Real-World Impact of Comprehensive Genomic Profiling on Biomarker Detection, Receipt of Therapy, and Clinical Outcomes in Advanced Non-Small Cell Lung Cancer.

PURPOSE: Therapeutic decision making for patients with advanced non-small cell lung cancer (aNSCLC) includes a growing number of options for genomic, biomarker-guided, targeted therapies. We compared actionable biomarker detection, targeted therapy receipt, and real-world overall survival (rwOS) in patients with aNSCLC tested with comprehensive genomic profiling (CGP) versus small panel testing (SP) in real-world community health systems. METHODS: Patients older than 18 years diagnosed with aNSCLC between January 1, 2015, and December 31, 2020, who received biomarker testing were followed until death or study end (September 30, 2021), and categorized by most comprehensive testing during follow-up: SP (≤52 genes) or CGP (>52 genes). RESULTS: Among 3,884 patients (median age, 68 years; 50% female; 73% non-Hispanic White), 20% received CGP and 80% SP. The proportion of patients with ≥one actionable biomarker (actionability) was significantly higher in CGP than in SP (32% v 14%; P < .001). Of patients with actionability, 43% (CGP) and 38% (SP) received matched therapies (P = .20). Among treated patients, CGP before first-line treatment was associated with higher likelihood of matched therapy in any line (odds ratio, 3.2 [95% CI, 1.84 to 5.53]). CGP testing (hazard ratio [HR], 0.80 [95% CI, 0.72 to 0.89]) and actionability (HR, 0.84 [95% CI, 0.77 to 0.91]) were associated with reduced risk of mortality. Among treated patients with actionability, matched therapy receipt showed improved median rwOS in months in CGP (34 [95% CI, 21 to 49] matched v 14 [95% CI, 10 to 18] unmatched) and SP (27 [95% CI, 21 to 43] matched v 10 [95% CI, 8 to 14] unmatched). CONCLUSION: Patients who received CGP had improved detection of actionable biomarkers and greater use of matched therapies, both of which were associated with significant increases in survival.

Frequency and Causes of Burnout in US Community Oncologists in the Era of Electronic Health Records.

BACKGROUND: Physician burnout, characterized by exhaustion of physical or emotional strength, cynicism, and lack of achievement, has become a worsening phenomenon in medicine, contributing to higher health care costs and patient/physician dissatisfaction. How burnout has affected hematologists and oncologists is not well studied. METHODS: US community oncologists/hematologists were queried via a Web-based survey from September-November 2018. Physicians were asked about frequency of burnout symptoms, drivers of work-related stress, and their perceptions on management of workload. RESULTS: Among the 163 physicians surveyed, 46% felt a substantial amount of stress at work. Most physicians felt emotionally (85%) and physically (87%) exhausted. A majority of physicians felt lethargic (67%), ineffective (64%), and/or detached (63%). In a typical workweek, 93% needed time beyond time allocated to clinical care to complete work responsibilities. Electronic health record (EHR) responsibilities caused moderate to excessive stress at work for 67% of physicians; 79% of physicians worked on EHRs outside of clinic hours. Other sources of excessive stress were changing reimbursement models (33%), interactions with payers (31%), and increasing patient and caregiver demands (31%). A third of physicians have considered retiring early or changing their career path to cope. To combat burnout, physicians' practices have used advanced practice providers, invested in information technology, and/or hired additional administrative staff. However, the majority of physicians stated they had optimal or good control over their workload. CONCLUSION: Most oncologists experience burnout symptoms and require additional time beyond that allocated to clinical care to complete their workload. The discordance between oncologists' admission of stress and exhaustion while claiming good control over those same burdens warrants exploration in future research.

Clinical management patterns of advanced and metastatic gastro-oesophageal carcinoma after fluoropyrimidine/platinum treatment in France, Germany, Spain and the United Kingdom.

OBJECTIVE: To describe treatment patterns and resource utilisation in France, Germany, Spain and the United Kingdom (UK) in patients with unresectable locally advanced and/or metastatic gastro-oesophageal adenocarcinoma (GEA), who failed first-line fluoropyrimidine/platinum treatment. METHODS: Treating physicians completed a web-based chart review (2013-2015). Eligible patients were ≥ 18 years old; had unresectable locally advanced and/or metastatic gastric adenocarcinoma including the gastro-oesophageal junction; received first-line fluoropyrimidine/platinum-based therapy; and had ≥ 3 months of follow-up after first-line discontinuation. Data were summarised descriptively for each country. RESULTS: There were n = 201 patients in France, n = 202 in Germany, n = 208 in Spain and n = 200 in the UK whose charts were reviewed. Percentages of patients receiving second-line therapy were 55% (France), 48% (Germany), 54% (Spain) and 29% (UK). At the start of second-line therapy, most patients had an ECOG performance status of 1 (range 0-3). Second-line therapy was primarily monotherapy, but agents used varied within and across countries. Supportive care use and resource utilisation were frequent whether receiving additional therapy or not; >60% patients had clinic visits unrelated to chemotherapy administration, and > 30% has ≥ 1 hospital admission. CONCLUSIONS: For the time of study, established GEA treatment guidelines were generally followed. However, therapies varied widely in the second-line setting.

Metastatic Pancreatic Adenocarcinoma Treatment Patterns, Health Care Resource Use, and Outcomes in France and the United Kingdom Between 2009 and 2012: A Retrospective Study.

PURPOSE: In Europe, pancreatic cancer (PC) accounts for approximately 2.6% of all new cancer cases and is the fourth leading cause of cancer-related death. Despite substantial morbidity and mortality, limited data are available describing real-world treatment patterns and health care resource use in any European country. We evaluated PC-related treatment patterns and associated health care resource use among patients with metastatic PC in the United Kingdom and France. METHODS: One hundred three oncology specialists (53 in France and 50 in the United Kingdom) abstracted data from medical records of 400 patients whom they treated for metastatic PC. Eligible patients had a diagnosis of metastatic PC at age 18 years or older between January 1, 2009, and December 31, 2012; had ≥3 months of follow-up time beginning at metastatic diagnosis; and received at least 1 cancer-directed therapy for metastatic disease. Information on patient demographics, Eastern Cooperative Oncology Group performance status, location of primary tumor, presence of comorbidities, adverse events, and complications were collected. Data on cancer-directed treatments and supportive care measures were evaluated. All analyses were descriptive. FINDINGS: Approximately two thirds of patients were men, and median age at metastatic disease diagnosis was 62.2 years. Nearly all patients (97.3%) received chemotherapy to treat metastatic disease, 9.3% received radiation therapy, and 7.8% received a targeted therapy. Overall, the most frequently administered first-line regimens for metastatic disease were gemcitabine alone (46.0%), a combination chemotherapy regimen consisting of oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX; 20.1%); gemcitabine/capecitabine (10.8%); and gemcitabine/oxaliplatin (9.5%). Approximately 40% of patients in France and 15% of patients in the United Kingdom received second-line systemic therapy, whereas 20% of patients in France and 3.4% of patients in the United Kingdom received third-line systemic therapy for metastatic disease. Overall, 52.5% of patients experienced at least one complication of PC. More than two thirds of patients had ≥1 office visit unrelated to chemotherapy administration, 54.0% had ≥1 inpatient hospitalization, 36.8% had ≥1 emergency department visit, and 25.3% had ≥1 pain management clinic visit. A total of 26.5% of patients in France and 42.5% in the United Kingdom entered hospice or long-term care. IMPLICATIONS: This study provides new, detailed information for patients with metastatic PC in real-world settings in 2 European countries. A small proportion of patients received >1 line of systemic therapy for metastatic disease, which is likely due to the aggressiveness of this disease and the lack of effective therapeutic options.

The inpatient burden of abdominal and gynecological adhesiolysis in the US.

BACKGROUND: Adhesions are fibrous bands of scar tissue, often a result of surgery, that form between internal organs and tissues, joining them together abnormally. Postoperative adhesions frequently occur following abdominal surgery, and are associated with a large economic burden. This study examines the inpatient burden of adhesiolysis in the United States (i.e., number and rate of events, cost, length of stay [LOS]). METHODS: Hospital discharge data for patients with primary and secondary adhesiolysis were analyzed using the 2005 Healthcare Cost and Utilization Project's Nationwide Inpatient Sample. Procedures were aggregated by body system. RESULTS: We identified 351,777 adhesiolysis-related hospitalizations: 23.2% for primary and 76.8% for secondary adhesiolysis. The average LOS was 7.8 days for primary adhesiolysis. We found that 967,332 days of care were attributed to adhesiolysis-related procedures, with inpatient expenditures totaling $2.3 billion ($1.4 billion for primary adhesiolysis; $926 million for secondary adhesiolysis). Hospitalizations for adhesiolysis increased steadily by age and were higher for women. Of secondary adhesiolysis procedures, 46.3% involved the female reproductive tract, resulting in 57,005 additional days of care and $220 million in attributable costs. CONCLUSIONS: Adhesiolysis remain an important surgical problem in the United States. Hospitalization for this condition leads to high direct surgical costs, which should be of interest to providers and payers.

Hospital costs, length of stay and mortality associated with childhood, adolescent and young adult meningococcal disease in the US.

BACKGROUND: Assessments of vaccination programmes should account for several important factors, including efficacy, safety and costs of preventing and treating the disease. Because patients with invasive meningococcal disease (IMD) are managed primarily in an inpatient setting, hospital costs and outcomes are central endpoints in health economic evaluations of IMD. OBJECTIVE: The aim of the study was to estimate hospital costs, length of stay (LOS) and mortality associated with IMD among children, adolescents and young adults in the US. METHODS: The study design was a retrospective analysis of discharges from the 2006 Healthcare Cost and Utilization Project Kids' Inpatient Database. Infant (<1 year), childhood (1-10 years), adolescent (11-18 years) and young adult (19-20 years) IMD-related hospitalizations (International Classification of Diseases, Ninth Edition, Clinical Modification [ICD-9-CM] code 036) were selected. Regression-adjusted costs ($US, year 2009 values), LOS and mortality risk were compared between IMD hospitalizations and demographically matched (5 : 1) controls. RESULTS: A weighted total of 735 IMD admissions were identified. Among children, adjusted mean LOS and cost per admission was highest for infants (9.0 days and $US36 454 among cases vs 1.9 days and $US5041 for controls; all p < 0.0001). Adjusted costs and case fatality was highest among infants with meningococcal sepsis ($US49 626 and 11.6%, respectively). Versus controls, adjusted risks of death in IMD cases were 4.6- and 10.3-fold higher, respectively, for infants and adolescents (both p < 0.05). CONCLUSIONS: While the advent of vaccines for Haemophilus influenzae and Streptococcus pneumoniae has curtailed invasive bacterial infection rates, IMD continues to be a public health concern that presents greatly increased hospital costs, LOS and mortality risk, particularly for infants and adolescents.

Cost of acute hospitalization and post-discharge follow-up care for meningococcal disease in the US.

The combined costs of acute hospitalization and post-discharge follow-up care in patients with meningococcal disease have not been widely documented. In this study, data were retrospectively analyzed from three large databases of hospital discharge records and commercial insurance claims in the US. Cases of meningococcal disease were defined as admissions with an ICD-9-CM diagnosis code in the range of 036.x. From the 2005 HCUP Nationwide Inpatient Sample, 349 (weighted N=1,710) meningococcal-related hospitalizations were identified with a mean facility cost (in 2009 dollars) of $19,526 per admission. Similar estimates ($18,119 and $20,066, respectively) were obtained from 268 admissions identified in the LifeLink (formerly PharMetrics) database during 1999-2007 and from 1,058 hospitalizations in the Perspective Comparative Database (PCD) during 2000-2007. Using insurance claims from LifeLink, we estimated that payers incur an additional $26,178 in non-facility (professional and other ancillary) costs during the course of a meningococcal admission, as well as $22,230 in additional medical and pharmacy expenses for post-discharge care during the ensuing year. The majority of follow-up costs ($14,637) were attributed to repeat hospitalizations. Mean length of stay for meningococcal disease was consistently estimated across databases at 8 to 9 days. Data from the PCD further suggested that meningococcal disease carries, on average, nearly 2 days of intensive care unit utilization. In conclusion, hospital admissions for meningococcal disease are costly to payers. These costs are heightened when non-facility services and post-discharge care are also considered. Awareness of the full cost burden of meningococcal disease is needed when evaluating vaccination programs targeting the disease.

Cost-effectiveness of oral cancer screening: results from a cluster randomized controlled trial in India.

OBJECTIVE: To evaluate oral cancer screening by visual inspection. METHODS: A cluster randomized controlled trial was initiated in Trivandrum district, Kerala, India. Of 13 population clusters, seven were randomly allocated to three rounds of screening between 1996 and 2004, while standard care was provided in six (control arm). An activity-based approach was employed to calculate costs associated with various components of the screening trial. Information on the resources used and on clinical events in each trial arm was derived from trial databases. Total costs for each cluster were estimated in 2004 United States dollars (US$). The incremental cost per life-year saved was calculated for all eligible individuals and for high-risk individuals (i.e. tobacco or alcohol users). FINDINGS: The proportion of oral cancers detected at an early stage (i.e. stage I or II) was higher in the intervention arm than the control arm (42% versus 24%, respectively). The incremental cost per life-year saved was US$ 835 for all individuals eligible for screening and US$ 156 for high-risk individuals. Oral cancer screening by visual inspection was performed for under US$ 6 per person. CONCLUSION: The most cost-effective approach to oral cancer screening by visual inspection is to offer it to the high-risk population. Targeted screening of this group will ensure that screening can be offered at a reasonable cost in a limited-resource setting.

Identifying and controlling for program-level differences in comparative cost analysis: lessons from the economic evaluation of the National Breast and Cervical Cancer Early Detection Program.

Performing economic evaluations of established health care programs is essential to identify and control for underlying program-level variations and to make valid comparisons. At a time when the need for such evaluations is growing, health care professionals have limited information on the methodological challenges of performing these evaluations. In this study, we used the National Breast and Cervical Cancer Early Detection Program to illustrate these potential underlying variations. We performed site visits to four grantees and collected activity-based cost data from nine additional representative programs. We identified five specific types of cost factors that should be considered when evaluating and comparing health care programs: clinical services, service mix, in-kind contributions, indirect costs, and year-to-year expenditures of specific activities. A key lesson is that case studies and pilot testing should be performed before initiating cost analysis to identify underlying variation and to test appropriate methods to adequately control for these differences.

Cost of starting colorectal cancer screening programs: results from five federally funded demonstration programs.

INTRODUCTION: In 2005, the Centers for Disease Control and Prevention (CDC) started a 3-year colorectal cancer screening demonstration project and funded five programs to explore the feasibility of a colorectal cancer program for the underserved U.S. population. CDC is evaluating the five programs to estimate implementation cost, identify best practices, and determine the most cost-effective approach. The objectives are to calculate start-up costs and estimate funding requirements for widespread implementation of colorectal cancer screening programs. METHODS: An instrument was developed to collect data on resource use and related costs. Costs were estimated for start-up activities, including program management, database development, creation of partnerships, public education and outreach, quality assurance and professional development, and patient support. Monetary value of in-kind contributions to start-up programs was also estimated. RESULTS: Start-up time ranged from 9 to 11 months for the five programs; costs ranged from $60,602 to $337,715. CDC funding and in-kind contributions were key resources for the program start-up activities. The budget category with the largest expenditure was labor, which on average accounted for 67% of start-up costs. The largest cost categories by activities were management (28%), database development (17%), administrative (17%), and quality assurance (12%). Other significant expenditures included public education and outreach (9%) and patient support (8%). CONCLUSION: To our knowledge, no previous reports detail the costs to begin a colorectal cancer screening program for the underserved population. Start-up costs were significant, an important consideration in planning and budgeting. In-kind contributions were also critical in overall program funding. Start-up costs varied by the infrastructure available and the unique design of programs. These findings can inform development of organized colorectal cancer programs.

Cost analysis of the National Breast and Cervical Cancer Early Detection Program: selected states, 2003 to 2004.

BACKGROUND: The National Breast and Cervical Cancer Early Detection Program (NBCCEDP) was established by the U.S. Congress in 1990. In recent years, there has been an emphasis on ascertaining the NBCCEDP's costs of delivering screening and diagnostic services to medically underserved, low-income women. The objective of this report was to address 3 economic questions: What is the cost per woman served in the program, what is the cost per woman served by program component, and what is the cost per cancer detected through the program? METHODS: The authors developed a questionnaire to systematically collect activity-based costs on screening for breast and cervical cancer from 9 participating programs. The questionnaire was developed based on well established methods of collecting cost data for program evaluation. Data were collected from July 2003 through June 2004. RESULTS: With in-kind contributions, the cost of screening services to women in 9 programs was estimated at $555 per woman served. Without in-kind contributions, this cost was $519. Among the program components, screening and coalitions/partnerships accounted for the highest and lowest cost per woman served, respectively. The median cost of screening a woman for breast cancer was $94, and the cost per breast cancer detected was $10,566. For cervical cancer, these costs were $56 and $13,340, respectively. CONCLUSIONS: Costs per woman served, screened, and cancers detected are needed for programs to accurately determine the resources required to reach and screen eligible women. With limited program resources, these cost estimates can provide useful information to assist programs in planning and implementing cost-effective activities that could maximize the allocation of program resources.

Economic burden of contrast-induced nephropathy: implications for prevention strategies.

SUMMARY Contrast-induced nephropathy (CIN) is the third most common cause of hospital-acquired acute renal failure. There is increasing evidence that CIN has a significant adverse impact on patient morbidity and mortality. The objective of this study was to estimate the in-hospital and 1-year direct healthcare costs related to CIN. Using the values obtained from the literature review, a decision analytic model was developed to estimate the in-hospital and 1-year costs of CIN. Patients who develop CIN are more likely to experience adverse events, to undergo prolonged dialysis, to have longer hospital and intensive care unit stays and to have higher mortality rates. The average in-hospital cost of CIN is $10,345. The 1-year cost of treating a patient with CIN is $11,812. Overall, the economic burden associated with CIN is high. Adopting targeted interventions will reduce the incidence of CIN and its overall economic burden.