians identified challenges in each domain and their impact on patient care: 1) Physical: the inability to perform a physical exam impedes patient assessment, which is magnified in CI patients who may provide less reliable history or symptom reporting; 2) Decisional: difficulty determining functional status and treatment candidacy via telehealth, which hinders shared decision-making with CI patients; 3) Emotional: building rapport with patients is harder over telehealth and magnified with CI patients who may need more emotional support; 4) technological/structural: clinicians reported patients often had challenges connecting to the VA video platform, resulting in frequent conversion to phone visits which were inferior to video in all domains, particularly for patients with CI. Clinicians identified the following facilitators to help them provide more effective teleoncology care: virtual vitals, supportive caregivers, tools for patient education and clinician workflow, support staff, and information technology support. Clinicians noted most veterans liked how telehealth increased access to oncology care, especially for rural and frail veterans. Conclusions: Despite the potential for teleoncology to increase access for older adults, there are additional challenges for CI patients, especially if relying on phone visits, that impair the quality of care. Findings from this study will be combined with interview findings from patients and caregivers to inform development of an intervention to improve delivery of teleoncology care to CI patients.
Respiratory malignancies among patients hospitalized with acute respiratory failure: Nationwide trends in complications, resource utilization, and outcomes.
e20085 Background: Acute respiratory failure (ARF) is a common cause of hospitalization among patients with lung cancer. Prior nationwide analyses have evaluated ARF as a complication in patients admitted to the hospital with lung cancer as the primary diagnosis, providing insight into predictors and outcomes of respiratory decompensation within cancer-indexed cohorts. In contrast, less is known about the impact of underlying respiratory malignancies on complications, resource utilization, and outcomes in patients hospitalized with ARF. Oncology patients hospitalized with ARF may represent a clinically distinct subgroup with unique complications and outcomes. Methods: The National Inpatient Sample (NIS) database from 2016-2022 was used to identify hospitalizations with ARF (ICD-10 J96.x). Patient demographics, hospital characteristics, complications, and outcomes were extracted. Respiratory malignancies included primary lung cancer, pleural malignancies, mesothelioma, and secondary lung cancers. Survey-weighted analyses compared baseline characteristics and complications by cancer status. Multivariable regression models assessed the association between respiratory cancer and in-hospital mortality, palliative care utilization, length of stay (LOS), and hospital charges. Results: A total of 3,773,741 ARF hospitalizations were identified (mean age 64.6 years, 50.7% female), of which 4.44% had an underlying respiratory malignancy. Compared with those without cancer, ARF patients with respiratory malignancy were more likely to be male, White, and treated at teaching hospitals (all p<0.001). Respiratory malignancy was associated with higher rates of pulmonary complications, including any respiratory pathology (5.17% vs 2.49%), pleural disease (17.54% vs 3.28%), pneumonitis (7.10% vs 4.33%), pneumothorax (11.50% vs 4.35%), and COPD (5.67% vs 3.69%) (all p<0.001). Infectious complications were also more frequent, including TB pneumonia (6.25% vs 4.44%), non-TB pneumonia (5.15% vs 3.99%), and sepsis (4.90% vs 4.31%) (all p<0.001). On multivariable regression analysis, respiratory malignancy was associated with higher in-hospital mortality (OR 1.56, 95% CI 1.53–1.59), greater palliative care utilization (OR 3.93, 95% CI 3.88–3.99), longer LOS (β 0.17 days, 95% CI 0.13–0.21), and lower hospital charges (β −$2,445, 95% CI −$3,159 to −$1,731) (all p<0.001). Conclusions: Among patients hospitalized with ARF, the presence of a respiratory malignancy identifies a high-risk subgroup characterized by increased respiratory and infectious complications, increased in-hospital mortality, greater palliative care utilization, and modest differences in resource utilization. These national data demonstrate the prognostic relevance of respiratory malignancy in ARF hospitalizations.
Variation in metastatic colorectal cancer (mCRC) patient survival among different oncology practice settings with guideline-concordant molecular testing.
e23082 Background: Molecular testing is paramount for treating patients (pts) with mCRC. Guidelines, including ASCO and NCCN, recommend testing for mismatch repair deficiency (dMMR)/microsatellite instability high (MSI-H), BRAF V600E mutation, RAS mutations, and HER2 amplification, as these molecular subtypes have profound therapeutic implications. This study evaluates molecular testing rates in a real-world cohort of pts with mCRC at an academic center, an academic affiliate site, and a community practice. Methods: In this retrospective study, a cohort of pts was obtained using COTA electronic health record data. The study included adults diagnosed with mCRC between January 1, 2022, and January 1, 2024, at Lombardi Comprehensive Cancer Center (LCCC), Non-Lombardi MedStar settings (NLM), and a nearby community oncology practice (COP). Data were extracted to review pt characteristics by age, sex, race, tumor location, comorbidity count, and vital status (alive/deceased), along with rates of guideline-recommended molecular testing (dMMR/MSI-H, BRAF V600E, RAS, and HER2). Results: 140 pts met the inclusion criteria. Pt characteristics were similar across settings. There was no statistically significant difference in adherence to guideline-recommended molecular testing across practice settings, with testing performed for dMMR/MSI-H in 93% of pts, RAS in 68%, BRAF in 64%, and HER2 in 54%. At last follow-up, mortality rates were 62%, 37%, and 32% at COP, LCCC, and NLM, respectively (p = 0.0096). Across all sites, the full panel of guideline-recommended molecular profiling occurred in 51% of pts. Conclusions: Community practices achieved molecular testing rates comparable to academic centers. However, testing was suboptimal across all settings, with only 51% of pts receiving full guideline-recommended molecular testing. Despite this, the community cohort had a higher mortality rate, which was statistically significant, and this implies that factors beyond pt characteristics and guideline-concordant testing play a role. Further studies are warranted to determine whether access to subspecialty care, multidisciplinary models, availability of clinical trials, or treatment sequence contributes to the observed disparity. mCRC Patient characteristics, guideline-recommended molecular testing and vital status. Characteristic LCCC (N=63) NLM (N=25) COP (N=52) P value Baseline characteristics Mean age, years 61 65 66 NS Age ≥50, % 60 80 83 NS Male, % 62 48 42 NS Non-Hispanic Black, % 46 44 48 NS No comorbidities, % 79 64 67 NS Guideline-recommended molecular testing RAS, % 61.9 68.0 73.1 0.444 BRAF V600E, % 55.6 64.0 73.1 0.151 MMR/MSI, % 90.5 96.0 92.3 0.847 HER2, % 49.2 52.0 59.6 0.530 Complete molecular testing panel, % 46.0 52.0 55.8 0.577 Vital status at last follow-up 0.0096 Alive, % 63.5 68.0 38.5 Deceased, % 36.5 32.0 61.5
Prognostic impact of comorbidity burden on overall survival in patients with Waldenström macroglobulinemia in the United States.
7083 Background: Waldenström macroglobulinemia (WM), also known as lymphoplasmacytic lymphoma (LPL), is a rare indolent Non-Hodgkin B-cell lymphoma affecting approximately 1500 patients annually in the US. Existing prognostic models: IPSS-WM, revised IPSS-WM, and MSS-WM focus primarily on disease specific factors including age, albumin, hemoglobin, platelet count, β2-microglobulin, LDH, and monoclonal IgM at diagnosis, and were derived from small cohorts. However, comorbidity burden is not included in these models, despite data showing that mortality is frequently attributed to comorbidities unrelated to lymphoma. We conducted this analysis to identify prognostic factors with emphasis on the impact of comorbidity burden on overall survival in WM. Methods: In this IRB approved retrospective study, we analyzed 17130 patients with histologically confirmed WM (ICD-O-3 9761/3) from the NCDB (2004–2023). Univariable and multivariable Cox regression identified independent prognostic factors for overall survival. Age stratified sub-analysis assessed the prognostic impact of comorbidity within each age group. Analyses were performed using SAS 9.4. Results: On multivariable Cox regression with backward elimination, Charlson comorbidity score (CC) ≥1 emerged as a significant independent predictor of mortality (HR 1.7 95% CI 1.58–1.75 p < 0.0001). Age-stratified analysis confirmed CC ≥1 significance in all age groups (HR 1.52-2.07, p<0.0001). Seven additional prognostic factors were identified: advanced age was associated with progressively worse survival (55≤age<65: HR 1.7; 65≤age<75: HR 2.3; age≥75: HR 5.5; all p<0.0001), while female sex was protective (HR 0.86; p<0.0001). Lower median household income was associated with worse outcomes (<$40,227: HR 1.38; $40,227–$50,353: HR 1.26; $50,354–$63,332: HR 1.1; all p<0.0001). Private insurance was associated with better OS compared with uninsured (HR 1.7; p<0.0001) and governmental insurance (HR 1.3; p<0.0001). Treatment at non-academic facilities (HR 1.13; p<0.0001) and multiple primary malignancies (HR 1.19; p<0.0001) were associated with inferior survival. No difference was observed between multi- and single-agent chemotherapy (HR 1.0; p=0.96), while patients not requiring chemotherapy had superior survival (HR 0.80; p<0.0001). Conclusions: In the largest WM cohort to date, we identified several prognostic factors impacting survival WM patients in the US. Among these factors, CC ≥1 was a strong independent predictor of mortality. Given that half of deaths in WM patients are due to comorbidities, comorbidity assessment is essential for accurate prognostication and individualized treatment planning. Managing comorbidities may be as important as treating the disease itself. CC or equivalent should be integrated into future prognostic models to improve clinical decision-making in WM.
Primary results of the phase 3 peak study of bezuclastinib + sunitinib vs sunitinib monotherapy in advanced gastrointestinal stromal tumors (GIST).
11500 Background: GIST, the most common mesenchymal malignancy of the gastrointestinal tract, is commonly driven by activating KIT mutations. Despite therapeutic advances, treating advanced GIST with KIT tyrosine kinase inhibitors (TKIs) remains challenging due to emergence of heterogeneous resistance mutations inadequately addressed by current approved therapies. Bezuclastinib, an oral, selective type 1 TKI, in combination with sunitinib, a type 2 TKI, inhibits common primary and secondary resistance mutations in advanced KIT -mutant GIST. The Peak study evaluated efficacy and safety of bezuclastinib + sunitinib vs standard second-line sunitinib monotherapy in patients with advanced GIST who received prior imatinib therapy. Methods: Peak was a multipart study: dose confirmation (Part 1a), 2 drug-drug interaction (DDI) assessments (Part 1b; DDI substudy), and a randomized phase 3 (Part 2; abstract focus). Patients were randomized 1:1 to bezuclastinib 600 mg once daily (QD) + sunitinib 37.5 mg QD (n=204) or sunitinib 37.5 mg QD (n=209). Primary endpoint was blinded independent central review (BICR)-assessed median progression-free survival (mPFS). Key secondary endpoints were objective response rate (ORR) per BICR and overall survival (OS). Crossover to combination was permitted at BICR-confirmed progression. Results: Patients (N=413) were randomized to either bezuclastinib + sunitinib or sunitinib monotherapy; median (range) age, 63 (30-88) years; 59.6% and 14.0% had activating KIT mutations in exons 11 only and 9 only, respectively. The combination significantly improved mPFS (HR, 0.50; 95% CI, 0.39-0.65; P<0.0001). mPFS was 16.5 months (95% CI, 13.8-19.2) for the combination vs 9.2 months (95% CI, 7.2-11.0) for monotherapy. ORR significantly improved with the combination vs monotherapy (46% vs 26%; risk difference, 20%; 95% CI, 10.6-28.6; P<0.0001). As of Sep 30, 2025, OS data remain immature. Incidence of adverse events (AEs) was similar between arms. Grade (Gr)≥3 AEs were comparable, with no significant increase in common sunitinib-associated AEs. Higher rates of Gr≥3 ALT/AST elevations and anemia were observed with the combination and were manageable with dose modification. ALT/AST elevations led to bezuclastinib dose reductions in 13.2% and discontinuations in 1.5% of patients in the combination arm; all Gr3 hepatic AEs resolved; no Gr4 events occurred. Additional treatment-emergent AEs leading to discontinuation of either drug in >1 patient in the combination arm were neutropenia (2.9%) and diarrhea (1%). No treatment-related AEs led to death in the combination arm. Conclusions: Combined KIT inhibition with bezuclastinib + sunitinib significantly improved mPFS vs sunitinib monotherapy, reducing the risk of progression or death by 50% and increasing ORR from 26% to 46%. The combination was well tolerated with no new safety findings. Clinical trial information: NCT05208047 .
Tumor methylation subtypes as a predictor of clinical outcome to immunotherapy in pleural mesothelioma patients from the NIBIT-EPI-MESO study.
8052 Background: Pleural mesothelioma (PM) is an aggressive malignancy with a poor prognosis. The clinicalefficacy of standard therapy with immune checkpoint inhibitors (ICI) is limited and heterogeneous acrossPM subtypes. Tumor-intrinsic characteristics (i.e., inflammatory phenotype, molecular features, DNAmethylation) may influence immune responsiveness, but predictive biomarkers of ICI therapy efficacy inPM are still lacking. Methods: NIBIT-EPI-MESO is a retrospective, multicenter study, sponsored by theNIBIT Foundation, evaluating biological correlates of clinical outcomes in PM patients (pts) treated withICI (i.e., anti-CTLA-4 plus anti-PD-1, anti-CTLA-4 plus anti-PD-L1, or anti-CTLA-4 monotherapy). Pre-ICI therapy FFPE tumor samples were analyzed by RRBS methylation (n = 83 pts) and RNA-seq (n = 82pts), with methylation subtypes defined by consensus clustering of the top 1% most variable CpGs.Tumor microenvironment (TME) was characterized by multiplex immunofluorescence analysis of CD4,CD8, CD20, CD68, CD163 (n = 35 pts). Integrated multi-omics analyses were used to associate tumorbiology with clinical outcome of PM pts. Results: Unsupervised methylation profiling identified four PMsubsets with increasingly global DNA methylation levels: demethylated (DEM), LOW, intermediate (INT),and CpG island methylator phenotype (CIMP). Methylation subtypes were significantly associated withresponse to ICI, with LOW/DEM enriched among responder (R) pts and INT/CIMP in non-R pts (p =0.002); no association of response to ICI was found with PM histotype (p = 0.33). The LOW subsetexhibited the longest median overall survival (mOS) and the highest 3-year OS rate, expressed genesinvolved in pathways associated with innate and adaptive immune responses, and showed an “inflamed”TME (i.e., CD8+ T cells, CD20+ B cells). Conversely, the CIMP subtype had the shortest mOS and OSrate, was characterized by genes enriched in developmental, morphogenetic and cell cycle-relatedprocesses, along with a “desert” TME. Functional characterization of the identified methylation classes ofPM was validated in the MESOMICS dataset. Accordingly, a PM methylation subtype classifier wasdeveloped to predict response to ICI therapy. Conclusions: Tumor DNA methylation defines biologicallyand clinically distinct immune phenotypes in PM and robustly predicts clinical response and long-termsurvival in ICI-treated PM patients, regardless of tumor histology.
Clinical characteristics, treatment patterns, and outcomes of patients aged ≥ 80 years with aggressive lymphomas: A real-world single-center experience.
e13772 Background: Population aging has led to a growing number of patients aged ≥80 years diagnosed with lymphoma. However, this clinically heterogeneous group remains underrepresented in real-world data on aggressive lymphomas, particularly in Latin America. Methods: We conducted a retrospective observational cohort study of patients aged ≥80 years at diagnosis with aggressive lymphomas treated at Fundación Santa Fe de Bogotá between 2015 and 2025. Overall survival (OS) and progression-free survival (PFS) were estimated using the Kaplan–Meier method. Results: A total of 33 patients aged ≥80 years were included. Mean age was 87 years (SD 3.8), and 54.5% were female. Functional status was largely preserved: 81.8% had an ECOG performance status of 0–1, and 85.2% were functionally independent; frailty was identified in 14.8% based on geriatric assessment. Diffuse large B-cell lymphoma (DLBCL) was the most frequent histology (60.6%), followed by transformed follicular lymphoma and grade 3B disease (18.2%). Advanced disease was common, with 37.5% presenting with Ann Arbor stage IV and 73.9% having an International Prognostic Index (IPI) ≥3. Systemic therapy was administered to 93.9% of patients, most commonly anti-CD20–based regimens (90.6%). First-line treatment consisted primarily of R-CHOP (41.9%) or R-mini-CHOP (29%). Overall, 79.3% received standard-intensity therapy and 20.7% attenuated-intensity regimens. First-line therapy was completed in 84% of patients. Dose reductions occurred in four patients. Nearly half of patients (45.5%) experienced no adverse events. Second-line therapy was administered in eight patients (25.8%), most commonly anti-CD20–based regimens (75%). Chronological age, functional dependence, frailty, and ECOG performance status were not associated with treatment receipt, treatment intensity, or discontinuation. After a median follow-up of 61.3 months, median OS and PFS were not reached, with no significant differences observed according to treatment intensity or ECOG status. Conclusions: Among patients aged ≥80 years with aggressive lymphomas, preserved functional status and low frailty were common. Systemic therapy, including standard-intensity regimens, was feasible and well tolerated in selected patients regardless of chronological age. These findings support treatment decisions guided by biological and functional assessment rather than age alone in octogenarian patients with aggressive lymphoma. Baseline clinical and geriatric characteristics of patients aged ≥80 years with aggressive lymphomas. Characteristics DLBCL (n=17) tFL (n=6) Frailty, n (%) 3 (17.6%) 0 (0%) Functionally independent 13 (92.8%) 5 (83.3%) Ann Arbor stage III 6 (31.58%) 3 (50%) Ann Arbor stage IV 6 (31.58%) 2 (33.3%) R-CHOP 9 (47.3%) 2 (40%) R-mini-CHOP 5 (26.3%) 1 (20%)
Outcomes of immune checkpoint inhibitor therapy in patients with pre-existing autoimmune disease: A propensity-matched real-world analysis of baseline corticosteroid use.
e23096 Background: Patients with pre-existing autoimmune disease are frequently excluded from immune checkpoint inhibitor (ICI) clinical trials due to concerns regarding immune-related toxicity and reduced efficacy, particularly in the setting of baseline immunosuppression. As a result, real-world evidence guiding the safety and outcomes of ICIs in this population remains limited. We evaluated clinical outcomes associated with baseline prednisone use among ICI-treated patients with autoimmune disease using a large, multi-institutional electronic health record database. Methods: We conducted a retrospective cohort study using the TriNetX Research Network, identifying adult patients with documented autoimmune disease who received immune checkpoint inhibitors. Patients were stratified based on baseline systemic prednisone exposure at the time of ICI initiation (any dose vs none). Propensity score matching (1:1) was performed to balance demographics, comorbidities, cancer characteristics, ECOG performance status, and key laboratory parameters. Outcomes were assessed after matching using Cox proportional hazards models and Kaplan-Meier survival analysis, excluding patients with outcomes occurring prior to the defined time window. The primary outcome was all-cause mortality. Secondary outcomes included emergency department (ED) visits, hospitalization, and sepsis. Results: After propensity score matching, 3,110 patients receiving baseline prednisone were matched to 3,110 patients without prednisone exposure. Median follow-up after matching was 412.5 days in the prednisone group and 310 days in the non-prednisone group. All-cause mortality occurred in 43.0% of patients receiving baseline prednisone compared with 41.7% in the non-prednisone group. Kaplan-Meier analysis demonstrated no statistically significant difference in overall survival between groups (median survival 914 vs 832 days; hazard ratio [HR] 0.93, 95% CI 0.86-1.00; log-rank p = 0.060). Baseline prednisone use was associated with a higher risk of hospitalization (34.9% vs 26.2%; HR 1.29, 95% CI 1.13-1.48; p < 0.001) and sepsis (16.2% vs 12.9%; HR 1.16, 95% CI 1.02-1.32; p = 0.042). Rates of emergency department visits were similar between groups. Conclusions: In this large real-world cohort of ICI-treated patients with pre-existing autoimmune disease, baseline prednisone use was not associated with a statistically significant increase in mortality, despite higher rates of hospitalization and sepsis. These findings may suggest that selected patients with autoimmune disease receiving baseline corticosteroids may still derive survival benefit from immune checkpoint inhibitors. Prospective studies are needed to define optimal immunosuppression strategies and dosing thresholds in this high-risk population.
Budget impact analysis of heated intraperitoneal chemotherapy at interval cytoreductive surgery for stage III high grade serous carcinoma of tubo-ovarian origin.
5589 Background: Heated Intraperitoneal Chemotherapy (HIPEC) at interval cytoreductive surgery (ICS) for high grade serous carcinoma of tubo-ovarian origin (HGSOC) improves overall survival (OS) by 11.6 months and increases platinum sensitivity at recurrence. Our aim was to estimate the payer budget impact of adopting HIPEC in BRCA wild-type patients at a quaternary Canadian center. Methods: A retrospective review was conducted of patients undergoing surgery for metastatic HGSOC at Vancouver General Hospital, Vancouver, Canada between January 1 and December 31, 2024. A payer-perspective Markov model was constructed with monthly cycles and a five-year horizon. Six cycles of carboplatin and paclitaxel were costed in the initial episode. Health states were progression-free (PF), first platinum-sensitive recurrence (PS1), second platinum-sensitive recurrence (PS2), platinum-resistant recurrence (PR), and death. PF progression hazards were derived from median PFS reported in randomized clinical trials. Post-progression mortality hazards were calibrated to match OVHIPEC-1 median overall survival. Direct medical costs were estimated in 2025 Canadian dollars using publicly available provincial drug pricing data in British Columbia and institution-specific costs for surgery, HIPEC, and inpatient care. Results: Annual volume of ICS patients was 98, of whom 25 were eligible for HIPEC and wtBRCA. Over 5 years, with 25 new patients entering annually, total costs were $9.05M without HIPEC versus $11.07M with HIPEC, yielding an incremental budget impact of $2.02M ($16,186 per patient). Incremental cost was driven by the surgical episode (+$1.90M), longer duration of maintenance niraparib (+$0.26M), and treatment of platinum-sensitive recurrence (+$0.15M) with carboplatin doublets. Incremental cost was partially offset by an estimated 11 fewer platinum-resistant recurrences within the 5-year horizon, resulting in cost savings of −$0.28M from reduced platinum-resistant treatment. Conclusions: Adding HIPEC at ICS to patients with stage III wtBRCA HGSOC increases 5-year payer spending by $2M for a 25 patient per year program. Additional cost is driven by provision of HIPEC surgery and postoperative care and is partially offset by near-term savings on platinum-resistant recurrence. Treatment cost across a 5-year horizon for 25 patients treated annually (n = 125). Category No HIPEC HIPEC Incremental Cost Incremental Cost Per Patient Surgery +/- HIPEC $2,085,500 $3,983,250 $1,897,750 $15,182 Initial chemotherapy $1,829,348 $1,829,348 $0.00 $0.00 Niraparib Maintenance $2,376,117 $2,638,599 $262,482 $2,100 Platinum Sensitive Recurrence $1,243,222 $1,389,325 $146,103 $1,169 Platinum Resistant Recurrence $1,515,639 $1,232,611 -$283,027 -$2,264 Total $9,049,824 $11,073,132 $2,023,308 $16,186
Association of GLP-1 receptor agonist use with overall survival in patients with colorectal cancer and type 2 diabetes: A multicenter real-world study.
e15556 Background: Colorectal cancer (CRC) is closely linked to obesity and type 2 diabetes mellitus (T2DM), conditions associated with worse oncologic outcomes. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) improve glycemic control, but their association with survival after CRC diagnosis remains unclear. We evaluated the association between GLP-1 RA exposure and overall survival (OS) in patients with CRC and T2DM. Methods: We performed a retrospective cohort study using the TriNetX research network (2010–2024). Adults (≥18 years) with incident CRC and T2DM were identified. Patients receiving GLP-1 RAs were compared with patients receiving other antidiabetic therapies, including metformin, insulin and insulin analogues, sodium–glucose cotransporter 2 (SGLT2) inhibitors, sulfonylureas, and dipeptidyl peptidase-4 (DPP-4) inhibitors. Propensity score matching (1:1) was performed using demographics, comorbidities, medications, cancer characteristics, and baseline laboratory values. Overall survival was assessed using Kaplan–Meier methods and Cox proportional hazards models. Results: After matching, 1,485 CRC patients remained in each group. In the matched cohort, the mean age was 67.7 years; 55% were male and 45% female. Most patients had colon cancer (77%), and the cohort was predominantly White (68%). Baseline metabolic profiles and comorbidities were well-balanced between groups (Table 1). Among non–GLP-1 RA users, the most common antidiabetic therapies included metformin (54%), followed by insulin or insulin analogues (35%), SGLT2 inhibitors (27%), sulfonylureas (22%), and DPP-4 inhibitors (7%). GLP-1 RA use was associated with improved overall survival. One-year OS was 92.7% in the GLP-1 RA group versus 90.2% in the non–GLP-1 group (log-rank p = 0.017; HR 0.73, 95% CI 0.56–0.95). At the longest duration of sufficient follow-up, 5-year OS was 78.6% versus 72.0%, respectively (log-rank p = 0.0003; HR 0.72, 95% CI 0.60–0.86). Conclusions: In this large multicenter real-world cohort of patients with colorectal cancer and type 2 diabetes, GLP-1 receptor agonist use was associated with significantly improved short- and long-term overall survival. These findings support further investigation of GLP-1 RAs as potential prognostic modifiers in colorectal cancer. Baseline characteristics (Matched Cohort). Characteristic GLP-1 RA (n=1,485) Non–GLP-1 Therapy (n=1,485) Demographics Age, mean ± SD (years) 67.7 ± 10.9 70.1 ± 11.1 Male sex, % 55.0 54.6 White, % 68.2 68.2 African American, % 15.1 14.0 Hispanic, % 9.8 9.2 Metabolic Profile Body mass index, mean ± SD (kg/m²) 33.7 ± 8.0 33.0 ± 7.7 Hemoglobin A1c, mean ± SD (%) 7.54 ± 1.78 7.33 ± 1.73 Comorbidities Hypertension, % 71.0 71.0 Cardiovascular disease, % 19.7 19.9 Chronic kidney disease, % 15.1 15.2 Chronic Liver disease, % 8.9 8.9 COPD, % 7.3 7.3
Pilot study of CTC enumeration and AR-V7 detection using a microporous chip filtration system in metastatic prostate cancer.
e17054 Background: Circulating tumor cells (CTC) are one of key components of liquid biopsy which provide phenotype and molecular information of prostate cancer (PCa). The androgen receptor splice variant 7 (AR-V7) has been implicated as a marker of resistance to androgen receptor pathway inhibitors (ARPI) in PCa. An automated high density microporous chip filtration system (Smart Biopsy Cytogen, Seoul, Korea) utilizes size-based physical separation, taking advantage of the relatively large size and rigidity of CTCs compared to leukocytes and erythrocytes. This study was conducted to evaluate CTC counts and AR-V7 detection from the blood of metastatic prostate cancer (mPCa) patients using Smart Biopsy. Methods: 20ml of Peripheral blood samples from 12 patients with mPCa and 5 healthy controls were collected. CTCs were isolated from 5ml of blood using Smart Biopsy. 15ml of blood was used for AR-V7 detection by droplet digital PCR (ddPCR). The patients were divided into an ARPI sensitive group and an ARPI refractory group to compare age, Gleason grade, time since metastasis, PSA, and CTC and ddPCR counts and follow-up PSA 6months after CTC analysis. Results: Median age of patient group and control group were 73.0 (range 58.0–85.0) and 43.5 (range 35.0–56.0; p < 0.001), respectively. Median follow up period after ARPI treatment was 25 months (range 1-144). The median CTC count was significantly higher in mPCa patients compared to controls (18 vs 1; p = 0.003). Median time since metastasis was significantly longer in the refractory group (32 months vs 6 months, p = 0.022) (Table). Although baseline PSA levels showed no significant difference, follow-up PSA was markedly higher in the refractory group (156 ng/mL vs 0.64 ng/mL, p = 0.017). CTC counts and ddPCR levels showed no significant intergroup differences, but patients with CTC ≥ 10 were more frequent in the refractory cohort (100% vs 33.3%; p = 0.046). Conclusions: This pilot study demonstrates the feasibility of using a microporous chip–based system for the isolation and molecular analysis of CTCs in patients with metastatic prostate cancer. The system effectively distinguished mPCa patients from healthy controls and showed significant correlation with ARPI resistance. These findings suggest that Smart Biopsymay serve as a promising, non-invasive tool to guide ARPI treatment strategies in mPCa. Comparison of molecular characteristics of patients with mPCa according to ARPI response status. Variable ARPI effective (n=3) ARPI refractory (n=9) p-value Age (years) 73.0 (63.0–85.0) 78.0 (58.0–81.0) 0.926 Gleason grade 0.250 3 1 (33.3%) 0 4 2 (66.6%) 4 (44.4) 5 0 5 (55.6) Time since metastasis (mo) 6 (3 – 6) 32 (12 – 144) 0.022 PSA (ng/mL) 742.0 (451.4–1460.0) 161.0 (0.7–900.0) 0.064 CTC/5mL 9 (8 –90) 40 (10–926) 0.2664 CTC≧10 (n) 1 (33.3%) 9 (100%) 0.0455 ddPCR 1.5 (0 – 6) 2 (0 - 24) 0.6404 F/U PSA (ng/mL) 0.64 (0.01 – 1.18) 156 (2.97 – 653.0) 0.017
Effects of SECN-15, a neuropilin-1–targeting antisense oligonucleotide, on resistance to immune checkpoint inhibitors in preclinical tumor models.
2613 Background: Neuropilin-1 (NRP1) is a transmembrane co-receptor implicated in tumor growth, metastasis, angiogenesis, and immune suppression. High NRP1 expression is associated with poor prognosis in multiple solid tumors, including gastric cancer (GC) and breast cancer. SECN-15 is a high-affinity antisense oligonucleotide (ASO) designed to selectively downregulate NRP1. In light of recent clinical success of combined PD-1/PD-L1 and anti-angiogenic strategies and given its dual role in angiogenesis and immune suppression, NRP1 represents an attractive target to overcome resistance to immune checkpoint inhibition. Methods: NRP1-specific ASOs were identified using the OligoCreator platform. Anti-tumor efficacy was assessed following systemic administration in multiple syngeneic mouse tumor models, both as monotherapy and in combination with immune checkpoint inhibitors. Target engagement was evaluated at the RNA level in tissues and at the protein level in plasma via soluble NRP1 quantification. In silico analyses of patient transcriptomic datasets were conducted to prioritize indications for clinical development. PK/PD characterization and dose optimization studies are currently underway to support dose selection for GLP toxicology studies and first-in-human evaluation. Results: Systemic administration of SECN-15 achieved robust target knockdown in tumors across multiple cell populations and modulated the tumor microenvironment, including downregulation of extracellular matrix and EMT genes. A single dose resulted in near-complete and sustained suppression of plasma soluble NRP1 levels for up to 28 days, consistent with durable target engagement. SECN-15 delayed tumor growth as monotherapy, with complete regressions observed in a subset of animals, and significantly enhanced anti-tumor activity in combination with immune checkpoint inhibitors in models with limited responsiveness to checkpoint blockade alone. Single-cell RNA-seq analyses from gastric cancer patients identified endothelial cells and macrophages as major NRP1-expressing populations, with NRP1high subsets exhibiting TGF-β, hypoxia, and EMT pathway activation and suppression of allograft rejection signatures, consistent with an immunosuppressive, pro-angiogenic tumor microenvironment. In silico analyses showed that high NRP1 expression correlates with poor survival and advanced disease stage in gastric cancer, supporting its prioritization for clinical development. Conclusions: Targeting Neuropilin-1 with the ASO SECN-15 remodels the tumor microenvironment and enhances responsiveness to immune checkpoint blockade, supporting NRP1 inhibition as a strategy to overcome resistance to ICI therapy in solid tumors. The program is approaching IND-enabling development to support the clinical translation of SECN-15.
Comparative assessment of skin toxicity in prone vs supine positions during preoperative breast radiotherapy: A systematic review and meta-analysis.
e24148 Background: Skin toxicity remains one of the most common side effects of breast radiotherapy and can meaningfully affect patient comfort and treatment tolerance. Prone positioning has been proposed as a way to reduce skin dose, but results across studies have been inconsistent. We conducted a systematic review and meta-analysis to better define how patient positioning influences acute and late skin toxicity during preoperative whole-breast radiotherapy. Methods: We searched PubMed, Embase, and Scopus for studies comparing prone and supine positioning during preoperative whole-breast radiotherapy. Nine studies met inclusion criteria after screening 132 records. Outcomes of interest included moist desquamation, acute skin toxicity by grade, pain, and fibrosis. Pooled risk ratios (RRs) with 95% confidence intervals (CI) were calculated using random-effects models, and heterogeneity was assessed with I² statistics. Results: Across three studies including 834 patients, prone positioning was associated with a significantly lower risk of moist desquamation compared with supine treatment (RR:0.48, CI:0.26–0.88; p=0.02), with moderate heterogeneity (I²=49%). Although the magnitude of benefit varied, the overall direction of effect consistently favored prone positioning. For more severe acute skin reactions (Grade ≥ 2 dermatitis or erythema), prone positioning showed a trend towards benefit, but results were mixed and did not reach statistical significance. Patients treated prone also experienced slightly less acute pain, with a borderline significant reduction in Grade ≥1 pain and highly consistent findings across studies. For higher-grade erythema or dermatitis, no statistically significant differences were observed between positions, although absolute event rates were generally higher in the supine group. In contrast, prone positioning showed a tendency toward more mild (Grade 1) erythema, suggesting that toxicity may shift toward lower severity rather than being eliminated altogether. Analyses combining broader toxicity categories showed no clear differences, but interpretation was limited by heterogeneity. Importantly, late toxicity outcomes were reassuring. Across three studies, the risk of fibrosis was similar between prone and supine positioning, with highly consistent findings. Conclusions: Prone positioning during preoperative breast radiotherapy is associated with fewer clinically significant skin reactions, particularly moist desquamation, and may reduce treatment-related pain without increasing late toxicity. While mild skin changes may be more common, overall toxicity severity appears lower. These findings support the selective use of prone positioning to improve patient comfort and skin tolerance during breast radiotherapy.
First-line carboplatin-paclitaxel (CP) for metastatic anal squamous cell carcinoma (ASCC): An analysis of dosing schedules.
e15501 Background: CP is the backbone of first-line therapy for recurrent or metastatic ASCC. In practice, Q3-week CP has been explored as a potential alternative to the standard (d1,8,15 Q28-day cycle) dosing, though its efficacy is not known. This study evaluated CP scheduling and clinical survival associations in metastatic ASCC. Methods: This multicenter retrospective cohort study included patients with metastatic ASCC treated with first-line CP, identified using the Mayo Data Explorer database. Electronic health records were reviewed to collect baseline clinical characteristics, treatment regimens, responses, progression-free survival (PFS), and overall survival (OS). Descriptive statistics were used to summarize patient demographics. Survival was estimated using Kaplan–Meier methods. Multivariable Cox proportional hazards models were used to compare survival by dosing schedule, adjusting for age, ECOG performance status, HPV (p16) status, liver metastasis, and prior chemoradiation. Results: 54 patients treated between 2020-2025 with first-line CP for metastatic ASCC were included. Baseline patient demographics were balanced between dosing groups (Table 1). Median follow-up time was 26.2 months. For Q3-week CP (n = 21), median PFS and OS were 9.8 (95% CI 8.1, NR) and 27.0 (95% CI 15.7, NR) months, respectively, while median PFS was 6.5 (95% CI 4.5,15.3) months with standard CP (n = 33) and median OS was not reached (95% CI 11.2, NR). Response rate was 76% with Q3-week and 60.6% with standard CP (p = 0.23) dosing. Survival outcomes were similar when comparing Q3-week CP relative to standard CP dosing using multivariable analysis (PFS HR 0.68, 95% CI 0.33–1.41; OS HR 1.67, 95% CI 0.67–4.14). Higher ECOG and liver metastasis were independently associated with inferior outcomes, while HPV was associated with improved survival. Subsequent therapy patterns were similar between CP schedule groups. Ten patients (16.9%) received local therapy, and 24 of 28 patients with progression received further systemic therapy, including 21 (87.5%) treated with immunotherapy. Conclusions: Survival outcomes were similar across dosing schedules, suggesting Q3-week CP may be a reasonable alternative to standard CP, with potential to reduce treatment-related burden in metastatic ASCC. Future analysis will compare toxicity profiles between CP dosing schedules, including in combination with PD1 inhibitors given the results of the POD1UM-303 trial. Patient demographics (n=54). Variable Q3-week CP (n=21) Standard CP (n=33) p-value Sex Female 16 (76.2%) 24 (72.7%) 0.77 Male 5 (23.8%) 9 (27.3%) Age Median (Q1, Q3) 62 (50.5, 69) 64 (55.5, 70) 0.57 BMI Median (Q1, Q3) 27.1 (21.9, 34.4) 27.4 (22.5, 31.7) 0.72 ECOG 0 9 (42.9%) 11 (34.4%) 0.53 ≥ 1 12 (57.1%) 21 (65.6%) Confirmed HPV (p16) Positive 16 (76.2%) 24 (72.7%) 0.77 Prior chemoradiation Yes 17 (81.0%) 21 (63.6%) 0.17
Real-world cardiotoxicity with HER2 antibody–drug conjugates and survival after treatment continuation.
1057 Background: HER2 antibody–drug conjugates (ADCs) are central to HER2-positive breast cancer (BC) treatment, yet cardiotoxicity remains a clinically relevant complication that may prompt treatment interruption. While HER2-related cardiac dysfunction is frequently reversible, uncertainty persists regarding the safety and survival impact of treatment continuation, particularly with newer ADCs. We assessed real-world cardiotoxicity and the association between treatment continuation and overall survival (OS), focusing on trastuzumab deruxtecan (T-DXd) and trastuzumab emtansine (T-DM1). Methods: Using the TriNetX Research Network (2010–2025), adults with BC treated with HER2-targeted therapy and no prior diagnosis of heart failure or cardiomyopathy were identified. Incident cardiotoxicity (heart failure or cardiomyopathy) within one year of therapy initiation was captured. OS from cardiotoxicity diagnosis was compared between patients (Pts) who resumed versus discontinued HER2-targeted therapy. Kaplan–Meier methods were used to estimate survival, and Cox proportional hazards models generated hazard ratios (HRs) with 95% confidence intervals (CIs). Results: Among 31,656 HER2-treated Pts, 4,593 (14.5%) developed cardiotoxicity within one year; 629 (11.1%) occurred with HER2 ADCs. Incidence was lower with ADCs than non-ADC therapy (T-DM1 11.6%, T-DXd 9.9%). After cardiotoxicity, 3,374 Pts (73.5%) resumed HER2 therapy, including 48.5% with T-DM1 and 47.7% with T-DXd. 5-year OS was significantly higher with HER2-targeted treatment resumption versus discontinuation (79.5% vs 66.9%; absolute difference 12.6%; p<0.0001), with a 55% mortality risk reduction (HR 0.45, 95% CI 0.39–0.51). ADC-specific analyses showed benefit, greatest for T-DXd (HR 0.25, 95% CI 0.14–0.43; absolute 5-year OS difference 19.3%) and T-DM1 (HR 0.34, 95% CI 0.23–0.50; absolute difference 21.0%). Pts who resumed therapy were younger than those who discontinued (58.0±13.1 vs 61.8±13.5 years). After multivariable adjustment, treatment resumption remained independently associated with improved OS (adjusted HR 0.45, 95% CI 0.39–0.51), though residual confounding cannot be excluded. Conclusions: In this large real-world cohort, continuation of HER2 ADCs after cardiotoxicity was associated with substantially improved OS. These findings support a multidisciplinary cardio-oncology approach and suggest that, when feasible, resuming HER2 ADCs—particularly T-DXd and T-DM1—may confer meaningful survival benefit. Cardiotoxicity and survival outcomes with HER2/ADCs. Agent Total Treated (N) Cardiotoxicity (%) Therapy Resumed (%) 5-year OS % (Resumed vs Not) Absolute OS Difference HR (95% CI) All HER2 31,656 14.5 73.5 79.5 vs 66.9 +12.6% 0.44(0.39-0.51) T-DM1 4,085 11.6 48.5 74.9 vs 53.9 +21.0% 0.34(0.23-0.50) T-DXd 1,558 9.9 47.7 48.0 vs 28.7 +19.3% 0.25(0.14–0.43)
ELEVATE: Empowered social media coaching for oncologists.
e21016 Background: Oncologists interested in building a social media presence often lack the training and tools to do so. The ELEVATE social media program offered individual coaching to oncologists to help them build their social media platforms with the support of their institution. Methods: A 1-on-1 social media coaching program was developed and made available to all oncologists at the institution. ELEVATE stands for: E– Establish a trusted professional presence, L– Lead with expertise, E– Engage meaningfully, V– Validate science through accessible content, A– Advocate, T– Transform online presence into real-world impact, E– Empower patients and colleagues. A system-wide email invited applicants. Once accepted, they received a worksheet to outline social media strategy and interests. Intake included a formal review of participants’ social media use and goals. The coaching sessions imparted knowledge, skills, and a plan of action to create and grow their online presence across various platforms, including X, LinkedIn, Facebook, Instagram, and TikTok. A post-program anonymous quality improvement survey was shared with participants. Results: Twenty-nine individuals expressed interest in the program. Twenty-three joined and were scheduled for one-on-one coaching. Sessions varied from 1 to 3 monthly sessions. Survey response rate was 61% (14/23). On a 1–5-point scale from “very dissatisfied” (1) to “very satisfied” (5), 100% reported a 4 or 5 in response to both questions “Overall, how satisfied were you with the coaching?” and “How would you rate the quality of the coaching?” In response to the question “Receiving coaching regarding which topics was most valuable to you?” responses included: 57% “starting a new professional social media platform,” 57% “professional development and networking,” 43% “content strategy and planning” (Table 1). In response to the question “After participating in the coaching program, I feel MORE confident managing my presence online,” 93% reported a 4 or 5, and 93% would “likely recommend the coaching program to their colleagues.” Conclusions: Overall, participation in the coaching program was high and satisfaction was uniformly strong, with all respondents rating the experience and coaching quality as very good or excellent. Expansion of the program is needed to understand its full impact. "Receiving coaching regarding which topics was most valuable to you?" Percentage (%) Starting a new professional social media platform 57.1 Expanding my already-existing social media platform 50.0 Content strategy and planning 42.9 Platform-specific tips 14.3 Audience engagement and growth 21.4 Professional development and networking 57.1
Immune checkpoint inhibition for advanced cutaneous squamous cell carcinoma in patients with concomitant chronic lymphocytic leukemia: Integrated single-center and national Cosmos analyses.
e21565 Background: Patients with chronic lymphocytic leukemia (CLL) have immune dysregulation and increased risk of aggressive cutaneous squamous cell carcinoma (cuSCC), yet prospective ICI trials largely excluded this population. We combined detailed single-center chart review with a national real-world dataset to characterize safety, hematologic trajectory, imaging patterns, and overall survival (OS) with PD-1 blockade in cuSCC with concomitant CLL. Methods: We combined a single-center retrospective chart review (2017-2025) of adults with CLL and advanced cuSCC treated with PD-1 blockade and a national Cosmos EHR cohort of ICI-treated cuSCC (2017-2025) comparing patients with vs without CLL comorbidity. Patients with other cancer types were excluded. Primary endpoint was overall survival (OS) from ICI start. Within the Cosmos dataset, propensity matching on age and sex and COX regression were used. Data used in this study came from and is available through Epic Cosmos, a dataset created in collaboration with a community of health systems using Epic representing more than 300 million patient records from over 1,800 hospitals and 40,000 clinics as of December 2025. Within the single-center cohort we also looked at longitudinal CBCs, irAEs, CLL treatment initiation, and FDG-PET/CT patterns. Results: In Cosmos, 10,540 ICI-treated cuSCC patients were identified; 226 (2.1%) had CLL comorbidity. CLL patients were older (mean 80.20 vs 71.88 years) and more often male (85.0% vs 70.9%). ICI selection differed (Cemiplimab 45.1% with CLL vs 21.3% without; pembrolizumab 54.9% vs 78.7%). Unadjusted mortality was 46.9% with CLL vs 44.0% without (p = 0.417). In an age/sex propensity-matched sample (n = 452), OS was similar between groups (Cox HR 1.06, 95% CI 0.80–1.39; p = 0.696). In the single-center cohort (n = 10; median age 80.5), any irAE occurred in 5/10, including 2 grade ≥3 events, with no treatment-related deaths. Longitudinal CBCs and hematologic Rai groupings were generally stable without a consistent pattern suggestive of leukemic acceleration; 3/10 initiated CLL-directed therapy after ICI. FDG-PET/CT (9/10) typically showed intensely FDG-avid cuSCC lesions with lower-grade uptake in background CLL adenopathy, though occasional SUV overlap required clinicopathologic correlation. Conclusions: This integrated analysis provides, to our knowledge, the largest description of ICI-treated advanced cuSCC in patients with concomitant CLL. In a national real-world cohort, concomitant CLL was not associated with inferior OS after age/sex matching. Single-center demographics mirrored the national cohort (older, predominantly male), supporting generalizability of the detailed toxicity, hematologic, and imaging findings while emphasizing biopsy when SUVs overlap.
Outcomes of inferior vena cava filters in breast cancer patients with DVT: National Inpatient Sample–based comparative analysis.
e12763 Background: Venous thromboembolism (VTE), including deep vein thrombosis (DVT), is a frequent complication of breast cancer and contributes to substantial morbidity and mortality. Inferior vena cava (IVC) filters are often used when anticoagulation is contraindicated; however, their impact on bleeding and mortality in breast cancer-associated DVT remains unclear. We evaluated the association between IVC filter placement and in-hospital outcomes in hospitalized breast cancer patients with DVT. Methods: We conducted a retrospective cohort study using the National Inpatient Sample (NIS) database. Adult patients hospitalized with breast cancer and DVT (N = 55,480) were stratified by IVC filter placement. Baseline characteristics, bleeding events (identified using ICD diagnosis and procedure codes), and in-hospital mortality were compared using descriptive statistics and multivariable logistic regression. Odds ratios (ORs), standard errors, 95% confidence intervals (CIs), and p-values are used to assess statistical significance. Results: IVC filters were placed in 1,220 patients (2.2%). Patients receiving filters were slightly younger (63.5 vs 65.1 years) with similar sex and racial distributions- White (61.9% vs 62.6%), African American (27.3% vs 22.8%). Patients were predominantly female (98.4% vs 98.5%, p = 0.88). No differences existed by hospital size, teaching status, or income quartile. Comorbidity burden and hospital characteristics were comparable between groups. Bleeding risk showed no statistical difference: gastrointestinal bleed (3.7% vs 2.7%, p = 0.35), intracranial hemorrhage (1.2% vs 2.0%, p = 0.40), major bleeding (0.4% vs 0.5%, p = 0.88), and procedure-related bleeding (1.6% vs 2.0%, p = 0.68). Overall in-hospital mortality was 8.8%, with no significant difference by IVC filter status (p > 0.05). Factors independently associated with increased mortality included age (OR 1.02, p = 0.031), sepsis (OR 4.38, p < 0.001), higher Charlson Comorbidity Index (global p < 0.001), intracranial hemorrhage (OR 2.84, p < 0.001), gastrointestinal bleeding (OR 1.64, p = 0.005), and pulmonary bleeding (OR 1.63, p = 0.015). Hormonal therapy (OR 0.46, p < 0.001) and obesity (OR 0.60, p < 0.001) were associated with lower mortality. Conclusions: In hospitalized breast cancer patients with DVT, IVC filter placement was not associated with increased in-hospital mortality or bleeding. Mortality was driven primarily by age, comorbidity burden, infection, and bleeding complications. These findings suggest that IVC filters may be used selectively in breast cancer patients with contraindications to anticoagulation without worsening short-term outcomes, while highlighting the importance of optimizing comorbidity and infection management.
(RW) post-progression outcomes after first-line (1L) treatment with ribociclib + an aromatase inhibitor (AI) vs AI alone in US patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2–) metastatic breast cancer (MBC).
e13044 Background: Ribociclib remains the only cyclin-dependent kinase 4/6 inhibitor to consistently demonstrate overall survival (OS) benefits in the MBC setting, with statistically significant and clinically meaningful OS results reported in all three MONALEESA studies in HR+/HER2− MBC. However, because of the short follow-up period observed among RW patients treated with ribociclib, comprehensive evaluation of OS remains limited. Hence, RW progression-free survival 2 (rwPFS2) and chemotherapy-free survival (rwCFS) can serve as reliable post-progression endpoints. Methods: This retrospective study utilized deidentified electronic health record–derived data from the Flatiron Health Research Database: 5,649 US female patients (including 3,466 patients ≥65 years of age) with HR+/HER2− MBC who initiated 1L ribociclib in combination with an AI or AI monotherapy between January 1, 2020 and January 31, 2025 with follow-up through July 31, 2025. Analyses of rwPFS2 (time from start of 1L to first disease progression during 2L, or death during 1L or 2L, whichever occurred first) and rwCFS were performed using unadjusted and adjusted time-to-event methods, including the Kaplan-Meier method and Cox proportional hazards regression. To account for differences in baseline characteristics, inverse probability of treatment weighting with stabilized weights was used (sIPTW). Key patient demographics and clinical characteristics were used for adjustment; details to be provided in the full presentation. Results: After sIPTW, median rwPFS2 was extended by 14.1 months with ribociclib plus AI compared with AI monotherapy (hazard ratio [HR], 0.58 [0.52–0.65]) in the overall cohort. Among patients aged ≥65 years, the extension was 16.7 months (HR, 0.58 [0.49–0.68]). Moreover, median rwCFS improved by 12.5 months with ribociclib plus AI vs AI alone in the overall cohort (HR, 0.64 [0.57–0.72]) and by 13.3 months in those aged ≥65 years (HR, 0.60 [0.51–0.71]). Conclusions: These RW findings augment clinical trial results, reinforcing that ribociclib provides consistent and substantial post-progression survival benefits in patients with HR+/HER2− MBC, including patients aged ≥ 65 years.