bluuebunny/crossref_metadata_2025 huggingface dataset:
Clinical-pathological characteristics associated with multigene assay risk scores, and prognostic impact of multigene risk scores in patients with invasive lobular carcinoma.
Authors: Lee Young-Won , Kim Jisun , Lee Sae Byul , Chung Il Yong , Yoo Tae-Kyung , Kim Hee Jeong , Ko Beom Seok , Lee Jong Won , Son Byung Ho , Lee Hee Jin , Gong Gyungyub , Jeong Hyehyun , Jeong Jae Ho , Ahn Jin-Hee , Jung Kyung Hae , Kim Sung-Bae
Published: May 2024

546

Background: Invasive Lobular Carcinoma (ILC), a unique breast cancer subtype, exhibits distinct clinical and pathological features. Multigene assays, notably the Oncotype DX (ODX) test, provide personalized prognostic insights in breast cancer. However, a research gap exists for clinical-pathological characteristics affecting multigene assay risk scores in ILC. This study aims to address this gap, investigating factors specific to ILC, distinct from those in invasive ductal carcinoma (IDC), contributing to refined risk stratification and personalized treatment decisions for ILC patients. Methods: Retrospective analysis was conducted on 238 ILC type breast cancer patients who underwent surgery at AMC between 2012 and 2022 and had undergone the ODX test. The ODX test assessed the Recurrence Score (RS) with defined categories: low (0-15), intermediate (16-25), and high (26 or above). Additionally, binary analysis categorized patients into low and high-risk groups using a cutoff of 25. The cutoffs were determined based on existing research findings. Results: Among patients undergoing ODX testing, the distribution of RS differed significantly between ILC and invasive ductal carcinoma (IDC) patients. Notably, the percentage of high-risk cases was higher in ILC (4.2%) compared to IDC (16.9%). Examination of patient characteristics revealed a prevalence of younger individuals, premenopausal status, and those undergoing breast-conserving surgery (BCS) among the low-risk binary group. In multivariate logistic regression analysis, PR negativity emerged as a significant factor influencing ODX high risk across the entire cohort (OR 23.224, 95% CI 3.732-144.527, p=0.001). Subgroup analysis by age identified specific risk factors, including PR negativity in younger patients (OR 11.896, 95% CI 1.247-113.523, p=0.031), larger tumor size (more than 2cm) (OR 4.180, 95% CI 1.229-14.214, p=0.022), and PR negativity in older patients (OR 25.030, 95% CI 3.505-178.756, p=0.001). Conclusions: In ILC, factors predicting ODX differ from IDC, emphasizing the need for tailored risk prediction models. PR negativity emerged as a consistent predictor of ODX high risk, warranting attention in risk stratification models. Recognizing this distinction is crucial for enhancing precision in prognostic assessments and optimizing patient management in ILC.
Adjunctive statistical standardization of quantitated adjuvant ER and PgR in CCTG MA.27.
Authors: Chapman Judy-Anne Williams , Bayani Jane , SenGupta Sandip , Battlett John MS , Piper Tammy , Quintayo Mary Anne , Virk Shakeel , Goss Paul E , Ingle James N. , Ellis Matthew James , Sledge George W. , Budd George Thomas , Rabaglio Manuela , Stearns Vered , Perez Edith A. , Gelmon Karen A. , Whelan Timothy Joseph , Shepherd Lois E. , Chen Bingshu E. , Taylor Karen J
Published: May 2024

567

Background: We proposed adjunctive statistical standardization of quantitated ER and PgR to improve inter-laboratory comparability of biomarker results and therapeutic management of breast cancer. Methods: We utilized CCTG MA.27 (NCT00066573), an adjuvant phase III trial of exemestane versus anastrozole in postmenopausal women with ER+ and/or PgR+ tumours. IHC ER and PgR HSCORE and % positivity (%+) were centrally assessed by machine image quantitation, and each statistically standardized to mean of 0, standard deviation of 1 following Box-Cox variance stabilization transformations of square for ER; for PgR, 1.) natural logarithm (0.1 added to 0 HSCOREs and 0 %+), 2.) square root. The primary endpoint was STEEP distant disease-free survival (DDFS) at the longest trial follow-up of median 4.1 years; a secondary endpoint was event-free survival (EFS). Survival was described with Kaplan-Meier plots and tested with the univariate Wilcoxon (Peto-Prentice) test statistic. We examined cut-points at standard deviations about mean of 0 (<-1; (-1,0]; (0,1]; >1) and explored single cut-points. Cox multivariate regressions were adjusted for age, T and N stage, grade, lymphovascular invasion, treatment, and baseline patient demographics; 2-sided Wald tests had nominal significance if p<0.05. Results: Of the 7576 women accrued, 3048 women had machine-quantitated image analysis results: 2900 (95%) for ER; 2726 (89%) for PgR. Statistically standardized HSCORE and %+ units differentiated both univariate DDFS and EFS; DDFS was significantly different by ER levels (p<0.001) and PgR levels (p<0.001). In multivariable assessments, ER HSCORE and %+ were not significantly associated (p=0.52-0.88) with the DDFS primary endpoint in models with PgR, while higher PgR HSCORE and %+ had significantly better DDFS (p=.001, in all instances) in models with ER. Conclusions: DDFS was superior for patients with higher ER and PgR standardized units compared with those with HSCOREs and %+ <-1. The adjunctive statistical standardization of ER and PgR performed here is similar to that mandated for clinical practice by the World Health Organization for BMD. [Table: see text]
Systemic inflammatory markers in neoadjuvant pembrolizumab therapy for triple-negative breast cancer: Prognostic insights and nomogram construction.
Authors: Giovanardi Filippo , Casartelli Chiara , Di Cicilia Roberto , Bologna Alessandra , Gasparini Elisa , Moretti Gabriella , Degli Esposti Claudia , Bisagni Giancarlo , Pinto Carmine
Published: May 2024

e12649

Background: Systemic inflammatory markers derived from peripheral blood cells, such as the neutrophils and lymphocytes ratio (NLR), derived neutrophil lymphocyte ratio (dNLR), platelet-lymphocyte ratio (PLR), and lymphocyte–monocyte ratio (LMR), have shown promise as prognostic markers. Currently, neoadjuvant treatment (NACT) for early triple-negative breast cancer (eTNBC) involves the addition of an immune therapy, and little is known about the variation of these markers in this specific context. Methods: This study evaluated two groups who received NACT for eTNBC in a single third-level cancer center. The first received NACT with EC X4 and a weekly paclitaxel regimen, the second pembrolizumab and NACT. A total of 70 patients were included, 37 patients in the pembrolizumab group. NLR was defined as the absolute blood neutrophil count (N) divided by the absolute lymphocyte count (L), dNLR was defined as the N divided by the derived L (absolute leukocyte count — N), PLR was defined as the absolute platelet count divided by the L, LMR was defined as the L divided by the absolute monocyte count. Association between systemic inflammatory markers and pathological complete response (pCR) was analyzed using statistical tests. Inflammatory markers were evaluated at the time of diagnosis, at the time of chemotherapy regimen change, and 1 week before surgery. The χ2 test or Fisher’s exact test was used for correlation and Student’s t-test to compare different groups. Results: The pCR rates were 60,6% in the standard therapy and 77,8% in the pembrolizumab. There were no significant differences in clinical characteristics between the two groups. NLR, dNLR, PLR and LMR at 6 months showed significant differences compared to baseline levels. dNLR in the immunotherapy group, at the end of therapy, showed statistical significance with the Welch Two Sample t-test with p-value = 0.001. Variables were weighted with respect to the type of treatment and the outcome was assessed as pCR. On the basis of these data, a nomogram was constructed to predict the likelihood of achieving pCR in patients undergoing neoadjuvant pembrolizumab therapy. Conclusions: This study highlights the potential of systemic inflammatory markers as prognostic indicators in patients with eTNBC undergoing NACT. dNLR is a novel biomarker associated with clinical outcome in solid tumors. In this study, for the first time, a correlation was found between the use of pembrolizumab and the change in dNLR and consequently its impact on pCR. A nomogram was constructed to predict the outcome of pCR. [Table: see text]
Predicting pathological response in early-stage triple-negative breast cancer: Exploring the role of BRCA gene mutations—A retrospective single-institution study.
Authors: Eldib Howide , Nwanwene Kemnasom , Kachynski Yury , Wright Thomas , Abdallah Mahmoud , Kumar Love , Mahdi Ahmad , Alhusari Leena , Shenouda Mina , Tirona Maria Tria
Published: May 2024

e12656

Background: Triple-negative breast cancer (TNBC) is a highly aggressive subtype of breast cancer, constituting approximately 15-20% of all breast cancer cases. While less than 10% of all breast cancer patients harbor BRCA1/2 mutations, ~20% of TNBC patients carry these mutations. Notably, at least one-third of BRCA1 carriers develop TNBC. This study aimed to investigate the association between BRCA mutation status and pathological response (PR) in early-stage TNBC patients, specifically, the impact of BRCA positivity on achieving pathological complete response (pCR), and identify other potential predictors of PR. Methods: We conducted a retrospective cohort study of patients with early-stage (Stage I-III) triple-negative breast cancer diagnosed and treated at our institution between January 2012 and June 2022, following Institutional Review Board (IRB) approval. Patients were identified from our Institutional Cancer Registry based on complete data availability (including other inclusion criteria) excluding patients who did not receive neoadjuvant chemotherapy. Data on demographics, tumor characteristics, treatment regimens, and pathological response (assessed according to [specified criteria]) were extracted from the charts. Results: Out of 228 patients diagnosed with early-stage triple-negative breast cancer, 54.6% had no genetic mutations, while 7.9%, 4.9%, and 8.4% harbored BRCA1, BRCA2, and other mutations, respectively. Notably, 23.4% did not receive genetic counseling or testing at our institution. Patients with BRCA2 mutations had a 100% pathological response rate, of which 57.14% had pCR, compared to 85.7% for BRCA1, of which 71.43% had pCR. Furthermore, 93.8% of patients with other genetic mutations had pathological response, of which 56.25% had pCR, as compared to 68.42% in non-mutated cases of which 26.7% had pCR ( P=0.038). Analysis of other variables revealed no significant impact of age, BMI, performance status, or neoadjuvant chemotherapy regimen on pathological response. Conclusions: This retrospective study suggests a trend towards higher complete pathological responses in early-stage triple-negative breast cancer patients with BRCA and other genetic mutations compared to those without. These findings were statistically significant, indicating a potential clinical trend that specific genetic mutations may be associated with improved response to neoadjuvant chemotherapy in early-stage triple-negative breast cancer. Further research is needed to confirm these findings and guide the development of personalized treatment strategies based on a patient's genetic profile. Additionally, our findings highlight the importance of genetic testing for all patients with early-stage triple-negative breast cancer, regardless of age or family history.
Treatment outcomes of the KEYNOTE-522 regimen in an ethnically diverse patient population: A real world experience.
Authors: Ng'ang'a Mukuhi , Burdette-Radoux Susan , Borgen Patrick I. , Kodali Abhigna , Andaz Charusheela , Urazov Anna , Sobol Gene , Silver Michael , Feinberg Joshua
Published: May 2024

e12663

Background: Pembrolizumab (pembro) in combination with neoadjuvant chemotherapy (NACT) became standard of care for high risk, early stage TNBC on July 26, 2021, as a result of the KEYNOTE-522 trial. Black women are disproportionately affected by TNBC with more advanced stage at diagnosis, however the KEYNOTE-522 did not collect data on race. This retrospective review evaluates response to pembro plus NACT in a racially diverse population to assess the generalizability of the trial findings to potentially under-represented patient populations. Methods: This is a single center, retrospective review of patients with stage II/III TNBC diagnosed between 08/2020 to 08/2023, treated with pembro plus NACT at Maimonides Medical Center, a safety-net hospital in Brooklyn, New York serving a diverse patient population. Exclusion criteria included age < 18 years, ER/PR/Her2 positivity, NACT without pembrolizumab and unreported race. Data were collected from electronic health records and analyzed using SPSS Statistics. Results: 50 patients met inclusion criteria, among whom 40 patients had complete information available for review. 52.5% (95% CI: 38% - 69%) of patients had a pCR. Nearly half of the patient population (47.5%) were African American. Subgroup analysis of ethnicity demonstrated a lower pCR amongst African American women, but this was not statistically significant (table). 5 patients had progression of disease with the development of distant metastasis (2 whilst on treatment and 3 following completion of therapy). 3 patients had grade 3/4 adverse events (pembro associated endocrine and cardiac dysfunction). Notably, lack of complete imaging response to treatment was significantly associated with lack of pCR (p=0.003). Conclusions: In this retrospective review of a racially diverse patient population, the pembrolizumab-NACT regimen was well tolerated with an acceptable side effect profile. While our rate of pCR is lower than the findings of the Keynote-522 trial; 52.5 % (95% CI: 38% - 69%) vs. 64.8% (95% CI: 59.9%-69.5%), our sample size is not large enough to detect a statistically significant difference. Sub-analysis of patient ethnicity demonstrated varying rates of pCR, however findings are limited by a small sample size. Additional data collection is in progress and future analysis will provide insight into a potential correlation between race and therapy response. [Table: see text]
Optimizing colorectal cancer screening outreach: A probability-based strategy by Temple University Hospital.
Authors: Grivas Christopher , Vallabhaneni Manasa , Ifrah Abraham , Gillow Gabrielle , Graham Brianna , Dahake Nikita , McNeilly Shelby , Khatri Rishabh , Raab Claire
Published: May 2024

e13502

Background: Temple University Hospital has created an initiative to increase colorectal cancer (CRC) screening to a historically underserved population in Northern Philadelphia through the administration of Fecal Immunochemical Tests (FIT). FIT testing possesses the advantage of being inexpensive and easy to use. Moreover, FIT testing serves as an additional opportunity for underserved patients to be integrated into a health network to receive lifesaving care when utilized by a large health system such as Temple Health. This study demonstrates how healthcare institutions, such as Temple Health, can employ probability-based modeling created from empiric data to navigate uncertainty and establish goals for the number of colonoscopies they aim to perform per a specific quantity of FIT tests distributed within the community. By doing so, they can significantly enhance the overall screening efforts in Northern Philadelphia and provide an essential service to those who need it most. Methods: FIT tests were distributed to the participants at community engagement events. FIT response rates, positivity rates, and progression to colonoscopy rates were determined and fit to a binomial distribution in Palisades @Risk software and underwent a Monte Carlo simulation of 10,000 iterations to determine the different probabilities of response rates, positivity rate, and colonoscopies performed per 1000 FIT tests distributed. Results: A total of 292 tests were distributed with a response rate of 56.5% (165 patients) and a positivity rate of 8.9% (26 patients). Out of 292 patients, 2.4% (7 patients) have had a colonoscopy or are scheduled to have a colonoscopy at Temple University Hospital. Probability curves were created to demonstrate the probability of number of responses, number of positive tests, and number of colonoscopies performed per 1000 FIT tests administered to the community. Lastly, we modeled the number of FIT tests that need to be administered to the community to perform at least 100 colonoscopies with different levels of certainty (Table). Conclusions: Here we show how hospital systems, like Temple Health, can use probability distributions based on empiric data to set tangible goals regarding their community engagement efforts to increase access to CRC screening. Through the utilization of probability distributions, healthcare organizations can gain deeper insights into resource allocation needs and strategically direct their initiatives, ultimately fostering a more inclusive and equitable approach to population-based CRC screening. [Table: see text]
Association between patient tumour characteristics and five-year survival in Nigerian patients with breast cancer.
Authors: Fatiregun Omolara Aminat A. , Lasebikan Nwamaka
Published: May 2024

e13504

Background: Breast cancer is a heterogeneous disease. The sociodemographic features and biological profile of breast cancer differ globally, especially in women of African descent. In Nigeria, limited studies explore the impact of these breast cancer-related factors on survival. This study evaluated the association between patients' tumour characteristics and survival in breast cancer patients in three regional tertiary cancer treatment centres across Nigeria. Methods: Data were extracted from patients' case files with a histopathologic diagnosis of breast cancer from January 1, 2005 - January 1, 2019. Patients' sociodemographic and clinical features were presented, and survival probabilities were reported; the Log-rank test was used to determine the association between time to death and categorical variables. Results: The study included 1020 patients across the three centres. Five-year survival probability was 0.65; 95% C.I: 0.60- 0.69. Most patients were between ages 30 and 49, and 49% presented with left-sided breast cancer. Patients aged>70 had significantly better survival. Only 40% had Immunohistochemistry (IHC) done, out of which HR+ breast cancer accounted for 43% while triple-negative breast cancer was 30%. Patients who received Herceptin and had molecular subtyping (immunohistochemistry) done had a higher survival probability. Conclusions: Most breast cancer patients in Nigeria present at earlier ages with advanced disease. Regardless of patient tumour characteristics, 5-year survival rates are lower than global rates. Only a few patients have access to optimal breast cancer management, molecular subtyping and targeted treatment inclusive. There is an urgent need to fund the National Cancer Control program to aid in implementing its strategic framework for breast cancer screening and management to improve access to cancer care in Nigeria.
Informing optimal treatment (tx) sequences for platinum-eligible patients with locally advanced or metastatic urothelial carcinoma (la/mUC) in the United States: Results of a clinical simulation modeling exercise.
Authors: Sanchez Alvarez Javier , Benedict Agnes , Tichy Eszter , Kongnakorn Thitima , Ike Chiemeka , Kearney Mairead
Published: May 2024

e13514

Background: Platinum-based chemotherapy (PBT) followed by avelumab (AVE) as first-line (1L) maintenance for patients with nonprogressive disease (PBT ± AVE) is the standard of care in la/mUC. This study compared the overall survival (OS) and cost-effectiveness of the tx sequence of PBT ± AVE followed by enfortumab vedotin (EV) or other therapies, including immuno-oncology (IO), in second line (2L; ie, PBT + 2L EV/IO or PBT + AVE + 2L EV/IO) vs 1L EV + pembrolizumab (PEM) for PBT-eligible patients (PBTp) from a US commercial payer perspective. Methods: A partitioned survival model compared outcomes with PBT ± AVE and EV + PEM among PBTp. Inputs included progression-free survival and OS, time to tx discontinuation, adverse event (AE) incidence, and health utilities and costs. Efficacy inputs were sourced and extrapolated from patient data in JAVELIN Bladder 100 (data cut: Jun 4, 2021), AVENANCE real-world study (1), and published data (EV-302 trial). Safety data were sourced from US prescribing information. Drug, subsequent tx, disease management, and AE management costs (2023 USD) were calculated. The optimal tx sequencing scenario assumed 80% of patients starting PBT were eligible to receive AVE (2023 Flatiron data cut; (2)), 70% of patients progressing on PBT ± AVE would start 2L, and 70% of those would be eligible for EV. Outcomes included life-years (LYs), quality-adjusted LYs (QALYs), costs, and incremental cost-effectiveness ratio (ICER). Scenarios and probabilistic sensitivity analyses (PSAs) were conducted to assess uncertainty. Results: LY, QALY, costs, and ICER modeling outcomes are shown in the Table. Use of EV in 2L after PBT ± AVE is associated with 0.76 lower QALYs, but given the large cost saving, it represents a cost-effective use of resources at the $150,000/QALY willingness to pay (WTP) threshold. PSAs showed that PBT ± AVE is likely to be more cost-effective over a broad and relevant WTP threshold range ($0-500,000/QALY). Results were sensitive to drug acquisition costs and eligibility to receive AVE and 2L EV. Conclusions: Based on this simulation exercise, the use of 2L EV after PBT ± AVE achieves considerable survival benefit at substantially lower costs vs 1L EV + PEM in PBTp with la/mUC. Given the shift toward value-based care in oncology, such analyses are becoming increasingly relevant to guide clinical decision-making. There is a need to assess tx alternatives that balance healthcare costs while optimizing outcomes in patients with la/mUC. 1. Barthélémy et al, J Clin Oncol 2024;42[suppl 4]: Abstract 561. 2. Moon et al, J Clin Oncol 2023;41[suppl 16]: Abstract 4567. [Table: see text]
Access to care for blood cancer: Allogeneic hematopoietic cell transplant caregiver requirements.
Authors: Preussler Jaime , DeSalvo Anna , Tweeten Ben , O'Brien Brenna , Schoeppner Katie , Sees Coles Jennifer A
Published: May 2024

e13515

Background: Caregiver requirements can be a major barrier to treatment access for many patients with cancer, especially those patients with blood cancer when alloHCT is a potential cure. This can be illustrated with allogeneic hematopoietic cell transplant (alloHCT). Patients are generally required to have a caregiver to proceed with alloHCT, often for at least 100 days. However, as different family and social structures evolve, the availability of a caregiver may lead to more access barriers. The aim of this study was to learn more about caregiver requirements and perspectives on those requirements from social workers, patients, and caregivers. Methods: We conducted interviews and focus groups from May 2022-February 2023 with 50 stakeholders, including social workers (n = 22), patients (n = 12), and caregivers (n = 16) in the United States (U.S.). Focus groups and interviews were recorded and transcribed for analysis by two independent reviewers. Results: All 22 social workers said their transplant center (TC) required a patient to have a caregiver to proceed to HCT; though requirements varied from 60 to 100 days post-HCT. One participant noted, “ I do have worries that patients aren't being referred who don't have caregivers and we just don't know about them and they're falling through the cracks.” Most patients and caregivers said their TC required a caregiver to proceed to alloHCT, but the length of time varied (from no requirement up to 180 days post-HCT). All patients who participated had a caregiver. Patients and caregivers had differing perspectives on the requirements, with some saying it was too short and they needed more time, and others saying it was too long and they could have used less time. Many said the amount of time a caregiver was needed depended on the patient’s recovery. All participants identified several solutions to help patients who did not have a caregiver; including a volunteer caregiver registry, having the patient stay in the hospital, using technology solutions (e.g., telehealth visits), changing/removing the requirements, having a shared caregiver in a community setting, having funding available for patients and caregivers, and/or home visits and checks. Conclusions: Patients with cancer face many barriers to treatment; for alloHCT and many other treatments, the need to have a caregiver is one of those barriers. This study found variation across TCs, suggesting a lack of evidence informing the requirements. These requirements can also lead to equity issues. This study was limited to patients who received an alloHCT; further research is needed to learn about the perspectives of patients who are unable to receive an alloHCT due to not having a caregiver available.
A cancer center department of supportive oncology: Patient demographic characteristics.
Authors: York Beth , Walsh Declan
Published: May 2024

e13518

Background: Supportive Oncology is critical to whole-person, modern cancer care. Our Department of Supportive Oncology (DSO) provides the following services: palliative medicine, senior oncology, integrative oncology, cancer survivorship, genetics, cancer rehabilitation, oncology nutrition, patient navigation, and psycho-oncology. Little is known on the patient population who access these services which makes program development difficult. We describe the key demographic variables in a Supportive Oncology Department (DSO) for age, payor, gender, language preference, and race across our health system, geographical locations, and DSO services. Methods: Patient encounters, as noted in the EMR, were analyzed in a Microsoft PowerBI (www.microsoft.com) database using visits from July 1, 2022 through December 31, 2023. Variables were pre-defined by the healthcare system. Descriptive statistics in grouped frequency distribution tables were used. Results: Female, White, English-speakers (respectively) were the top utilizers across our healthcare system (57%,62%,94%), the oncology service line (64%,69%,97%), and DSO (68%,68%,96%). By gender, females were predominant users (84%) of Integrative Oncology & Survivorship services. Males used Senior Oncology & Palliative Medicine most often of all DSO services (45%). Differences in race were noted in geography (Black urban 26% vs rural 18%). In DSO services, Black patients access for senior oncology/palliative medicine (combined) was highest at 26%. Lowest utilization for Blacks was psycho-oncology & genetics at 18 and 13% respectively. While the overall system had more managed care (55%), both the oncology service line and DSO had more Medicare and less Medicaid. DSO had more managed care (46%) than the service line (42%). In rural settings, DSO patients (39%) were more likely to be in managed care than those in the service line (34%). DSO had more patients in younger age groups (ages 45-64, 42%) than both the oncology service line (35%) and the health system (24%), regardless of urban/rural location. In both the health system and the oncology service line, younger patients were more likely to be in urban locations and older were more likely rural. For DSO services, younger patients (ages 18-44) were more involved in psychology (27%), genetics (26%), and integrative & survivorship care (19%). Older patients were more likely to utilize palliative medicine and senior oncology (ages > 65, 47%). Conclusions: This Supportive Oncology population reveals variation in service access related to demographic characteristics that can inform future program development. Important similarities and differences were noted compared to the wider oncology service line and health system. Age, gender, geographic, payor, and racial disparities may influence service utilization in Supportive Oncology.
Understanding barriers to guideline-concordant treatment in foregut cancer: From data to solutions.
Authors: Fonseca Annabelle L. , Amin Krisha , Tripathi Manish , Hearld Larry , Heslin Martin J. , Bhatia Smita
Published: May 2024

e13521

Background: Receipt of guideline concordant treatment (GCT) is associated with improved prognosis in foregut (gastric, pancreatic, and hepatobiliary) cancers. However, a large proportion of patients with foregut cancers do not receive GCT. This single institution study from the Deep South sought to understand barriers to receipt of GCT using a root cause analysis (RCA) approach. Methods: A retrospective review of 498 patients with foregut adenocarcinoma diagnosed between 2018-2022 was performed. GCT was defined using National Comprehensive Cancer Network guidelines. The Ishikawa cause and effect model was used to establish main contributing factors to non-receipt of GCT. Results: Overall, 170 patients (34.1%) did not receive GCT. Median (Interquartile range [IQR] time from symptoms to start of workup was 8.8 weeks (4.3-16.4); time from diagnosis to first oncology appointment was 4.6 weeks (1.6- 6.6), and time from oncology appointment to start of treatment was 11 weeks (3.7- 18.2). Root causes of non-GCT included Patient, Physician, Institutional Environment and Broader System-related factors. Non-GCT was often a function of multiple intersecting patient, physician, and institutional factors. Barriers to receipt of GCT along the cancer care continuum included: receipt of incomplete therapy due lack of follow-up with surgical oncologist after initial appointment (16.5%), deconditioning on chemotherapy resulting in non-receipt of surgical therapy (15.3%), multiple delays in care due to patient resource constraints resulting in loss to follow-up after receipt of some therapy (11.2%), physician factors including provider knowledge (leading to delayed or non-diagnosis) or specialist non- adherence to GCT (11.2%), lack of documented treatment plan after referral to oncologist (11.2%), loss to follow up before oncology referral without record of health system attempt to re-establish care (10%), non-referral to oncologist (9.4%), non-referral to surgical oncologist in patients with resectable disease (8.8%), and complications during treatment preventing completion of treatment (6.5%). Findings from this study will allow us to propose targeted solutions to improve receipt of GCT, such as development of automated systems to improve patient follow-up and compliance with GCT; institutional prioritization of resources to enhance staffing for navigation, physical therapy, social services, and care coordination; financial counselling and assistance programs; and development and integration of structured prehabilitation programs into cancer treatment pathways. Conclusions: A substantial percentage of patients with foregut cancer do not receive GCT due to multiple barriers along the cancer care continuum. This RCA approach allows us to propose and develop solutions that may improve receipt of GCT.
Primary health clinicians' attitudes towards liquid biopsy as diagnostic test for advanced lung cancer.
Authors: Lo Danyon , Wong Jenny , Keenan Rawiri , Wong Annie N. M.
Published: May 2024

e13525

Background: Lung cancer remains a leading cause of cancer mortality globally. In New Zealand (NZ), lung cancer disproportionately affects our indigenous Māori population with both incidence and mortality being three times higher than NZ-Europeans. Incidence of endothelial growth factor receptor mutated lung cancer is two to three times higher in Māori, Pacific, and Asian people compared to NZ-Europeans. Diagnostic delays arise from tissue biopsy difficulties and a lack of standardization in molecular testing. These delays could potentially be reduced if testing was augmented by liquid biopsy (LB) at the outset of diagnosis. LB could be more accessible, faster, and lower cost compared to tissue biopsy. We aimed to evaluate primary health clinicians’ (PHCs’) attitudes towards use of LB for molecular testing and lung cancer diagnosis. Methods: A NZ national survey was conducted of PHCs. The online survey was distributed through PHC bulletins, newsletters, and social media. It was open to circulation between November 2023 to January 2024 and consenting clinicians completed this via REDCap. Descriptive analysis was performed and reported in aggregate. Results: Seventy-two PHCs responded with 58 complete responses. Respondents were 78% urban and 25% worked in practices of very low-cost access. Current diagnostic challenges reported include limited PHC appointments, poor access to imaging, and limited access to specialist care. Fast track diagnostic pathway to specialist care existed for 55% of respondents. 92% were initially unaware of LB for molecular testing. 79% were not comfortable with pre-test genetic counselling associated for this. Concerns raised about LB included subsequent patient access to secondary care and establishing a culturally appropriate pathway particularly for Māori. Some rural PHCs highlighted the potential of LB to complement existing procedures. Provided there were adequate training and funding for LB, 72% of respondents would be comfortable requesting LB and associated counselling. The most preferred types of training were PHC focused articles (70%), online clinical pathways (68%), webinar (61%), online course (51%), and in-person presentation (46%). Conclusions: Most PHCs were not familiar with LB for molecular testing but 72% supported these tests to be incorporated into current pathways. There is a need to develop culturally safe pathways with sufficient training and funding, in order to reduce health inequities.
Oncology triage utilization among patients with gynecologic cancers.
Authors: Ojo Ayotomiwa , Kildee Isabelle , Modi Reena , Caulfield Victoria Lynn , Mulcahy Mary Frances , Foley Olivia , Barber Emma Longley
Published: May 2024

e13551

Background: Emergency department (ED) utilization among patients with cancer is associated with significant burden including financial costs, resource allocation, and the patients’ experience of time spent seeking care. Moreover, studies have demonstrated that cancer patients are commonly seen in the ED for issues that do not require inpatient management and could be managed in outpatient settings. Oncology-specific urgent care centers have previously been demonstrated to decrease ED utilization and may be a potential remedy to the time toxicity experienced by patients receiving cancer care. This retrospective review aims to identify patient characteristics, resource utilization, and disposition of patients with gynecologic cancers who present to an advanced practice provider-driven, cancer-specific urgent care center (“oncology triage”) embedded in a tertiary academic center in an urban setting. Methods: We conducted a retrospective review of all gynecologic oncology patients who presented to oncology triage for any indication from May 16, 2022 to May 16, 2023.We describe the patient population utilizing oncology triage, the services provided, and time-based outcomes to assess efficiency, including time from presentation until being roomed, time to admission, and time to undergoing imaging. Results: 104 patients with gynecologic cancer were seen in oncology triage during the study period. Most patients had ovarian (43.2%) and endometrial (42.3%) cancers, and fewer had cervical cancer (10.6%). 60.6% were on their first or second line of systemic treatment. Insurance coverage included 17.3% Medicaid, 33.7% Medicare, 46.2% private, and 2.9% were uninsured. Pain (40.4%) and nausea (31.7%) were the most common chief complaints. 25.0% and 23.1% of patients had an X-ray or CT scan ordered, respectively. Intravenous fluids (69.2%) and supportive medications (e.g., antiemetics, opiates; 51.9%) were the most frequent therapeutics administered. 19% were evaluated and reassured by provider without needing additional treatment. 35.5% of all patients seen were admitted. On average, patients were roomed and seen by the care team in 9 minutes. The average time from presentation to oncology triage to hospital admission was 5 hours and 1 minute. Conclusions: In a single-center study of oncology triage utilization among patients with a mix of gynecologic cancers, we found that an oncology-specific urgent care center evaluates and manages common acute cancer-related complaints in a timely fashion. Oncology triage offers a high-acuity patient population an alternative to the ED that is much more time efficient when compared to historic ED wait times. Our findings support oncology-specific triage as a valid model of care for a subset of common acute gynecologic cancer-related problems and highlight its potential to improve patients’ experience of their cancer care.
Expanding access to care through physician and medically integrated dispensing: Legal and regulatory considerations.
Authors: Dresser Jesse C.
Published: May 2024

e13556

Background: Oncology providers face a myriad of challenges, especially in navigating the intricate legal and regulatory aspects of physician dispensing and pharmacy practices. This session will dissect these complexities, offering insights into medically integrated dispensing and its importance in enhancing patient outcomes. We will provide a thorough overview of the current state-of-the-market, highlighting the benefits of a medically integrated model, such as immediate access to patient health records, substantial cost savings, integration of prescription data with patient health information, and the presence of dedicated staff for personalized patient education and monitoring. Methods: This section will elaborate on the structured approach and methodologies employed to navigate and demystify the legal and regulatory challenges in expanding access to care through physician and medically integrated dispensing. It encompasses: 1) Defining the Landscape: Introduces essential terms and concepts to understand legal nuances in oncology. 2) Legal and Regulatory Environment: Examines legal challenges, regulatory influences, and the impact of PBMs on care delivery. 3) Case Studies in Network Access: Presents real-world challenges and legal strategies in oncology performance and medication reimbursement. 4) Coverage & Reimbursement: Discusses complexities and strategies in oncology coverage, reimbursement, and patient steering. 5) Staying Compliant: Highlights compliance with standards like USP 797/800 and the impact of pharmacy regulations on dispensing. 6) Legal Empowerment: Provides legal tools and strategies for effective patient advocacy, network access, and handling disputes. Results: This section will analyze the success of applied methodologies in oncology, highlighting improvements in provider empowerment, patient outcomes, and practice operations within legal boundaries. It will demonstrate how these strategies enhance legal understanding among oncology professionals, improving care delivery and access to health services. Conclusions: Frier Levitt addresses legal issues in oncology dispensing, integrating legal analysis, case studies, and strategies to enhance care delivery. The session focuses on engaging with PBMs, insurers, and regulators for fair treatment and compliance. It aims to empower attendees with practical approaches for improving patient care amidst healthcare changes. The presentation contributes significantly to the Care Delivery/Models of Care track, offering a detailed perspective on legalities in physician dispensing and pharmacy practices.
Use of bispecific antibodies (BsAbs) in community practices: Key attributes to develop logistics and workflow for management of cytokine release syndrome (CRS).
Authors: Donnellan William Bruce , Abbas Jonathan , Berdeja Jesus G. , Byrne Michael , Chandler Jason Claud , Cassoli Lourenia , Lin Shih-Wen , Masaquel Anthony , Raff Lisa
Published: May 2024

e13575

Background: Establishing workflows to monitor and manage CRS in community practice settings presents unique challenges that may not be encountered in more specialized centers. Real world experience was gathered from OneOncology specialists to understand key steps, common challenges, and best practices to establish CRS workflows in community practices. Methods: Qualitative data were gathered via a 90-minute focus group and follow-up interviews. Participants were MD or PharmD community heme-oncology providers in physician-owned practices with 10-20 physicians. As of January 2024, participants had treated over 30 patients with commercially available BsAbs. Theme matrix techniques facilitated data analysis and presentation. Results: Catalysts for developing CRS workflows were the addition of BsAbs to the practice formulary, identification of practice leaders willing to drive protocol development, and education of clinic and hospital staff who would manage patients treated with BsAbs. Key steps in the workflow included defining lines of communication within the practice during and after office hours, designating leads to oversee staff training, and creating practice-specific management plans. A process for potential inpatient admission for moderate/severe CRS was developed in collaboration with hospital administrators and nursing leaders. Lines of communication between the treating practice, pharmacy, and hospital care staff before, during, and after treatment were established, and methods to ensure availability of necessary medications were identified. Finally, patient support and the logistics of patient/caregiver education on BsAb therapy, symptoms of CRS, and how and when to access care was highlighted. Conclusions: Use of BsAbs in the community requires thoughtful coordination between oncology practices and hospitals. Keys to success include defining flexible, practice-specific workflows for managing CRS, transitioning patients efficiently from clinic to inpatient setting, and careful training of staff, patients, and caregivers. [Table: see text]
Development and validation of MOSPROC, an easily applicable predictive score of mortality for patients with prostate cancer.
Authors: Dominguez Correa Juan Manuel , Zamora Rafael , De All José Antonio , Galmarini Carlos Maria
Published: May 2024

e13598

Background: Predicting life expectancy in prostate cancer patients is particularly difficult as different clinical factors significantly influence clinical outcome. Here we have developed MOSPROC, a simplified mortality predictive score to identify prostate cancer patients at high risk of mortality. Methods: The training set (TRS) (n=2,035) included metastatic Castration Resistant PC (mCRPC) patients from 4 randomized phase 3 trials (NCT00273338, NCT00988208, NCT00617669, and NCT00519285). The validation set included patients from NCT00554229 (mCRPC; n=256) (TS1) and NCT00626548 (M0 CRPC; n=661) (TS2) trials. Clinical trial datasets were obtained from www.projectdatasphere.org . All datasets contained more than 100 clinical variables per patient at baseline. Synthetic representations of every patient were generated and input into a deep learning framework to identify subgroup of patients based on their similarities. The resultant subgroups were correlated with overall survival (OS). Differential variables between subgroups were identified and included in a multivariable logistic regression model. Independent predictive factors found to be statistically significant were used to generate a predictive score of survival that was validated in the validation sets. Results: The deep learning framework identified two different subpopulations in the TRS: LL (n=824) and HH (n=1,204) with significantly different survival outcome. Patients in HH had a higher risk of death compared to LL (median OS 17.6 months vs. 27.3 months, respectively; HR 2.09 95%CI 1.84-2.39; p<.0001). Feature contribution analysis identified 36 differential features between both subpopulations including anthropometrics, performance status, vital signs, biochemistry, previous and current cancer therapies, and concomitant medications. From these, PSA, ALP, and AST were the best independent predictive factors that were then selected to create a simplified predictive score for survival. A score ≥34 points was considered a high score (HS) while if < 34, a low score (LS). When applied to TRS, the predictive score yielded an area under the curve of 0.91. Patients with HS presented a significantly shorter OS (median OS 18.4 vs. 23.9 months; HR 1.49 95%CI 1.31-1.71; p<.005). The predictive score was then validated in two additional trials with similar results. In both cases, patients with a HS presented a significantly shorter OS (TS1: HR 2.56, 95%CI 1.79-3.66, p<.01; TS2: HR: 3.46, 95%CI 1.89-6.33, <.001). Conclusions: By combining deep learning and classical biostatistical tools, we have developed MOSPROC, an easily applicable predictive score that, based on baseline values of PSA, ALP and AST, can identify prostate cancer patients with a higher risk of death. Further work is required to validate this approach in prospective cohorts of PC patients in additional clinical trials and/or real-world datasets.
Clinical large language model to predict loss to follow up for oncology patients discharged to skilled nursing facilities.
Authors: Liu Tianshi , Chen Ziyi , Wu Yonghui , Guo Yi , Chatzkel Jonathan Alexander , Bian Jiang
Published: May 2024

e13602

Background: The prognosis of cancer patients is heavily influenced by performance status which also informs an oncologist’s decision for initiating or continuing with cancer treatment. From SEER data, there is evidence that oncology patients who are discharged to a skilled nursing facility are less likely to receive chemotherapy and radiation. Patients with advanced cancer discharged from hospital also have a readmission rate as high as 34 percent. Those that are unlikely to follow up are a vulnerable population that should be identified to discuss how to best optimize post hospitalization care. Methods: University of Florida's Integrated Data Repository (IDR) was queried for established oncology patients at University of Florida Health from 2012 – 2023. The cohort was further narrowed down to patients who had exposures to antineoplastics within 6 months and loss to follow up was defined as not having a clinic visit within 6 months of hospital discharge. The study cohort included 194 patients and 97 patients were not lost to follow up and 97 patients were lost to follow up. Structured health data including ICD-9 and 10 codes, antineoplastic drug exposures, Area Deprivation Index (ADI), discharge vitals were extracted. Dataset was split into 70% training and 30% testing. Using logistic regression, random forest and XGBoost, loss to follow up was predicted with 5 fold cross validation and hyperparameter tuning with GridSearchCV for the best ROC AUC. Results: The median Charlson score for cohort was 11, median length of stay in the hospital was 7 days, median ED visits within 6 months was 8, median LACE score of 21. 86% of the cohort had Medicare, 6% with Medicaid, 6% Blue Cross, 2% Managed Care and 0.5% Other. There were 96 females and 98 males. 66% of the cohort was Caucasian and 31% Black, 3.9% Hispanic, 1% Asian, 0.5% multiracial. XGBoost and random forest performed better than logistic regression, both achieving a AUC ROC of 0.83 vs. 0.78. XGBoost had a higher F1 score of 0.75, sensitivity of 0.71, compared to 0.68 and 0.55 respectively for both Random Forest and logistic regression. The most important features for Random Forest were ED visits within 6 months, followed by diastolic blood pressure, heart rate, temperature then systolic blood pressure on day of discharge. The most important features for XGBoost were diagnoses of pulmonary congestion, pulmonary embolism, pleural effusion and type 2 diabetes with complications. Conclusions: Our XGBoost model achieved metrics which are in line with the higher performances seen with machine learning models predicting readmissions following hospital discharge. This serves as a good baseline model to compare against new state of the art models that incorporate unstructured data such as clinical notes and radiology image reports. These models are currently under development by the same authors using the clinical large language model GatorTron.