tbuckley/cabot-search huggingface dataset:
VERSATILE-003: A phase 3, randomized, open-label trial of PDS0101 and pembrolizumab compared with pembrolizumab for first-line treatment of patients with HPV16-positive recurrent/metastatic head and neck squamous cell carcinoma.
Authors: Katharine Andress Rowe Price, Kevin Joseph Harrington, Francis P. Worden, Ricard Mesia, Caroline Even, David Schaaf, Sally Jones, Nabil F. Saba, Robert I. Haddad
Journal: Journal of Clinical Oncology (2025)

TPS6111 Background: Human papillomavirus (HPV)-related head and neck squamous cell carcinoma (HNSCC) has surpassed cervical cancer as the most common HPV-related cancer in the US, with the majority being caused by HPV16. Persistent expression of HPV16 oncoproteins E6 and E7 by host genome may promote HNSCC. HPV16-positive HNSCC may be associated with poor clinical outcomes in the recurrent/metastatic (R/M) setting. PDS0101 (Versamune HPV) is an HPV16-immunotherapy that generates a potent, targeted T cell attack against HPV16 E6 &amp; E7. In a Phase 2 study, PDS0101 plus pembrolizumab has shown encouraging safety and survival benefit in patients with HPV16-positive R/M HNSCC. (Weiss J et al. ESMO 2024. Poster 879P. NCT04260126). Methods: VERSATILE-003 is a global Phase 3, randomized, controlled, open-label study evaluating PDS0101 plus pembrolizumab vs. pembrolizumab in patients with HPV16-positive R/M HNSCC with PD-L1 positive disease (CPS ≥1). Key eligibility criteria include age ≥18-years-old, histologically- or cytologically-confirmed diagnosis of R/M HNSCC with primary tumor location of oropharynx, oral cavity, hypopharynx, or larynx and no prior systemic anticancer treatment in the R/M setting, HPV16 tumor positivity (centrally tested), PD-L1 positivity defined as CPS ≥ 1 using FDA-approved PD-L1 IHC 22C3 pharmDx kit, and measurable disease based on RECIST 1.1 confirmed by blinded independent central review (BICR). Patients will be randomized 2:1 to receive pembrolizumab 200 mg IV Q3W with PDS0101 1 mL SC administered concurrently during Cycles 1, 2, 3, 4, and 12 (investigational arm), or pembrolizumab 200 mg IV Q3W alone (control arm). The primary objective is to compare overall survival (OS) between the investigational and control arms. Secondary objectives include objective response rate (ORR), disease control rate (DCR), duration of response (DOR), and progression-free survival (PFS) using RECIST 1.1 and assessed by BICR. Exploratory objectives include tumor response assessed by investigator and by irRECIST, PFS2, quality of life as assessed by EQ-5D, QLQ-C30, and QLQ H&amp;N35, and assessment of ctHPVDNA. Updated enrollment data will be provided. Clinical trial information: NCT06790966 .
Impact of protein energy malnutrition on hospitalized patients with breast cancer: A United States population-based cohort study.
Authors: Arshi Syal, Yajur Arya, Akshay Ratnani, Colton Jones, Nitya Batra, Himil Mahadevia, John Charles Leighton
Journal: Journal of Clinical Oncology (2025)

11067 Background: Advances in chemotherapeutics and surgical options have improved survival in patients with breast cancer. With prolonged survival, these patients are often predisposed to comorbidities affecting their quality of life. Patients with breast cancer suffer from varying degrees of protein-energy malnutrition (PEM) due to multiple factors, including cachexia, sarcopenia, and adverse effects of chemotherapeutics. However, the impact of PEM on outcomes among patients with breast cancer needs further exploration. Methods: We utilized the 2020 National Inpatient Sample (NIS) Database in conducting this retrospective cohort study. We identified patients with breast cancer and PEM using appropriate ICD-10 diagnostic codes. We stratified patients with breast cancer based on the presence or absence of PEM. A survey multivariable logistic and linear regression analysis was used to calculate adjusted odds ratios (ORs) for the primary and secondary outcomes. A p value of &lt;0.05 was considered statistically significant. The aim of this study was to investigate the impact of PEM on in-hospital mortality, hospital length of stay (LOS), and total hospitalization charge among hospitalized patients with breast cancer. Results: We identified a total of 24770 hospitalized patients with breast cancer, of which 6.17% (1530/24770) had comorbid PEM. The overall in-hospital mortality among patients with breast cancer was 3.37% (835/24770). Among those with concomitant PEM, the mortality rate was significantly higher at 12.74% (195/1530, p&lt;0.001). Utilizing a stepwise survey multivariable logistic regression model that adjusted for patient and hospital level confounders, PEM was found to be an independent predictor of increased in-hospital mortality (adjusted OR 2.74; 95% (confidence interval [CI] 1.74-4.30; p&lt;0.001), longer LOS (coefficient 3.56 days; CI 2.67-4.45; p&lt;0.001), but not higher total hospitalization charge ($4400; CI -$9818-$18620; p=0.544) or increased need for mechanical ventilation (adjusted OR 2.26; CI 0.89-5.69; p=0.084). Conclusions: Our analysis demonstrated that PEM was widely prevalent in hospitalized patients with breast cancer and was associated with significantly worsened in-hospital mortality and longer LOS. Efforts should be made to promote nutritional assessment and screening mechanisms to include early nutritional support as indicated. Further prospective studies with larger sample sizes are warranted to understand these associations better.
Adjuvant abemaciclib outcomes in routine clinical practice (experience of several Moscow centers).
Authors: Katerina Grechukhina, Margarita Sukhova, Daria Filonenko, Dmitriy Popov, Irina Andreiashkina, Daniil Stroyakovskiy, Anastasia Danilova, Ilya Pokataev, Tatiana Antonova, Mikhail Fedyanin, Vladimir Evdokimov, Nikolay Sokolov, Lyudmila Zhukova
Journal: Journal of Clinical Oncology (2025)

e12522 Background: Adjuvant abemaciclib (aA) combined with endocrine therapy (ET) is one of standard treatment for HR+/HER2- early breast cancer (BC). While efficacy has been established in MonarchE clinical trial, comprehensive real-world evidence of abemaciclib effectiveness, especially in high-risk populations with early BC, remains limited. This multicenter observational study evaluated aA outcomes in routine clinical practice. Methods: This retrospective analysis included 160 HR+/HER2- breast cancer patients receiving A with ET across multiple centers in Moscow. Primary endpoint was invasive disease-free survival (iDFS). Secondary endpoints included safety, treatment duration, and reasons for discontinuation. Survival estimates were calculated using Kaplan-Meier methodology. Data cutoff was December 2024, with median follow-up of 21.0 months (range 5.5-46.1). Results: Median age was 50 years (range 27-74); 46.3% patients were premenopausal. Disease stage distribution included Stage II (40%), and Stage III (60%). Among Stage III patients (n=96), 45% had T4 disease and 39.4% had N3 nodal involvement. Most patients (81.2%) presented with high-risk features: Ki-67&gt;20%, grade 3 (37.4%), lymph node involvement (83.1%). Prior treatment included neoadjuvant chemotherapy in 62.5% and adjuvant in 37.5% of patients, with 88.1% receiving anthracycline-taxane combinations. At baseline, 89.4% received aromatase inhibitors, 10% switched from tamoxifen to aromatase inhibitors, and 0.6% continued tamoxifen as ET partner. Seven progression events (4.4%) were documented during follow-up. The iDFS rates were 99.4%, 96.2%, and 95.6% at 12, 24, and 36 months, respectively. Median time to progression in patients with disease recurrence was 17.7 months (range 6.1-29.8). At data cutoff, 101 patients (63.1%) continued treatment, 29 (18.1%) completed planned therapy duration. Main reasons for discontinuation included toxicity (n=13, 8.1%), disease progression (n=7, 4.4%), treatment refusal (n=7, 4.4%) and other reasons (n=3, 1.9%). Most common adverse events were neutropenia (13.8%, including Gr. 3 in 5%) and diarrhea (10.6%, predominantly Gr. 1-2). Dose reductions were required in 22% of patients. Conclusions: In this real-world cohort of HR+/HER2- with locally advanced BC disease and high-risk features, abemaciclib demonstrated favorable efficacy with 12, 24 and 36 months iDFS rates comparable to MonarchE despite more unfavorable patient characteristics. Safety profile was manageable through dose modifications, with most patients maintaining long-term treatment. These results support adjuvant abemaciclib's effectiveness in routine clinical practice, particularly in high-risk patient populations.
Cancer incidence among indigenous adults in Brazil: A 19-year analysis of hospital cancer registry data (2000–2018).
Authors: Prof. Dr. Luís Carlos Lopes-Júnior, Wesley Rocha Grippa, Vitor Fiorin de Vasconcellos
Journal: Journal of Clinical Oncology (2025)

e13830 Background: Cancer disparities persist among Indigenous populations due to socio-demographic, cultural, and environmental factors. In Brazil, limited healthcare access contributes to late diagnoses and worse outcomes. While cancer trends have been extensively studied in the general population, evidence on Indigenous adults remains scarce. This study evaluates temporal trends in cancer incidence among Indigenous adults in Brazil from 2000 to 2018, using data from the Brazilian Hospital-based Cancer Registry (HbCR), and compares findings with estimates from the Brazilian Demographic Census. Methods: A retrospective cohort study was conducted using HbCR (SIS-RHC) data. The cohort included Indigenous individuals aged ≥18 years, diagnosed with malignant neoplasms (ICD-10), and treated within the Brazilian Unified Health System (SUS). Temporal trends in cancer incidence were assessed using the Mann-Kendall test, with bivariate analyses evaluating associations between variables. Cumulative incidence rates (CIR) were calculated based on the Brazilian Demographic Census of 2000 and 2010. Results: Among 3,701 Indigenous individuals (mean age: 56.91 years, SD: 16.22), 58.61% were female, 51.44% had elementary education, and 32.14% resided in the Northeast. Family history of cancer was reported by 35.22%; 62.19% did not consume alcohol, and 53% were non-smokers. Multiple primary tumors were absent in 96.93% of cases. The most common cancers were cervical (19.02%) and breast (11.51%), followed by non-melanoma skin (10.81%) and prostate (8.46%) cancer. Most cases were localized (stages I–II, 35.38%), while 33.71% were regional (stage III) and 30.92% metastatic (stage IV). Diagnoses at localized and regional stages (I–III) increased significantly (p &lt; 0.001). Significant differences were observed across sexes and age groups (p &lt; 0.001). Annual cancer case counts rose significantly from 2000 to 2018 (S = 113; p &lt; 0.001), with 337 cases (8.84%) reported from 2000–2004, 982 (26.53%) from 2005–2009, 849 (22.94%) from 2010–2014, and 1,238 (33.45%) from 2015–2018. Overall, cases increased by 378.59% during the study period. The CIR calculated for the period, were as follows: 2000 to 2009: 169.59 cases/100,000 Indigenous individuals; and 2010 to 2018: 188.05 cases/100,000 Indigenous individuals. Conclusions: Cancer incidence among Indigenous adults in Brazil increased substantially from 2000 to 2018, with cervical and breast cancers being the most prevalent. Despite improvements in early detection, a significant proportion of cases remain diagnosed at advanced stages. These findings highlight the need for targeted public health efforts to improve screening, early diagnosis, and access to culturally tailored cancer care. This study provides critical insights to inform future cancer prevention and control efforts tailored to Indigenous populations in Brazil.
Trends and disparities in sepsis-related mortality among patients with malignancies: A 25-year nationwide analysis.
Authors: Malik WZ Khan, Muhammad Ahmad, Amna Gul, Shammas Bajwa, Sundus Huma, Hassan Ali, Abdul Wali Khan, Fariha Hasan, Nouman Shafique, Arslan Inayat
Journal: Journal of Clinical Oncology (2025)

11062 Background: Sepsis is a leading cause of mortality worldwide, with cancer patients at higher risk due to immune suppression from the disease and its treatments. Despite advancements in sepsis care, their impact on sepsis-related mortality among cancer patients remains unclear. Understanding these trends is crucial for developing targeted interventions to improve sepsis outcomes in patients with malignancies. Methods: We conducted a retrospective cohort analysis using the CDC WONDER database from 1999 to 2023, focusing on adults aged &gt;25 years with malignancies. Deaths were identified using international classification of disease 10 (ICD-10) codes for instances where both sepsis and malignant neoplasms were listed as causes of death. Age-adjusted mortality rates (AAMR) per 100,000 population were extracted, and temporal trends were analyzed using Joinpoint regression to calculate the annual percentage change (APC) and its weighted average, the average annual percentage change (AAPC). Results were stratified to evaluate temporal, gender-based, racial, and geographic disparities in mortality. Results: From 1999 to 2023, a total of 684,930 sepsis-related deaths were recorded among adults with malignancies. Over this period, the AAMR increased significantly from 12.06 to 14.21, with an AAPC of 0.86 (95% CI: 0.74 to 1.06). Males had a higher overall AAMR (15.09) compared to females (9.91), but females experienced a sharper increase over time (23.77% vs. 9.56%). Non-Hispanic (NH) Black or African Americans had the highest AAMR (18.98), followed by NH American Indian or Alaska Natives (11.59) and NH Whites (11.35), while NH Asians/Pacific Islanders exhibited the lowest rate (10.24). Geographic disparities were significant, with state-specific AAMRs ranging from 24.62 in the District of Columbia to 7.50 in Montana. States in the top 90 th percentile included Mississippi, Rhode Island, West Virginia, New Jersey, and the District of Columbia, while those in the bottom 10 th percentile included Montana, Oregon, Idaho, and Wisconsin. Regionally, the Northeast had the highest AAMR (12.65), followed by the South (12.49) and West (11.69), with the Midwest exhibiting the lowest rate (11.08). Conclusions: This nationwide analysis highlights a concerning rise in sepsis-related mortality among patients with malignancies over the past 25 years, with females, NH Blacks and residents of the Northeastern region emerging as the most vulnerable populations. These findings underscore the need for prompt implementation of targeted strategies designed to overcome these disparities.
Barriers to guideline concordant cancer care for patients with limited english proficiency: A mixed methods study.
Authors: Sacha Moufarrej, Sophia Butler, Sakshith Reddy Chintala, Tala Al-Rousan, Winta Tsegay Mehtsun
Journal: Journal of Clinical Oncology (2025)

e13842 Background: Approximately 25 million people in the United States have limited English proficiency (LEP), posing challenges in communication and disparities in healthcare access, particularly for cancer care. However, the quality and guideline concordance of cancer care for patients with LEP remains understudied, particularly in cancers that have high incidence in migrant populations, such as colon and gastric cancer. The aims of this mixed methods study are to 1) quantitively identify rates of guideline concordant care (GCC) for colon and gastric cancer among LEP patients versus comparable non-LEP patients treated at UCSD, which serves a significant LEP population as a border-adjacent hospital, and to 2) qualitatively identify facilitators and barriers to GCC for LEP patients. Methods: For our first aim, we identified all UCSD patients diagnosed with colon or gastric cancer between 2012 and 2022 using the University of California Data Warehouse (UCDW). Descriptive analysis was conducted to assess the demographic distribution of the patient cohorts in preparation for our assessment of guideline concordance. For our second aim, semi-structured interviews, based on the Andersen Behavioral Model of Health Services Use framework, were conducted with colon and gastric cancer care providers at UCSD to collect the physician perspective on multilevel factors affecting care for their LEP patients. Results: Our cohort includes 5,403 and 1,777 patients diagnosed with colon and gastric cancer, respectively, at UCSD. Among all patients, 859 (15.9%) colon cancer patients and 423 (23.8%) gastric cancer patients have a preferred language other than English listed in their electronic health record. In both cohorts, significantly more LEP patients than non-LEP patients are on Medicaid insurance: 292 (34.0%) versus 531 (11.7%) colon cancer patients (p &lt; 0.001), and 202 (47.8%) versus 232 (17.1%) gastric cancer patients (p &lt; 0.001). A majority of providers interviewed expressed concerns for more advanced disease presentation in patients with LEP due to the intersection of multiple barriers, including language (100%), health literacy (80%), geographical distance from cancer centers (40%), insurance (40%), and fluctuating border policies (40%). Additional patient-level considerations include cultural norms on bodily integrity and the physician’s prominent social role (60%), which impact shared decision-making. Institution-level barriers include the understaffing and underfunding of supportive staff such as in-person interpreters and patient navigators (100%). Conclusions: Language differences are widely prevalent, augmenting multi-level barriers to care for colon and gastric cancer patient populations served by UCSD. These findings will inform future studies examining the patient experience and designing and implementing an intervention to increase receipt of GCC for LEP patients.
Long-term lung cancer risk in breast cancer survivors: A 40-year comprehensive analysis.
Authors: Yujen Wang, Chi-Cheng Huang
Journal: Journal of Clinical Oncology (2025)

e12501 Background: Breast cancer survivors face an increased risk of secondary malignancies, with lung cancer being one of the most concerning long-term adverse effects. This study provides a comprehensive analysis of the incidence and survival outcomes of lung cancer in breast cancer patients treated with postoperative radiotherapy, emphasizing long-term risk assessment and temporal trends over four decades. Methods: This retrospective cohort study utilized data from the Breast Cancer Health Database, encompassing 304,550 breast cancer patients diagnosed between 1979 and 2020. The association between postoperative radiotherapy and secondary lung cancer risk was evaluated using Cox proportional hazards models, adjusting for confounding variables including surgery, chemotherapy, immunotherapy, endocrine therapy, and targeted therapy. Kaplan-Meier survival analyses were conducted to evaluate overall survival, stratified by treatment modalities and diagnosis periods. Temporal trends in survival and treatment efficacy were analyzed across decades to assess the evolution of risk-benefit profiles. Results: Among the cohort, 3,112 patients were diagnosed with secondary lung cancer. Postoperative radiotherapy was associated with a significant increase in lung cancer risk (hazard ratio [HR]: 1.61; 95% confidence interval [CI]: 1.414–1.691; p &lt; 0.0001). The median time to secondary lung cancer diagnosis was 124 months, with risk influenced by radiation exposure levels. While radiotherapy was associated with a heightened lung cancer risk, it concurrently demonstrated improved overall survival in breast cancer patients. Temporal analysis revealed enhanced survival benefits for radiotherapy recipients during more recent periods (2010–2017) compared to earlier decades, reflecting advancements in radiotherapy techniques. Stratified analysis indicated that treatment combinations influenced outcomes: chemotherapy was associated with a reduced lung cancer risk (HR: 0.845; p = 0.0001), whereas targeted therapy significantly increased risk (HR: 2.033; p &lt; 0.0001). Conclusions: Postoperative radiotherapy in breast cancer survivors is associated with an elevated long-term risk of secondary lung cancer but offers substantial overall survival benefits. Temporal improvements in radiotherapy delivery and personalized treatment strategies have likely contributed to a more favorable risk-benefit profile in recent years. These findings underscore the critical need for long-term surveillance and the development of tailored therapeutic approaches to balance the risks and benefits of radiotherapy in breast cancer management.
Socio-behavioral needs and prostate and breast cancer mortality rates in African Americans, Hispanics, and Non-Hispanic Whites: A national descriptive exploration within groups.
Authors: Valerie C Valerio, Talita Honorato-Rzeszewicz, Peter Smittenaar, Sema K. Sgaier, Camille Jimenez
Journal: Journal of Clinical Oncology (2025)

e13825 Background: While previous studies have identified higher mortality rates in African Americans diagnosed with prostate and breast cancer compared to other groups in the U.S, there remains a critical need to understand how socio-behavioral (SB) needs differ within racial/ethnic groups living in areas with different cancer mortality rates across the country. Methods: We investigated socio-behavioral needs differences within racial/ethnic groups living in counties classified per tertiles of high, medium, and low average cancer mortality rates. We obtained age-adjusted breast and prostate cancer mortality rates data stratified by race and ethnicity between 2018 and 2022 for African Americans, Hispanics, and Non-Hispanics Whites, from the National Cancer Institute. We obtained county-level data for 59 social and behavioral determinants of health (SBDH) and population counts by race and ethnicity sourced from various national surveillance sources. The SBDH variables were classified into 7 categories: community solidarity education, health literacy and digital connectivity quality care; housing and environmental risks; economic livelihoods; lifestyle behaviors; and care engagement. SB-needs scores were calculated for each racial/ethnic group by mortality rate tertile. Results: 3,142 counties were included. Among female adults, 13.5 million (84%) Non-Hispanic African Americans, 16 million (78%) Hispanic, and 71 million (94%) Non-Hispanic Whites of the population were included. The highest SB-needs scores for all women were lifestyle behaviors, economic livelihoods and community solidarity. Among male adults, we included 11 million (78%) Non-Hispanic African Americans , 14.6 million (70%) Hispanics, and 67 million (91%) Non-Hispanic Whites. For men, SB-needs scores were high for housing &amp; environment and low for access to quality of care. For White women and men, higher overall SB-needs scores correlated with higher mortality rate tertiles. Among African Americans and Hispanic women, the overall SB-needs score showed a more significant increase when transitioning from low to medium mortality rate counties than from medium to high mortality rate counties. For Hispanic men, SB-needs scores did not align with higher mortality tertiles. Conclusions: SB-needs scores exhibit varying relationships with breast and prostate cancer mortality rates within racial/ethnic groups. These findings generate hypotheses that (1) a linear relationship may exist between SB-needs and mortality rates for Non-Hispanic Whites, while (2) a non-linear relationship may characterize African Americans and Hispanics. Additionally, there may be a threshold for the association of SB-needs on mortality rates, beyond which other factors, such as structural racism (not measured in this study), may play a substantial role.