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Breaking the silence: Sexual quality of life in Moroccan women after gestational trophoblastic tumors—A cross-sectional study.
e24139 Background: Gestational trophoblastic tumors (GTTs) are rare gynecologic malignancies with excellent cure rates. However, survivorship issues, particularly sexual quality of life (SQoL), remain underexplored. Treatment-related toxicity, hormonal disturbances, fatigue, and psychological distress may significantly impair sexual health. In low- and middle-income countries (LMICs) such as Morocco, sociocultural taboos and limited access to sexual health counseling may further exacerbate these challenges. This study aimed to evaluate SQoL and its determinants among Moroccan women treated for GTTs. Methods: We conducted a cross-sectional study in the Medical Oncology Department of CHU Hassan II, Fez, including women who had completed treatment for GTTs. Sexual function and quality of life were assessed using validated instruments, including the Female Sexual Function Index (FSFI) and the EORTC QLQ-C30. Additional items explored sociocultural barriers and partner-related factors. Clinical and demographic data were collected. Statistical analyses were performed to identify factors associated with impaired SQoL. Results: Fifty women aged 23–52 years were included. Based on FSFI scores, 68% presented with sexual dysfunction. After treatment, 10% reported complete cessation of sexual activity. Decreased libido was reported by 74% of participants, vaginal dryness by 58%, and dyspareunia by 52%. Women treated with multi-agent chemotherapy had significantly lower FSFI scores compared with those receiving single-agent regimens (p < 0.05). Qualitative analysis identified lack of partner support, stigma surrounding sexuality, and insufficient medical counseling as major contributors to impaired SQoL. Conclusions: A substantial proportion of Moroccan women treated for GTTs experience persistent sexual dysfunction, driven by both treatment-related and sociocultural factors. These findings highlight the need to integrate sexual health assessment and counseling into routine oncologic follow-up. Addressing sociocultural barriers and improving awareness may enhance survivorship care and quality of life, particularly in LMIC settings.
Investigating the extent of consensus among oncologists in treatment selection for NSCLC patients with co-occurring biomarkers.
e13727 Background: Literature demonstrates that non-actionable biomarkers (BMs) can co-occur with actionable ones in NSCLC and impact patient outcome. Our research sought to examine oncologists’ perspectives on hierarchy of clinical relevance of established and emerging BMs, their decision framework for managing co-occurring BMs, and how it could play out in future when these non-actionable BM become actionable. Methods: Between November-December 2025, 50 US-based Oncologists from a diverse set of practice settings and experience managing patients with metastatic NSCLC were recruited. They completed a 45-minute one-on-one interview where they shared perspective on their BM-informed treatment philosophy – BM prioritization, treatment algorithm over multiple lines of therapy when co-occurring BM are detected, and how they arrived at those beliefs in the present context. Results: Among the oncologists included in the study, 60% practiced in community settings and 40% in academic settings. Across practice types, the primary factors guiding treatment selection were efficacy, safety, alignment with clinical guidelines and FDA approval. Overall, 92% of respondents (45/49) reported that NCCN guidelines were useful for evidence-based decision-making, including 28% (14/49) who found them extremely helpful. Despite this reliance on guidelines, nearly 60% of responders (29/49) indicated that there is no clearly defined protocol for managing co-occurring BM or reported being unfamiliar/uncertain about available guidance. When presented with a clinical scenario involving co-occurring EGFR and TP53 mutation, 28 oncologists shared their perspectives. Approximately half (15/28) reported they would initiate therapy with an anti-TP53 drug followed by EGFR inhibitor, provided the anti-TP53 drug demonstrated ~20% higher efficacy in comparison to 'historical EGFR inhibitor outcomes in patients with co-occurring EGFR and TP53 mutation’, even if the registrational trial for anti-TP53 drug did not give details on patients with co-occurring mutations, or if such patients were excluded from the trial. Remaining oncologists preferred initiating treatment with an EGFR inhibitor and sequencing anti-TP53 therapy upon progression, citing greater familiarity with EGFR-directed treatments. These perspectives were similarly distributed across community and academic practice settings. Conclusions: This study shows that in the absence of clear regulatory or clinical guidance, treatment decisions for patients with co-occurring BMs may vary widely. While clinicians draw on conferences data and published research, this evidence base is insufficient to ensure consistent care. Our findings underscore the need for coordinated action from researchers, regulators and guideline bodies to establish clear standards of care to improve outcomes for patients with BM-complex disease.
A DESTINY-Breast09 analysis of treatment duration and clinical outcomes by best response to trastuzumab deruxtecan (T-DXd) + pertuzumab (P).
1021 Background: In DESTINY-Breast09 (NCT04784715), first-line (1L) T-DXd + P demonstrated durable responses, a near doubling of complete response (CR) rates, and significantly improved progression-free survival (PFS) vs taxane + trastuzumab + pertuzumab for patients (pts) with HER2+ advanced/metastatic breast cancer (a/mBC). Pts had a median treatment duration of 21.7 months (mo) with T-DXd + P. Safety was consistent with the known profiles of each treatment. These results led to US approval in Dec 2025. Here, we report an exploratory analysis of efficacy and safety outcomes by pts’ best confirmed response to T-DXd + P. Methods: Pts had no prior systemic therapy for a/mBC (1 line of endocrine therapy was allowed). Endpoints included PFS and duration of response (DOR), both by blinded independent central review per RECIST 1.1, and safety. Best response subgroups included CR, partial response (PR), and stable disease / progressive disease (SD/PD). Results: Of 377 evaluable pts assigned to T-DXd + P, 58 (15.4%) had a CR, 268 (71.1%) had a PR, and 51 (13.5%) had SD/PD at interim data cutoff (Feb 26, 2025). Median time to PR was 1.5 mo (95% CI 1.4, 1.5), and median time to CR was 8.4 mo (95% CI 5.6, 11.1). Additionally, median time to achieve maximum tumor reduction (nadir) in the overall population (n=383) was ~11 mo (~16 cycles). Pts with a CR or PR had favorable PFS (see Table) and a longer median treatment duration (CR, 28.0 mo [range 4.8–44.5]; PR, 22.2 mo [range 2.8–42.7]) vs those with SD/PD (4.4 mo [range 0.3–37.2]). Exposure-adjusted incidence rates (EAIRs) of drug-related Grade ≥3 adverse events (AEs) were 0.30, 0.30, and 0.57 per pt-year, respectively. EAIRs of any AEs leading to discontinuation were 0.14, 0.11, and 0.16 per pt-year. Rates of adjudicated drug-related interstitial lung disease (ILD)/pneumonitis by CR, PR, or SD/PD were similar: 12.1% (n=7, all Grade 1/2), 11.9% (n=32, all Grade 1/2), and 12.2% (n=6, two Grade 5), respectively. Pts with a CR had a longer median time to first onset of ILD/pneumonitis (484 days [d] [range 84–967]) than those with a PR (227 d [17–1028]) or SD/PD (99 d [37–211]). Conclusions: In this exploratory analysis of DESTINY-Breast09, achieving a durable CR or PR was associated with favorable PFS outcomes and prolonged treatment duration. Complete response or maximum tumor reduction (nadir) was achieved with sustained T-DXd + P treatment. Safety findings were consistent with previously reported profiles of T-DXd and P. Clinical trial information: NCT04784715 . CR(n=58) PR(n=268) SD/PD(n=51) Median DOR, mo (95% CI)* NC 39.2 (34.8, NC) – Median PFS, mo (95% CI)* NC 40.7 (36.0, NC) 13.0 (4.0, 25.7) 6-mo PFS rate, % (95% CI) 100 (100, 100) 97.7 (95.0, 99.0) 57.2 (41.2, 70.4) 12-mo PFS rate, % (95% CI) 94.8 (84.8, 98.3) 89.8 (85.4, 92.9) 51.9 (35.9, 65.7) 24-mo PFS rate, % (95% CI) 85.1 (72.2, 92.3) 72.9 (66.6, 78.2) 35.5 (21.1, 50.2) *Calculated by Kaplan-Meier technique. NC, not calculable.
Novel myeloma therapy utilization in digital health advocacy users: A large US cohort analysis of >1,500 patients.
11189 Background: Real-world data consistently demonstrates that access to novel myeloma therapies (CAR-T and Bispecific Antibodies [BsAb]) is restricted by "classic" disparities, including lower income, rural geography, and distance from academic medical centers. However, evidence suggests that strong institutional support and patient navigation can mitigate these factors. While direct-to-patient platforms remain underexplored, high digital engagement—driven by education and medical data ownership—are hypothesized to mitigate traditional barriers. To evaluate this, the HealthTree Registry was queried to determine if its engaged cohort exhibits the disparities observed in the general population. Methods: A total of 1,519 Multiple Myeloma patients, diagnosed after 2014, and who connected their Electronic Health Records (EHR) and provided survey data within the HealthTree, were originally extracted. Line of treatment data was extracted from clinical plan and progress notes. Eligibility for novel therapies was retrospectively determined based on FDA approval criteria (lines of therapy and dates). Utilization rates comparisons against demographic variables using Chi-square and ANOVA tests. Results: Among the cohort, 277 patients were eligible for CAR-T and 91 for BsAbs. Contrary to general population trends, digital engagement appeared to neutralize classic socioeconomic barriers. We found no significant difference in novel therapy utilization based on median zipcode income (Users: $103k vs. Non-Users: $95k, p = 0.88), distance to clinic (p = 0.64), or rural/urban status (p = 0.808). Utilization rates: 30% (84/277) of eligible patients received CAR-T compared to 54% (49/91) for BsAbs. Patients receiving novel therapies had a mean age of 65.9 years and initiated treatment 3.7 years after diagnosis. BsAbs were utilized later in the disease course (Mean Line of Therapy [LOTs]: 6.0) compared to CAR-T (Mean Line of Therapy: 4.8), due to FDA eligibility criteria restrictions. CAR-T utilization was high during early LOTs (2-4) at 48%. While economic and geographic barriers were mitigated, a significant gender disparity emerged in continuous therapy usage. For BsAbs, 66% (33/50) of eligible men received therapy, compared to only 39% (16/41) of eligible women (p = 0.018). No gender difference was observed for CAR-T (p = 1.0). Conclusions: In this cohort, although a greater proportion of patients met eligibility criteria for CAR-T than for BsAb, eligible patients were more likely to initiate BsAb treatment. However, digital engagement of patients facilitated early use of CAR-T therapy and reduced traditional barriers like distance and income, which may be less limiting than previously thought. In contrast, a pronounced gender disparity in BsAb therapy utilization suggests that continuous therapies may impose a disproportionate logistical burden on eligible female patients.
Ivonescimab plus gemcitabine/cisplatin and stereotactic body radiotherapy as first-line treatment for advanced biliary tract cancer: A single-arm, open-label, phase II exploratory study.
e16170 Background: Although gemcitabine/cisplatin (GC) plus immunotherapy is now standard first-line treatment for advanced biliary tract cancer (BTC), efficacy remains limited with survival outcomes still failing to meet clinical needs. Ivonescimab (AK112), a novel PD-1/VEGF bispecific antibody, exerts synergistic antitumor activity by simultaneously blocking PD-1 and VEGF pathways. This study aimed to evaluate the efficacy and safety of AK112 combined with GC and stereotactic body radiotherapy (SBRT) as a first-line treatment for advanced BTC. Methods: This prospective, single-arm, open-label, phase II exploratory study enrolled patients with histologically or cytologically confirmed locally advanced or metastatic BTC deemed unresectable by both radiologic evaluation and surgical assessment, with no prior systemic therapy. Patients first received SBRT to the primary tumor (18–60 Gy in 3–8 fractions), followed within one week by ivonescimab (20 mg/kg, Q3W) combined with GC (gemcitabine 1000 mg/m², D1 and D8; cisplatin 25 mg/m², D1 and D8; Q3W) for up to 8 cycles, then ivonescimab maintenance therapy (up to 24 months). The primary endpoint was ORR per RECIST v1.1 and mRECIST. Secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety. Results: As of December 18, 2025, 22 patients were enrolled. Median age was 63 years (range: 47–72), and 68.2% (15/22) were male. Tumor types included intrahepatic cholangiocarcinoma in 15 patients (68.2%) and gallbladder cancer in 7 patients (31.8%); 86.4% (19/22) had distant metastases. Twenty patients completed at least one radiologic assessment (1 lost to follow-up, 1 still on treatment). Per RECIST v1.1, CR in 0 (0.0%), PR in 11 (55.0%), SD in 7 (35.0%), and PD in 2 (10.0%). The ORR was 55.0% (11/20) and DCR was 90.0% (18/20). Based on mRECIST, 15 patients were evaluable, with a CR rate of 0%, ORR of 60.0% (9/15), and DCR of 86.7 % (13/15). All patients (21/22, 95.5%) experienced treatment-related adverse events (TRAEs). Grade ≥3 TRAEs occurred in 36.4% (8/22), mainly including leukopenia/neutropenia (18.2%), hyperbilirubinemia (13.6%), thrombocytopenia (9.1%), intestinal obstruction (9.1%), elevated transaminases (4.5%), and esophageal ulcer (4.5%). No treatment-related deaths occurred. Conclusions: Ivonescimab combined with GC chemotherapy and SBRT as first-line treatment for advanced BTC demonstrated encouraging antitumor activity with a manageable safety profile. This combination regimen may represent a promising new treatment option for patients with advanced BTC and warrants further validation in larger studies. Clinical trial information: ChiCTR2400088480.
Text-based electronic patient-reported outcome monitoring in oncology: A 180-day longitudinal analysis of symptom burden changes in 701 cancer patients.
11113 Background: Digital electronic patient-reported outcome (ePRO) systems promise to improve symptom management in oncology, yet evidence demonstrating sustained clinical benefit across diverse cancer populations remains limited. This study evaluated the longitudinal effectiveness of a text-based ePRO platform delivering weekly validated symptom assessments in reducing overall symptom burden among cancer patients over 180 days. Methods: This retrospective study consisted of 701 patients with cancer recruited between 2022–2025. The patients were eligible if they were on the platform for at least 90 days, completed the baseline survey within 14 days of enrollment, and had a survey completion rate of at least 30%. ePRO responses triggered review by a virtual care team that provided protocolized symptom management outreach and triage in collaboration with treating oncology practices. The primary outcome was the change in overall symptom burden over 180 days, measured by the Edmonton Symptom Assessment System (ESAS; total score 0–90). Secondary outcomes included physical symptoms (0–60), emotional symptoms (0–20), and well-being (0–10). Stratified analyses were done using paired t-tests. Results: The final cohort (mean age 64.6 years; 57.2% female; 20.5% metastatic; mean adherence 66.1%) demonstrated significant reduction in total symptom burden (20.99 to 18.11 points; -2.89 points, -13.7%, p < 0.001) and physical symptoms (14.86 to 12.18 points; -2.68 points, -17.0%, p < 0.001). Emotional symptoms and well-being showed no significant change. Efficacy was engagement-dependent: high-engagement patients (N = 465) achieved -2.80-point reduction (p < 0.001) versus non-significant changes in medium/low-engagement groups. Stratified analyses revealed heterogeneity: breast cancer patients demonstrated exceptional response (-8.96 points, -46.3%, p = 0.008), while GI cancer patients showed resistance (-0.43 points, p = 0.915). Non-metastatic patients (-3.06 points, p < 0.001), females (-3.27 points, p < 0.001), and patients aged < 50 years (-4.28 points, p = 0.011) demonstrated superior outcomes compared to metastatic, male, and elderly (≥75 years) patients. Conclusions: Text-based digital ePRO monitoring significantly reduced symptom burden in cancer patients over 180 days, with physical symptom improvement as the primary driver. Clinical benefit was engagement-dependent and varied substantially by cancer type, metastatic status, age, and gender. These findings validate the clinical utility of SMS-delivered ePRO systems while identifying highly responsive populations (breast cancer, non-metastatic, younger patients) and vulnerable subgroups requiring enhanced symptom management support.
Phase II clinical study of ACT001 combined with radiotherapy in newly diagnosed pediatric diffuse intrinsic pontine glioma.
2074 Background: Diffuse intrinsic pontine glioma (DIPG) is an extremely lethal type of malignant tumor in the central nervous system of children. Currently, standard radiotherapy has limited efficacy, and there is an urgent need to explore novel therapeutic regimens. This study aims to evaluate the safety and efficacy of ACT001, a novel blood-brain barrier-permeable agent, combined with standard radiotherapy in the treatment of newly diagnosed pediatric DIPG. Methods: This open-label, single-arm, multicenter phase II trial enrolled 5–15-year-old patients with newly diagnosed DIPG. Patients received radiotherapy ( 54 Gy/30 fractions) plus ACT001 (700 mg/m² BID orally, fasting) for 6 weeks (concurrent phase), followed by ACT001 maintenance until progression/toxicity. The primary endpoints were objective response rate (ORR) and overall survival (OS), while the secondary endpoints included progression-free survival (PFS), 1-year OS rate, and safety. Statistical analyses used Kaplan-Meier and Cox regression. Results: A total of 41 patients were screened, with 33 included in the full analysis set (FAS). Thirty-one patients completed the concurrent phase and were included in the per-protocol (PP) set. The median age was 8 years; 18.2% (6 cases) were biopsy-confirmed (83.3% harboring the H3K27M mutation) and 81.8% (27 cases) were radiologically diagnosed. In the FAS, ORR was 30.3% (10 partial responses [PR]), and the disease control rate was 75.8%; 21.2% (7 cases) in the PP set achieved >50% tumor reduction in pontine lesions. Median OS was 12.7 months (95% CI: 8.7–NA) with a 1-year OS rate of 50.1%; median PFS was 5.9 months (95% CI: 4.3–7.8) with a 6-month PFS rate of 45.3%. Multivariate analysis showed a higher baseline Lansky score was a favorable prognostic factor for OS (HR=0.899, P=0.0069), and achieving PR was favorable for PFS (HR=0.232, P=0.0162). Nineteen patients received salvage therapy post-progression; those undergoing re-irradiation had a median OS of 17.9 months, significantly better than non-re-irradiated patients (P=0.031). Ninety-six point nine percent (32/33) of patients experienced treatment-related AEs (mostly grade 1–2). The incidence of grade ≥3 AEs was 18.2%, with the most common being lymphopenia, weight loss, and upper respiratory tract infection (each 6%). No treatment-related deaths occurred, and no patients discontinued ACT001 due to toxicity. Additionally, 96.9% (31/32) of patients had improved or stable Lansky scores post-treatment. Conclusions: ACT001 combined with standard radiotherapy exhibits certain antitumor activity in the treatment of newly diagnosed pediatric DIPG, with improved OS compared to historical data, as well as a manageable safety profile and good tolerability. This regimen provides a new treatment option for pediatric DIPG and warrants further verification in larger-scale randomized controlled trials. Clinical trial information: ChiCTR2300074598.
Cerebrospinal fluid biomarker profiling in patients with non–small cell lung cancer and leptomeningeal disease.
2026 Background: Cerebrospinal fluid (CSF) cytology remains the standard for diagnosing leptomeningeal disease (LMD) and monitoring treatment response, but its clinical utility is limited by low sensitivity and nonquantitative results. The role of novel CSF biomarkers, such as circulating tumor cells (CTCs), in improving disease assessment in non–small cell lung cancer (NSCLC) with LMD is not fully defined. Methods: We performed retrospective clinical and genomic analysis of patients with NSCLC and LMD who underwent CSF CTC testing using the CellSearch platform at Memorial Sloan Kettering between 1/1/2015 and 11/5/2025. Time-to-event analyses were calculated from initial positive CSF CTC measurement (≥3 cells/3mL) or from completion of proton craniospinal irradiation (pCSI). Optimal CTC cutoffs were determined using recursive partitioning analysis (RPA). CSF cytologic clearance was defined as an initial positive cytology followed by two consecutive negative results at least 4 weeks apart. Next-generation sequencing was performed using MSK-IMPACT. Results: Among 148 patients with NSCLC and LMD, 72% (n=105) were female, 53% (n=78) were never-smokers, and 92% (n=136) harbored an oncogenic driver alteration, most commonly epithelial growth factor receptor ( EGFR) mutations (60%, n=89). Fourteen percent (n=20) were diagnosed with LMD at time of metastatic disease, whereas 54% (n=80) had received 2 or more prior lines of therapy. Sixty-two percent (n=92) received radiation therapy for LMD, including 43% (n=64) undergoing pCSI and 18% (n=26) undergoing photon radiation (involved field radiation therapy [IFRT] to brain/spine, n=10; whole brain radiation therapy [WBRT] alone, n=10; WBRT + IFRT to spine, n=4; photon CSI, n=2). With a median follow-up of 21.6 months (95% CI 16.2–37.9), patients with a lower baseline CSF CTC count (≤90 CTCs/3mL, n=66; cutoff identified through RPA) had longer median overall survival (mOS; 10.2 vs 6.6 months; HR 0.53, 95% CI 0.35–0.79; p=0.002) compared with those with higher counts (>90 CTCs/3mL, n=82). Among patients who underwent pCSI with serial CSF testing (n=34), a ≥30% reduction in CTCs was associated with a longer mOS (13.1 vs 6.2 months; HR 0.15, 95% CI 0.05–0.47; p=0.0001) compared with those with <30% reduction; only 12% (n=4) achieved CSF cytologic clearance. In EGFR- mutant NSCLC, genomic analysis of CSF samples with higher baseline CTC count (>90 CTCs/3mL, n=24) demonstrated a higher frequency of TP53 (p=1.559e-3) and MTAP (p=8.31e-3) alterations, and a lower frequency of MDM2 (p=0.05) alterations, compared to patients with lower baseline CTC counts (≤90 CTCs/3ml, n=23). Conclusions: Lower baseline CSF CTC counts and reductions following pCSI are associated with improved survival in patients with NSCLC and LMD. CSF CTC assessment provides a quantitative measure of LMD burden and may complement conventional CSF cytology.
Treatment pathway utilization after endoscopic ultrasound in pancreatic cancer.
e16366 Background: Pancreatic malignancies, primarily pancreatic ductal adenocarcinoma (PDAC) with a smaller proportion of pancreatic neuroendocrine tumors (pNETs), have rising incidence and high mortality. In the United States, 5-year survival remains about 12–13% overall and ~44% for localized disease, though most patients present beyond a curable stage. Diagnosis relies on multimodal imaging and EUS-guided tissue acquisition, with growing use of FNB needles to improve yield. Delays between cross-sectional imaging and endoscopic ultrasound (EUS) may influence access to definitive therapy. This study assessed whether the imaging-to-EUS interval is associated with downstream time to treatment and overall treatment uptake. Methods: We performed a retrospective cohort study using the TriNetX United States Collaborative Network. Adults with pancreatic cancer (ICD-10 C25.x) who had an abnormal imaging code (R93.x) and underwent EUS within 90 days were included. Patients were grouped by imaging-to-EUS interval: ≤1 week, 1–2 weeks, 2–4 weeks, and 4–12 weeks. Primary outcomes were time from EUS to initiation of chemotherapy or pancreatectomy within 365 days. The secondary outcome was entry into any treatment pathway. Comparisons between academic and non-academic centers were descriptive. Results: A total of 4,669 patients met criteria. The median imaging-to-EUS interval was 8 days and similar across center types. Median time from EUS to chemotherapy was stable across groups (26–30 days). In contrast, median time from EUS to pancreatectomy increased with later EUS (32 days when performed within 1 week vs 46 days when performed 4–12 weeks after imaging). The proportion without a documented treatment pathway rose with delay (46.7% at 1–2 weeks vs 56.2% at 4–12 weeks). Earlier EUS, particularly within 2 weeks, was associated with higher treatment uptake and shorter time to surgery. Conclusions: Earlier EUS after index imaging was associated with faster initiation of surgical therapy and greater likelihood of entering any treatment pathway, while time to chemotherapy remained largely stable across timing windows. These findings support diagnostic timeliness, particularly rapid-access EUS and high-yield tissue acquisition, as an actionable lever to expedite definitive care in pancreatic cancer. Time to treatment following endoscopic ultrasound (EUS), stratified by the interval from imaging to EUS. EUS timing N No Pathway n (%) Treatment n Median (days) Mean ± SD (days) Min Max ≤1 week 2,012 1,009 (50.1%) Chemotherapy 722 27 38.794 ± 40.373 1 305 Pancreatectomy 178 32 67.758 ± 76.014 2 357 1-2 weeks 895 418 (46.7%) Chemotherapy 345 26 37.771 ± 38.080 1 274 Pancreatectomy 83 49 69.795 ± 68.037 3 348 2-4 weeks 821 408 (49.7%) Chemotherapy 276 30 44.656 ± 48.266 2 352 Pancreatectomy 95 43 67.768 ± 68.008 3 298 4 weeks-3 months 941 529 (56.2%) Chemotherapy 237 29 50.907 ± 58.838 1 348 Pancreatectomy 106 46 77.264 ± 77.004 1 348
The burden of breast cancer among women aged ≥70 years: Global trends in DALYs and mortality by socio-demographic index, 1990–2023.
e12700 Background: Breast cancer remains a major public health concern with high morbidity and mortality worldwide, particularly among women aged ≥70 years. Despite advances in diagnosis, treatment, and prevention, substantial disparities in DALYs and mortality persist across socio-demographic index (SDI) regions. Methods: Data from GBD 2023 were used to assess Disability Adjusted Life Years (DALYs) and mortality rates per 100,000 population in women aged ≥70 years. Analyses were stratified by SDI groups (low, low-middle, middle, high-middle). Joinpoint regression estimated trends, and AAPC with 95% CI was calculated; p < 0.05 indicated significance. Results: From 1990 to 2023, the consistently higher rates in DALYs were observed in the middle SDI group, with rates rising from 120.79 in 1990 to 299.32 in 2023 (AAPC: 2.83; 95% CI: 2.74 to 2.91; p < 0.000001). This was followed by the low-middle SDI group, which showed a continuous increase in DALYs from 117.09 in 1999 to 297.63 in 2023 (AAPC: 2.87; 95% CI: 2.66 to 3.09; p < 0.000001). The low SDI group demonstrated comparatively lower rates; however, DALYs still rose markedly from 114.47 in 1999 to 262.25 in 2023 (AAPC: 2.52; 95% CI: 2.32 to 2.72; p < 0.000001). The high-middle SDI group also experienced a modest but comparatively lower increase, with DALYs rising from 143.67 in 1990 to 230.74 in 2023 (AAPC: 1.46; 95% CI: 1.30 to 1.62; p < 0.000001). A similar pattern was noted in mortality trends. From 1980 to 2023, the middle SDI group exhibited the highest mortality rates, increasing from 5.02 in 1980 to 14.88 in 2023 (AAPC: 2.59; 95% CI: 2.52 to 2.66; p < 0.000001). The low-middle SDI group followed, with mortality rising from 4.82 in 1980 to 14.26 in 2023 (AAPC: 2.58; 95% CI: 2.28 to 2.87; p < 0.000001). The low SDI group recorded lower but steadily increasing rates, from 4.84 in 1980 to 11.73 in 2023 (AAPC: 2.08; 95% CI: 1.90 to 2.26; p < 0.000001). The high-middle SDI group showed the smallest relative rise, with mortality increasing from 6.46 in 1980 to 11.69 in 2023 (AAPC: 1.38; 95% CI: 1.23 to 1.53; p < 0.000001). Conclusions: Breast cancer in women aged ≥70 years remains a significant global health burden, with the highest impact in middle and low-middle SDI regions. Strengthening geriatric-focused screening, timely diagnosis, and equitable treatment strategies is critical to reduce disease burden in this population. Average annual percentage changes (AAPC) for mortality rates and disability adjusted life years (DALYs) rates for each region. Mortality Rates per 100,000 Disability Adjusted Life Years (DALYs) per 100,000 Region AAPC Region AAPC Low SDI 2.0817* Low SDI 2.5255* Low-middle SDI 2.5810* Low-middle SDI 2.8792* Middle SDI 2.5916* Middle SDI 2.8313* High-middle SDI 1.3828* High-middle SDI 1.4662* *Shows that the trend was statistically significant at alpha = 0.05.
The role and mechanism of tertiary lymphoid structure and its associated B cells in the resistance of immune checkpoint inhibitor therapy in acral melanoma.
e14591 Background: Recently studies have suggested that TEX, TLS and B cells are associated with prognosis and sensitivity to ICI therapy in a variety of tumors. Based on these findings, we propose to utilize the previously collected AM and CM samples with different ICI therapy responses to explore the mechanism of ICI therapy resistance of AM by single-cell multi-omics methods. Methods: The subtypes, phenotypes, effector pathways, and regulatory factors of TEX in AM will be detected and investigated. The regional characteristics, cell lineages, maturation levels, and key molecules and signaling pathways of TLS of AM will be detected and analyzed. Classification, BCR clone variations, surface immune checkpoint molecule expression, interactions with other immune cells, and functional regulatory factors of B cells will be explored. Results: 1. TLS Architecture and Maturation: TLS in melanoma exhibit distinct structural organization with a central B-cell zone (CD20+) surrounded by T-cell zones (CD4+, CD8+). Three maturation stages were identified: immature aggregates (Agg), primary follicles (FL1), and secondary follicles (FL2), distinguished by differential expression of CD21 and CD23 markers, with mature TLS showing denser B-cell clusters.2. Prognostic Impact: In a cohort of 174 melanoma patients, the presence and abundance of TLS demonstrated significant prognostic value. Patients with TLS had substantially superior overall survival (OS) and progression-free survival (PFS) compared to those without TLS. Moreover, TLS-rich patients showed better outcomes than TLS-poor patients, with statistically significant differences (p < 0.0001 for OS, p = 0.00021 for PFS).3. Cellular Landscape: Single-cell transcriptomic analysis of 22 patients revealed that TLS-high (TLShi) tumors were enriched in T and B cells, while showing reduced proportions of melanoma cells and endothelial cells compared to TLS-low (TLSlow) tumors.4. Spatial Validation: Stereo-seq spatial transcriptomics confirmed the precise localization of TLS through integrative analysis of histopathology (HE/IHC) and computational deconvolution. TLS signature gene sets accurately colocalized with anatomically defined TLS structures, validating the molecular characterization. Conclusions: This study provides compelling evidence that TLS serve as a robust positive prognostic biomarker in melanoma. The correlation between TLS abundance and improved survival suggests that TLS actively contribute to anti-tumor immunity. The multi-omics approach successfully mapped the spatial architecture and cellular composition of TLS, establishing a foundation for understanding their functional role in the melanoma microenvironment and potential therapeutic targeting.
Fine-scaled genomic ancestry clusters to reveal population-specific cancer enrichments in the All of Us Research Program.
10514 Background: Specific populations exhibit known enrichments for certain cancers, such as breast cancer (BC) in Ashkenazi Jewish individuals. However, identification typically relies on self-reported race or broad continental genomic labels, which can obscure risks in understudied or admixed U.S. populations. Methods: Using All of Us (AOU) v8 (n=415k), participants with electronic health records (EHR) and whole-genome sequencing (WGS) were grouped into clusters based on genomic segments identical by descent. Clusters were labeled using genomic and anthropological references. We curated clinical data to remove duplicate or mislabeled entries (e.g., misidentifying metastatic lesions as primary tumors). Enrichment was determined via logistic regression, adjusting for age, sex, BMI, socioeconomic status, smoking, and recruitment site, with correction for multiple hypothesis testing using Benjamini-Hochberg. Results: A total of 245k individuals with EHR and quality-controlled WGS were assigned to 58 clusters; 41876 individuals were identified with at least one primary cancer diagnosis, spanning 19 broad types. A non-comprehensive selection of model results are presented in Table 1. These include previously established risks, such as BC enrichment in Ashkenazi-Jewish populations and prostate cancer in African Americans compared to Non-Jewish Europeans (NJE). Other, more novel findings include significant BC enrichment in admixed Hawaiians and colorectal cancer (CRC) in Puerto Rican and Dominican groups (not observed in the African American cluster). While individuals of Mexican ancestry showed lower lung cancer enrichment, this was not consistent in other admixed Hispanic populations, such as Colombians. Conclusions: Fine-scaled genomic clustering identifies cancer risks with higher precision than race-based or broad ancestral statistics. This methodology facilitates the identification of globally rare, potentially pathogenic variants that are enriched within specific subpopulations. These results underscore the necessity of granular ancestry data in understanding the genetic architecture of complex diseases like cancer. Cancer Population Population Case N (%) NJE Case N (%) Odds Ratio (95% CI) q-val BC 1 Ashkenazi Jewish 915 (10.6%) 6.9% 1.33 (1.23-1.44) <0.001 Prostate 2 African American 852 (5.4%) 8.0% 1.51 (1.38-1.65) <0.001 BC 1 Hawaiian <20* (9.4%) 6.9% 2.64 (1.39-5.03) 0.040 CRC Puerto Rican 89 (1.5%) 1.5% 1.54 (1.24-1.93) 0.003 CRC Dominican 81 (1.4%) 1.5% 1.85 (1.32-2.61) 0.008 CRC African American 491 (1.2%) 1.5% 1.16 (1.04-1.30) 0.06 Lung Mexican 95 (0.4%) 1.1% 0.66 (0.53-0.82) 0.005 Lung Colombian <20* (0.7%) 1.1% 0.92 (0.33-2.54) 0.97 1: Percentages only include female participants. 2: Percentages only include male participants. *: Counts of less than 20 are hidden to comply with AoU reporting requirements.
An ongoing phase 1–2a study of EO1001, an oral brain-penetrant pan-ErbB inhibitor, in patients with advanced ErbB-driven solid tumors including CNS disease.
TPS8681 Background: Central nervous system (CNS) metastases and primary brain tumors remain a major cause of morbidity and mortality in patients with ErbB-driven malignancies, particularly as improved systemic therapies prolong survival. Aberrations in the ErbB family of receptor tyrosine kinases—including EGFR, HER2, and HER4—are frequently associated with CNS progression, therapeutic resistance, and poor outcomes across multiple tumor types. In glioblastoma and other CNS malignancies, specific EGFR extracellular domain (ECD) alterations, including EGFRvIII and recurrent ECD missense variants, have been previously reported to promote ligand-independent signaling, invasive tumor biology, and resistance to currently available EGFR-targeted therapies. EO1001 is a novel, oral, irreversible pan-ErbB inhibitor designed to achieve sustained CNS exposure and broad ErbB pathway inhibition. This ongoing Phase 1–2a study is evaluating the safety, pharmacokinetics, and preliminary antitumor activity of EO1001 in patients with advanced ErbB-driven solid tumors, including those with CNS involvement. Methods: This is a first-in-human, multicenter, open-label Phase 1–2a study of once-daily oral EO1001. The Phase 1 dose-escalation component uses an accelerated titration design transitioning to a standard 3+3 schema following the occurrence of ≥Grade 2 treatment-related toxicity. A Phase 2 expansion component is enrolling patients at or below the recommended Phase 2 dose (RP2D). Eligible patients are adults with advanced or metastatic ErbB-expressing solid tumors that have progressed following standard therapy; patients with treated or untreated CNS disease are eligible. EO1001 is administered once daily in 28-day cycles following an initial single-dose pharmacokinetic assessment. The primary objectives are to evaluate safety and tolerability and to determine the RP2D. Secondary objectives include characterization of the pharmacokinetic profile and assessment of preliminary antitumor activity using RECIST v1.1 and/or RANO criteria, as appropriate. Exploratory objectives include evaluation of pharmacodynamic and molecular biomarkers in available tissue and optional cerebrospinal fluid sampling to further assess CNS exposure and pathway modulation. Current Status: Dose escalation has been completed across multiple dose levels, and enrollment is ongoing in Phase 2 expansion cohorts designed to further characterize safety, pharmacokinetics, and CNS-directed antitumor activity at biologically active dose levels. Clinical trial information: ACTRN12620000583943.
Terminal admission phenotypes and inpatient mortality in gastrointestinal malignancies: A national analysis of U.S. hospitalizations, 2018–2023.
e23231 Background: Inpatient mortality in gastrointestinal (GI) malignancies is often reported as a binary outcome, limiting insight into acute pathways preceding death. We characterized terminal admission phenotypes among hospitalized adults with GI cancers and quantified their national prevalence, resource utilization, and variation by cancer site and hospital characteristics. Methods: We conducted a survey-weighted cross-sectional analysis of the National Inpatient Sample (NIS), 2018–2023. Adult hospitalizations (≥18 years) with any-diagnosis GI malignancy (ICD-10-CM C15–C26) were included; terminal admissions were defined by in-hospital death. Terminal hospitalizations were hierarchically classified into mutually exclusive phenotypes using diagnosis-based groupings and utilization proxies: sepsis/infection, respiratory failure/ARDS, bleeding/anemia, cachexia/malnutrition/dehydration, hepatic failure, bowel obstruction/perforation, procedure-associated, ICU escalation without procedure, and other/unclassified. Cancer site was assigned using the principal diagnosis when available, with any-diagnosis fallback. Outcomes included phenotype prevalence, length of stay, hospitalization cost, ICU escalation, and procedure utilization. All estimates incorporated NIS stratification, clustering, and discharge weights, with 95% confidence intervals (CI). Results: GI malignancies accounted for 1.98% of U.S. hospitalizations (weighted mean 0.0198, 95% CI 0.0196–0.0200), representing 221,090 weighted inpatient deaths from 44,218 unweighted terminal admissions. Terminal phenotypes were dominated by sepsis/infection (51.9%, 95% CI 51.3–52.5), followed by respiratory failure/ARDS (12.8%, 95% CI 12.5–13.2), bleeding/anemia (10.1%, 95% CI 9.83–10.41), cachexia/malnutrition/dehydration (7.91%, 95% CI 7.62–8.22), and hepatic failure (5.94%, 95% CI 5.72–6.17). Distributions varied by cancer site, with hepatic failure prominent in hepatocellular/liver cancer (14.9%, 95% CI 14.1–16.0) and respiratory failure/ARDS in esophageal cancer (18.0%, 95% CI 16.9–19.2). Mean LOS and costs were highest for sepsis/infection (9.28 days, 95% CI 9.10–9.46; $43,357, 95% CI $42,041–$44,672). ICU escalation was common in sepsis/infection (42.9%, 95% CI 42.3–43.6) and bleeding/anemia (45.5%, 95% CI 44.0–47.0), but infrequent in cachexia/malnutrition/dehydration (6.86%, 95% CI 6.01–7.72). Conclusions: Inpatient mortality among hospitalizations involving GI malignancies reflects a limited set of terminal admission phenotypes, most often acute infectious, respiratory, bleeding, and nutritional complications. These phenotypes show distinct utilization patterns and vary by cancer site and hospital type, supporting a phenotype-based framework for identifying potentially modifiable acute-care pathways.
Whole-genome sequencing–based ctDNA testing for post-surgical monitoring and early detection of recurrence or progression in uterine cancer.
5623 Background: Reliance on clinicopathologic risk factors to guide adjuvant therapy in early-stage uterine cancer (UC) has not improved survival, underscoring the need for biomarkers for post-treatment monitoring. In this study, we evaluate ctDNA as a prognostic biomarker using a whole-genome sequencing (WGS)–based assay in the post-surgical UC setting. Methods: We performed a retrospective analysis of clinically annotated residual samples from commercial ctDNA testing in 118 patients diagnosed with UC. Signatera Genome assays (Natera, Inc.) were designed from the WGS data of matched tumor tissue and normal blood samples to detect and quantify ctDNA in serially collected post-operative plasma. Descriptive statistics were used to compare association of ctDNA across stages and timepoints. Results: Among 118 UC patients, 20/118 were metastatic and excluded from analysis. Of the remaining 98 patients, 77 had stage I and 21 had stage II-III disease. Median clinical follow-up was 11.2 months (range: 0.8–33.2) with 13% (13/98) of patients having recurrence/progression within a median of 8.5 (range: 3.9-25.1) months from surgery. ctDNA analysis was performed across 1004 total tests with a median of 8 tests per patient (range: 2–16) and a median testing cadence of 2.9 (range: 0-12.7) months. Post-surgical ctDNA assessment (2–8 weeks post-operatively) was available for 35 stage I patients with a ctDNA detection rate of 9% (3/35). Focusing on the 32 patients with >12 months of postoperative clinical follow-up, one patient was ctDNA-positive postoperatively and recurred 7.2 months after surgery. Among the ctDNA-negative patients (N=31), 84% (26/31) remained serially negative with no evidence of recurrence at a median clinical follow-up of 26.3 (range: 13.5-38.7) months post-surgery. The remaining ctDNA-negative patients (N=5) converted to positive during longitudinal monitoring, all subsequently experiencing recurrence/death. Longitudinal ctDNA detection rate during surveillance was 32.1% (25/78) in stage I and 47.6% (10/21) in stage II-III. Of the stage I patients with recurrence (N=8), 100% were ctDNA-positive prior to or at the time of the clinical finding, with a median lead time of 5.2 (range: 1.2–15.8) months. Similarly, in stage II-III patients with recurrence/progression (N=5), 100% were ctDNA-positive prior to the clinical finding with a median lead-time of 6.07 (range: 4.1-23.7) months. Conclusions: ctDNA positivity postoperatively identifies UC patients at increased risk of recurrence/progression, often preceding clinical relapse by several months. Serial ctDNA negativity using a tumor-informed, WGS-based ctDNA assay correlated with absence of recurrence. Postoperative longitudinal ctDNA monitoring shows promise as a clinically actionable biomarker to guide adjuvant treatment decisions and improve post-operative surveillance.
Efficacy of surgical glove-compression therapy as a prevention of paclitaxel-induced peripheral neuropathy: Randomized controlled trial.
12131 Background: Paclitaxel is a common cause of chemotherapy-induced peripheral neuropathy (CIPN), a dose-limiting toxicity for which no preventive intervention is currently recommended. This randomized controlled trial evaluated the efficacy of surgical glove-compression therapy (SGCT) in preventing paclitaxel-induced peripheral neuropathy. Methods: Patients with solid malignancies scheduled to receive paclitaxel every three weeks were randomized 1:1 to SGCT or placebo. SGCT consisted of bilateral double-layer surgical gloves one size smaller than patient’s hand size, covered with outer cotton gloves, worn from 30 minutes before paclitaxel infusion until 30 minutes after completion. The placebo group wore non-compression gloves with identical cotton gloves for the same duration. Patients were followed for four cycles of paclitaxel. The primary endpoint was the incidence of paclitaxel-induced sensory neuropathy of Common Terminology Criteria for Adverse Events (CTCAE) version 6.0 grade ≥2. Secondary endpoints included Patient Neurotoxicity Questionnaire (PNQ) grade ≥D, Functional Assessment of Cancer Therapy–Gynecologic Oncology Group–Neurotoxicity (FACT/GOG-NTX) scores, and loss of protective sensation assessed by monofilament testing. Analyses were conducted using the intention-to-treat approach. Sensitivity analyses included per-protocol analysis and treatment effect adjustment for important prognostic factors for CIPN. Results: Between November 2024 and November 2025, 39 patients were randomized to SGCT (n=19) or placebo (n=20). Most patients were female, had breast cancer, and received single-agent paclitaxel. In the intention-to-treat analysis, sensory CIPN grade ≥2 occurred significantly less frequently in the SGCT group than in the placebo group (26.3% vs. 60.0%; p=0.034). This finding was consistent in the per-protocol analysis (27.8% vs. 66.7%; p=0.019). The protective effect of SGCT remained statistically significant after adjustment for sex, cancer type, and chemotherapy regimen (adjusted OR 0.10; 95% CI, 0.02 to 0.58; p=0.010). No significant differences were observed in secondary outcomes, including motor CIPN, PNQ grade ≥D, monofilament test abnormalities, or FACT/GOG-NTX scores. Any-grade sensory CIPN was common and did not differ between groups. SGCT was well tolerated, with no serious adverse events and high adherence. Conclusions: SGCT significantly reduced the incidence of clinically meaningful paclitaxel-induced sensory neuropathy and was safe and well-tolerated. These findings support SGCT as a simple, low-cost preventive strategy for CIPN. Clinical trial information: NCT06763575 .
Post-treatment recovery patterns among patients with early-stage cancer who develop taxane-induced peripheral neuropathy (TIPN): SWOG S1714 (NCT03939481).
12117 Background: The primary analysis of S1714 developed and validated a TIPN risk prediction model including 5 clinical risk factors. Recovery patterns of TIPN are not well described. Although some symptoms may improve with time, other symptoms may persist or worsen as a result of permanent nerve damage. We describe the incidence of TIPN over 3 years and report on the post-treatment patterns of TIPN in those individuals who report TIPN at the end of taxane treatment (EOT) as a secondary analysis of S1714. Methods: S1714 enrolled participants > 18 years with Stage I-III primary lung, breast, or ovarian cancer starting treatment with a taxane-based regimen for a planned duration of 8 to 18 weeks. Participants were followed over the course of 3 years and assessed for TIPN using the patient-reported EORTC QLQ-CIPN20, which is composed of 3 subscale scores reported from 0-100, with increasing scores representing worse TIPN. EOT TIPN was defined as an increase in the CIPN20 sensory subscale score of ≥8 points from pre-treatment to EOT. Results: Among 1336 enrolled patients, N = 1321 were evaluable: Median age 55.7 years (range 23-85), 98.9% female, 11.3% Black/4.5% Asian/10.5% Hispanic/Latino, 90.7% with breast cancer. Paclitaxel was administered to 60.3% and docetaxel to 39.7%; 98.4% planned to start treatment with full dose of taxane. EOT TIPN was reported in 553 participants (41.9%). We identified 3 patterns of TIPN in these 553 participants over the 3 year period using the EOT CIPN20 sensory score as the reference. Improvement in TIPN from EOT was seen in 268 participants (48.5%), defined as a decrease of ≥8 points from the EOT CIPN20 sensory score. Stable TIPN was seen in 187 participants (33.8%), defined as < 8 point increase or decrease from the EOT CIPN20 sensory score. Worsening of TIPN from EOT was seen in 98 participants (17.7%), defined as an increase of ≥8 points from the EOT CIPN20 sensory score. Of the 553 individuals with TIPN at EOT, 283 (51.2%) still had clinically meaningful TIPN at 3 years compared to the baseline pre-treatment CIPN20 sensory score (defined as increase in CIPN20 sensory score > 8 points from pre-treatment timepoint to final assessment). Conclusions: Among individuals experiencing TIPN at EOT, nearly half experienced clinically meaningful TIPN improvement but almost one fifth had worsening of TIPN by the final 3-year assessment. The identification of clinical and correlative risk factors for persistent or worsening TIPN after completion of taxane treatment will allow for more informed decision-making regarding the long-term risks of taxane treatment and prioritize selection of patients in the investigation of interventions for prevention and treatment of TIPN. Funding: NIH/NCI/NCORP grant UG1CA189974, The Hope Foundation for Cancer Research. Clinical trial information: NCT03939481 .
Trends in ischemic stroke and ischemic heart disease-related mortality among patients with malignancies in the United States: A 25-year CDC-WONDER analysis (1999-2023).
11154 Background: Substantial advances in cancer screening, diagnostics, and therapeutic strategies have improved survival and quality of life. Despite these efforts, cancer-related complications continue to contribute significantly to morbidity and mortality. Malignancies induce a prothrombotic state and substantially increase the risk of venous and arterial thromboembolism. As a result, the patients with cancer have a higher incidence of Ischemic stroke (IS) and ischemic heart disease (IHD) compared to the general population. The greatest risk of these thromboembolic diseases is greatest during the first six months of cancer diagnosis, but remains elevated thereafter. In this study, we sought to assess temporal trends and sociodemographic differences in ischemic stroke and ischemic heart disease related mortality among patients with neoplasms. Methods: We analyzed deidentified CDC WONDER death certificate data to assess malignant neoplasm, (ICD = C00-C97) and ischemic heart disease (ICD = I20-I25) and ischemic stroke (ICD = I63) related mortality in patients of all ages. Age-adjusted mortality rates (AAMR) per 100,000 persons and average annual percent change (AAPC) were calculated and stratified by year, gender, state, urban-rural status, census region, place of death (POD), and age group. Results: From 1999 to 2023, 1235844 deaths were attributed to Ischemic stroke and ischemic heart disease-related deaths in cancer patients. Overall, AAMR decreased from 19.7 in 1999 to 12.9 in 2023 (APC -1.74*, 95% CI: -1.88 to -1.63). Males had higher mortality rates than females throughout the period (23.26 vs 8.88, respectively). Racial analysis showed that non-Hispanic whites had the highest mortality (AAMR: 15.064), followed by Blacks or African Americans (AAMR: 14.24); in contrast, Asians or pacific islanders had the lowest mortality (AAMR: 7.48, data available till 2020). The Midwest region had the highest mortality of all census regions (AAMR: 15.92). Lastly, non-metropolitan areas had higher mortality rates than metropolitan areas (AAMR of 15.75 vs 14.04, respectively). Conclusions: Overall mortality rates in cancer patients with co-morbid ischemic stroke and ischemic heart diseases declined from 1999 to 2023. However, higher mortality rates were observed among men, non-Hispanic Whites, residents of the Midwest, and those living in non-metropolitan areas of the U.S., underscoring the need for targeted public health efforts, and equitable access to cardio-oncology preventive care in these high-risk groups.
Generative adversarial networks for enhanced performance prediction of square CFST members under axial tension
Taking square concrete-filled steel tubular (CFST) members under axial tension as the research object, a three-dimensional mesoscopic finite element model was established based on the experimental results of six specimens. Ten parametric models were further developed to investigate the effects of section size, confinement coefficient, and slenderness ratio on tensile performance. In addition, code-based comparisons and machine learning predictions were carried out. The results indicate that the finite element simulations agree well with the test results, with the ratios of simulation results to test results all being below 0.95, indicating that the simulation predictions are within a reasonable range of the experimental data, which reflects good agreement. The parametric analysis shows that when the confinement coefficient increases from 0 to 0.99, the maximum load rises from 182 kN to 895 kN; when the slenderness ratio increases from 8 to 20, the maximum load exhibits an overall decreasing trend. The code comparison shows that the predictions from the Chinese code are closer to the finite element results, with an average error of approximately 4.57%. To improve prediction accuracy with limited data, a Generative Adversarial Network (GAN)-based data augmentation method was employed. Using both original and WGAN-GP-augmented data, predictive models were developed. Among these models, the Random Forest model achieved the best overall performance. On the augmented test set, the coefficients of determination (R 2 ) for ultimate load and displacement prediction reached 0.997 and 0.9855, respectively. The findings provide a reference for tensile performance analysis and rapid assessment of this type of member, demonstrating the effectiveness of GAN-based data augmentation in enhancing predictive accuracy.