tbuckley/cabot-search huggingface dataset:
Relationship between cognitive and emotional domains of prognostic awareness with quality of life and psychological distress in patients with advanced cancer.
Authors: Claire Greydanus, Mitchell W. Lavoie, Jennifer S. Temel, Joseph A. Greer, Elyse R. Park, Vicki Jackson, Areej El-Jawahri, Hermioni L. Amonoo
Journal: Journal of Clinical Oncology (2024)

11106 Background: Prognostic awareness, a measure of patients’ cognitive and emotional perception of their illness and prognosis, allows individuals to align their medical decision-making with their goals and values. Prior studies have shown mixed findings regarding the relationship between prognostic awareness with better quality of life (QOL) and less psychological distress in patients with advanced cancer. However, studies have not investigated whether it is the cognitive or the emotional aspects of patients’ awareness of their prognosis that are associated with QOL and psychological distress in patients with advanced cancer. Methods: We conducted a cross-sectional study of patients with metastatic solid malignancies not being treated for curative intent at a single academic center from 11/2019-6/2022. We used the Prognostic Awareness Questionnaire (PAIS) to measure the cognitive (i.e., the capacity to understand one’s prognosis characterized by the accurate perception that a cancer is curable or not) and emotional coping with prognosis (i.e., the capacity to emotionally process prognostic uncertainty and terminal prognosis). We used the Functional Assessment of Cancer Therapy-General (FACT-G), Hospital Anxiety and Depression scale (HADS), and the Peace, Equanimity and Acceptance in the Cancer Experience (PEACE) scale to measure, QOL, psychological distress, and acceptance of illness, respectively. We used multivariate regression models controlling for age, gender, and cancer type to assess the relationship between the cognitive and emotional prognostic awareness domains and patient-reported outcomes. Results: Overall, 632 participants (age 65 years (SD=11.3), 51% female, 76% married or living with a partner) were enrolled in the study. In multivariate models, higher cognitive understanding of prognosis was not associated with QOL (b=-2.134; p=0.069), psychological distress (i.e., anxiety: b=0.331; p=0.232 and depression; b=0.233; p=0.368), or peaceful acceptance of terminal illness (b=-0.045; p=0.838). However, emotional coping of prognosis was associated with better QOL (b=1.981; p&lt;0.001), less anxiety (b=-0.516; p&lt;0.001) and depression (b=-0.370; p&lt;0.001) symptoms, and more peaceful acceptance of terminal illness (b=0.438; p&lt;0.001). Conclusions: Patients’ emotional coping with their prognosis, rather than their cognitive understanding of their terminal prognosis, was associated with their QOL, psychological distress, and acceptance of their illness. These findings underscore the importance of examining prognostic awareness and its association with patient-reported outcomes by domains. We also highlight the need to develop supportive care interventions to promote effective coping strategies for patients after prognostic disclosure.
Trends in prices of checkpoint inhibitors in the US, 2016-2023.
Authors: Jeddeo Paul, Aaron Philip Mitchell, Aaron S Kesselheim, Benjamin N Rome
Journal: Journal of Clinical Oncology (2024)

11075 Background: Checkpoint inhibitors have revolutionized the treatment of several cancers since the first Food and Drug Administration (FDA) approval in 2014. Yet the cost of these drugs remains high, with implications for patient access and healthcare sustainability. We assessed pricing trends for drugs targeting program death-ligand 1 (PD-L1) or programmed cell death protein 1 (PD-1) from 2016-2023. Methods: This study included 6 PD-L1 or PD-1 inhibitors approved through 2019. Quarterly Medicare Part B spending limits, which are based on the average sales prices of drugs from manufacturers to wholesalers or direct purchasers, were collected from public files. To directly compare drugs, prices were converted to prices per month (28 days), based on the FDA-labeled dosage and frequency for metastatic non-small cell lung cancer (NSCLC), a common cancer for which each drug was approved. Prices were adjusted to 2023 dollars using the consumer price index for all urban consumers. Results: In 2016, monthly prices for pembrolizumab ($15,604) and nivolumab ($15,814) were similar. Prices for these 2 drugs and avelumab, approved in 2017, remained within 5% of each other throughout the study period. Three other drugs (cemiplimab, atezolizumab, and durvalumab) were approved from 2016-2018 and had prices 3%-20% lower than the other 3 drugs (Table). Inflation-adjusted prices for all drugs remained stable from 2016-2019 and decreased from 2020-2023, corresponding with a period of higher inflation. In 2023, monthly prices for the 6 drugs ranged from $11,961 (durvalumab) to $15,043 (pembrolizumab). From 2016-2023, inflation-adjusted prices decreased, by an average of 0.7% (pembrolizumab) to 4.8% (cemiplimab) per year. Conclusions: Although the FDA approved 6 mechanistically similar PD-1 or PD-L1 inhibitors from 2014-2018, prices remained generally unchanged during those years and through 2023, with slight declines in real prices attributable to post-COVID consumer inflation. Competition among these brand-name cancer drugs did not meaningfully affect prices. Regulators should investigate why price competition has not emerged, and policymakers should grant more opportunities to negotiate lower prices for patients and the health care system, as is being rolled out this year in Medicare following passage of the Inflation Reduction Act. [Table: see text]
Cost-effectiveness of short-course radiotherapy versus long-course chemoradiation in organ preservation for locally advanced rectal cancer.
Authors: Anna Dornisch, Christina Cui, William Yu Luo, Michael Vincent Sherer, James Don Murphy
Journal: Journal of Clinical Oncology (2024)

11089 Background: Short-course radiation therapy (SCRT) has previously been found to be cost-effective compared to long-course chemoradiation (LCRT) for patients with locally advanced rectal cancer undergoing operative management. However, non-operative management protocols have recently become a standard treatment option for patients diagnosed with locally advanced rectal cancer achieving a complete clinical response after total neoadjuvant therapy (TNT) as surgery has significant impacts on quality of life. Recent data suggests higher rates of local regrowth and a correspondingly lower rate of organ preservation with SCRT-TNT compared to LCRT-TNT. With this study, we evaluated the cost-effectiveness of SCRT versus LCRT in the setting of non-operative management for locally advanced rectal cancer. Methods: We built a microsimulation model to simulate 5-year outcomes for 1 million hypothetical patients aged 65 years with locally advanced rectal cancer treated with TNT including either SCRT or LCRT. Patients achieving a complete clinical response with TNT opted for a non-operative management approach, undergoing surgery only with subsequent local progression. Patients not achieving a complete clinical response went directly to surgery. The model incorporated costs, quality of life (measured by health utility), and probabilities of disease progression and death. We extracted probabilities of disease progression and death and health utilities from published literature. We assessed costs from the healthcare payer perspective. We measured cost-effectiveness with incremental cost-effectiveness ratio (ICER), with ICERs under $100,000 per quality-adjusted life-year (QALY) considered cost-effective. One way and probabilistic sensitivity analyses were used to test model uncertainty. Results: We found that compared to SCRT, LCRT increased overall cost by $10,457 and improved effectiveness by 0.16 QALYs resulting in an ICER of $67,200/QALY. The model was most sensitive to assumptions about risks of local recurrence in the non-operative setting, the health utility of non-operative management, and the costs of LCRT and SCRT. The model was not sensitive to assumptions about costs of diagnostic evaluation (i.e. flexible sigmoidoscopy) and probability of distant recurrence. Probabilistic sensitivity analysis demonstrated that LCRT was cost-effective in 91% of iterations. Conclusions: Long-course chemoradiation could represent a cost-effective strategy compared with short-course radiotherapy in the non-operative management of patients with locally advanced rectal cancer. The ongoing ACO/ARO/AIO-18.1 trial testing the hypothesis that LCRT-TNT will increase organ preservation rates relative to SCRT-TNT will help confirm these findings.
Access barriers and cost of varenicline for smoking cessation: A national comparative analysis of Medicare standalone part D and Medicare Advantage plan.
Authors: Changchuan Jiang, Qian Wang, Arthur S Hong, Megan A Mullins, Jiazhang Xing, Tianci Wang, Xin Hu, Ryan David Nipp, Robin Yabroff, Joshua Liao, Xuesong Han, Ya-Chen Tina Shih
Journal: Journal of Clinical Oncology (2024)

11080 Background: Smoking cessation is a critical part of cancer prevention and control. Oral varenicline is the most cost-effective medication for smoking cessation, yet seniors enrolled in Medicare Part D Prescription Drug Plans (PDPs) can potentially face costs and access barriers to varenicline in the forms of prior authorization and quantity limits. Although over half of Medicare beneficiaries are now insured and receiving drug benefits through Medicare Advantage, it remains unclear how costs and access barriers compare between PDPs and MA drug plans (MADPs). This study compared plan-level costs and prevalence of prior authorization and quantity limit policies between PDPs and MADPs for oral varenicline. Methods: We used 2023 Q3 MA and PDP data from the Center for Medicare and Medicaid Services, excluding employer-sponsored and Supplemental Need Plans (including dual-eligible plans) and plans with &lt;10 enrollees. We focused on two generic varenicline forms: 0.5mg and 1mg tablets. To compare medication quantities, we calculated the plan-level median (IQR) cost for 30-day supply, based on the average unit cost. Price benchmarks were defined based on average wholesale acquisition cost (WAC) from Micromedex Red Book. T-test and Chi-squared tests were used to compare costs and prevalence of prior authorization and quantity limits. Results: Across 3512 MADPs and 813 PDPs, median costs for a 30-day supply of varenicline were similar (0.5mg tab: $375.32 vs. $376.87, p=0.64; 1mg: $371.88 vs. $376.87, p=0.49, respectively). Median costs for both PDPs and MAPDs were higher than benchmarks; p&lt;0.01 for all). For both varenicline dosages, MAPDs had higher rates of prior authorization (27.1% vs 16.2%, p&lt;0.01) and quantity limits (48.0% vs 30.4%, p&lt;0.01) than PDPs. Conclusions: Varenicline prices in both PDPs and MAPDs were much higher than benchmarks. Compared to PDPs, MAPDs used more prior authorization and quantity limit to control cost. This can create access barriers to this cost-effective medication, burdening patients, physicians, health systems, and pharmacies. [Table: see text]
Oral cancer drug repositories: Challenges and solutions.
Authors: Medha Sharath, Scott F. Huntington, Stephanie Halene, Osama Abdelghany
Journal: Journal of Clinical Oncology (2024)

11063 Background: Frequent drug shortages and high out-of-pocket costs due to inadequate and unaffordable insurance coverage hinder access to oral chemotherapy. Amidst this, oral cancer drugs estimated a mean of $4290/patient are wasted due to dose modification, discontinuation or death[Lam M. et al, JAMA Oncol. 2023;9(9):1238-1244]. To combat this discrepancy, multiple states have passed laws establishing drug repositories that collect unused oral cancer medications and redistribute them to patients in need. ASCO has also endorsed these programs, even advocating for open distribution systems allowing donations from individuals. Methods: We analysed statewise cancer drug repositories(source:National Conference of State Legislatures) and communicated with representatives from programs including SIRUM, RemediChain and I-DROP Coalition. We used a mixed methods approach to examine the breadth and functioning of these programs. Results: 28 out of the 44 states with laws establishing prescription drug repositories operate state-run drug recycling programs (Updated September 2023). However, only 14 states (California, Florida, Iowa, Michigan, Minnesota, Montana, Nebraska, Nevada, Ohio, Pennsylvania, Tennessee, Utah, Washington and Wisconsin) have provisions for donation of cancer medications, or for creation of separate cancer drug repositories. Other nonprofits like RemediChain and SIRUM function at a national level, covering 47 states and Washington D.C. between them. Conversations with 3 such programs revealed multiple obstacles that limit the effectiveness of drug recycling. All 3 programs reported inadequate donations, ranging from 2-3 donations/month in a state level program (I-DROP) to 1-10 donations/day in a larger national level program (RemediChain). 3/3 programs received more donations of unused pills from patients or their families than from pharmacies/health facilities. All 3 surveyed programs reported limited and inconsistent supply of donated drugs; expiration of drugs before redistribution; lack of demand for specialty drugs and unavailability of common oncology drugs that patients request since these drugs are less likely to go unused. All surveyed programs mentioned struggling with funding and staffing. Notably, all 3 repositories stressed that informing patients about recycling options right at the beginning of treatment was crucial to improve donation rates; and that expanding repository donor and recipient coverage could increase the chances of successfully redistributing drugs. Conclusions: Improving awareness amongst providers and patients, campaigning for federal funding and increasing the scale of coverage by expanding repository programs to all states and allowing interstate transfer of drugs could address current challenges to drug recycling. This would limit wastage of expensive medication while reducing financial burden on patients and improving access to life saving treatment.
Feasibility and utilization of electronic patient-reported outcome measures for lung cancer in routine clinical care.
Authors: Ethan Basch, Huamao Mark Lin, Mary Lynn Cala, Melpomeni Styliadou, Aaron Galaznik, Debra Wujcik, Emelly Rusli, Nicholas C Coombs, Emily R Beamon
Journal: Journal of Clinical Oncology (2024)

11107 Background: Prior studies have shown the value of Patient-Reported Outcomes (PRO) in cost burden, quality of life (QoL), and survival in cancer care. To facilitate focus on patient-centricity and value-based care, the International Consortium for Health Outcomes Measurements (ICHOM) and European Health Outcomes Observatory (H2O) developed a Core Outcomes Set (COS) in lung cancer. We explored the feasibility of deploying standardized PRO measures among patients with lung cancer in US clinical practice. Methods: A retrospective database study was conducted, with IRB waiver, using Carevive PROmPT, an electronic PRO (ePRO) remote symptom monitoring platform with weekly surveys comparable in scope to ICHOM/H2O COS, of symptomatic adverse events (PRO-CTCAE), physical function (PROMIS 4A Physical Function), and QoL items (EORTC QLQ-C30 items #29,30). Severe PRO-CTCAE symptom scores triggered care team alerts. From 9/2020 to 5/2023, 207 patients enrolled across 9 US cancer centers. Patients were ≥18 years, with lung cancer, and in current treatment. Patient engagement was measured by survey compliance, follow-up time, and completeness; clinician engagement was measured by platform utilization time, time to alert response, and clinical action taken. Results: Participants were 50% female, 86% White, 12% African American, median age 68, 81% NSCLC, and 26% with metastatic disease. Median survey persistence: 8 weeks, with 85% compliance over that time. Of domains assessed, 37 (58%) from Carevive data overlapped with ICHOM/H2O COS, with 19 measured over time. Overlapping domains included 15 clinical outcomes with 60% median completion rate and 22 PRO domains with 98% median completion. Of 19 domains assessed longitudinally, median compliance was 76%. Of patients triggering ≥1 ePRO symptom alert, 87% were within 4 weeks, with 46% requesting call-backs. Median clinician follow-up to alerts was 20 hours, with 69.3% addressed within 48 hours. Clinicians accessed the platform 2-3 times weekly, for median 2 minutes (range: 1-14 minutes) per login for nurses and Advanced Practitioners (AP). 89% of alerts were addressed by nurses and AP. Of alert responses, 66% indicated continuation of treatment, 12% were escalated to the clinical team, and 1% were escalated to hospitalization or ER visit. Conclusions: Results support the feasibility of integrating a standard set of multi-domain ePRO measures, comparable to the ICHOM/H2O COS, into routine cancer care, across multiple sites, with consistent patient engagement and provider utilization. One limitation is that clinical and financial impact were not directly assessed. Future research should explore direct clinician feedback, systematic implementation of PRO measures, and impacts on patient outcomes, resource utilization, and health systems.
Disparities in stereotactic radiosurgery practice patterns for treatment of brain metastases: A large national cancer database study.
Authors: Kekoa A. Taparra, Jonathan Shih, Manali I. Patel, Erqi L. Pollom
Journal: Journal of Clinical Oncology (2024)

11094 Background: Brain metastases (BM) portend high mortality rates. While whole brain radiation therapy (WBRT) is a commonly used treatment strategy for BM, stereotactic radiosurgery (SRS) has less neurocognitive toxicity with comparable survival. The objective of this study was to compare treatment practice patterns for SRS vs WBRT using a large national hospital database. Methods: The National Cancer Database (NCDB) was queried for patients ≥18 years treated with radiotherapy (RT) for a BM diagnosis between 2004-2017 and with known follow-up. 12 cancers were included based on highest prevalence including: breast, colorectal, kidney/bladder, liver, lung, lymphoma, melanoma, oral cavity, pancreas, prostate, and thyroid. Patients were grouped by first course RT modality (SRS vs WBRT) confirmed by fraction number (SRS: 1-5; WBRT: 5-15). Multivariable logistic regression assessed predictors of SRS as adjusted odds ratios (aOR) with 95% confidence intervals (95%CI). Analyses were adjusted for patient and cancer characteristics. Results: Of 88,539 patients with BM, 17,734 (18%) received SRS. Median age was 64 years. Most patients were White (84%), diagnosed in 2011-2017 (58%), with a higher income (55%), more education (55%), and Medicare/Medicaid (58%). The most common cancer treated with RT for BM was lung (86%). Patients were less likely to be treated with SRS if they were Hispanic (aOR=0.85; 95%CI=0.76-0.96), lower income (aOR=0.90; 95%CI=0.86-0.95), lower education (aOR=0.87; 95%CI=0.83-0.91), with Medicare/Medicaid (aOR=0.83; 95%CI=0.79-0.87) or no insurance (aOR=0.46; 95%CI=0.41-0.51), at a Midwest hospital (aOR=0.74; 95%CI=0.71-0.78; vs Northeast), and at a community (aOR=0.28; 95%CI=0.25-0.30; vs academic) or comprehensive community cancer program (aOR=0.50; 95%CI=0.47-0.52). Patients were more likely to be treated with SRS if they were older (aOR=1.01; 95%CI=1.01-1.01), diagnosed in 2011-2017 (aOR=2.39; 95%CI=2.30-2.49; vs 2004-2010), lived farther from the hospital (aOR=1.09; 95%CI=1.07-1.11), and received chemotherapy (aOR=1.41; 95%CI=1.35-1.47). SRS was most often used to treat BM from primary colorectal cancer (aOR=1.99; 95%CI=1.65-2.40), endometrial cancer (aOR=1.52; 95%CI=1.08-2.10), kidney/bladder cancer (aOR=3.09; 95%CI=2.68-3.55), and melanoma (aOR=2.74; 95%CI=2.39-3.14), while less often used to treat BM from lymphoma (aOR=0.18; 95%CI=0.11-0.30), vs breast primary cancers. Conclusions: In one of the largest BM studies with nearly 90,000 US patients, disparities in SRS treatment patterns were identified. On adjusted analysis, SRS was less likely to be used for patients who were of Hispanic ethnicity, lower income, lower educational attainment, without private insurance, and treated at community centers. The data highlight populations with cancer and BM who may benefit from increased access to SRS.
Cost-effectiveness of a circulating tumor fraction molecular biomarker for treatment response monitoring.
Authors: Zachary Rivers, Charu Aggarwal, Marc Ryan Matrana, Josephine Louella Feliciano, Akash Mitra, Halla Nimeiri, Rotem Ben-Shachar, Cathy Eng, Sheetal Mehta Kircher
Journal: Journal of Clinical Oncology (2024)

11082 Background: Clinical validation studies have demonstrated that molecular biomarkers quantifying ctDNA changes in circulating tumor fraction (TF) predict survival outcomes and may be used for treatment response monitoring (TRM). While clinical utility studies to determine the impact on outcomes of molecular biomarker-driven treatment decisions versus standard of care imaging are ongoing, cost-effectiveness has not been evaluated. Here we evaluate the cost-effectiveness of a molecular biomarker, Tempus xM, used for TRM. Methods: xM quantifies changes in TF from baseline and on-treatment liquid biopsies. We use a patient-level Markov simulation to compare xM-guided treatment (intervention) to diagnostic imaging-guided treatment (control) over 24 weeks of therapy. In both arms xM and imaging is assessed at 12 weeks and treatment decisions are made based on xM (intervention) or diagnostic imaging (control). Imaging and xM concordance (Table) was based on a retrospective, real-world (RW) study of 51 patients tested with xM that received rw-imaging that evaluated the association of xM with rw-outcomes in advanced pan-cancer patients treated with immune checkpoint inhibitors (ICIs) +/- chemotherapy (CT). We assume non-responders discontinue ICIs and switch to CT and responders remain on ICIs. Appropriate (inappropriate) therapy was defined as treatment decisions concordant (discordant) with xM results. Costs were calculated from Medicare’s perspective in 2023 USD. Control patients do not accrue the cost of xM. Sensitivity analyses were conducted. Results: Intervention patients saved $4,400 ($63,424 vs. $67,824 in controls) by preventing use of ineffective therapy (4.3 weeks avoided vs 0.2 weeks in controls), a savings of $1076 per week of ineffective therapy avoided. In all sensitivity analyses, xM-guided therapy remained cost effective (Table). The timing of therapy intervention and the cost of therapy had the largest impact on savings. Conclusions: This model demonstrates that xM-guided treatment is cost-saving compared to imaging alone during 24 weeks of treatment. Future work will incorporate variable clinical uptake and long-term outcomes by expanding the time horizon and including treatment discontinuation due to toxicities and mortality. [Table: see text]