tbuckley/cabot-search huggingface dataset:
National Comprehensive Cancer Network guideline compliance in an oncology value-based care program serving Medicare members.
Authors: Shirisha Reddy, Anthony Larrarte, Robert Cullum, Kevin Hastings, Brooke Byrd, Rogelio Alberto Brito, Josh Eaves, Kiana Mehring, Lucio Gordon
Journal: Journal of Clinical Oncology (2025)

e23219 Background: Value-based care (VBC) focuses on improving patient health outcomes while reducing the overall cost of healthcare. The National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) provide evidence-based and consensus-driven recommendations for the management of cancer. These guidelines aim to ensure that patients receive the most effective preventive, diagnostic, treatment, and supportive services to achieve optimal outcomes. They are considered the standard for clinical direction and policy in cancer care and are regularly updated. The NCCN Guidelines are designed to assist healthcare professionals, patients, and their families in making informed decisions and improving patient care and outcomes. 1 While studies have shown that compliance to NCCN guidelines improves survival, little information exists regarding the impact of compliance in VBC arrangements. This study aimed to evaluate compliance to NCCN regimen guidelines in Medicare members being treated for cancer under a VBC arrangement. Methods: This is a cohort study of individuals receiving care, in a single state, enrolled in a VBC contract within a large national insurer from January 18, 2024 to October 28, 2024. Medicare members with bladder, colon, lung, breast, hepatocellular, rectal, pancreatic, kidney, biliary tract and prostate cancer with at least one oncology claim within the measurement time period were included. NCCN compliance was a quality measure of the VBC, was defined using pharmacy and medical claims and deemed as concordant if the entire prescribed treatment regimen matched an NCCN recommended regimen (Level 1 and 2a); members not receiving an NCCN recommended regimen were deemed to be non-concordant. Results: This study included 332 patients, the mean [SD] age was 73.7 [6.9] years with 183 [55.1%] members identified as female. Avg Age Female [73.7] while Male was [73.8]. The total population captured through the automated prior authorization platform yielded 95.7% NCCN compliance. Conclusions: In this study, individuals receiving chemotherapy participating in a shared savings VBC demonstrated 95.7% compliance to NCCN guidelines. Embedding NCCN regimen compliance into VBC quality measures, coupled with online, real-time compliance assistance helps drive optimal NCCN compliance rates in Medicare patients and, in turn, improve clinical outcomes for patients. References #1: https://www.nccn.org/guidelines/guidelines-process/about-nccn-clinical-practice-guidelines#:~:text = The%20NCCN%20Guidelines%C2%AE%20are,in%20any%20area%20of%20medicine .
Insurance coverage of germline genetic testing for ovarian, pancreatic, and early-onset colorectal, endometrial, and breast cancers, stratified by self-reported race and ethnicity.
Authors: Erica M. Vaccari, Trevor J. Williams, Kate E. Krempely, Michael J. Hall, Ed Esplin
Journal: Journal of Clinical Oncology (2025)

11080 Background: Universal germline genetic testing (GGT) for patients with ovarian (OV), pancreatic (PANC), and early-onset colorectal, endometrial cancer, and breast cancer (CRC &lt;50, ENDO &lt;50, and BR ≤50) is the medically necessary standard of care per clinical guidelines and many payer medical policies. Individuals with multiple cancers, diagnosed at any age (MULTI), also commonly meet these guidelines for GGT. We report a single national laboratory experience with GGT coverage for these indications. Methods: Patients with GGT between 6/1-12/31/2023 from a commercial laboratory were stratified by cancer type (using ICD-10s), age at testing, and self-reported race and ethnicity. We assessed differences in coverage rates, frequency and types of denial codes (technical and clinical denials), and appeal success across cancer types. Reported p-values are from G-Tests of independence, only groups containing at least 100 individuals were retained in statistical tests. Results: We reviewed 12,304 patients with cancer, 19% with OV, 29% with PANC, 13% with CRC &lt;50, 2% with ENDO &lt;50, 26% with BR ≤50, and 9% with MULTI. Of all patients, GGT was not covered for 31%, including 29% of OV, 27% of PANC, 35% of CRC &lt;50, 39% of ENDO &lt;50, 35% of BR ≤50, and 27% of MULTI. Of all cases with no coverage for clinically indicated GGT, 30% had clinical denial codes (e.g. medical necessity, non-covered services, experimental), 68% had only technical denial codes, and 2% had no denial codes. Overall, appeals were successful in 32% of cases, including 27% of OV, 25% of PANC, 44% of CRC &lt;50, 39% of ENDO &lt;50, 33% of BR &lt;50, and 22% of MULTI. The proportion of cases with coverage differed significantly by self-reported race and ethnicity (58%-81%, p &lt;0.00001), with Black and Hispanic individuals being less likely to be covered in comparison to Ashkenazi Jewish, Asian, and White individuals. Whereas the proportion of those receiving denial codes differed between self-reported race and ethnicity groups (p &lt;0.00001), the percentages of technical vs. clinical denial codes received did not (p = 0.56). Conclusions: Despite clinical guidelines and payer medical policy affirming the medical necessity of universal GGT in these cancer types, these data demonstrate that 30% of patients did not receive coverage for standard of care GGT, and was lower in traditionally under-represented groups. Denials overturned on appeal suggest those cases should not have been denied initially. These data suggest that coverage denials are a substantial obstacle to medically necessary GGT for patients with cancer despite clinical practice guidelines.
Eliciting the patient perspective: Using design-thinking methodology to assess the utility of incorporating narrative medicine tools in inpatient cancer.
Authors: Sabiha Tamima, Somalee Banerjee
Journal: Journal of Clinical Oncology (2025)

e23212 Background: Integrating narrative medicine (NM) into oncologic care presents a promising opportunity to enhance patient-centered care by addressing the emotional and psychological challenges faced by cancer patients. Although studies have demonstrated the positive impact of NM in outpatient settings, its perception and utility in inpatient settings remain underexplored. Methods: Using design-thinking methodology, we conducted a quality improvement project to assess how NM techniques can be used to better understand patients’ illness experience and enhance their inpatient cancer care. This human-centered approach allowed us to examine the needs and viewpoints of our stakeholders, which included patients admitted for chemotherapy to the Leukemia and Lymphoma Center at Kaiser Permanente East Bay and the center’s nursing staff. The process began with immersion into the care unit and informal interviews to gain inspiration for potential NM activities. During the ideation stage, participant feedback was integrated to develop a prototype of a NM exercise that allowed for patients to reflect on their care and work through their emotions. Implementation focused on live prototyping to promote patient engagement in their care, as well as collaboration with nursing leadership to assess feasibility of embedding NM activities into the existing inpatient workflow. Results: We elicited the interest of 6 out of 12 patients (50%) who participated in the NM activity; these patients not only endorsed a positive experience but also reported feeling more empowered to be actively involved in their cancer care. Interestingly, nursing staff were considerably more optimistic and in favor of NM tools, noting 11 out of 12 nurses (92%) who predicted that such tools could improve patient care by fostering therapeutic relationships and serving as an outlet for patient healing. Conclusions: Narrative medicine (NM) offers a way to enhance inpatient cancer care by addressing patients' unique experiences, emotions, and survivorship goals. Through a design-thinking approach, we found that while NM can be valuable, its effectiveness varies among patients. By engaging both patients and clinical staff, we identified differing levels of interest, emphasizing the need for NM to be a flexible, patient-driven tool rather than a universal intervention. Future efforts should focus on addressing barriers to patient engagement and developing practical strategies that consider patient vulnerability and workflow constraints, to seamlessly integrate NM interventions into inpatient cancer care.
Single arm prospective study evaluating the relationship of ctDNA molecular complete response (mCR) and pathologic complete response (pCR) in a diverse early triple-negative breast cancer patient (TNBC) population receiving neoadjuvant chemotherapy (NAC).
Authors: Elizabeth John, Simranjit Sekhon, Terrence Jones, Parnian Kheirkhah Rahimabad, Christine Son, Srishti Sareen, Laila Vidal, Sonia M. Benn, Leonard Jefferson Harris, Gregory A. Vidal
Journal: Journal of Clinical Oncology (2025)

e12553 Background: Chemotherapy plus pembrolizumab in neoadjuvant and adjuvant settings (Keynote-522) is standard of care for early-stage triple-negative breast cancer (TNBC), improving pathologic complete response (pCR) and overall survival (OS). Circulating tumor DNA (ctDNA) may provide a minimally invasive tool to assess early response, guide therapy de-escalation, and detect recurrence. Methods: This single-center, prospective pilot study enrolled 31 patients with early-stage TNBC undergoing NAC. ctDNA was collected at baseline, every 3 weeks during NAC, and every 4-12 weeks in the adjuvant setting using a tumor-informed test. Primary endpoints were concordance between mCR and pCR. Secondary endpoints included mCR at 3, 6, and 9 weeks, imaging CR (iCR) correlation, and event-free survival (EFS). Treatments included paclitaxel-carboplatin-pembrolizumab (tcP) followed by doxorubicin-cyclophosphamide-pembrolizumab (ACP) or ACP before tcP. This report presents EFS outcomes comparing patients who achieved mCR with those who did not after NAC. Results: Of 31 enrolled patients, 29 had sufficient tissue for ctDNA analysis. Of these, 64% were African American (AA), 34.4% Caucasian (CA), and 3.4% Asian. After NAC, 48% (14/29) achieved pCR, and 66% (19/29) demonstrated favorable pathologic response (RCB 0/1). All patients with RCB 0/1 achieved ctDNA clearance at 6 weeks, increasing to 86% (25/29) post-surgery. After a median follow-up of 20 months from initiation of NAC, there were six recurrence or death events, with 83% (5/6) occurring in patients who did not achieve mCR. Among these, 66% (4/6) were due to local or systemic progression, and one patient died from unrelated causes before completing NAC. The estimated EFS was 37.5% for ctDNA positive patients versus 95.2% for ctDNA negative patients (hazard ratio (HR): 17; p-value: 0.0096). HR is inflated due to the scarcity of events. When analyzing the correlation between pCR and survival, all four events occurred exclusively in patients who did not achieve pCR (4/12, 33.3%), with no events in those who achieved pCR (0/15). This resulted in a significant survival advantage for patients who achieved pCR (log-rank p = 0.0081). Conclusions: These findings demonstrate that ctDNA clearance and pCR are powerful predictors of improved EFS in early-stage TNBC patients receiving neoadjuvant therapy. The correlation between mCR and survival outcomes suggests that ctDNA monitoring could be valuable for risk stratification and treatment decisions.
Whole person cancer care: Analyzing patient needs and service utilization at Inova Schar Cancer.
Authors: Austin Frisch, Melissa Farmer Miller, Jennifer Bires
Journal: Journal of Clinical Oncology (2025)

e23216 Background: Whole person cancer care is an approach that addresses the comprehensive physical, emotional, social, and practical needs of cancer patients and their families. Inova Schar Cancer (ISC) delivers holistic care through Inova Peterson Life with Cancer (PLWC), an interdisciplinary team providing integrative and supportive care services at no cost. PLWC also manages distress screening at ISC. Service usage is monitored via registrations for group programs and one-on-one consults documented in Epic. This quality improvement initiative aims to: (1) describe patient distress and unmet needs, (2) analyze participation in services to identify programming gaps, and (3) identify data collection limitations. Methods: A retrospective analysis was conducted on data collected from January 1 to December 31, 2024, encompassing distress screening, PLWC program registrations, and one-on-one consultations. Patients were screened for distress, which included reviewing and marking concerns from a list of 27 items. Results: In 2024, 7,381 patients were screened for distress (51% ≥65 years, 5% &lt; 40 years; 61% female); 1,652 were identified as having elevated distress. The top concern was difficulty sleeping followed by nutrition, understanding treatment, mobility and strength, managing emotions, and memory changes/concentration. A total of 2,527 PLWC group programs were held; 51% fitness classes. Of the non-fitness programs, 41% were support/networking, 22% were educational, and 22% focused on stress reduction. One-on-one consults consisted of 47% behavioral health therapists, 31% nurse navigators, and 22% registered dietitians. Data collection gaps highlight the need for improved course documentation. This can include detailed program classification based on audience characteristics (e.g., patient, caregiver, age, cancer type/status), program type, and cancer symptoms likely to be impacted by the program, according to scientific evidence. Data did not include one-on-one fitness consults, psychiatry, acupuncture, or massage. Conclusions: PLWC programs and consultations effectively meet patient needs by addressing non-pharmacological symptom management through physical activity, nutrition, group support, behavioral health interventions, and education. This support is backed by evidence to improve sleep, emotional well-being, and overall quality of life. Potential growth areas include expanding programs to address brain fog and tailoring services to specific patient groups or communities. Next steps include linking PLWC service data to the EMR to characterize trends in service usage, identify patients underutilizing PLWC services, and assess the impact of ISC PLWC on patient outcomes, healthcare utilization, and cost.
Association between obesity biomarkers and breast cancer risk in Nigeria.
Authors: Ifeyinwa Nnakenyi, Nwamaka Lasebikan, Emeka Nnakenyi
Journal: Journal of Clinical Oncology (2025)

e12556 Background: Obesity is an important risk factor for breast cancer, but current strategies have not addressed it for primary prevention of breast cancer. To provide evidence for this need, we aimed to determine the prevalence of overweight and obesity, serum levels of certain obesity biomarkers and association between those biomarkers and breast cancer risk. Methods: This was a case-control study at Oncology clinic, University of Nigeria Teaching Hospital, Enugu. Adult females diagnosed with breast cancer were recruited as cases, while adult females who were free of any type of cancer were the controls. Questionnaires were used to collect data, anthropometry measurements taken and venous blood obtained for determination of biomarkers (serum insulin, IGF-1, estradiol and leptin) concentrations. The serum were analyzed using ELISA methods. Statistical analysis was done with SPSS, and p-value &lt; 0.05 was considered as statistically significant. Results: Forty cases and 40 controls were included in the study with mean±sd age of 49±10.4years and 47±13.8years respectively, p &gt; 0.05. There was no difference in the body mass index (BMI) (27±6.6 vs 26±5.0 kg/m2), waist circumference (89±12.4 vs 89±11.8 cm), and waist-to-hip ratio (0.91±0.04 vs 0.91±0.06 between the cases and controls (p &gt; 0.05). Prevalence of overweight and obesity among the cases using BMI was 57.5% (23/40). Their serum biomarkers had median (interquartile range) of Estradiol 50.6 (43.4 – 75.7)pmol/L, Leptin 7.0 (2.1-16.5)ng/ml, IGF-1 4.3 (2.2-9.3)nmol/L and insulin 23.8(8.4-55.0)pmol/L; which were statistically different from the controls p &lt; 0.05, but not insulin. Significant associations with breast cancer risk were Estradiol OR 0.996 (95%CI 0.993-0.999) p = 0.023*, and Leptin OR 0.905 (95%CI 0.826-0.991) p = 0.032*. Conclusions: Estradiol and Leptin- a hormone predominantly made by adipose cells, showed significant associations with breast cancer risk. Since the mechanism of estradiol in breast cancer pathogenesis has already been well described, there is need to elucidate the complex molecular network of leptin signaling responsible for breast cancer which may provide novel ideas for prevention and therapeutic target. Association of obesity biomarkers with breast cancer risk. Obesity Parameters B S.E. Wald df Sig. Exp(B) 95.0% C.I.for EXP(B)Lower 95.0% C.I.for EXP(B)Upper BMI (kg/m 2 ) .882 1.211 Waist circumference (cm) -.008 .042 .038 1 .846 .992 .914 1.077 Waist to hip ratio 9.521 7.152 1.772 1 .183 1.364E4 .011 1.668E10 Insulin (pmol/L) .014 .010 1.967 1 .161 1.014 .994 1.034 IGF1 (nmolL) -.054 .066 .664 1 .415 .948 .833 1.078 E2 (pmolL) -.004 .002 5.192 1 .023* .996 .993 .999 Leptin (ng/mL) -.100 .046 4.602 1 .032* .905 .826 .991 Constant -6.662 6.177 1.163 1 .281 .001
Considering the caregiver in early-phase clinical trials.
Authors: Leah Louisa Thompson, Caterina Florissi, Nadia Saeed, Jaewon Yoon, Layla Mungekar, Rachel Jimenez
Journal: Journal of Clinical Oncology (2025)

e13899 Background: Patients enrolled in early-phase clinical trials (EP-CTs) often rely on family and friends for caregiving support. In these settings, informal caregivers take on significant challenges, including complex care tasks, demanding appointment schedules, and substantial financial burdens. Despite this, small qualitative studies suggest EP-CT caregivers receive minimal guidance regarding trial structure and caregiving responsibilities. To date, no studies have systematically assessed how EP-CTs may consider and orient caregivers around their involvement. Thus, this study sought to characterize how caregivers are addressed in key study documents, including informed consent forms and trial protocols. Methods: We identified all adult EP-CTs registered on clinicaltrials.gov from 1990–2025 with available informed consent and study protocol documents. Subsequently, three trained research assistants manually reviewed all forms. Using a structured codebook, they recorded whether caregivers were mentioned. If so, they searched for references related to the following categories: 1) involvement in informed consent discussions, 2) education on trial tasks (i.e. medication administration), 3) attendance at trial visits, 4) adherence monitoring, 5) symptom surveillance or management, 6) communication with the study team, and 7) supportive care resources. Descriptive statistics were used to summarize all data. Results: A total of 145 EP-CT trials (66 phase I, 79 phase I/II) met eligibility criteria and were included in the analysis. The median trial size was 27 participants, and included cancer types varied (66.9% solid only, 26.2% hematologic only, 6.9% mixed). Overall, 78.6% of studies referenced caregivers. Most trials suggested or encouraged caregiver involvement in informed consent discussions (77.2%), though only 6.2% explicitly committed to discussing study details with caregivers. A minority offered structured education on trial responsibilities (9.0%), and fewer addressed expectations related to attendance at trial visits, adherence monitoring, symptom surveillance or management, or communication with the study team (&lt; 5.0%). No trials mentioned available supportive care resources for caregivers. Conclusions: Despite the demands that EP-CTs place on caregivers and their pivotal role in patient participation, caregivers receive limited mention in key study documents. Efforts to incorporate language addressing caregiver involvement in EP-CTs may enhance caregiver inclusion and preparedness, while further optimizing patient care during trial participation.
Comprehensive germline sequencing and MLPA analysis in breast cancer patients: 4 years of experience from an Indian cancer institute.
Authors: Bhuvan Chugh, Aditi Chaturvedi, Devavrat Arya, Charu Garg, Harit Chaturvedi, Charu Bahl, Aparna Dhar
Journal: Journal of Clinical Oncology (2025)

e12542 Background: This study captures the clinical data and prevalence of the various germline mutations across breast cancer patients in India. It provides a comprehensive understanding of the common germline mutations along with their effect on treatment outcomes. Methods: Between 2021 and 2024, 208 unselected breast cancer patients, irrespective of gender or age, were enrolled for germline testing during treatment. Comprehensive demographic, clinical, pathological, and treatment data were collected. Germline testing utilized a targeted gene sequencing panel covering 145 genes, including promoter regions and clinically significant variants from databases like ClinVar and BRCA Exchange. Deletion/duplication analysis of 30 genes, including BRCA1/2, was performed using digital MLPA. Variants were classified per ACMG guidelines, and descriptive statistics were applied to analyze mutation patterns. Results: Among 208 patients, 114 (54.8%) had mutations, with 30 (14.4%) carrying pathogenic/likely pathogenic (P/LP) mutations. BRCA1/2 mutations constituted 7.2% (15/208) and accounted for 50% of all P/LP mutations. ATM (2.4%), PALB2 (0.5%), and CHEK2 (0.5%) mutations in addition to the BRCA1/2 mutations, represented 73.3% of all P/LP mutations involving the DNA damage repair (DDR) pathway. Notably, 2.4% (5 patients) carried TP53 mutations linked to Li-Fraumeni syndrome, with phenotypic differences noted within families. Co-mutations were observed in 3 patients, such as BRCA1-MLH1 and ATM-CHEK2, warranting further exploration. Median age of the cohort was 48 years. Patients with P/LP mutations had a significantly lower median age (43 years) compared to those with any mutation (48 years; U test, P=0.038). Male patients (2.8%) showed no pathogenic findings, likely due to sample size limitations. MLPA identified pathogenic mutations in 1% of cases, detecting BRCA1/2 mutations missed by NGS. Pathogenic mutations were disproportionately higher in triple-negative breast cancers (43.3%), with 67% of BRCA1/2-positive cases being triple-negative. TNBC patients were significantly more likely to have a pathogenic mutation compared to HR+ and HER2+ subgroups (Chi-square test, P=0.028). ATM mutations were exclusively hormone receptor-positive, with a subset also HER2-positive. Conclusions: Pathogenic germline mutations were detected in 14.4% of patients, with two-third detected in the DDR pathway, predominantly in BRCA1/2 genes. Additional MLPA testing increased BRCA1/2 mutation detection. TNBC showed higher mutation rates, emphasizing the need for genetic profiling in personalized treatment. Younger patients demonstrated higher mutation prevalence, underscoring the importance of early genetic testing. These findings support integrating genetic profiling into clinical practice especially in high-risk subtypes, to improve outcomes.