tbuckley/cabot-search huggingface dataset:
A phase 2 study of fianlimab (anti–LAG-3) plus cemiplimab (anti–PD-1) versus cemiplimab plus placebo in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) with positive PD-L1 expression.
Authors: Danny Rischin, Paolo Bossi, Nabil F. Saba, Tanguy Y. Seiwert, Deborah J.L. Wong, Qiong Zhao, Shikha Bansal, Mark Salvati, Israel Lowy, Matthew G. Fury, Ahmed Khaled
Journal: Journal of Clinical Oncology (2025)

TPS6112 Background: Concurrent blockade of lymphocyte activation gene 3 (LAG-3) may enhance the efficacy of anti–programmed cell death-1 (PD-1) therapies. In a multicohort study, fianlimab (anti–LAG-3) plus cemiplimab (anti–PD-1) showed signs of clinical activity with durable responses and a generally manageable safety profile in patients with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) warranting further investigation. Methods: This randomized, multicenter, Phase 2 study (NCT06769698) will investigate fianlimab (anti–LAG-3) plus cemiplimab (anti–PD-1) versus cemiplimab plus placebo in patients with R/M HNSCC with positive programmed cell death-ligand 1 (PD-L1) expression. The primary objective is to evaluate investigator-assessed objective response rate (ORR) with combination therapy (fianlimab + cemiplimab) versus cemiplimab monotherapy (cemiplimab + placebo). Key inclusion criteria: (1) aged ≥18 years; (2) histologically confirmed R/M HNSCC; (3) primary tumor location of oral cavity, oropharynx, larynx, or hypopharynx; (4) confirmed positive PD-L1 expression status with a Combined Positive Score of ≥1 based on a previous immunohistochemistry (IHC) test performed on a surgical/core biopsy specimen; (5) for patients with oropharynx disease, human papillomavirus (HPV) status must be established by p16 IHC or HPV DNA or RNA in situ hybridization (ISH) test; biopsy can be from primary tumor or nodal/distant metastasis; (6) for patients with squamous cell carcinoma of neck node with occult primary, a positive HPV DNA or RNA ISH test; (7) measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1; (8) Eastern Cooperative Oncology Group performance status of ≤1; (9) adequate bone marrow, hepatic, and renal function. Key exclusion criteria: (1) patients who have progressive disease within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC; (2) patients who have received prior systemic anticancer therapy in the R/M HNSCC setting. Approximately 120 patients will be enrolled across two cohorts. Patients will receive fianlimab + cemiplimab intravenously (IV) every 3 weeks (Q3W) or cemiplimab (350 mg) + placebo IV Q3W. Cohort 1 (n=60, HPV positive HNSCC) will be randomized 1:1 to receive: a) fianlimab + cemiplimab, b) placebo + cemiplimab. Cohort 2 (n=60, HPV negative HNSCC) will be randomized 1:1 to receive: a) fianlimab + cemiplimab, b) placebo + cemiplimab. The primary endpoint is ORR per investigator assessment. The secondary endpoints are progression-free survival, disease control rate, duration of response, safety, pharmacokinetics, and immunogenicity. Clinical trial information: NCT06769698 .
Impact of a novel oral medication delivery device on patient engagement and discontinuation in individuals receiving oral oncolytic medications.
Authors: Melissa Taylor, Kristopher Fuhr, Kelsey Heiland, Scott F. Huntington, Maryam B. Lustberg, Sarah Schellhorn
Journal: Journal of Clinical Oncology (2025)

11063 Background: Patient-reported outcomes (PROs) are essential for monitoring patient status and improving outcomes. ReX by Dosentrx physically administers oral medications and collects PROs at the time of dosing, allowing healthcare teams to track patient adherence, medication tolerance, and side effects. ReX aims to identify early toxicities between clinic visits, reduce acute care utilization, and improve adherence and overall outcomes. This study evaluates the impact of ReX on treatment adjustments and discontinuations in individuals taking either ribociclib or acalabrutinib. Methods: The study focused on a cohort of individuals prescribed either ribociclib or acalabrutinib. Patients using ReX were tracked for at least 6 months. The primary objective was to evaluate discontinuation rates at 3, 6, and 12 months. Secondary objectives included evaluating dose reductions and reasons for discontinuation. Outcomes from individuals using the ReX device were compared to a historical control group drawn from the same clinics prior to ReX implementation. Results: In the ribociclib group, 69 patients were in the historical control cohort and 63 in the ReX cohort, with median ages of 56 and 53, respectively. For acalabrutinib, the historical control had 94 patients and the ReX cohort 81, both with a median age of 70. Table 1 presents the discontinuation at 3, 6, and 12 months, along with the clinical reasons for discontinuation. Dose reductions were lower in the ReX group, with 11% for ribociclib at 10 months and 1% for acalabrutinib at 15 months, compared to 29% and 6% in the control group. Conclusions: ReX demonstrated a lower percentage of medication discontinuation at 3, 6, and 12 months for patients taking ribociclib or acalabrutinib, with fewer adverse event-related discontinuations and dose reductions compared to a historical control group. Additional studies investigating the impact of this novel medication delivery device on longer term medication adherence and clinical outcomes is currently underway. Discontinuation at 3, 6, and 12 months and reason for discontinuation. Discontinuation 3-months 6-months 12-months Control ReX Control ReX Control ReX Ribociclib 17.8% 6% 24.9% 11% 31.8% 11% Acalabrutinib 10.6% 2.5% 15% 8.6% 24.5% 13.5% Clinical Discontinuation Reason Disease Progression Adverse Events Medication Change Control ReX Control ReX Control ReX Ribociclib 55% 0% 27% 0% 18% 100% Acalabrutinib 55% 50% 27% 25% 18% 25%
Racial disparities in major adverse cardiovascular and cerebrovascular events outcomes among gastric cancer patients.
Authors: Amanda Lussier, Rachna Vashi, Dev Lotia, Niti Chokshi, Siddharth Pravin Agrawal, Sharan Jhaveri, Kanishka Uttam Chandani, Syed Naqvi
Journal: Journal of Clinical Oncology (2025)

11070 Background: Racial disparities in healthcare outcomes represent a critical challenge in achieving equity in gastric cancer care. Gastric cancer, often associated with high morbidity and mortality, also places patients at risk for major adverse cardiovascular and cerebrovascular events (MACCE). This study explores racial disparities in MACCE outcomes among gastric cancer patients using data from the National Inpatient Sample (2016–2021), focusing on differences in mortality, myocardial infarction (MI), arrhythmias, and healthcare resource utilization. Methods: A retrospective cohort analysis of the NIS database from 2016 to 2021, identifying adult gastric cancer patients using ICD-10 codes. Demographic and clinical variables, including race/ethnicity, age, sex, income, and hospital characteristics, were analyzed. MACCE outcomes, including mortality, myocardial infarction (MI), atrial fibrillation (A-fib), arrhythmias, and other cardiovascular events, were compared across racial groups. Multivariable logistic regression adjusted for confounders to evaluate the odds of MACCE outcomes and healthcare utilization disparities. Results: Among 243,544 gastric cancer patients, the racial distribution included White (53.2%), Black (16.5%), Hispanic (17.3%), Asian or Pacific Islander (7.8%), Native American (0.7%), and Other (4.1%). Significant disparities were noted in MACCE outcomes: Black patients had higher odds of mortality (OR 1.196, p &lt; 0.001) and sudden cardiac arrest (OR 2.206, p &lt; 0.001) compared to Whites. Hispanic and Asian patients had significantly lower odds of myocardial infarction (OR 0.768, p = 0.011; OR 0.998, p = 0.991, respectively). Atrial fibrillation was significantly less frequent among Black (OR 0.486, p &lt; 0.001), Hispanic (OR 0.4, p &lt; 0.001), Asian (OR 0.466, p &lt; 0.001), and Native American (OR 0.568, p = 0.009) populations compared to Whites. Notably, Hispanic and Asian or Pacific Islander patients had significantly higher total charges (TOTCHG) compared to Whites ($7,945.6 and $13,467.1 higher, respectively, p &lt; 0.001). Length of stay (LOS) was significantly longer for Black patients (0.707 days, p &lt; 0.001) compared to Whites. Conclusions: This study highlights significant racial disparities in MACCE outcomes, mortality, and healthcare resource utilization among gastric cancer patients. Black and Other racial groups demonstrated higher odds of mortality and sudden cardiac arrest, while Hispanic and Asian patients showed a protective effect against myocardial infarction and atrial fibrillation. Disparities in healthcare charges and LOS further emphasize systemic inequities. Addressing these disparities requires targeted interventions to reduce cardiovascular risks and improve healthcare access and equity for minority populations with gastric cancer.
Stepping back from the brink: time for reason and rapprochement between India and Pakistan
Authors: Zulfiqar A Bhutta, Sanjay Nagral, Srinath Reddy, Tayyaba Butt, Iqbal A Memon, Huma Cheema, Neelam Mohan, Rajeev Seth, Monica Thomas, Jamal Raza, Samiran Nundy
Journal: BMJ (2025)
A review of additional primary cancers in breast cancer patients from a tumor registry of a large teaching hospital.
Authors: Rafi Aibani, Christine A. Welch, Jennifer Collins, Mohammad Alamgir, Amir Kamran
Journal: Journal of Clinical Oncology (2025)

e12529 Background: While advancements in healthcare access, screening, early detection, and treatment have enhanced survival rates and reduced mortality, breast cancer remains a major global health concern. Additionally, as survival outcomes improve for all cancers, the risk of developing second primary cancers has increased, creating new challenges for patients and healthcare systems. This study aims to quantify the prevalence and types of additional primary cancers in breast cancer patients, analyze differences in patient characteristics, and evaluate their impact on survival outcomes. Methods: This study utilized data from a large teaching hospital cancer registry to evaluate additional primary cancers in breast cancer patients over a 10-year period (2010–2019). Patients with a single primary cancer that also had a clinical or pathological stage IV disease were excluded. Statistical analyses, including chi-square, T-test, Wilcoxon, and Log-Rank tests, were conducted using SAS 9.4. Results: Among 2,721 breast cancer cases, 226 (8.31%) were found to have an additional primary cancer, comprising 154 (5.66%) cases of a second primary breast cancer and 72 (2.65%) cases of a primary cancer at another site. The most common non-breast primary cancers were gynecological (45.00%, n = 32), followed by colorectal (12.51%, n = 9), thyroid (9.72%, n = 7), and 5.51% (n = 4) each for lung, bladder, and kidney cancers. Family history of breast cancer was significantly higher in patients with a second primary (37.56%, p &lt; 0.01) compared to those with a single primary (27.30%). Tobacco use was similar across both groups (30%). Patients with a second primary were older (p &lt; 0.05) than those with a single breast primary [mean ± SD age: second primary breast, 66.5 ± 13 years; other primary sites, 67 ± 11 years; single primary, 61.7 ± 13 years]. Most single primary breast cancer cases (94.86%) were stage IIA or lower, with stage IA being the most common (33.33%). Among those with prior breast cancer, the median time to a second primary was 57.50 months (IQR = 49.00). Patients with a second primary had a significantly shorter mean survival 125 ± 4.1 months (mean ± SE, p &lt; 0.01) compared to those with a single primary 135 ± 4.1 months (mean ± SE). Conclusions: Additional primary cancers are an influential concern in breast cancer patients, with second breast cancers, gynecological, colorectal, and thyroid cancers being the most common. Older age and a family history of breast cancer were key risk factors to developing an additional primary. Moreover, survival was significantly shorter in patients with second primaries compared to those with a single primary. These findings underscore the importance of long-term monitoring and tailored management strategies for breast cancer patients, particularly those at higher risk of developing additional primary cancers, to improve outcomes and survival.
Expanding access to care through sustainable replicable model of care delivery.
Authors: Dinesh Pendharkar, Chandramauli Tripathi
Journal: Journal of Clinical Oncology (2025)

e13862 Background: Access to equitable care remains a major challenge. In most countries, access to specialized care is limited because of socioeconomic, geographical, and human resource constraints.To meet the challenge, multiple models are being tested worldwide: Buttaro, Australian, Canada, Montana, and District Cancer Care Model (Pendharkar model). The district model has evolved over more than ten years and has proven its sustainability, replicability, acceptability, and scalability. We offer a review of the 10 years of progress. Methods: In 2014, a cancer model was designed based on WHO framework of strengthening the health system. District hospitals in India are the peripheral pillars of the state-owned health system, where comprehensive care is feasible. Multiple regulations have been introduced to create district cancer units, empowering the delivery of cancer care from diagnosis to end-of-life. One physician was trained over a short period and offered a 24x7 hub and spoke mentorship in one state. In follow-up, other states of India independently reviewed the program and extended. Results: After launch in February 2014, over the last ten years, the program has been extended to eight states, nearly 200 districts, covering an area of 1200 million square kilometers and a population of 400 million. Five more states are committed to initiating the district cancer care model in 2025. More than 290 physicians and 550 nurses have been trained . The program offers consultation and chemotherapy services ,including free drugs,to more than 300,000 patients.The same units were trained to provide palliative care. The funding for the program is generated internally by the state and is available sustainably. The chemotherapy list has evolved annually and has gradually increased from 20 to 150 in a few states. It includes a complete basket of WHO essential oncology drug list. Conclusions: To date, this district cancer model based on the creation of an alternate oncology workforce using existing physical and human resources appears to be the most sustainable replicable model. Government-owned health systems, especially in LMIC, could be the single most important point of empowerment. Primary physicians can effectively offer patient-centric, consistent, and comprehensive services. Building and maintaining a decentralized and sustainable cancer care program is feasible. The district cancer care model can assist in improving access to care and resolving disparities. Data from the Rajasthan state district cancer care programme. Year Outpatient Visits Patient Number New In Patient Visits IV Chemo Oral Chemo Palliative Care 2018-19 48153 8069 20648 13070 2796 7709 2019-20 23113 3873 9911 6274 1342 3700 2020-21 37458 4781 16187 11751 2602 6040 2021-22 29937 4339 15883 11879 2681 5815 2022-23 33335 4887 16934 12316 3167 6204 2023-24(upto Oct. 23) 24144 2806 11756 10162 2381 4369 Total 196140 28755 91319 65452 14969 29468
Analysis of quality-of-life outcomes in patients with head and neck squamous cell carcinoma.
Authors: Aysswarya Manoharan, Kyle Edwards, Chinmay Jani, Estelamari Rodriguez, Gilberto Lopes, Coral Olazagasti
Journal: Journal of Clinical Oncology (2025)

e23208 Background: Patients with head and neck squamous cell carcinoma (HNSCC) are known to experience decline in quality of life due to the side effects of treatments. In recent years, there has been a shift towards preserving organ functionality with the goal of improving quality of life for patients. However, it is unknown if these novel treatment paradigms exert a meaningful difference in quality-of-life (QOL) measures. Methods: A total of 594 patients with HNSCC were included in this retrospective study. Demographic, clinicopathologic characteristics, and wellness scores (including GAD-7, PHQ-9, PROMIS, and patient reported quality of life scores) were analyzed. Descriptive statistics and independent-samples t-tests were used to analyze differences in wellness and QOL outcomes amongst patients who received different treatment paradigms including chemotherapy, radiation and surgery (organ sparing vs non-organ sparing). Results: In our sample, 40% underwent chemotherapy while 60% did not undergo chemotherapy. Patients who underwent chemotherapy had significantly higher mean GAD-7 scores (10 vs 2, p = 0.044) and PHQ-9 scores (11 vs 2, p = 0.004) compared to those who did not receive chemotherapy. However, there was no significant difference in patients’ self-reported measures of fatigue, pain, or physical function. In regard to radiation therapy, 66% of the sample received radiation while 33% did not. Patients who underwent radiation has higher levels of pain (p = 0.09) as well as worse physical function scores (p = 0.138). Of the patients included in the study, 40.9% underwent organ-sparing surgery ,19.4% underwent non-organ sparing surgery and 39.7% did not undergo any surgery. When comparing patients who underwent organ sparing vs non-organ sparing surgery, it was found that patients who underwent organ-sparing procedures did not have a significant difference in GAD-7 and PHQ-9 scores. When comparing PROMIS scores which assess patient reported outcomes that impact quality of life, a few trends were noted. First, patients who underwent organ-sparing treatment had a significantly lower fatigue scores (50 vs 54, p = 0.031). Furthermore, patients who underwent organ-sparing treatment had lower self-reported pain scores (53 vs 56, p = 0.07). Conclusions: Patients who undergo chemotherapy have significantly higher levels of anxiety and depression. However, patients undergoing radiation did not demonstrate a similar pattern. Instead, patients reported higher levels of pain and worse physical functioning. Patients who underwent organ sparing surgery reported significantly lower levels of fatigue; however, there was no significant difference in anxiety and depression levels. This analysis was limited by sample size. However, these findings warrant further investigations to assess the true impact of these novel treatment strategies and their impact on QOL.
Patient-reported communication and satisfaction in breast cancer: Does doctor-patient identity concordance matter?
Authors: Kamaria L. Lee, Mark Munsell, Sam Meske, Marisa C. Weiss, Fumiko Chino
Journal: Journal of Clinical Oncology (2025)

11071 Background: Effective communication is a key element in patient engagement, adherence, and satisfaction. Prior research has shown that doctor-patient race and/or gender concordance may improve both health outcomes and patient satisfaction, however the effects of identity concordance in oncology and specifically within breast cancer are less studied. Methods: Between 7/2023-8/2023, cancer survivors were recruited from Breastcancer.org and consented to participate in an anonymous online survey in English or Spanish. Eligibility included: US resident, age ≥18, and diagnosed within the past 10 years. Survey assessed patient-reported aspects of communication as well as patient-identified provider race/ethnicity and gender. Chi-square and Fisher’s exact tests tested associations between patient and/or provider identity and patient-reported satisfaction with communication. Results: Of 997 who completed the survey, 759 reported provider race/ethnicity and gender and were included in this analysis. Patients were median age 63 (range, 32-97), mostly White race (91%) and non-Hispanic (99%); almost all were women (98%). Patients were a median of 3.3 years (1.4-10) post diagnosis. Overall, 60% had concordant gender with their provider. 64% had concordant race; White patients had higher racial concordance 68% (n=470/690) than Black (14%, n=5/35) or Asian/Pacific Islander patients (50%, n=9/18) (p&lt;0.0001). 0% of Hispanic patients (n=0/11) had ethnic concordance with their provider. Patients reported high levels (94-97% “usually” or “always”) of being treated with courtesy/respect, with no significant differences by identity concordance (either racial, ethnic, or gender concordance). Similarly, they reported their doctors listened carefully (89-98% usually/always) and explained things in a way they could understand (89-98% usually/always), with no differences by concordance. Most patients reported no one talked to them about possible clinical trial options (75% White, 51% Black, 56% Asian patients, p=0.003 comparison), but there were no differences by concordance. There were no significant differences by patient-reported race for questions regarding courtesy/respect, listening, explanations, or discussing clinical trials. Similarly, there were no significant differences by patient-reported provider race or gender. Conclusions: In this study of breast cancer survivors, patient-provider identity concordance did not have effects on patient-reported communication. There were no identified differences in communication by race, ethnicity, or gender of patient or provider, although overall satisfaction was very high with limited sample diversity which may stymie capacity for identifying differences. Very few Black and zero Hispanic patients had racial or ethnic concordance with their provider, reflecting known gaps in the oncology workforce.