Citations

Background: Colorectal cancer (CRC) remains one of the common causes of cancer-related morbidity and mortality in the United States. Emerging increases in early-onset CRC and persistent disparities remain major public health concerns. Objective: To characterize long-term CRC incidence and mortality trends in the United States, with particular emphasis on identifying demographic groups experiencing rising or plateauing disease burden. Methods: We conducted a population-based ecological study using CRC incidence data from the United States Cancer Statistics database (1999–2022) and mortality data from CDC WONDER (1999–2023). Temporal trends were evaluated using Joinpoint regression to estimate annual percent change (APC) and average annual percent change (AAPC), stratified by age, sex, race/ethnicity, and urbanization level. Results: Overall CRC incidence and mortality declined during the study period (both AAPC approximately −2.08%). However, incidence increased significantly among adults younger than 55 years, particularly those aged 20–24 years. Mortality also increased among younger adults aged 25–44 years and remained elevated among individuals aged 45–54 years. Non-Hispanic Black individuals consistently experienced the highest incidence and mortality rates. Mortality declines plateaued in several older age groups after 2018–2020. Conclusions: Despite overall improvements in CRC burden, increasing incidence and mortality among younger adults and persistent disparities highlight the need for risk-stratified prevention, earlier detection strategies, and tailored therapeutic approaches.

Background/objectives: To develop expert consensus on peripheral venous access devices (PVAD) and associated care practices, and to formulate guidance recommendations aimed at improving peripheral venous access and management, including the integration of vein visualization technology. This is particularly important for patient populations with peripheral venous depletion, who often present with compromised vasculature that complicates successful PVAD access and increases the risk of complications. Preserving vascular integrity in these patients is essential for maintaining treatment pathways and preventing long-term vascular damage. Methods: A multi-phase approach to consensus development was used consisting of the following: (1) a literature review, (2) a survey and consultation with a vascular access expert panel ( n = 9), and (3) a consultation meeting with patient and public representatives ( n = 2). Results: Survey results and consultation findings from the expert panel demonstrated consensus for 14 of 24 statements. Further analysis resulted in a total of four key problem statements on peripheral venous access and care, and 11 recommendations for future development. Following review by patient and public representatives, three additional recommendations were added, and three existing recommendations were refined. The final consensus statement reflects four problem statements with 14 recommendations. Conclusion: This expert consensus presents 14 evidence-informed statements designed to strengthen practice, improve patient safety, and enhance clinician confidence and competence. Central to these recommendations is the adoption of routine structured pre-insertion vessel assessment using vein visualization technology where appropriate to minimize vessel trauma, and promote more consistent, high-quality vascular access care.

TPS655 Background: Early (14-28 day) on-treatment suppression of tumor proliferation during neoadjuvant endocrine therapy (NET) is strongly associated with favorable long-term outcomes in estrogen receptor–positive (ER+) HER2– breast cancer. In premenopausal women, tamoxifen with or without ovarian function suppression (OFS) results in suboptimal Ki-67 suppression compared with aromatase inhibitor + OFS. (Z)-endoxifen (ENDX), the active metabolite of tamoxifen, dually inhibits ER signaling and PKCβ1-mediated AKT activation, supporting its evaluation as an alternative NET strategy in this population. Methods: EVANGELINE (NCT05607004) is an ongoing, multicenter, open-label Phase 2 study evaluating daily 40 mg ENDX plus goserelin administered every 28 days as neoadjuvant therapy in premenopausal women with ER+/HER2–, cT2–3, cN0–1 breast cancer. The primary objective is to determine the proportion of patients with baseline Ki-67 >10% who achieve Ki-67 ≤10% after 4 weeks of therapy. A Simon two-stage design is used to test whether the Week 4 Ki-67 ≤10% rate is at least 65%, with 20 patients enrolled into the first stage and, if promising, another 25 patients enrolled into the second stage (cohort A). A parallel cohort of 20 patients with baseline Ki-67 ≤10% (cohort B) is enrolled to assess objective response rate (ORR) at 24 weeks per RECIST v1.1. Secondary objectives include examining safety and tolerability, residual cancer burden, and PEPI score. Correlative analyses include examining effect of treatment on select tumor and plasma biomarkers. Clinical trial information: NCT05607004 .

TPS5632 Background: Concurrent chemoradiation therapy (CCRT) is the standard of care for locally advanced cervical cancer (LACC); however, outcomes remain suboptimal in patients with high-risk disease. Recent studies suggest that integration of immunotherapy (IO) with definitive chemoradiation, or induction chemotherapy prior to CCRT improves outcomes. Whether treatment intensification with induction systemic therapy and IO prior to CCRT and IO further improves disease control remains unknown. Induction chemotherapy may reduce tumor burden, eradicate micrometastatic disease, and improve tumor immunogenicity prior to definitive CCRT. Preclinical and clinical data support synergy between systemic therapy or radiotherapy and immune checkpoint blockade, providing the rationale for evaluating an induction strategy incorporating chemotherapy and immunotherapy before standard CCRT with immunotherapy, followed by maintenance immunotherapy. Optional tumor tissue and blood samples will be collected for exploratory correlative analyses, including immune and molecular biomarkers associated with response, resistance, and patterns of failure. Methods: NRG-GY037 is a prospective, multi-institutional phase III randomized trial conducted through NRG Oncology. A total of 336 patients will be enrolled (168 per arm). Patients will be stratified by FIGO stage (III vs. IVA) and presence or absence of para-aortic lymph nodes (N2). The primary endpoint is progression free survival (PFS). The study has 90% power to detect PFS hazard ratio of 0.65 in the experimental arm. Treatment: Patients with previously untreated, high-risk LACC are randomized to receive either induction chemotherapy with pembrolizumab for 6 weeks followed by CCRT with pembrolizumab and pembrolizumab maintenance, or standard CCRT with pembrolizumab followed by pembrolizumab maintenance. Major Eligibility Criteria: Eligible patients have histologically confirmed cervical carcinoma (squamous, adenocarcinoma, or adenosquamous), TNM T3 and T4 disease, N0-2, ECOG performance status 0–1, and no prior definitive therapy for cervical cancer. Current Enrollment Status: The trial is actively accruing patients. No efficacy or safety data are available at the time of submission. Clinical Trial Registration: ClinicalTrials.gov identifier: NCT07061977. Clinical trial information: NCT07061977 .

TPS1147 Background: Due to dramatic improvements in neoadjuvant and adjuvant HER2-directed therapy (tx), most patients (pts) with early HER2+ breast cancer are cured. As a result, over half of pts newly diagnosed with HER2+ metastatic breast cancer (MBC) now present with de novo stage IV disease. Anti-HER2 tx has also significantly extended survival for pts with HER2+ MBC, with a subgroup of exceptional responders alive many years (yrs) after diagnosis. However, the paradigm for HER2+ MBC remains non-curative, and pts receive tx indefinitely with significant toxicities and costs. The SAPPHO study is investigating whether an intensification approach of sequential, non-cross resistant anti-HER2 tx followed by tx discontinuation is associated with long-term disease control in pts with HER2+ MBC. Methods: SAPPHO is an open-label, phase II, single-arm trial testing a sequential regimen of non-cross resistant, HER2-targeted tx with curative intent in pts with de novo HER2+ MBC. Eligible pts must have biopsy-proven, de novo MBC with high HER2 expression (3+ by immunohistochemistry). Pts with brain metastases are eligible upon receipt of local tx. Treatment consists of an induction regimen (trastuzumab-pertuzumab-taxane [THP] x 4 cycles, followed by trastuzumab deruxtecan [TDXd] x 6 cycles, followed by trastuzumab emtansine [TDM1]-tucatinib x 4 cycles), followed by a maintenance regimen (HP-tucatinib for 1 yr). Given results from DESTINY-Breast09, the sequence of TDXd-P x 6 cycles followed by THP x 4 followed by TDM1-tucatinib x 4 can be chosen as alternative induction tx per investigator and patient choice. Pts who remain progression-free after completing maintenance will stop all anti-HER2 tx. Endocrine tx will be continued for pts with hormone receptor+/HER2+ tumors. Tumor specimens from breast and a metastatic site are collected at baseline and the end of induction. Serial plasma samples for ctDNA analysis are collected at baseline, during treatment, and during follow-up. The primary endpoint is the probability of being progression-free and off anti-HER2 tx 4 yrs from the start of induction. With a sample size of 72 pts, the study is designed to have 91% power to reject the null hypothesis that the probability of being off anti-HER2 tx and progression-free is less than 24%, with an alternative hypothesis of 40%. Key secondary endpoints are overall survival, overall response rate by modified RECIST 1.1 after induction, and safety. Correlative endpoints include the relationship between ctDNA dynamics and outcomes. Patient-reported outcomes will be analyzed, including quality of life, illness intrusiveness, financial toxicity, anxiety, distress about cancer progression, perception of benefit and risk of progression. SAPPHO began enrollment in Q3 2024, and the study is open at 4 US sites within the Translational Breast Cancer Research Consortium (NCT05721248). Clinical trial information: NCT05721248 .

e24122 Background: Using multiple channels and theory-based recruitment messaging are strategies to enroll diverse audiences in cancer clinical trials (CCTs) and reducing sociodemographic health disparities. 1-7 Customizing recruitment content to participants, such as including race-concordant images (i.e., images that match participants race/ethnicity) and translating information to a community-level (i.e., message framing) is linked to positive health-seeking behavior among minorities and their intention to enroll in clinical trials. 8,9 Drawing on Communication Accommodation Theory and social identity theories, this paper evaluated recruitment channels used to successfully enroll underrepresented participants in CCTs, and preferences for race-concordant images and message framing. Methods: Social media ads, flyers, and postcards were used to recruit rural, African American/Black, and Hispanic adults interested in cancer prevention and screening. Participants ( N = 430, M = 40 years old, SD = 14.47, range 18-85) were recruited to the study with unique links to track the stimuli they viewed, and demographics were collected. Participants viewed one of four images and one of two motivational recruitment message frames. Specifically, given our interest in recruiting rural, African American/Black, and Hispanic populations to CCTs, three images were selected to feature each population, and a fourth Inclusive image featuring all three. Additionally, the person-centered message frame conveyed participating in research is motivated by one’s own benefit, whereas the other-centered frame conveyed motivation for other people’s benefit. Results: In social media ads, across a three-week campaign there were 2,653 clicks on recruitment stimuli ads, resulting in a 6.17% response rate of recruited and enrolled. Across all recruitment channels, enrolled participants engaged with the Inclusive (n = 202) and Black/African American (n = 130) recruitment stimuli the most. In the case of framing, person- (n = 174) and other-centered (n = 199) had similar engagement. Investigating within-race preferences, a chi-square analyses revealed Black/African American participants preference for Inclusive (n = 172) and Black/African American (n = 109) visuals over Hispanic (n = 13) and Rural (n = 17), X 2 (30, N = 419) = 194.94, p < .001; as well as preference for other-centered (n = 180) vs person-centered (n = 129) framing, X 2 (30, N = 419) = 183.95, p < .001. Conclusions: Our findings indicate that Black/African American participants are more likely to interact with race-concordant or sociodemographic inclusive stimuli, and a preference for other-oriented framing. To reduce health disparities in CCT participation, recruitment must avoid monolithic approaches and instead segment outreach by sociolinguistic and social identity factors.

e13677 Background: The development of AI led to the emergence of tools such as AIS, which have been increasingly adopted in medicine. However, formal evaluation of barriers and clinical care gaps in HemOnc is limited, particularly regarding treatment plan complexities and toxicity documentation. Methods: Structured investigator-developed surveys about AIS availability, adoption, benefits, and challenges were developed on Qualtrics and approved by the IRB. HemOnc faculty physicians (FP), advanced practice providers (APP), and trainees (HOT) were surveyed between 11/14/25-1/16/26. Surveys were distributed in the USA via email, social media (on X), and ASCO myConnection. Descriptive statistics were used for analysis. Results: 132 participants responded to the survey: 55 FP (42%), 14 APP (11%), and 63 HOT (48%). 80% of them reported having AIS at their institutions, and 54% of those reported using these tools in their clinical practice. Among FP and APP, 72% practiced in academic settings, 14% in community, and 13% in hybrid centers. Among those not using AIS, identified barriers were issues with note formatting (56%), lack of training (25%), and concerns that the note content is incorrect or inadequate (25%). 60% are willing to use AIS if note formatting matched their preference, and 42% would try it if contents better reflected the patient encounter. Table 1 details the proportion of encounters using AIS, the portion of documentation it was used for, and the perceived challenges with these tools. Among AIS users, the average satisfaction score was 5.3 on a 7 point scale, corresponding to participants being somewhat satisfied. Participants agreed slightly that AIS had reduced their feeling of work-related burnout, with an average score of 3.6 on a 5 point scale. Overall, participants felt neutral about how well-suited AIS are for HemOnc, with an average score of 4.0 on a 7 point scale. Conclusions: Despite AIS being widely available, 46% of the surveyed HemOnc workforce do not use them in clinical practice. Those who do reported decreased time spent on documentation outside work hours and a slight reduction in the feeling of burnout. Formatting issues and record integration remain barriers, with substantial concerns about AIS not adequately describing HemOnc treatment plans. To bridge the last mile of integration into HemOnc, partnership between AIS developers and the clinical workforce is essential to meet clinical needs, while prioritizing patient safety and data privacy. FP + APP % HOT % Patient encounters where AIS is used 62 44 Used AIS for the subjective portion of note 68 96 Used AIS for the assessment/plan portions of note 40 25 AIS decreased the time on clinical documentation outside work hours 96 93 AIS note formatting needs improvement 68 57 Issues integrating AIS and outside records 46 71 AIS note contents about the plan are suboptimal 32 61

e13121 Background: Triple-negative breast cancer (TNBC) lacks reliable prognostic biomarkers beyond standard clinical staging, limiting individualized risk stratification and treatment planning. The neutrophil-to-lymphocyte ratio (NLR), a readily available marker of systemic inflammation, has been proposed as a prognostic indicator in TNBC; however, existing evidence remains inconsistent. We performed an updated systematic review and meta-analysis to evaluate the prognostic value of pretreatment NLR in the contemporary treatment era. Methods: PubMed, Embase, Cochrane CENTRAL, and ClinicalTrials.gov were systematically searched from database inception through January 1, 2026, for randomized and observational studies reporting associations between pretreatment NLR and survival outcomes in TNBC. Two reviewers independently screened studies and extracted data with discrepancies resolved by consensus. Outcomes included overall survival (OS), disease-free survival (DFS), and progression-free survival (PFS). Hazard ratios (HRs) were pooled using random-effects models. Risk of bias was assessed using ROBINS-I tool. Prespecified subgroup and sensitivity analyses were performed based on NLR cut-off values, follow-up duration, geographic region, and risk of bias. Results: Twenty-three retrospective studies comprising 4,731 patients with TNBC were included. On multivariate analysis, elevated pretreatment NLR was independently associated with poorer OS (HR 2.21, 95% CI: 1.56–3.13) and DFS (HR 1.97, 95% CI: 1.65–2.37. Similar associations were observed on univariate analysis (OS: HR 1.70, 95% CI: 1.07–2.72; DFS: HR 1.84, 95% CI: 1.14–2.98). No statistically significant or consistent association was observed between NLR and PFS. Associations between high NLR and adverse OS and DFS remained robust across prespecified subgroup and sensitivity analyses, representing the largest contemporary synthesis of multivariable-adjusted outcomes in TNBC. Key pooled outcome associations are summarized in Table 1. Conclusions: Elevated pretreatment NLR is independently associated with worse OS and DFS in patients with TNBC, supporting its potential role as a low-cost tool for clinical risk stratification and treatment planning. Given its availability from routine blood tests, NLR may assist in identifying high-risk patients who could benefit from intensified surveillance or therapeutic strategies. Prospective validation in the modern chemo-immunotherapy era is warranted. Summary of pooled associations between pretreatment NLR and survival outcomes in TNBC. Outcome Studies (n) Interpretation Overall survival 14 Worse survival Disease-free survival 15 Worse survival Progression-free survival 3 Inconclusive

e12697 Background: Postpartum-associated breast cancer (PABC) has been defined clinically as breast cancer (BC) diagnosed within the first 5 years of the most recent birth. Though generally rare, incidence rates are increasing in conjunction with delayed childbearing and older maternal age at first birth. Currently, there are limited data regarding serial patient-reported outcomes in this patient population compared to non-PABC patients. Methods: Patients with PABC from the Mayo Clinic Breast Disease Registry who completed baseline, 2, and 4-year surveys were matched 1:1 to BC patients whose cancers occurred more than 5 years after their most recent birth (or in the setting of nulliparity) based on age, clinical stage, treatment received, and tumor subtype. Survey results from the Patient Health Questionnaire-2 (PHQ-2), Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10), and Impact of Event Scale-Revised (IES-R) collected at approximately two and four years after diagnosis were compared between PABC and non-PABC patients. Univariable analyses used Wilcoxon rank sum tests, whereas multivariable analyses employed linear regression models adjusting for potential confounding effects. Results: A total of 222 individuals were included (111 with PABC). A higher proportion of individuals in the PABC cohort were married compared to the non-PABC cohort (80% vs. 42%, p < 0.001); otherwise, the groups were well-balanced across multiple categories, including age, gender, race/ethnicity, menopausal status, and germline mutation status. In univariable analyses, the Year 2 composite PHQ-2 score was significantly worse among individuals with non-PABC (p = 0.04), and the non-PABC cohort reported greater difficulty with sleep (p = 0.03) as measured by IES-R at Year 4. Both associations attenuated in a multivariable analysis controlling for marital status. In marital status-adjusted analyses of Year 4 survey results, PABC participants reported greater difficulty in carrying out social activities but were less likely to report emotional distress as evaluated by PROMIS-10 (compared with non-PABC participants). No other variables were significant univariably or multivariably (p > 0.05). Conclusions: In general, quality of life is similar among survivors of PABC compared to those diagnosed with breast cancer outside the postpartum period (or when nulliparous). However, our findings reveal that individuals with PABC are less likely to experience emotional distress 2 and 4 years after the BC diagnosis, which is unexpected, given that postpartum patients typically report higher levels of distress compared to their non-postpartum counterparts. Further investigation into these findings is warranted.

e12691 Background: Breast cancer prognosis is influenced not only by tumor-specific factors but also by systemic inflammatory responses. Elevated circulating neutrophils after surgery may reflect one such systemic inflammatory response that promotes a pro-tumorigenic environment. Neutrophil extracellular traps (NETs) have been recognized as promoters of cancer activity. However, there have been no studies looking at neutrophil count alone as an independent inflammatory marker in cancer. Clinical prognostic significance of post-operative neutrophil counts remains incompletely understood. If proven significant, neutrophil count is a simple, widely available measure to predict post-operative outcomes in patients with breast cancer. Methods: Data from the Mayo Clinic Platform were retrospectively analyzed, including only breast cancer patients with normal BMI and neutrophil counts recorded within one week after breast surgery. Patients who underwent radical mastectomy were excluded. Patients were stratified into two groups based on neutrophil count: high (>7×10⁹/L) and normal (1.7–7×10⁹/L). Clinical outcomes assessed included age distribution and 5-year overall survival. Age differences were evaluated using Cohen’s D, and Kaplan-Meier survival curves and hazard ratio estimation were performed using the Mayo Clinic Platform's tool. Results: A total of 899 patients were included in the study cohort: 303 in the high neutrophil group (Cohort A) and 596 in the normal neutrophil group (Cohort B). Age distributions were comparable between groups (Cohort A mean 59.2 ± 13.1 years; Cohort B mean 59.1 ± 14.3 years; Cohen's d = 0.0079). High neutrophil counts were significantly associated with reduced 5-year survival (77.8% vs. 84.5%) and an increased risk of mortality (HR 1.63; 95% CI: 1.16–2.29; P = 0.0041). Conclusions: Recent literature supports that surgery-induced NET formation may drive metastatic progression. Findings from this retrospective analysis at Mayo Clinic suggest that elevated neutrophil counts after breast cancer surgery are associated with poorer survival and may reflect systemic inflammation. While markers like NLR and NPAR have prognostic value, neutrophil count alone is a practical, accessible biomarker for clinical use. Limitations of this study include potential confounding factors such as lifestyle and comorbidities, and lack of subgroup analysis by breast cancer type, stage, and other treatments in addition to surgery. Further prospective studies are still needed for validation. Five-year survival rate comparison. Statistic High Neutrophil counts Normal Neutrophil counts Patient Count 303 596 1 Month Survival 99% 99.8% 5 Month Survival 97% 99.3% 10 Month Survival 94.4% 97.3% 30 Month Survival 85.4% 91.9% 60 Month Survival 77.8% 84.5% Hazard Ratio* 1.63 (95% CI: 1.16–2.29) P = 0.0041.