tbuckley/cabot-search huggingface dataset:
Impact of carboplatin and cisplatin shortages on treatment patterns in patients with metastatic solid tumors.
Authors: Emily Castellanos, Qianyu Yuan, Niquelle Wadé, Khilna Patel, Catherine Rinaldi, Samantha Reiss, Eunice Hankinson, Aaron B. Cohen, Melissa Estevez
Journal: Journal of Clinical Oncology (2024)

11149 Background: The United States experienced cisplatin (CP) and carboplatin (CB) shortages in 2023, leading to potential rationing or switching to alternative therapies in multiple cancers. Using a US nationwide, real-world oncology dataset, we assessed changes in the use of CP and CB in 7 cancers during the shortage period. Methods: All patients (pts) from the Flatiron Health electronic health record-derived de-identified database (~280 cancer clinics, ~800 sites of care) with a machine learning-extracted metastatic (met) diagnosis of a cancer of interest between March 2022 and June 2023 and evidence of first-line (1L) therapy, were selected. Pts with multiple primaries were excluded. Platinum of interest was identified based on frequency of pre-period 1L use for a given cancer. The pre-period was June 2022 through first month of reported shortage (February 2023 for CP; April 2023 for CB); data cutoff was June 2023. Clinical characteristics of platinum-treated pts stratified by pre- vs post-period by disease were assessed. 1L platinum utilization rates (UR), calculated as the proportion of 1L-treated pts initiating CB/CP within 30 days of met diagnosis, were plotted by month. Cohort-level impact was evaluated with an interrupted time series analysis—overall and stratified by practice type, practice size, and socioeconomic status (SES). Multiple testing was controlled using the Benjamini-Hochberg procedure. Results: 10,983 pts received 1L therapy in the study period. Monthly platinum UR were stable across diseases in the pre-period. However, there was a significant post-period decrease in CB usage for non-small cell lung (NSCLC) and endometrial cancers (EC), and a decreasing trend in UR for CB in bladder (BC), ovarian (OC), and small cell lung cancers (SCLC). We also observed a decreasing trend in CP usage for cholangiocarcinoma (CC). Post-period monthly UR were stable for CB and CP in head and neck cancer (HNC), and for CP in BC. Odds ratios (OR) representing the month-over-month change in the odds of receiving platinum therapy during both pre- and post-periods are shown (table). OR trends varied by practice type and disease; no notable trends were seen by practice size or SES. UR with additional follow-up times will be presented. Conclusions: We observed decreased platinum use across multiple cancers during the shortage period, most notably for met NSCLC and EC, suggesting shortages led oncologists to seek alternatives to standard 1L platinum-based regimens. Further study of how treatment changes due to platinum shortages impacted pt outcomes is warranted. [Table: see text]
Improving quality of oncology (onc) documentation and enhancing structured data collection using a standardized onc note template.
Authors: Matthew Folstad, Arun Augustine, Fauzia Hollnagel, Cibele Carroll, Ashleigh Saner, Jeff Pier, Michael Lavitschke, Peter Kleinschmidt, Heidi Twedt, Amye Juliet Tevaarwerk, Hamid Emamekhoo
Journal: Journal of Clinical Oncology (2024)

11128 Background: To improve documentation quality in Medical Onc outpatient clinics, a standardized template was created. In this template we embedded: 1. An Epic SmartForm to collect structured data (SD) about patient, disease, and response status at each encounter. Minimal Common Oncology Data Elements (mCODE) compatible SD elements were used to enhance interoperability. 2. Several clinically impactful quality metrics (QM) selected based on the Quality Onc Practice Initiative (QOPI) guidelines. In this analysis, we aim to assess how template use impacted documentation quality. Methods: 113,376 outpatient encounters occurred between 01/2018 – 12/2022 (41 providers: 35 physicians, 6 APPs). The template go live was 3/19/2019. 2,520 randomly selected encounters were manually reviewed. Distinct documentation of 8 items served as QMs (Table). Of note, using the template was voluntary and data entry in the embedded form is not mandated. Documentation of each QM was compared between notes authored with/without template. For each note, a completeness score was calculated based on total number of QMs present/note. Categorical comparisons were made using chi-squared or Fisher’s exact tests. Numerical/continuous values were summarized using means and standard deviations. A template “user” was defined as a provider using the template in &gt;10% of encounters after go live. This QI project was exempted by IRB. Results: 154/2520 encounters were excluded after manual review (visits not for solid tumor malignancy). The template was used in 38.7% (917/2366) of the reviewed notes. Cancer diagnosis was documented in &gt;99.8% of notes regardless of template use. Template use was associated with increased documentation of 7 QMs (Table). Documentation overall completeness improved from 62% to 90% with a very large effect size (Table). Template use positively correlated with female gender and fewer years since last training (p&lt;0.001). In the subgroup of notes written by “users” (21 physicians, 4 APPs), individual QM and overall completeness scores improved with template use (p&lt;0.001). Conclusions: Template use profoundly improved QM documentation (statistically significant and clinically meaningful) by Onc clinic providers. This strategy enhances mCODE compatible structured data collection and semantic interoperability between systems, strengthening the available real-world data (RWD) in EHR. [Table: see text]
EROS: Engendering reproductive health within oncologic survivorship—ECOG-ACRIN E1Q11 paradoxical provision of reproductive health.
Authors: Ashlesha Patel, Ju-Whei Lee, Howard A. Zaren, Erika K Radeke, Rachel E. Lerner, Jami Aya Fukui, Della F. Makower, Deimante Tamkus, Kendrith M. Rowland, William M. Adler, Alyssa Throckmorton, sharad A. ghamande, Jessica Jones Croley, Andrew William Pippas, Rubina Qamar, Michael Jordan Fisch, David Cella, Lynne I. Wagner, Mary Helen Helen Hackney
Journal: Journal of Clinical Oncology (2024)

11123 Background: For the 10% of women diagnosed with cancer in the reproductive age, reproductive health (RH) is a critical component of oncologic survivorship. RH includes oncocontraception (OC), oncofertility (OF) and sexuality. Guidelines segregate these components resulting in fragmented reproductive health care management. Methods: The EROS trial is a clustered randomized trial performed at 17 NCI Community Oncology Research Program (NCORP) sites (including 8 NCORP sites and 9 Minority/Underserved NCORP sites) from 2016-2023. Eligible subjects included reproductively capable women aged 15-55 with new cancer diagnosis. Intervention included RH didactics and decision aids. Childbearing interest was dichotomous, not completed childbearing (including either pregnant or future childbearing interest) or completed childbearing. The objective of this study is to determine provision of OC and OF referral by providers at the baseline visit based on patient’s self-reported childbearing interest at study entry. Chi-square tests were used to compare distribution differences in the referral status (receipt: yes vs. no) between treatment arms. Results: The EROS study enrolled 420 subjects. Of the 63.6% (267/420) completed childbearing, 62.4% (58/93) in the intervention arm and 40.2% (70/174) in the non-intervention arm received an OC referral (p=0.0006), whereas 98.9% (92/93) in the intervention arm and 93.7% (163/174) in the non-intervention arm received an OF referral (p=0.0487). Of the 36.4% (153/420) not completed childbearing, 48.3% (28/58) in the intervention arm and 33.72% (32/95) in the non-intervention arm received an OC referral (p=0.0729), while 77.6% (45/58) in the intervention arm and 70.5% (67/95) in the non-intervention arm received an OF referral (p=0.3388). Conclusions: While the intervention increased the rates of provision of oncocontraception and oncofertility for patients with completed childbearing, our study shows provision of oncofertility referrals at a markedly higher rate than oncontraception. Referral patterns were inconsistent with patient need particularly in completed (receiving OF referral) or delayed childbearing (not receiving OC referral) interest of the patient. The bias favoring oncofertility referral may reflect oncology guidelines emphasizing this aspect of reproductive health despite comprehensive needs of patient.
Timing of EGFR or ALK inhibitor initiation and survival among patients with advanced NSCLC.
Authors: Tawee Tanvetyanon, Dung-Tsa Chen, Jhanelle E. Gray
Journal: Journal of Clinical Oncology (2024)

11148 Background: ALK or EGFR inhibitor is an ideal frontline treatment for patients with advanced non-small cell lung cancer (NSCLC) harboring targetable alteration in ALK or EGFR. However, in the real-world setting, frontline treatment may be delayed or unideal. For such patients, the magnitude of survival benefit when initiating ALK or EGFR inhibitor at a much later timepoint remains unclear. Methods: We utilized a nationwide electronic health record-derived, deidentified database collected from diverse oncology practices across the United States to investigate the timeliness of preferred targeted therapy (PTT), defined as osimertinib, lorlatinib, alectinib or brigatinib. Individualized data obtained from patients with stage IV NSCLC at diagnosis treated with PTT during 2018 to 2023 were analyzed. Timing of PTT initiation was modeled as time-varying covariate. Results: Data from 3250 patients were analyzed: 2640 patients (81%) with EGFR mutation and 610 patients (19%) with ALK rearrangement. The median time to PTT was 7 weeks from diagnosis with 26.4% of patients started PTT within 1 month. Landmark analyses using timepoints ranging from 1 to 12 months after diagnosis showed that at all timepoints, patients who had started on PTT had a significantly better survival than those who had not (Table). In a multivariable analysis, time to PTT ≤ 1 month from diagnosis was an independent predictor of survival: HR 0.74 (95% CI: 0.62-0.89), p=0.002. Prolonged time to PTT was significantly associated with advanced age, positive smoking status and genomic class being ALK as compared to EGFR. Conclusions: In this population-based analysis, an initiation of PTT occurring as late as at least 1 year from diagnosis still resulted in a significant survival benefit, though the magnitude of benefit appeared decreased as time passed. [Table: see text]
Enhancing inpatient chemo/immunotherapy stewardship: A novel scoring rubric approach to optimize utilization and reduce costs.
Authors: Aarti Sonia Bhardwaj, Jessica Lyublinsky, Tianxiang Sheng, Priya Jain, Robert Thomas, Cardinale B. Smith
Journal: Journal of Clinical Oncology (2024)

11130 Background: Most inpatient chemo/immunotherapy (IC) is not reimbursed because of the diagnosis-related group code structure for reimbursement. We implemented the use of a novel objective scoring rubric to guide and automate IC stewardship at an academic cancer center to decrease the inappropriate use of IC especially at the end of life. Methods: We created a scoring rubric for non-formulary IC that includes type and phase of trial, FDA/NCCN approvals, performance status, line, and goal of therapy. Clinicians enter these criteria in a Redcap form which automatically calculates a score which is then verified by 2 disease specific physicians and a clinical pharmacist. If the threshold score is not met, IC is not approved for administration. IC that is on formulary and standard of care is automatically approved. We compared post-implementation year 1 (1/2022-8/2022) to post-implementation year 2 (1/2023-8/2023) on two primary outcomes: drug cost and utilization. Comparisons were assessed using the Wilcoxon Signed-Rank Test. Results: There was a total of 74 requests with 12% not approved in 2022 compared to 96 with 14% not approved in 2023. We compared the median values of the number of times each non-formulary IC was dispensed from January to August in both 2022 (median=6) and 2023 (median=2), p= 0.01. In 2022 the median of average monthly IC drug charges was $$840730 compared to $434586 in 2023 (p= 0.02). In 2022 the median of average monthly ICI drugs was($91651) compared to $55368.35 (p= 0.25) for 2023. The total annual charge of IC decreased by 44% from 2022 to 2023 with the total annual charge of immune checkpoint inhibitors decreasing by 26% (Table). Conclusions: Implementation of a novel objective scoring rubric for IC stewardship effectively reduced inappropriate administration, as evidenced by a significant decrease in the number of times non-formulary IC was dispensed and a substantial reduction in drug charges. The total annual charge of IC significantly decreased by 44% showing a sustained improvement over a 2 year period. This approach offers a promising strategy to optimize resource utilization and ensure appropriate utilization of IC, particularly in patients nearing the end of life. Further studies are warranted to evaluate the long-term impact of this intervention on patient outcomes and healthcare costs.[Table: see text]
Estimating adult cancer cachexia prevalence and impact on survival in the US: Real-world data analysis.
Authors: Eric Roeland, Jeffrey Crawford, Richard Francis Dunne, Ira Allen Jacobs, John Groarke, Michelle I Rossulek, Nilo B. Cater, Philip D. Bonomi
Journal: Journal of Clinical Oncology (2024)

11141 Background: Cancer cachexia is defined by weight loss that nutritional support cannot fully reverse, leading to worse pt outcomes. Cachexia prevalence across cancer types relies on outdated studies. This study assesses the frequency of cachexia diagnosis using ICD9/10 codes or observed weight loss consistent with real-world cachexia diagnosis and its impact on survival. Methods: Retrospective, observational, real-world analysis using deidentified adult pt data from Clinformatics Data Mart database (Aug 1, 2016-Jul 31, 2021). Pts with at least 1 of 23 cancer types were identified using diagnostic and procedure codes and classified in 1 of 3 cachexia categories: (1) diagnosed (diagnostic code identified); (2) observed (BMI decrease: &gt;10% within 12 mo, &gt;5% within 6 mo, or &gt;2% with a BMI &lt;20 kg/m 2 ), (3) none (with no cachexia diagnostic code/observed). For observed, pts required ≥10 BMI records. Summary statistics presented as mean, median, or n (%). Survival rates compared using Cox proportional hazards model. Results: 672,665 pts were identified; 278,923 met inclusion criteria. Diagnosed + observed (subgroup) cachexia rates are shown for the 5 most prevalent cancer types (Table). Over 5 y, diagnosed cachexia rates ranged from 0.9-6.3%; observed from 60-83% (in subgroup with ≥10 BMI records). After cancer diagnosis, observed cachexia was identified on average 0-11 mo, while formal diagnosis occurred on average 11-24 mo. At least 16% of diagnosed and 31% observed pts received diagnosis or met observed criteria at or before cancer diagnosis. Average percent BMI decrease over 5 y was 22.0% ± 12.1, 17.8% ± 9.5, and 6.8% ± 5.5 for diagnosed, observed, and none, respectively. Compared with no cachexia, diagnosed and observed showed worse survival (HR 10.72 [95% CI 10.56-10.88]; HR 2.35 [95% CI 2.32-2.38]), respectively. Conclusions: Across all cancer subtypes, prevalence of observed cachexia cases documented by weight loss far exceeded cachexia prevalence based on diagnostic coding. After cancer diagnosis, pts met diagnostic criteria of cachexia within 1 y, but formal diagnosis took up to 2 y. The presence of cancer cachexia (diagnosed or observed), with or without metastatic disease, was associated with lower survival.[Table: see text]
Breaking through barriers: Unraveling challenges in clinical trial participation among oncologic patients in a developing country.
Authors: Erika Bushatsky, Andressa Liz Cândido, Daniel Agustin Vasquez Quispe, Rafaela Paiola, Alessandra Cristina Machado Barata Tavares, Felipe Melo Cruz, Lilian Martins Arruda
Journal: Journal of Clinical Oncology (2024)

11144 Background: Clinical trials are vital for advancing cancer research and treatment development, yet obstacles to participation impede progress, particularly in regions with limited clinical research awareness, such as Brazil. Methods: This study was conducted in a single cancer center in São Paulo, Brazil, between 2020 and 2022. A tailored questionnaire comprising demographic (age, gender, income) and barrier-related sections explored patient-related (10 questions), protocol-related (7 questions), and physician-related (5 questions) barriers. Results: Among 206 oncologic patients enrolled in the study, 43.7% were from the public healthcare system, and 56.3% had private insurance. Patients who self-declared as white were 59.7%, and those who self-declared as brown/black were 35.9%. Patient-related challenges included unfamiliarity with trial participants (84.6%), concerns about daily life disruptions (75.4%), and transportation difficulties (66.2%). Protocol-related obstacles involved fears of unknown side effects (62.3%), inability to choose treatment (47.6%), and potential assignment to a placebo group (46.8%). Physician-related barriers included communication issues, strained doctor-patient relationships (94.7%), and patient deference to doctors' decisions (55.4%). Higher-income patients and those in the public health system demonstrated greater clinical research awareness. Conclusions: The study emphasizes the critical role of patient education in overcoming barriers to clinical trial participation in oncologic patients. Furthermore, it underscores the necessity of addressing disparities among minority populations, such as non-white individuals with lower incomes, to transform clinical research and ensure universal access to newer therapies. Efforts should be directed towards inclusivity, bridging awareness gaps, and fostering a comprehensive understanding of the benefits of clinical trial participation for all cancer patients.
Examining the relationship between ECOG performance status and immunotherapy outcomes: Insights from real-world data analysis.
Authors: Rachel Chernet, Devashish Desai, Rahul Rajendran, Amber Bixby, Susan Faso, Josh Wallace, Michel R Nasr, Tamara Jamaspishvili, Alina Basnet
Journal: Journal of Clinical Oncology (2024)

11131 Background: The impact of Eastern Cooperative Oncology Group Performance Score (ECOG) on immunotherapy (IO) outcomes is intricate, as historically clinical trials have primarily enrolled patients with ECOG scores of 0 or 1. The National Comprehensive Cancer Network (NCCN) advises against administering IO to patients with ECOG scores of 2 or higher. However, conflicting findings from research studies and variations in real-world clinical practice complicate this relationship. Our study aims to elucidate the association between ECOG status and the outcomes of immunotherapy. Methods: Data collected from SUNY Upstate Medical University treated cancer patients who underwent immunotherapy and chemotherapy was used for analysis. The Kaplan-Meier method and Cox regression were used to analyze survival probability based on therapy, age, and ECOG. Results: Of 813 patients included in the study, 46.99% (n=382) received immunotherapy. 51.85% (n=421) were females. The mean age was 64.1 years in IO group and 67.7 years in non-IO/chemo group. 52.5% (n=187) of patients who were ≤ 64 years received IO compared to only 42.7% (n=195) of patients who were ≥ 65 years (p=0.005). 48.6% (n=118) of patients with ECOG score 0 received IO, while only 40.5% (n=72) patients with ECOG score of ≥3 received IO (p=0.279). Patients who received IO with ECOG score of ≥3 had higher probability of survival compared to other groups (p&lt;0.0001). While, in non-IO group, patients with ECOG 0 had higher probability of survival compared to ECOG 3 (HR 1.773, 1.209 – 2.600). There was no difference in overall survival in patients receiving IO based on age categories (p=0.2627, HR 1.148, 0.901 – 1.462). Conclusions: Our findings suggest that relying solely on ECOG status to determine eligibility for immunotherapy may be overly restrictive. Patients with significant comorbidities could still derive benefits from immunotherapy. Further investigation is warranted to comprehensively assess the influence of ECOG status on immunotherapy outcomes.
End of life (EOL) care in head and neck squamous cell carcinoma (HNSCC) compared to other solid tumors (OST) in Washington (WA) State.
Authors: Lauren Shih, Qin Sun, Catherine R. Fedorenko, Neal D. Futran, Brittany Barber, Emily Marchiano, Upendra Parvathaneni, Jay Justin Liao, Cristina P. Rodriguez, Scott David Ramsey, Veena Shankaran
Journal: Journal of Clinical Oncology (2024)

11147 Background: Real world data describing EOL care in HNSCC is limited. We performed a retrospective study evaluating EOL in HNSCC vs OST in a population-based sample of patients in WA. Methods: We used a database linking WA state cancer registry records with claims records from Medicare, Medicaid, and two large commercial insurers. Patients with HNSCC (oral cavity, oropharynx, hypopharynx, or larynx) were compared to OST (any solid tumor diagnosis). Adults with AJCC stage II-IV or SEER stage Regional/Distant who died in 2011-2021 with continuous insurance enrollment 6 months before death were included. We compared proportions of patients with &gt;1 ED visits in the last 30 days of life, ICU admission in the last 30 days of life, chemotherapy in the last 14 days of life, and hospice enrollment at least 3 days prior to death. We performed multivariate regression analysis to determine factors associated with hospice enrollment. Results: 1,389 patients with HNSCC and 41,412 patients with OST were identified. Demographics for HNSCC vs OST included median age 68 vs 73, white race 91.5% vs 90.1%, stage IV 57.5% vs 45.3%. Insurance types for HNSCC vs OST were commercial 8.4% vs 9.8%, Medicaid 16.6% vs 8.8%, Medicare 59.1% vs 65.5%, multiple 15.8% vs 15.9% (p&lt;0.0001). HNSCC patients had lower rates of &gt;1 ED visits compared to OST (14.1% vs 16.4%, p=0.02); there was no significant difference in ICU admission (25.1% vs 24.0%, p=0.3) or chemotherapy receipt (6.3% vs 5.1%, p=0.056). Hospice enrollment was significantly lower in HNSCC patients (49.0% vs 56.4%, p&lt;0.0001). A stratified analysis limited to stage IV patients yielded consistent findings in all categories. HNSCC patients died more at home and less in hospice (20.2% vs 12.7% and 41.5% vs 52.0%, p&lt;0.0001). In a multivariate regression analysis (Table) HNSCC, black race, living with a partner, or living in neighborhoods with higher area deprivation index (ADI) was associated with lower hospice enrollment. Patients with Medicare or multiple insurance types were more likely to enroll in hospice; AJCC stage was not significant. Conclusions: In this population-based sample, compared to OST, a greater proportion of HNSCC patients were insured by Medicaid at EOL and were less likely to enroll in hospice prior to death. The reasons driving these observed disparities in hospice enrollment warrant further study to optimize EOL care among patients with HNSCC. [Table: see text]