bluuebunny/crossref_metadata_2025_split huggingface dataset:
Value of care by reducing treatment terminations during radiation therapy.
Authors: Nosrati Jason Daniel , Ma Daniel , Bloom Beatrice , Hwang Jamie , Herman Joseph M. , Potters Louis , Chen William Chun-Ying 
Published: October 2023

6 Background: Disruptions in cancer care adversely affect patient clinical outcomes, particularly when a patient does not complete the prescribed course of treatment. Adverse outcomes include decreased overall survival and earlier/increased disease relapse or progression requiring additional salvage, palliative, and/or supportive therapies. We have reported on the incidence of treatment terminations (TT) in a large multi-center academic radiation medicine department. This study addresses the healthcare expenditure toward sub-optimal treatment associated with TT. Methods: TT of patients undergoing radiation treatment between 1/2013 and 1/2023 were prospectively tracked as part of departmental quality and safety monitoring. A TT was defined as the discontinuation of therapy at any point following informed consent and treatment simulation. The rate of TT was calculated as a percentage of all new patients who start radiation treatments. Cost of care was estimated using mean values from the 2023 Medicare Part B Fee schedule for New York, accounting for consultation, simulation and planning, treatment delivery, and weekly physician and physics treatment checks prior to TT. Cuts to the Medicare Physician Fee Schedule, Medicare reimbursement, and stagnant Medicare Conversion Factor relative to inflation over the 10 years were not accounted for. Results: There were a total of 1,467 TTs out of 28,707 planned treatment courses (5.1%). The average expenditure prior to TT was $8,584 per patient. Aggregated over the past decade, $12.59 million represents an underestimate of healthcare spend toward these situations at one institution. The rate of TT decreased from 9.3% in 2013 to 3.3% in 2022. As discussed separately, this TT rate was reduced via prospective analysis as part of our ongoing department quality and safety program, with incremental changes to pre-treatment evaluation, on-treatment management, and scheduling processes. Assuming stagnant clinical volume, this translates into decreased spend of $1.48 million annually toward incomplete (sub-optimal) treatments. Conclusions: Radiation TTs reflect major deviations from the original care plan. By understanding reasons for TT, we have more effectively selected optimal treatment paradigms and supported patients proactively through their treatment course. Avoiding divergence from intended cancer care decreases adverse outcomes, thereby improving value of the treatment course.
Social determinants of physicians’ treatment recommendation in early glottic cancer.
Authors: McGuire Dehra , Kilpatrick Kayla W , Kuchibhatla Maragatha , Cohen Seth M , Osazuwa-Peters Nosayaba 
Published: October 2023

65 Background: Glottic cancer is often diagnosed early due to its deleterious effects on the voice. National cancer treatment guidelines recommend larynx preserving treatment, either surgery or radiation, since both modalities have similar rates of local control and recurrence. Without any survival advantage for either treatment modality, physicians may make treatment recommendations based on other clinical or nonclinical factors. Methods: Using the National Cancer Database, a national hospital-based cancer registry data, this retrospective cohort analysis included adult patients, aged 18 years and older, with clinically confirmed diagnosis of early-stage (T1 and T2) glottic cancer between 2004 and 2017 (n = 27,632). The outcome of interest was physicians’ treatment recommendation of surgery or radiation therapy. Main measures included social determinants of health variables, including race/ethnicity, urban/rural status, health insurance status, and income. We further adjusted for covariates, including age and gender. Logistic regression analysis estimated odds of physicians’ recommendation of radiation versus Surgery, based on social determinants of health factors and adjusting for all covariates in the model. Results: More patients received recommendation for radiation treatment vs surgery (78% vs 22%). Female patients were less likely to receive a recommendation of radiation (aOR = 0.90; 95% CI 0.82, 0.98), while Black patients had increased odds of being recommended radiation compared to White patients (aOR = 1.16, 95% CI 1.04, 1.29). Both facility type and location, and patients’ urban vs. rural status were all associated with treatment recommendation, and individuals residing in rural areas had 32% increased odds of being recommendation radiation treatment vs surgery (aOR = 1.32; 95% CI 1.06, 1.64). Conclusions: Radiation treatment is prevalent in early-glottic cancer care, and we found an association between social determinants of health and physician recommendation of treatment. Further research should examine concordance of patient treatment preference vs physician recommendation.
Tailored doses, tailored savings: Optimizing dosing strategies of immune checkpoint inhibitors.
Authors: Desai Aakash , Jensen Chelsee , Soefje Scott A. , Das Devika Govind , Hussaini S. M. Qasim , Sridhar Arthi 
Published: October 2023

68 Background: While immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment, their high cost and limited global supply pose major challenges. Optimizing ICI dosing to achieve a minimum effective dose that has shown to maintain clinical benefit may be a potential solution with significant savings to the health system. We investigated potential savings in Medicare that could be attained from alternative ICI dosing. Methods: We conducted a literature review including original Phase 1/2 trials describing the minimal effective dose of three commonly used ICIs: Pembrolizumab (P), Nivolumab (N) and Atezolizumab (A). Alternate dosing strategies based on existing data for Pembrolizumab (2 mg/kg), Nivolumab (1 mg/kg) and Atezolizumab (4 mg/kg) were proposed. Publicly available CMS data on Medicare Part B expenditure for these therapies was utilized to obtain average cost per dosage unit, mg/dosage unit, and number of Medicare beneficiaries between 2018-2021. Average cost per dose and total cost per ICI was calculated based on current FDA approved dosing and alternate dosing strategies. Results: The average wholesale cost per fixed dose for P (200 mg), N (480 mg), and A were $9,242.00, $12,460.80, and $8,616.00, respectively. Implementing the proposed alternate dosing strategies led to a substantial reduction in drug costs: P ($7,393.60), N ($2,076.80), and A ($2,297.60). The ensuing cost savings were calculated based on the annual number of Medicare beneficiaries. From 2018-2021, the average total savings were estimated to be $95,545,182 for Pembrolizumab, $294,734,264 for Nivolumab, and $62,937,582 for Atezolizumab (Table). The cumulative average total cost savings from 2018-2021 exceeded $453 million. Conclusions: We demonstrate potential savings in Medicare with implementation of an alternative ICI dosing strategy. Our study underscores an urgent need to better understand clinical efficacy and cost savings from a patient perspective, and feasibility from a regulatory standpoint. This perspective may hold considerable global implications, providing a roadmap for cost-effective care in the domain of immunotherapy. [Table: see text]
Time trends of Part D drug expenses and Part D risk adjustment in the Oncology Care Model at a community oncology network.
Authors: Indurlal Puneeth , Wilfong Lalan S. , Thomas Hope Ives , Staggs Stuart George 
Published: October 2023

72 Background: The Oncology Care Model (OCM) was a 6-year Medicare value-based care (VBC) program that rewarded practices for providing high-quality cancer care to Medicare beneficiaries receiving system anti-cancer therapy, while decreasing Total Cost of Care (TCOC) compared to a benchmark price. TCOC in the model was driven by drug expenses and included both physician-administered (Part B) and prescription (Part D) medications. The past decade has seen several novel oral anti-cancer drugs revolutionize cancer treatment. The impact of the shift to oral anti-cancer drugs, the associated costs, and risk adjustments in the OCM is studied here. Methods: Using Medicare episodes data for 15 practices in The US Oncology Network (The Network) participating in the OCM, we evaluated the time trends of Part D drug expenses between July 2016 and June 2022, assessed the risk adjustment for episodes with and without Part D, and studied impacts on TCOC & benchmark prices. Results: Mean per episode spending at The Network practices increased 16.4% (3.4% CAGR) driven by a mean Part D expense per episode increase of 59% (8% CAGR) from 2016 ($5,532) to 2022 ($8,796) for OCM beneficiaries. Much of the increase was led by the approval of new oral cancer medications, cost increases on legacy oral medications, and expanded indications for oral medications in various cancer diagnoses. Mean Part D expenses increased 46.5% for Multiple Myeloma, 68.7% for Chronic Leukemia, and 124.2% for Breast Cancers. The OCM risk adjustment methodology used to determine baseline and benchmark prices includes a Part D risk adjuster that applies to patients with Part D coverage (with and without low-income subsidy eligibility) during the episode. The Part D risk adjuster increased the episode benchmark on an average by 5.1% ($2,112) (range between 2.9% ($850) in 2016, and 6.1% ($2,500) in 2022)), less than the actual increased Part D episode expenses. 81.4% of episodes in the OCM had Part D coverage that ranges between practices: 66% to 88.6%. Variation in Part D coverage between practices translates to variable impact of Part D risk adjustment in the OCM. Conclusions: Novel drugs, cost increases and newer indications for oral anti-cancer medications have translated into higher Part D spending for patients with cancer. Part D risk adjusters alone did not proportionately adjust benchmarks for increased Part D spending, disproportionately affecting those practices with higher Part D coverage. A modified risk adjustment approach for Part D is needed in TCOC VBC programs to account for variations in Part D coverage and increases in Part D expenses.
Engagement of patients with advanced cancer (EPAC) randomized clinical trial: Long-term effects on survival and healthcare use.
Authors: Patel Manali I. , Agrawal Madhuri , Blayney Douglas W. , Asch Steven M , Bundorf M. Kate , Milstein Arnold 
Published: October 2023

76 Background: The Engagement of Patients with Advanced Cancer (EPAC) randomized Veterans with newly diagnosed stage 3 or 4 cancer or recurrent disease to usual care (control) or usual care with 6-month community health worker (CHW) support (intervention) to engage Veterans in end-of-life (EOL) goals of care discussions. At 6- and 15-months follow-up, the intervention tripled goals of care documentation (primary), doubled hospice (secondary), and reduced end-of-life (EOL) acute care use (secondary) and total costs (secondary). This post-hoc analysis after 10 years from study initiation evaluates effects on overall survival (OS) and EOL healthcare use and costs. Methods: We abstracted dates of death, emergency department (ED), hospitalization, palliative care (PC), hospice use, and costs within and outside Veterans Affairs (VA) using electronic health record and claims before data cut-off on February 1, 2023 for all EPAC participants. We compared OS using Kaplan Meier and log-rank, risk of death using Cox-proportional hazard models, ED, hospitalization, PC, hospice use and costs in the last 30 days of life using Logistic Regression, and incidence rate ratios of ED and hospitalizations using Poisson regression. Results: Among 213 participants, there were no imbalances in demographic or clinical characteristics. 165 (77.4%) were White, 211 (99%) males, 80 (37.6%) had lung cancer, and 118 (55.3%) had stage 4 disease. Median follow-up was 298 days (range 12-3438). Intervention group participants had greater OS (log rank p=0.03), 25% reduction in risk of death, lower acute care use, greater PC and hospice, and lower total costs (p<0.001) than control group participants. Conclusions: The CHW-led intervention significantly improved OS and maintained robust effects on EOL healthcare use and costs. Results support integration of CHWs into care to improve clinical outcomes. Clinical trial information: NCT02966509 .[Table: see text]
Rapid care transition: Implementation of an undiagnosed cancer clinic.
Authors: Triglianos Tammy , Sorah Jonathan D , Cao Felicia , Bunch Joshua , Collichio Frances A. , Allard Melanie , Medley Chaely , Basch Ethan , Sanoff Hanna Kelly 
Published: October 2023

80 Background: There is a critical need to address potential delays in care for patients (pts) with new, undiagnosed cancer in academic medical centers that operate on a subspecialty clinic model. To bridge this gap, we established an Undiagnosed Cancer Clinic (UCC) staffed by oncology physicians and advanced practice providers (APP) to provide rapid access to specialty-led diagnostic work-up, symptom management, and disease education with the transition to subspecialists at a final diagnosis. Methods: A referral process was created, and specified provider template allocation (2 slots/week increased to 5) with a goal of referral to visit time <3 business days. A nurse navigator facilitates diagnostic procedures and helps overcome barriers to care. We collected data on time from referral to UCC visit, demographics, diagnosis, and symptoms managed. Results: Prior to the UCC, median wait time for undiagnosed pts at our institution was 17 days (range 7-49) over a 4-month historical cohort (n=14). In the first 9 months of the UCC, 52 patients were seen, with a decrease in median wait time to 5 business days (range 1-21); when excluding 13 pts who requested delays or were hospitalized, wait time was 3 business days (range 1-7). Referrals increased over time from 1 to 8 per month, most from primary care providers (PCP) (31%) and emergency department (ED) (25%). Demographics include race: 65% White, 25% Black/African American, 10% Other; ethnicity: 13% Hispanic; language: 90% English, 8% Spanish, and 2% Other. The most common cancers diagnosed were gastrointestinal (35%), lymphoma (12%), genitourinary (8%), and breast (8%); 79% of solid tumor pts had metastatic disease. No cancer was identified in 15%. 58% had at least one ED visit before UCC visit, and 8% between UCC visit and establishing care with a subspecialty team. Symptoms requiring intervention were present in 63% at the time of visit, including pain, nausea, vomiting, diarrhea, and constipation. 8% of those diagnosed were referred to hospice. Conclusions: The UCC is a high-value means of specialty-led care to work up a presumed cancer diagnosis while offering symptom management and patient-centered goals of care. A team of oncology providers and clinical navigation team decreased wait time and increased access in an outpatient setting, had a low rate of ED visits following UCC-established care, and provided support and coordination of care with the ability to address barriers for marginalized communities. We are actively partnering with EDs and PCPs to expand the reach of our UCC to a broader population.
“If we don’t speak the language, we aren’t offered the same opportunities”: Qualitative perspectives of palliative care coordination for women of color living with metastatic breast cancer.
Authors: Krishnamurthy Nithya , Smith Cardinale B. , Lin Jenny J. , Odom James Nicholas , Mazor Melissa 
Published: October 2023

88 Background: Black and Latina women with metastatic breast cancer (MBC) experience more severe distress, unaddressed symptom burden, and discordant provider communication relative to White women. Adequate care coordination has the potential to mitigate disparities in care access and outcomes, yet little is known regarding palliative care (PC) coordination experiences in women living with MBC. Methods: We conducted a qualitative thematic analysis of transcribed interviews of Black and Latina women with MBC (N=20) and interdisciplinary care providers (N=20). Participants were recruited from urban PC and oncology clinics, federally qualified health centers, and community organizations. Transcripts were reviewed and analyzed by a team of investigators, community scientists and community advisory board members. Themes were identified with inductive coding. Results: Barriers and facilitators of PC coordination were identified. Barriers included a) lack of communication between oncology, PC, and primary care teams, b) limited understanding and stigma surrounding PC among patients and non-PC providers, c) language and health literacy-related communication challenges, and d) racism and marginalization, including implicit bias and lack of diverse racial/ethnic representation in the supportive care workforce. Facilitators of PC coordination included a) patient-to-patient referrals, b) support groups breaking cultural stigma on topics including self-advocacy and PC, c) referrals from trusted providers, and d) community organization’s abilities to overcome challenges related to social determinants of health with logistical and financial support. Respondents reported barriers of quality PC coordination resulted in significant gaps in management of psychosocial and physical symptoms, including mental health, lymphedema, sexual health, cognitive health, and pain. Conclusions: Care coordination and patient reported PC outcomes are heavily influenced by social determinants of health and stigma surrounding PC. Patients and providers value patient-to-patient referrals, support groups, and community organizations in improving care coordination and early PC access. The results from this study will inform the design of ACCESS, a community navigator-led intervention for Black and Latina women with MBC focusing on acceptance of early PC and linkage to community and clinical resources.
Advance care planning among older cancer survivors in the United States.
Authors: Zhou Weijiao , Cho Youmin , Shang Shaomei 
Published: October 2023

91 Background: The goal of advance care planning (ACP) is to ensure that end-of-life (EOL) care is consistent with patient wishes and preferences. The ACP is particularly relevant to older adults with cancer due to their high risk of mortality. However, it remains unclear whether older cancer survivors have a higher rate of ACP engagement than general older adults. Methods: We used data from the National Health and Aging Trends Study (NHATS) Round 8, a nationally representative study of adults aged ³65. This cross-sectional analysis included 4,666 participants (1,568 cancer survivors), representing 33.93 million older Americans in 2018. The ACP was defined as having any of the three self-reported elements of ACP: EOL discussion, durable power of attorney (DPOA), or living will/advance directive. Cancer survivors were identified by self-reported cancer in Round 8 or prior rounds. Covariates were self-reported, including age, sex, race, marital status, education level, income, number of comorbidities, number of limitations in activities of daily living (ADL) and probable/possible dementia. We used logistic regressions to examine the association of cancer diagnosis and ACP engagement, adjusting for covariates and complex survey design and weights. Results: Older cancer survivors reported a higher rate of ACP engagement (80.10% vs 73.39), EOL discussion (66.94% vs 60.92%), DPOA (58.56% vs 51.02%) and living will/advance directive (63.34% vs 52.81%), compared to older adults without cancer. However, in adjusted logistic models, there was not significant difference between the two groups in ACP engagement (adjusted OR=1.12, 95% CI: 0.93, 1.36, P=0.22), EOL discussion (adjusted OR=1.08, 95% CI: 0.91, 1.29, P=0.37), DPOA (adjusted OR=1.07, 95% CI: 0.90, 1.28, P= 0.42) or living will/advance directive (adjusted OR=1.20, 95% CI: 1.00, 1.45, P=0.05). The oldest old (>80 years), women, White people, single/not married, with higher education, income, comorbidities and ADL limitations were more likely to engage in ACP (all P<0.01). The associations were similar across models that explored the individual elements of ACP. Conclusions: Despite the high mortality risk, older cancer survivors are not more likely to engage in ACP than the general older adults. About 20% of US older cancer survivors have not engaged in any form of ACP. Hospital, clinic and community strategies to introduce and encourage ACP among older cancer survivors are needed, especially for those minority populations.
As bleak as it sounds? Analyzing trends in oncology clinical trial initiation in the United Kingdom from 2013 to 2022.
Authors: Hadfield Matthew James , VanHelene Alex , Warner Jeremy Lyle , Lythgoe Mark 
Published: October 2023

93 Background: Clinical trials, especially phase 3 randomized clinical trials (RCTs), inform the standard of care in oncology, and their availability is the first step in ensuring opportunities for patient participation.A recent study by the Association of the British Pharmaceutical Industry showed a sharp decline in industry-sponsored clinical trials being performed in the United Kingdom (UK) over the past 5 years. In this study we sought to focus on UK participation in phase 3 RCTs of systemic anti-cancer therapy, both industry- and non-industry-sponsored, to evaluate if this decline applies more broadly to all phase 3 RCTs in the UK, especially within the context of Brexit in 2020. Methods: Data were identified and downloaded from ClinicalTrials.gov (CT.gov), a registry of privately and publicly funded clinical studies conducted globally, on March 14, 2023. Completed and recruiting trials with a start date on or after January 1, 2013, were identified using the keywords “neoplasms” and “cancer” and limited to “Phase 3”. Trials of supportive interventions or purely loco-regional interventions e.g., surgery, were excluded, as were randomized phase 2 trials. Eligible trials were categorized by year of commencement, participating countries, and the primary sponsor (e.g., industry or non-industry, including academic and cooperative groups). Results: 2345 of 3849 identified trials met the study eligibility criteria. The number of studies open in the UK increased from 48 in 2013 to 77 in 2021 but decreased to 49 in 2022. The number of UK trial sites included 383 in 2013 and decreased to 259 in 2022. Industry sponsored studies remained steady each year from 2017 to 2021 from 71 to 74 followed by a decline to 45 in 2022. In the European Union, excluding the UK, the number of open studies was 93 in 2013 and increased to 127 in 2021, but dropped to 93 in 2022. Combined trials in the US and Canada increased from 67 in 2013 to 105 in 2022. Conclusions: Clinical trials offer patients an avenue to experimental drugs and therapeutic combinations. Previous reports have raised concern that the UK has had precipitous drops in clinical trial initiation and enrollment secondary to the evolving regulatory landscape driven by concern about changes to the regulatory process and disharmonization due to Brexit. Our study highlights a reduction in clinical trials in the UK, however, this is consistent with declines in trial initiation across the EU, suggesting other factors (e.g., COVID-19) may be contributing factors. Paradoxically, trial initiation in the US and Canada increased over the same timeframe.[Table: see text]