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Shifting burden of cardiomyopathy deaths among United States cancer patients: A 25-year CDC WONDER analysis.
e24009 Background: Cardiomyopathies (CM) are increasingly recognized among patients with cancer. They may develop due to the direct effects of the tumor, side effects of cancer treatments, or other underlying health conditions. These disorders can cause heart failure, abnormal heart rhythms, and impact overall well-being. Recognizing and managing cardiomyopathies in cancer patients is crucial for improving treatment outcomes and survival. Methods: We analyzed CDC WONDER data to estimate age-adjusted mortality rates (AAMRs) for cancer (ICD-10: C00-D48) among adults aged ≥25 years with cardiomyopathies (ICD-10 I42.0 to I42.9). AAMRs were calculated per 100,000 population. Temporal trends and average annual percent changes (AAPCs) were assessed using Joinpoint regression, stratified by sex, race/ethnicity, and geographic factors, including urbanization and U.S. census region. Results: A total of 58,583 deaths related to CM among cancer patients were identified, with most deaths occurring in medical facility inpatient settings. Overall, the AAMR declined from 1.21 in 1999 to 0.97 in 2023 (AAPC: −0.87; 95% CI: −1.25 to −0.49). A modest decline was observed between 1999 and 2008 (APC: −0.65), followed by a more pronounced decrease through 2016 (APC: −3.31). However, mortality rates showed significant increase from 2016 through 2023 (APC: 1.69; 95% CI: 0.83 to 2.56). The decline in mortality was more pronounced among men than women (AAPC: −1.46 vs. −0.54). Among racial and ethnic groups, the highest mortality burden was observed in Non-Hispanic Black individuals (AAPC: −2.17%), while the lowest decline was noted among Hispanic or Latino individuals (AAPC: −1.80%). Geographic disparities were evident, with the Midwest experiencing the greatest mortality burden (AAPC: −0.54%), whereas the West showed the least impact (AAPC: −1.33%). Non- metropolitan areas consistently showed higher AAMRs than metropolitan areas, although metropolitan regions experienced a slightly steeper decline over time (AAPC: −1.36 vs. −1.15). Conclusions: CM remains a significant cause of death among patients with cancer, with higher burden observed in men, non-Hispanic Black individuals, and those living in the Midwest. Although mortality rates declined overall, a recent increase was noted, which highlight the need for focused cardio-oncology care and targeted prevention strategies for high-risk populations. Deaths and Average Annual Percentage Change (AAPC) per 100,000 population for Cardiomyopathy and cancer trends, 1999-2023. Variable Deaths AAPC (95%CI) Overall 58,583 -0.87 (-.25 to 1.75) Male 35,243 -1.46 (-2.41 to -0.50) Female 23,340 -0.53 (-1.04 to -0.02) NH Blacks 8,048 -2.17 (-2.58 to -1.77) Hispanic 2,576 -1.80 (-2 50 to -1.11) Midwest 15,176 -0.54 (-1.37 to 0.29) West 11,309 -1.33 (-1.75 to -0.91) Metropolitan 41,531 -1.36 areas (-2.05 to -0.72) Non- Metropolitan areas 9,006 -1.55 (-1.66 to -0.64)
Bronchoscopic pulsed electric field ablation for locally advanced and metastatic NSCLC: A six-patient real-world experience from a rural community hospital.
e23399 Background: ALIYA pulsed electric field (PEF) ablation is a bronchoscopic, non-thermal local therapy designed to induce immunogenic tumor cell death while preserving stromal architecture. Real-world data from rural or non-tertiary settings remain limited. We describe feasibility, safety, and early outcomes following bronchoscopic ALIYA PEF in locally advanced or metastatic NSCLC treated in a rural community oncology program at Guthrie Clinic Sayre PA. Methods: We retrospectively reviewed all patients with NSCLC who underwent bronchoscopic ALIYA PEF between 03/2025 and 07/2025. Clinical characteristics, procedural details, treatment sequencing, radiographic response (RECIST v1.1), and adverse events (CTCAE v5.0) were abstracted from the medical record. Results: Six patients (median age 66.5 years; range 42–70) underwent PEF without procedural interruption or acute complications. Histology was adenocarcinoma in four patients and squamous cell carcinoma in two. PEF was performed upfront prior to chemoradiation/systemic therapy (n = 2) or at locoregional/metastatic recurrence (n = 4). Two patients underwent PEF during active immunotherapy, and 5/6 received immunotherapy during their treatment course. No pneumothorax, arrhythmia, hemodynamic instability, airway compromise, or PEF-related grade ≥3 toxicity occurred within 30 days. All patients initiated or continued systemic therapy without delay attributable to PEF. The best RECIST response was PR in 2 patients, SD in 1, and PD in 3. In-field control was maintained in 5/6 patients (83%), with one in-field recurrence and predominantly distant progression. Median time to progression (TTP; from PEF to first radiographic or clinical progression) was 7.5 months. At a median follow-up of 11.2 months (range 4.4–19), all patients were alive and receiving systemic therapy at last follow-up. No immune-related adverse events were clinically attributed to PEF. Conclusions: Bronchoscopic ALIYA PEF was technically feasible and well tolerated in a rural community oncology program, with no PEF-related grade ≥3 toxicity or systemic therapy delays. In-field control was maintained in most patients. These results support prospective evaluation of PEF as an adjunct to standard chemoradiation and immunotherapy strategies in NSCLC.
STING agonist JMKX000197 infusion in patients with malignant pleural effusion: Preliminary results from a prospective phase Ib study.
2598 Background: Indwelling pleural catheter (IPC) is frequently used for symptomatic malignant pleural effusion (MPE), its therapeutic benefits remain limited. JMKX000197 is a novel small molecule stimulator of interferon genes (STING) agonist that activates STING to induce type I interferons and pro-inflammatory cytokines and may have a promising clinical prospect for the treatment of MPE. Methods: Eligible patients had advanced solid tumors with moderate-to-large MPE and had progressed on systemic therapy or had poorly controlled effusion. Patients were randomized assigned in a 1:1:1 ratio to receive intrapleural infusions of JMKX000197 (150 μg or 300 μg) combined with IPC or IPC alone (control) on day 1 and day 8. Here, we report safety, tolerability, preliminary efficacy, and PK/PD characteristics from the phase Ib study of JMKX000197 (NCT06740019). Results: As of October 15, 2025, 35 patients were enrolled (45.7% female, median age 59 years, 71.4% with lung adenocarcinoma). 2 patients withdrew from the study without receiving any treatment after randomization, thus, the safety and efficacy analysis was based on 33 patients who received treatment. Among 33 patients, 1 patient in the 300 μg group withdrew the informed consent after one dose while 32 patients (97%) completed the two-dose regimen (11 in 150 μg group [N=11], 9 in 300 μg group [N=10], and 12 in control group [N=12]). Treatment-emergent adverse events (TEAEs) occurred in 100%, 90%, and 83.3% of patients in the 150 μg, 300 μg, and control groups, respectively. Grade ≥3 TEAEs occurred in 3(27.3%), 1 (10%) and 1 (8.3%) patients in each group. 2 patients in 150 μg group and 5 patients in 300 μg group experienced grade 1–2 cytokine release syndrome (CRS), which were adverse event of special interest, all resolved with supportive care. No TEAE led to treatment discontinuation or death. Puncture-free survival (PuFS) was defined as the period from the removal of the IPC immediately after the last dose of treatment to the next therapeutic puncture and/or drainage or death, whichever occurs first. The median PuFS was 37 days, 116 days, and 56 days in the 150 μg, 300 μg, and control groups, respectively. Limited exposure of JMKX000197 in plasma was observed (>700 fold lower than that in pleural effusion). PD analysis showed significant elevation of IFN-β in both plasma and pleural effusion (higher in pleural effusion), along with increased TNF-α, IP-10, MCP-1, and IL-6. Immunophenotyping demonstrated enhanced CD8+ T-cell activation and reduced Treg cell proportions post-treatment (both in peripheral blood and pleural effusion). Conclusions: Intrapleural JMKX000197 exhibited a manageable safety profile and promising preliminary efficacy in MPE patients, with a better efficacy at the 300 μg dose. JMKX000197 may induce the production of pro-inflammatory cytokines and subsequently activate the tumor microenvironment. Clinical trial information: NCT06740019 .
Reduced-intensity versus intensive induction in high-risk acute promyelocytic leukemia: A systematic review and meta-analysis.
e18521 Background: High-risk acute promyelocytic leukemia (APL), defined by WBC >10×10⁹/L, accounts for 20-30% of cases with increased early mortality. While all-trans retinoic acid (ATRA) + arsenic trioxide (ATO) is standard for standard-risk APL, optimal induction for high-risk disease remains debated. Reduced-intensity regimens combining ATRA+ATO with gemtuzumab ozogamicin (GO) or low-dose anthracycline have emerged as alternatives to intensive chemotherapy. We compared outcomes between these approaches. Methods: Following PRISMA guidelines, we systematically searched PubMed, EMBASE, and Cochrane Library from 2000–2025 (PROSPERO CRD420261293473). We included randomized controlled trials and observational studies reporting high-risk APL outcomes. Reduced-intensity regimens were defined as ATRA+ATO combined with gemtuzumab ozogamicin (GO), low-dose anthracycline (1–2 doses), or hydroxyurea. Intensive regimens consisted of ATRA-based therapy with ≥3 anthracycline doses. Risk of bias was assessed using RoB 2 for RCTs and ROBINS-I for observational studies. Primary endpoints were complete remission (CR) and early mortality (EM); secondary endpoints included event-free survival (EFS) and relapse. We pooled arm-level outcomes using random-effects meta-analysis with logit transformation for proportions and inverse-variance method for hazard ratios, with restricted maximum-likelihood (REML) estimation. Results: Seventeen studies comprising 25 treatment arms (1,234 patients) were included: 11 reduced-intensity arms (360 patients) and 14 intensive arms (874 patients). For CR (17 arms, 840 patients), pooled rates were 92.3% (95% CI 85.9–95.9%; I²=0%) with reduced-intensity versus 89.3% (82.6–93.6%; I²=56%) with intensive therapy (p=0.35). Early mortality (19 arms, 936 patients) was numerically lower with reduced-intensity: 8.8% (4.7–15.9%; I²=37%) versus 10.4% (6.8–15.5%; I²=45%; p=0.62). Pooled hazard ratio for EFS from two RCTs was 0.23 (95% CI 0.07–0.75, p=0.02), representing a 77% reduction in EFS events favoring reduced-intensity therapy. Relapse rates (17 arms, 836 patients) were 3.9% (1.5–9.6%) for reduced-intensity versus 5.5% (2.7–10.7%) for intensive regimens (p=0.49). In prespecified exploratory WBC-stratified analysis (11 arms, 569 patients), reduced-intensity regimens maintained stable CR across WBC strata (91.6% to 92.5%), whereas intensive chemotherapy showed declining efficacy from 96.0% at WBC <30×10⁹/L to 86.6% at WBC ≥30×10⁹/L. Conclusions: Reduced-intensity ATRA+ATO-based induction achieves equivalent complete remission, comparable early mortality, superior event-free survival, and lower relapse compared with intensive chemotherapy in high-risk APL. These findings support ATRA+ATO combined with gemtuzumab ozogamicin or low-dose anthracycline as preferred first-line therapy.
Osteoporosis and osteoporosis-related fractures among older male cancer patients: A nationwide study.
11196 Background: Osteoporosis is commonly viewed as a disease of postmenopausal women, leading to significant underdiagnosis in men. Older male patients with cancer experience accelerated bone loss due to androgen deprivation therapy, corticosteroid exposure, and malignancy-related skeletal remodeling. We examined the prevalence, tumor-specific risk factors, and outcomes of osteoporosis and related fractures in a national cohort of older male cancer patients. Methods: We analyzed Nationwide Readmissions Database hospitalizations from 2019–2022, identifying male patients aged ≥60 years with malignancy. Primary outcomes were osteoporosis (ICD-10-CM M80/M81) and major osteoporotic fractures (hip, spine, humerus, wrist); isolated hip fracture was a secondary outcome. Survey-weighted multivariable logistic regression models identified independent predictors, adjusting for age, cancer type, metastatic status, and clinical risk factors. Results: Among an estimated 5.17 million weighted cancer admissions, 2.79 million occurred in males. Osteoporosis was diagnosed in 1.29% of males versus 7.16% of females ( P < 0.001); mean age at diagnosis was 76.5 vs 78.0 years. Men with osteoporosis had markedly higher fracture rates than those without, including hip fracture (5.11% vs 0.85%) and any major fracture (8.36% vs 1.60%) (all P < 0.001). In multivariable analysis, odds of osteoporosis diagnosis increased with age (OR 1.06 per year, P < 0.001). Diagnoses were most strongly associated with multiple myeloma (OR 1.63), prostate cancer (OR 1.33) (both P < 0.001), and leukemia (OR 1.16, P = 0.008). Hypogonadism (OR 4.77), hyperparathyroidism (OR 3.53), vitamin D deficiency (OR 2.51), and tobacco use (OR 1.08; P = 0.009) were independent clinical predictors. In fracture models, prior osteoporosis diagnosis was the strongest predictor of any major fracture (OR 4.11) and hip fracture (OR 2.41) (both P < 0.001). Modifiable risks, including tobacco use (OR 1.55–1.61) and vitamin D deficiency (OR 1.68–1.88) (both P < 0.001), consistently increased fracture risk. Prostate cancer increased odds of both major (OR 1.11) and hip fractures (OR 1.21) ( P < 0.001), whereas multiple myeloma increased odds of major fracture (OR 1.19, P = 0.004) but was associated with lower odds of hip fracture (OR 0.80, P = 0.03). Conclusions: Older men with cancer face substantial, under-recognized risk for osteoporosis and fracture-related morbidity. Tumor-specific patterns and modifiable clinical factors identify clear opportunities for earlier risk assessment and integration of bone health strategies into routine oncologic care.
Global disparities in current clinical trials in cervical cancer.
5530 Background: Cervical cancer is one of the most disproportionately distributed cancers worldwide, with highest incidence and mortality rates occurring in low- and middle-income countries (LMICs). Although clinical trials provide the crucial foundation for the development of standards of care, oncology research is disproportionately concentrated in high-income settings. Methods: We assessed the current global landscape of cervical cancer clinical trials to determine whether trial activity aligns with disease burden and to characterize various disparities in trial representation. Interventional phase II and III cervical cancer clinical trials registered on ClinicalTrials.gov between January 1, 2014, and December 31, 2025, were identified. Trials were further categorized by intervention class, patient population, funding source, and location. Representation of trials in relation to disease burden for cervical cancer was determined using trial-to-age-standardized incidence rate (ASIR) from Global Cancer Observatory estimates. Countries were classified by World Bank Income Level and disease burden, where high burden countries had an ASIR above the global ASIR of 14.1. Non-parametric statistical tests were used to compare trial-to-ASIR ratios across groups. Results: A total of 269 eligible trials were included. Most studies were phase II (62.5%) and evaluated systemic or combination therapies (83.6%). The majority of trials were institutionally funded (55.0%), with industry sponsorship accounting for 33.5% of studies. Clinical trial activity was concentrated in a small number of countries, with single-country trials conducted predominantly in China (60.2%) and the United States (13.0%), while multinational trials were largely conducted in high-income countries. When adjusted for disease burden, most high-burden countries had few or no trials relative to incidence, resulting in significantly lower trials per ASIR compared with non–high-burden countries (P < .001). Significant disparities were also observed across income groups, with high-income countries demonstrating substantially higher trial-to-ASIR ratios than lower-income countries (P < .001). Conclusions: The global distribution of cervical cancer clinical trials remains misaligned with disease burden, with high-burden and lower-income countries underrepresented in research participation. Funding patterns and trial sponsorship may further influence where trials are conducted. Addressing these disparities will be essential to ensure equitable evidence generation and improve global cervical cancer care.
Neoadjuvant almonertinib followed by chemo-immunotherapy in II-IIIb EGFR-mutant NSCLC: A single arm, phase II study (NEOVADE).
8509 Background: Neoadjuvant target therapy has improved objective response rate (ORR) or major pathological response (MPR) of stage IIA-IIIB non-small cell lung cancer (NSCLC) with EGFR mutation. EGFR-TKI-induced evolution indicated a hot-tumor status in residual disease. However, the role of immunotherapy in this phrase remained unclear. Here, we present the results of a phase II, open-label study investigating the efficacy and safety of sequential almonertinib and chemo-immunotherapy (IO) in potentially resectable stage IIA-IIIB EGFR-mutant NSCLC patients. (NCT06300424). Methods: Untreated patients with II-IIIB NSCLC were enrolled in this study. Patients received almonertinib for 6 weeks, followed by 3 cycles of adebrelimab and chemotherapy before surgery. Primary end point was MPR, Secondary end points included pathological complete response (PCR), ORR, event-free survival (EFS), overall survival (OS) and safety. Results: A total of 32 patients were enrolled from Apr 2024 to Aug 2025. EGFR mutation subtype was 19del in 16 (50.0%) patients, L858R in 11 (34.4%) patients, others in 5 (15.6%) patients. All the patients completed neoadjuvant almonertinib, 30 (93.8%) patients completed 3 circles of chemo-IO and underwent surgery, R0 was achieved in 29 (96.7%) patients. ORR was 46.9% (15/32) and 59.4% (19/32) after target therapy and chemo-IO, respectively. MPR was documented in 13 (40.6%) patients, including PCR in 5 (15.6%) patients. In patients underwent resection, MRP and PCR rate were 66.7% and 33.3% in patients with PD-L1≥1%, compared with 21.4% and 0% in PD-L1 ＜1% subgroup, respectively, N downstage was confirmed in 44.8% (13/29) patients. After a median follow-up of 13.5 months (interquartile range [IQR], 7.5–16.1 months), 31 (96.9%) patients were alive. Median EFS and OS were not reached. One-year EFS and OS rate was 89.5% and 95.2%, respectively. Grade ≥ 3 AEs occurred in 28 (87.5%) patients during neoadjuvant therapy. Conclusions: This study met its primary endpoint, indicating almonertinib followed by chemo-IO was a feasible neoadjuvant treatment in patients with resectable stage IIA-IIIB EGFR-mutant NSCLC, especially in patients with PD-L1 expression. The study was partially supported by Jiangsu Hengrui Pharmaceuticals and Hansoh Pharmaceutical Group Co. Ltd. Clinical trial information: NCT06300424 . Primary and secondary outcomes. Outcomes ITT (N=32) Resection (N=29) Major pathological response rate 40.6% (13/32) 44.8% (13/29) PD-L1＜1% 18.8% (3/16) 21.4% (3/14) PD-L1≥1% 62.5% (10/16) 66.7% (10/15) Complete pathological response rate 15.6% (5/32) 17.2% (5/29) PD-L1＜1% 0.0% (0/16) 0.0% (0/14) PD-L1≥1% 31.3% (5/16) 33.3% (5/15) After receiving neoadjuvant TKI ORR 46.9% (15/32) 44.8% (13/29) DCR 93.8% (30/32) 96.6% (28/29) After receiving neoadjuvant TKI+IO ORR 59.4% (19/32) 58.6% (17/29) DCR 100.0% (32/32) 100.0% (29/29) TKI: Tyrosine kinase inhibitor; IO: Immunotherapy.
A phase 2 study of docetaxel (D), ramucirumab (R), and pembrolizumab (P) for patients with metastatic or recurrent non–small cell lung cancer (NSCLC) who progressed on platinum-doublet and PD-1/PD-L1 blockade.
8594 Background: NSCLC treatment (trt) efficacy remains modest after progression on platinum and immune checkpoint inhibitors (ICI). Salvage trt with D + R has a 6-month progression-free survival (PFS) rate of 37%. Methods: We conducted a phase 2, single-arm study of D (75mg/m 2 ), R (10mg/kg), P (200mg) given intravenously in 21-day cycles until disease progression or unacceptable toxicity. Eligibility: metastatic or recurrent NSCLC, progression on concurrent or sequential platinum and ICI, no prior exposure to D or R, ECOG 0-1, measurable disease, adequate organ function. A safety run-in cohort was performed followed by efficacy evaluation using Simon’s two-stage design. The null hypothesis (H 0 ) of 6-month PFS rate of 37% was tested against a one-sided alternative hypothesis with a rate >62% (α 0.1, power 80%). H 0 will be rejected if ≥11 of 21 patients (pts) remain free of progression or death by 6 months (m) with planned sample size of 30 to accommodate early dropout. PFS and overall survival (OS) were estimated using Kaplan Meier method. Results: 30 pts were enrolled. Median (range) age = 66.5 (57-84) years. 20 (67%) were white, 11 (37%) female, 25 (83%) ever-smoker, 23 (77%) non-squamous, 23 (77%) PD-L1 <50%, 29 (97%) received platinum + ICI concurrently, 19 (63%) progressed after 6m on prior ICI, 10 (33%) had brain metastases (mets), and 7 (23%) had liver mets. 28 pts completed at least one cycle of trt: 22 were evaluable for 6-month PFS (primary endpoint), 6 early dropouts <6m on trt w/o progression (including 1 prior to first imaging). No dose limiting toxicities were observed in the first month on trt. 14 (64%) of 22 pts were free of progression by 6m. Median PFS = 7.3m (95CI, 5.6-9.9); median OS = 15m (95CI, 8.4-18.9); ORR = 37%; 10 partial responses; median duration of response = 5.9m (95CI, 1.6-7.2); disease control rate = 96%; clinical benefit = 67%. Nine (31%) pts had trt-related serious adverse event (trSAE) including 1 (3%) death (Table 1). Median (range) cycles for D, R, P were 6 (1-11), 8 (1-23), 8 (1-23), respectively. Two pts remain on trt. Number of D cycles was associated with improved OS (HR 0.73; p = 0.01) and PFS (HR 0.83; p = 0.01). Presence of brain or liver mets (HR 3.13; p = 0.03) and progression in <3m on prior ICI (HR 5.42; p = 0.02) were associated with shorter OS. Conclusions: The study met its primary endpoint and demonstrated a manageable safety profile and a promising efficacy of this regimen. Clinical trial information: NCT04340882 . Summary of trSAE (n= 29). Lethargy / weakness 3 (10%) Pneumonia 3 (10%) Atrial Fibrillation 2 (7%) Dehydration / volume depletion 2 (7%) Low K/Mag 2 (7%) Neutropenia 2 (7%) Death 1 (3%) Diverticulitis 1 (3%) Fever 1 (3%) Interstitial nephritis 1 (3%) Infusion reaction with cardiac arrest 1 (3%) Neutropenic fever 1 (3%) Pancreatic fistula 1 (3%) Pancreatitis 1 (3%) Port infection 1 (3%) Pneumonitis 1 (3%) Septic shock 1 (3%)
Epcoritamab (epcor) + chemoimmunotherapy (CIT) in patients (pts) with relapsed/refractory large B-cell lymphoma (R/R LBCL) eligible for autologous stem cell transplant (ASCT): Pooled results from arms 4 and 10 of EPCORE NHL-2.
7061 Background: Pts with R/R LBCL can have inadequate response to salvage treatment (tx), precluding ASCT. While CAR T therapies are standard of care in the 2L setting for pts with early relapse (< 12 mo of 1L tx), their use is limited by eligibility, accessibility, or cost. Regimens that enhance salvage tx response rates enabling pts to proceed to ASCT are needed. In Arms 4 and 10 of the phase 1b/2 EPCORE NHL-2 trial (NCT04663347), epcor + CIT showed high response rates in ASCT-eligible R/R LBCL. A pooled analysis of these data is reported. Methods: ASCT-eligible pts received epcor + rituximab, dexamethasone, cytarabine, and oxaliplatin/carboplatin (R-DHAX/C) (Arm 4) or epcor + rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) (Arm 10). After salvage tx, pts could proceed to ASCT or remain on epcor mono tx. ORR per investigator, DOCR, PFS, OS, and safety are reported. Results: The analysis included 63 pts (Arm 4: n = 29; Arm 10: n = 34). Baseline characteristics: median age 61 y (range 28–77), 68% male, 71% stage III/IV, 13% (8/33 assessed) high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 translocations (central lab), 8% prior CAR T. 79% (n = 50) were receiving 2L tx; 57% (n = 36) were receiving 2L tx and were refractory or had early relapse to 1L tx. Median relative CIT dose intensity was ≥ 80%. At 18.3 mo median follow-up, ORR and CR rates were 84% and 67% (Table). 57% (n = 36) proceeded to ASCT; 16% (n = 10) remained on epcor mono tx due to pt/physician decision. Median DOCR, PFS, and OS were not reached in pts who proceeded to ASCT or who remained on epcor. Similar outcomes were seen in 2L pts and across 2L pts with early and late relapse. Overall, the most common any-grade TEAEs were anemia (68%), thrombocytopenia (68%), and neutropenia (62%). CRS occurred in 48% of pts and ICANS in 3%; all events were grade 1–2. Serious infections occurred in 17%. TEAEs led to tx discontinuation in 11%. There were no fatal TEAEs. Conclusions: In this pooled analysis of ASCT-eligible pts with R/R LBCL, tx with epcor + salvage CIT resulted in high CR rates, enabling a large proportion of pts to proceed to ASCT. Deep, durable responses were seen in pts who underwent ASCT and those who continued epcor mono tx. A high CR rate was also observed in 2L pts with early relapse. Safety was consistent with prior reports. Dose intensity of CIT was not impacted. These findings support epcor-based combination salvage strategies to increase response depth and facilitate higher ASCT rates and possible cure in ASCT-eligible pts with DLBCL. Clinical trial information: NCT04663347 . All pts(N = 63) 2L(n = 50) 2L with early relapse a (n = 36) Proceeded to ASCT(n = 36) Remained on epcor mono(n = 10) ORR/CR, % 84/67 84/68 81/61 100/94 100/80 DOCR, 18-mo rate, % 79 80 81 83 64 PFS, 18-mo rate, % 62 62 58 80 67 OS, 18-mo rate, % 82 82 77 93 100 a Pts receiving 2L tx who were refractory to or progressed <12 mo of 1L tx.
Comparative safety profiles of frontline BTK inhibitor–containing regimens in mantle cell lymphoma: A cross-trial analysis of phase III studies.
e19049 Background: Bruton tyrosine kinase inhibitors (BTKis) are increasingly incorporated into frontline mantle cell lymphoma (MCL) regimens, either combined with chemoimmunotherapy or as chemotherapy-free approaches. Given differences in BTKi selectivity and treatment backbone intensity, comparative safety data are needed to inform regimen selection. Methods: We performed a structured safety extraction from published phase III frontline MCL trials incorporating a BTKi: SHINE (ibrutinib + bendamustine-rituximab [BR]), ECHO (acalabrutinib + BR), TRIANGLE (ibrutinib integrated with cytarabine-based induction ± autologous stem cell transplantation [ASCT]), and ENRICH (ibrutinib-rituximab vs immunochemotherapy). Outcomes included grade ≥3 treatment-emergent adverse events (TEAEs), serious TEAEs, adverse events of special interest (atrial fibrillation, infections, cytopenias), and TEAEs leading to treatment discontinuation. Analyses were descriptive, based on published trial reports. Results: In SHINE, grade 3–4 TEAEs occurred in 81.5% with ibrutinib + BR versus 77.3% with placebo + BR. Atrial fibrillation was more frequent with ibrutinib (13.9% vs 6.5%), as was grade 3–4 pneumonia (20.1% vs 14.2%). Study-drug discontinuation due to adverse events occurred in 10.5% versus 9.1%, respectively. In ECHO, grade ≥3 TEAEs were comparable between acalabrutinib + BR and placebo + BR (88.9% vs 88.2%), while serious TEAEs were more frequent with acalabrutinib (69.0% vs 62.0%). TEAEs leading to discontinuation were higher with acalabrutinib (42.8% vs 31.0%), though atrial fibrillation rates remained low (~6–7%). In TRIANGLE, incorporation of ibrutinib into intensive induction and ASCT was associated with higher grade 3–5 infections (25% vs 13%) and neutropenia (44% vs 17%) compared with ASCT alone. In ENRICH, grade ≥3 adverse events occurred in 67% with chemo-free ibrutinib-rituximab versus 70% with immunochemotherapy. Grade ≥3 neutropenia was lower with ibrutinib-rituximab (9%) compared with R-CHOP (21%) and BR (19%). Conclusions: Frontline BTKi-containing regimens in MCL are associated with high but regimen-dependent toxicity burdens. Chemo-based BTKi combinations demonstrate moderately increased infections and cytopenias, while ibrutinib-containing regimens show moderately higher cardiovascular event rates. Chemo-free ibrutinib-rituximab offers a favorable cytopenia profile. These findings highlight the importance of individualized treatment selection and proactive toxicity monitoring when incorporating BTK inhibitors into frontline MCL therapy.
Survival of hematologic malignancy in patients with early-stage chronic kidney disease (SHIP-CKD).
7089 Background: Chronic kidney disease (CKD) is a common comorbidity among cancer patients and may influence treatment options and outcomes. However, the independent effect of CKD in patients with hematologic malignancies remains unclear. Methods: We conducted a retrospective cohort study using electronic medical records, including 1,238 adult patients diagnosed with hematologic malignancies between 2015 and 2019. Patients with CKD stages 1–3A were compared to those without CKD. The primary outcome was 5-year all-cause mortality. We used stratified Cox proportional hazards models adjusted for age, sex, and comorbidities (HIV, diabetes, hypertension, and COPD) and performed 1:1 propensity score matching without replacement. Subgroup analyses by cancer subtypes were performed. Results: Among 1,238 patients, 529 (42.7%) had CKD. CKD patients were older (67 vs. 55 years), with higher rates of hypertension (66.0% vs. 48.0%). Five-year mortality was higher in the CKD group (24.4% vs. 17.8%, p =0.006). In adjusted Cox models, CKD was not significantly associated with mortality (HR 1.08; 95% CI: 0.82–1.43). Subgroups by stages showed no significant risk: stage 1 (HR 1.27; 95% CI: 0.76–2.13), stage 2 (HR 1.05; 95% CI: 0.77–1.43), stage 3A (HR 1.03; 95% CI: 0.60–1.78). In matched analysis (n=758), CKD remained non-significant (HR 1.04; 95% CI: 0.77–1.41). Conclusions: Early-stage CKD was common and linked to higher unadjusted mortality, but not with increased mortality after adjusting for covariates. These findings suggest that early-stage CKD may not independently impact survival among patients with hematologic malignancies. Baseline characteristics by CKD status after propensity score matching. No CKD CKD P-value N=379 N=379 Age (years) 63.0 [57.0,68.0] 64.0 [56.0,69.0] 0.886 BMI (kg/m 2 ) 26.1 [23.5,29.9] 25.9 [23.3,29.8] 0.626 CKD No CKD 379 (100.0%) 0 (0.0%) <0.00 G1 0 (0.0%) 58 (15.3%) G2 0 (0.0%) 267 (70.4%) G3a 0 (0.0%) 54 (14.2%) Sex Female 154 (40.6%) 165 (43.5%) 0.46 Male 225 (59.4%) 214 (56.5%) Race/Ethnicity White 207 (54.6%) 245 (64.6%) Latino 67 (17.7%) 39 (10.3%) Asian 52 (13.7%) 44 (11.6%) Black or African American 21 (5.5%) 24 (6.3%) Multi-Race/Ethnicity 11 (2.9%) 11 (2.9%) Native American or Alaska Native 0 (0.0%) 2 (0.5%) Native Hawaiian or Other Pacific Islander 2 (0.5%) 0 (0.0%) Southwest Asian and North African 3 (0.8%) 3 (0.8%) Other 11 (2.9%) 5 (1.3%) Unknown/Declined 5 (1.3%) 6 (1.6%) Disease Follicular lymphoma 3 (0.8%) 3 (0.8%) 1.00 Non-follicular lymphoma 67 (17.7%) 67 (17.7%) Myeloma 200 (52.8%) 200 (52.8%) Acute leukemia 56 (14.8%) 56 (14.8%) Chronic leukemia 53 (14.0%) 53 (14.0%) HIV status No HIV 372 (98.2%) 374 (98.7%) 0.77 HIV 7 (1.8%) 5 (1.3%) Diabetes status No DM 316 (83.4%) 318 (83.9%) 0.92 DM 63 (16.6%) 61 (16.1%) Hypertension status No HT 151 (39.8%) 154 (40.6%) 0.88 HT 228 (60.2%) 225 (59.4%) COPD status No COPD 369 (97.4%) 372 (98.2%) 0.63 COPD 10 (2.6%) 7 (1.8%)
Redox status of endometrial tumors: A comparative study in endometrioid adenocarcinoma, serous, and clear cell carcinomas.
e17619 Background: Oxidative stress, reflecting an imbalance between the formation of reactive oxygen species and the body's antioxidant defenses, plays a key role in cancer development and progression. However, in endometrial cancer (EC), the leading oncogynecological malignancy, the characteristics of redox status across different histological types have not been sufficiently studied. The purpose of this study was to investigate the levels of lipid peroxidation (LPO) products, the activity of antioxidant enzymes, and the non-enzymatic components of the antioxidant system in tumors of different EC types. Methods: Levels of diene conjugates (DC) and malondialdehyde (MDA), activity of superoxide dismutase (SOD), catalase (CT), glutathione peroxidase (GPO), glutathione-S-transferase (GT), and contents of reduced glutathione (RG) and vitamins A and E were measured in tumor tissues of patients with endometrioid adenocarcinoma G3 (AC, n=15), clear cell endometrial carcinoma (CCE, n=11), and serous endometrial cancer (SEC, n=12) using standard biochemical methods. Parameters from intact uterine tissue of patients with myoma (n=8) served as the comparison group. Statistical analysis was performed with the Statistics 10.0 program. Results: The level of primary LPO products (DC) was increased in AC G3 by 2.9-fold (p=0.02), and in CCE and SEC by 4.0-fold and 3.5-fold, respectively (p<0.0005), compared with intact uterine tissue. The content of MDA was most elevated in AC G3 tumors — by 1.6-fold (p=0.001). The activity of first-line antioxidant enzymes was highest in CCE: SOD increased 8.3-fold and CT 11.3-fold; in SEC, the increases were 6.6-fold and 6.7-fold; in AC G3, 5.9-fold and 3.0-fold, respectively (p≤0.0003). An imbalance in the functioning of these enzymes was observed: in AC, SOD predominated by 2-fold, whereas in CCE and SEC, CT predominated by 1.4–1.5-fold. CCE was characterized by the highest activity of GT and GPO alongside an almost 3-fold decrease in RG. Conversely, in SEC, a 2-fold decrease in GPO activity, a 4-fold decrease in GT activity, and a 5-fold decrease in the levels of both vitamins were observed. Conclusions: In all types of endometrial cancer, activation of SOD and CT plays a key role in the antioxidant defense of tumor cells. In clear cell endometrial carcinoma, the glutathione system also contributes to protecting tumor cells from oxidative stress, potentially promoting aggressive growth and rapid invasion. The pronounced inhibition of glutathione-dependent enzymes and the marked reduction in vitamin levels in serous endometrial cancer may contribute to the formation of a mutated p53 protein, which is associated with aggressiveness and poor prognosis in this histological subtype.
Anatomical and clinical heterogeneity of dMMR colorectal cancer by tumor location.
e15725 Background: Deficient mismatch repair (dMMR) colorectal cancer is a biologically heterogeneous disease. Tumors from different anatomical sites arise from distinct embryonic layers and show variable clinical behavior, including differing responses to immunotherapy. However, large-scale studies systematically examining how tumor location influences dMMR patterns and associated clinicopathologic features remain limited. Methods: We retrospectively analyzed 1,021 patients with dMMR colorectal cancer confirmed by immunohistochemistry. Tumors were classified by location (right-sided colon, left-sided colon, rectum) and by dMMR pattern (MLH1/PMS2 loss, MSH2/MSH6 loss, isolated PMS2 loss, isolated MSH6 loss, and others. Clinicopathologic features were compared across locations and patterns using univariate and multivariable analyses. Results: Significant differences in dMMR patterns were observed across anatomical sites (P < 0.001). Right clon were predominantly MLH1/PMS2 loss (67.9%), while rectal showed higher prevalence of isolated PMS2 loss (30.9%). Left colon were more frequently associated with MSH2/MSH6 and isolated MSH6 loss. Clinically, right colon was characterized by larger diameters (P = 0.006), whereas rectal was significantly associated with younger age (P = 0.001), male sex (P = 0.034), and higher Ki-67 expression (P = 0.05). Multivariable analysis confirmed that dMMR subtype is an independent predictor of tumor location, specifically with MLH1/PMS2 loss strongly associated with right colon cancer. Conclusions: Our findings highlight the significant anatomical and clinicopathologic heterogeneity within dMMR colorectal cancer. These site-specific differences in dMMR subtypes and tumor aggressiveness may stem from distinct embryological origins. Consequently, dMMR alone is insufficient for clinical stratification; anatomical location and specific deficiency subtypes must be integrated to enable precise risk assessment and individualized therapeutic decision-making. Multivariable analysis of clinicopathologic factors associated with tumor location in dmmr colorectal cancer. Variable Right Colon VS Left Colon OR (95% Cl) P-value Rectum VS Left Colon OR (95% Cl) P-value Age (＜65 VS ≥65) 0.719 (0.444,1.163) 0.179 0.413 (0.247,0.691) 0.001 Sex (Male VS Female) 0.788 (0.489,1.268) 0.325 1.752 (1.043,2.942) 0.034 Maximum tumor diameter 1.164 (1.045,1.296) 0.006 0.794 (0.702,0.898) 0.000 Perineural Invasion (No VS Yes) 1.144 (0.446,2.932) 0.779 0.269 (0.112,0.651) 0.004 Ki-67 (Low VS High) 0.803 (0.260,2.481) 0.704 2.910 (0.998,8.485) 0.050 dMMR: MLH1/PMS2 loss (ref Other)dMMR: MSH2/MSH6 loss (ref Other)dMMR: MSH6 loss (ref Other)dMMR: PMS2 loss (ref Other) 3.765 (1.842,7.697)1.803 (0.761,4.274)0.805 (0.331,1.961)1.084 (0.443,2.654) 0.0000.1810.6330.859 0.810 (0.387,1.696)0.928 (0.382,2.253)0.628 (0.260,1.522)1.777 (0.772,4.087) 0.5760.8690.3030.176
Phase II trial of olaparib and ceralasertib in patients with recurrent osteosarcoma: Lung-only resectable cohort efficacy and correlative biomarker results.
10015 Background: Patients with osteosarcoma recurrence have limited treatment options and poor outcomes. The observed response to cisplatin in osteosarcoma, in vitro susceptibility of osteosarcoma cell lines to ATR and PARP inhibitors, and the presence of mutations in genes involved in DDR served as the basis for the development of this trial. Methods: We conducted a phase II trial of olaparib and ceralasertib in patients aged 12-40 with recurrent osteosarcoma. The primary endpoint for patients with resectable disease limited to the lung (Cohort 2) was submission of paired pre- and post-treatment tumor samples. Secondary endpoints for Cohort 2 included event-free status at 12-months, event-free survival (EFS) and overall survival (OS). Patients received Olaparib 150mg twice a day on days 1-28 and ceralasertib 80mg twice a day on days 1-14 of a 28-day cycle. Patients with unilateral disease received 2 cycles of treatment prior to surgery. Patients with bilateral disease had one side resected, then received 2 cycles of treatment followed by surgery of the contralateral side. Tumor, blood and plasma samples were obtained from Cohort 1 (measurable unresectable disease, efficacy results previously reported) and Cohort 2 patients for correlative studies. Results: Between 3/2021-9/2024, 10 patients from 4 centers were enrolled in Cohort 2. Four patients had bilateral and six had unilateral lung metastases. Median age was 19.3 (range 15.7-24.6). Patients had received a median of three prior therapy regimens. Seven patients (70%, 95%CI: 35%-93%) underwent planned thoracic surgery and had paired pre- and post-treatment tumor samples submitted for correlative studies. Four patients (40%, 95%CI: 12%-74%) were event-free at 12 months and received >12 cycles of olaparib and ceralasertib. The 12-month EFS±SE and OS±SE were 40±15.5% and 90±9.5%, respectively. Initial review of clinical sequencing on a subset of Cohort 1 and 2 patients suggests therapy resistance may be associated with high-risk genomic features, like MYC amplification. Conclusions: Patients with recurrent resectable osteosarcoma limited to the lung parenchyma can be included as a separate cohort in phase II trials of novel agents. In this cohort, it is feasible to incorporate pre-surgical treatment with experimental agents followed by surgical resection of pulmonary nodules and collection of pre- and post-treatment tumor samples, enabling correlative biology. 12-month EFS was 40% but with a wide confidence interval crossing the confidence interval of historical 12-month EFS of 20% from prior COG studies. Sequencing and ctDNA analyses for all enrolled patients (both cohorts) with available samples (N=40 patients with tumor samples and N=48 patients with ctNDA samples) are underway to further assess potential biomarkers of treatment response. Clinical trial information: NCT04417062 .
Efficacy, survival, and safety of neoadjuvant immune checkpoint inhibitors plus chemotherapy in early breast cancer: A systematic review and meta-analysis of randomized and real-world comparative studies.
e12679 Background: Neoadjuvant chemotherapy is a standard approach for high-risk early breast cancer, with pathologic complete response serving as a validated surrogate for long-term outcomes in biologically aggressive subtypes. The addition of immune checkpoint inhibitors (ICIs) to neoadjuvant regimens has led to substantial improvement in pCR in multiple randomized trials. However, uncertainty remains regarding the consistency of benefit across subtypes, the magnitude of long-term survival gains, and the real-world generalizability of these findings. Methods: We performed a systematic review and meta-analysis of randomized controlled trials comparing neoadjuvant ICIs plus chemotherapy with chemotherapy alone in early-stage breast cancer. Pathologic complete response was pooled using odds ratios, time-to-event outcomes using hazard ratios with generic inverse variance methods, and safety outcomes using risk ratios. A real-world comparative cohort (Connors 2024) was included to enhance external validity. A total of 9 randomized controlled trials and 1 real-world comparative cohort were included. Results: Across 10 comparative studies including 5,354 patients (5,114 from RCTs and 240 from real-world comparative data), neoadjuvant ICI-based therapy demonstrated consistent and clinically meaningful benefits: Pathologic complete response:ICI-based therapy significantly increased the likelihood of achieving pCR (OR 1.55; 95% CI, 1.37–1.75; P < 0.00001; I² = 61%), with consistent benefit observed across major breast cancer subtypes. Event-free survival:Treatment with ICIs was associated with a significant reduction in disease-related events (HR 0.71; 95% CI, 0.58–0.87; P = 0.0008; I² = 32%), indicating improved durability of disease control. Overall survival:A statistically significant overall survival benefit was observed (HR 0.61; 95% CI, 0.48–0.78; P < 0.0001; I² = 27%), demonstrating that early gains in tumor response translated into long-term survival advantage. Grade ≥3 immune-related adverse events:ICI-based regimens were associated with a substantially higher risk of severe immune-related toxicity (RR 3.15; 95% CI, 2.25–4.40; P < 0.00001; I² = 85%), reflecting the need for vigilant toxicity monitoring and risk mitigation. Conclusions: In early-stage breast cancer, neoadjuvant immune checkpoint inhibitor–based therapy is associated with robust improvements in pathologic complete response and meaningful gains in event-free and overall survival, supported by both randomized and real-world comparative evidence. These benefits are accompanied by a substantially increased risk of severe immune-related adverse events, underscoring the importance of individualized risk–benefit assessment and optimization of patient selection and management strategies
Diagnostic and prognostic performance of urinary metabolomic biomarkers in lung cancer: A systematic review and meta-analysis.
e20551 Background: Urinary biomarkers offer a non-invasive strategy for the detection and prognostication of lung cancer; however, reported diagnostic and prognostic performance varies substantially across biomarker classes, analytical platforms, and modeling strategies. This systematic review and meta-analysis aimed to synthesize the evidence on the diagnostic accuracy and prognostic value of urinary biomarkers in lung cancer. Methods: A systematic literature search was conducted in PubMed, Embase, and the Cochrane Library (2000–2026). Eligibility criteria and data extraction were guided by the PICO framework, encompassing adult lung cancer populations (NSCLC/SCLC) and appropriate control groups, urinary metabolomic profiling using liquid chromatography–mass spectrometry (LC-MS), gas chromatography–mass spectrometry (GC-MS), or nuclear magnetic resonance (NMR) platforms, and outcomes including diagnostic accuracy metrics and prognostic hazard ratios. Study screening was conducted using Rayyan, and random-effects meta-analyses were performed in R (version 4.4.2). Pooled diagnostic estimates were calculated using logit-transformed proportions, with heterogeneity quantified using the I² statistic. Prognostic hazard ratios were pooled on the logarithmic scale. Results: Eleven studies comprising 4,589 participants, including lung cancer cases (n = 2,019) and controls (n = 2,570), were included; histology was predominantly NSCLC or mixed populations, and staging information (available in nine studies) most commonly encompassed stage I–IV disease. Eight studies were diagnostic, two assessed both diagnostic and prognostic performance, and one was exclusively prognostic. Pooled diagnostic estimates showed a sensitivity of 89.2% (95% CI: 85.8–91.8%; I² = 26.2%), specificity of 86.6% (95% CI: 70.8–94.5%; I² = 97.1%), and overall accuracy of 86.0% (95% CI: 74.7–92.7%; I² = 90.8%). The pooled area under the curve (AUC) was 0.89 (95% CI: 0.85–0.94; I² = 93.8%), indicating strong discriminative performance. Prognostic meta-analysis of overall survival, based on two studies, yielded a pooled hazard ratio (HR) of 2.04, suggesting poorer outcomes in biomarker-defined high-risk groups, although confidence intervals were wide due to limited data. One additional study reported progression-free survival with similar adverse prognostic associations. Internal validation was performed in all studies, while normalization was reported in 94% of studies. Conclusions: Urinary biomarkers demonstrate clinically relevant diagnostic performance for lung cancer and emerging prognostic value for overall and progression-free survival. Harmonized analytical pipelines, predefined thresholds, and independent external validation are essential for successful clinical translation.
Clinical and pathological outcomes of patients with germ-cell tumor undergoing surgical resection of residual disease after high-dose chemotherapy.
e17012 Background: In patients (pts) with germ-cell tumor (GCT) treated with high-dose chemotherapy (HDCT) and peripheral-blood stem-cell transplantation (PBSCT), residual disease after HDCT both within and outside the retroperitoneum poses a major challenge. We report the pathologic and clinical outcomes of pts with GCT who underwent surgical resection of post-HDCT residual disease. Methods: The prospectively maintained Indiana University testicular cancer database was queried for pts who underwent surgery after HDCT with PBSCT from 1990-2025. The Kaplan-Meier method was used to analyze overall survival (OS) using the log rank test to compare groups. Start date for OS was time of first cycle of HDCT. Results: 97 pts underwent surgical resection after HDCT. The median age at diagnosis was 27.9 years (range, 16.1-54.5). Primary site was testis in 92% of pts. 95 pts (98%) had NSGCT. IGCCCG risk at diagnosis was good in 25 pts (26%), intermediate in 14 (14%) and poor in 58 (60%). 53 pts underwent a post HDCT RPLND, 14 underwent thoracic surgery, 4 underwent brain met resection and 8 underwent surgical resection at other sites. 18 additional pts underwent multiple surgeries; 5 underwent both thoracic surgery + RPLND, 6 underwent hepatectomy + RPLND and 3 underwent brain met resection with either an RPLND or lung surgery. Pathologic outcomes are described in Table 1. 75 out of the 97 pts (78.4%) who underwent post HDCT surgical resection had either residual non-teratomatous GCT or teratoma. In the 18 pts who underwent surgical resection at multiple sites, 10 (56%) had discordant pathologic findings between the sites. Post-HDCT surgery was done in the setting of elevated tumor markers in 40 (41.2%) pts vs. normal tumor markers in 57 (58.8%) patients. 5yr OS of the entire cohort was 64.2% (53.1-73.3). 5 yr OS of pts with normal tumor markers at resection was 74.3% (60.4-83.9). 5 yr OS of patients with residual non-teratomatous GCT at time of surgical resection was 34.4% (19.4-49.9). Conclusions: In pts who underwent post HDCT-surgery, irrespective of surgical location, 78% had either residual non-teratomatous GCT or teratoma. OS was worse for pts with residual non-teratomatous GCT at time of resection of post-HDCT residual disease. Pathologic outcomes**. Surgery TotalN= 97 RPLND-Teratoma -GCT-MT* -Necrosis only 5331 (58%)17 (32%)4 (7%)13 (25%) Thoracic-Teratoma-GCT-Necrosis only 144 (29%)8 (57%)5 (36%) Brain-Teratoma-GCT-Necrosis only 41 (25%)3 (75%)1 (25%) Other-Teratoma-GCT-MT-Necrosis only 81 (13%)5 (63%)1 (13%)1 (13%) *Malignant Transformation. **Several patients had multiple pathologic components at resection.
Exploring transportation insecurity among cancer patients in urban cancer clinics in Ontario, Canada.
1538 Background: Advancements in cancer therapeutics have led to increasing care complexity, higher visit frequency, and increased economic burdens for many patients undergoing cancer treatment. Emerging data suggests that transportation challenges may have an important, and uneven impact on the delivery of cancer care. We completed a cross-sectional survey to better understand the prevalence and impact of transportation insecurity in cancer clinics serving a diverse urban and inner-city patient population in a public-payor system. Objectives: The Care for All Health Equity Pilot aims to explore the barriers that patients experience when engaging with cancer treatment. In a pilot exploratory analysis we identified transportation insecurity as associated with missed oncology appointments. The objectives of this study were to explore factors associated with higher level of transportation insecurity amongst our patient population. Methods: A cross-sectional survey on patient demographics, financial toxicity (COST tool), transportation challenges, housing and food insecurity was delivered to all adult patients attending cancer clinics at two major urban centres in Toronto, Ontario from July – August 2025. We conducted an exploratory, descriptive, and bivariate analysis of factors correlated with higher levels of transportation insecurity amongst survey respondents. Results: 576 patients completed the survey, 48.6% of whom identified as female. 44.8% and 25.0% of respondents had solid tumour or malignant hematologic diagnoses respectively. The most common diagnoses were breast cancer (18.8%), and lymphoma (10.8). Nearly a third (28.8%) of survey respondents endorsed stress related to accessing and paying for transportation to and from their medical appointments. The most common transportation-related stressors preventing patients from attending appointments were parking/travel expenses (26.7%), and the ability to locate accessible parking (13.9%). In an exploratory bivariate analysis patient age, non-English preferred language, access to a personal vehicle, self-identifying with a disability, and living alone emerged as correlates for transportation insecurity. Conclusions: Health-related transportation insecurity is common, impacting nearly a third of adult cancer patients receiving care at major urban cancer clinics in a public-payor system. Transportation related costs, and lack of accessible parking, are key contributors to transportation related stress. A multivariate analysis exploring the impact of transportation insecurity on missed oncology appointments, and healthcare utilization, is underway and further information will be available at the meeting.
A phase II multicenter study of NASOX regimen as adjuvant chemotherapy for patients with resected pancreatic ductal adenocarcinoma.
4230 Background: Pancreatic ductal adenocarcinoma (PDAC) is the fifth leading cause of cancer-related mortality in China, with a 5-year survival rate of only 5%–7%. Surgical resection followed by adjuvant chemotherapy can improve this to 15%–25%, but more effective adjuvant regimens are urgently needed to further prolong survival. The PRODIGE 24/CCTG PA.6 trial demonstrated that the mFOLFIRINOX regimen significantly improved outcomes compared with gemcitabine alone. The NASOX regimen is a modified mFOLFIRINOX regimen, which uses irinotecan hydrochloride liposomes (nal-IRI) instead of irinotecan and oral fluoropyrimidine tegafur instead of fluorouracil, and has demonstrated a favorable safety profile. This study aims to assess the efficacy and safety of NASOX as an adjuvant chemotherapy regimen for patients with resected PDAC. Methods: This is a Phase II, single-arm, open-label, multicenter clinical trial to evaluate the efficacy and safety of NASOX as adjuvant chemotherapy in patients with resected PDAC. The primary endpoint is DFS. Secondary endpoints include overall survival (OS), safety, quality of life (QoL), compliance with adjuvant therapy, and nutritional status. Exploratory endpoints will involve genomic, metabolomic, and proteomic analyses to identify biomarkers that may predict response and safety to NASOX regimen Results: Between August 2024 and October 2025, 55 patients were screened, with 53 ultimately enrolled. Age ranged from 34 to 73 years (median: 59). Forty-six patients underwent at least one tumor assessment, with 11 experiencing disease recurrence and 3 deaths. Median follow-up was 11.5 months(interquartile range 9.9–15.5), yielding a 9-month DFS rate of 82.7% a 9-month OS rate of 97.7%, with median DFS and OS not yet reached. Treatment-related adverse events (TRAEs) occurred in 52 patients (100%), including grade 3 or 4 adverse events in 28 patients (53.85%). The most common Grade 3–4 treatment-related adverse events were diarrhea (17.31%), neutropenia (17.31%), hypokalemia (11.54%), and gastrointestinal pain (9.62%). Conclusions: NASOX regimen demonstrated the anticipated efficacy and safety profile in the adjuvant treatment of PDAC following surgery, warranting further investigation. Clinical trial information: NCT06361316 .
Impact of a real-time updated evidence library in addressing lag in guideline updates to aide physicians.
e13684 Background: Across oncology, practice-changing data emerges daily from peer-reviewed publications, major congresses, or FDA announcements. Physicians must identify, review, and interpret this changing treatment landscape, creating substantial burden. Delays in clinical guideline integration may further impact treatment decisions. This study evaluates the lag between evidence emergence and guideline incorporation, physician burden, and the use of a REal-time AI-assisted Living SLR (REAL-SLR) clinical decision support tool to address these gaps. Methods: REAL-SLRs were implemented using protocol-driven, PRISMA-aligned searches for non-small cell lung cancer (NSCLC), breast and prostate cancers with daily updates. Evidence from interventional clinical trials meeting predefined criteria was selected, mapped to U.S. regulatory and guideline recommendations, and integrated into an interactive platform. Regulatory and clinical guidelines were manually reviewed. As the National Comprehensive Cancer Network (NCCN) updates more frequently than other major guidelines (ASCO, ESMO), time evaluations are specific to NCCN. Results: In 2025, 20 FDA approvals across NSCLC (11), breast (5), and prostate (4) cancer were granted. Publication of primary data occurred a median 168 days before FDA approval. Supporting evidence came from a median of 5 (1-8) publications and 3 (1-6) distinct sources, highlighting the need for multiple searches. Time from FDA approval to NCCN update ranged from 12 days in NSCLC to 73 days in prostate cancer. As of January 20 th , the REAL-SLRs included 1540, 930, 740 clinical trials in NSCLC, breast, and prostate cancers, respectively. All guideline-cited phase 3 trials were captured, with platform integration occurring within 1–13 days of publication or approval, representing an 11–72 day lead time over guidelines. Compared to guideline incorporation, evidence on a REAL-SLR platform represents a 11-72 day lead-time. Since launch, 4,294 physicians across 20 European countries and 48 U.S. states accessed the platform. Conclusions: Significant delays exist between evidence emergence and guideline incorporation, requiring physicians to consult multiple sources to stay current. Use of a REAL-SLR clinical decision support tool reduced physician burden while maintaining rigorous research standards. Days from Publication to FDA approval, Median (Range) Days from FDA approval to REAL-SLR Platform Days from FDA approval to guideline, Median (Range) REAL-SLR lead-time (days), Median (Range) Breast 167 (127-288) 1 22 (4-32) 21 (3-31) NSCLC 135 (0-1143) 1 12 (7-48) 11 (6-47) Prostate 260 (56-307) 1 73 (4-76) 72 (3-75) Overall 168 (0-1143) 1 16 (4-75) 15 (3-75)