bluuebunny/crossref_metadata_2025 huggingface dataset:
Biomarker testing patterns in patients with stage IV non-small cell lung cancer (NSCLC) in U.S. community-based oncology practice setting.
Authors: Sireci Anthony , Krein Peter M , Hess Lisa M. , Khan Taha , Willey Joanne P. , Ayars Michael , Deyoung Kathryn , Bhaskhar Sandya , Mumuney Ganiat , Coutinho Anna D.
Published: September 2021

300

Background: This study evaluated rates of biomarker testing for patients with stage IV non-squamous NSCLC, which is known to have a ̃40% biomarker-positive rate (AMP, 2020), in a community-based oncology practice setting in the United States (US). Methods: A retrospective study was performed using data from a US electronic medical record database of patients aged ≥18 years with an initial diagnosis (index dx) of stage IV non-squamous NSCLC between Jan 1, 2015 and Dec 31, 2019. Unstructured data on molecular biomarker testing (single-gene and next-generation sequencing [NGS]-based) were abstracted from patient charts utilizing Natural Language Processing for EGFR mutation, ALK rearrangement, BRAF mutation, ROS1 rearrangement, MET exon14 mutation, RET fusion, NTRK fusion, and PD-L1 expression. Systemic therapy was obtained from structured data. Data were summarized using descriptive statistics. This study received a waiver of consent from Advarra IRB. Results: Of 646 patients identified in the database, 500 met all inclusion criteria and are included in this analysis. The majority (73.8%) were diagnosed in 2018 (n = 162; 32.4%) and 2019 (n = 207; 41.4%). Mean age (SD) was 70.0 (10.1) years, with 53.2% female. A total of 447 (89.4%) were tested for at least one biomarker after index diagnosis of which 81.2% (n = 406) had at least one single-gene test; 54.8% (n = 274) had an NGS test and 66.8% were tested for PD-L1. Single-gene or NGS-based testing was > 85% of patients across all index years. The use of NGS-based tests ranged from 35.0% among patients whose first diagnosis was in 2015 to 59.4% in 2019. Overall, 85.4% (n = 427) of the cohort received first-line treatment with chemotherapy (53.6%), immunotherapy (48.2%), or targeted therapy (14.2%). Among patients who received biomarker tests, 15.4% received targeted treatment and 49.7% received immunotherapy treatment, including checkpoint inhibitors, during first-line treatment. Conclusions: NGS testing utilization increased during the study period and by 2019, 59% of patients received NGS-based testing. Opportunities persist for practices to improve testing and achieve guideline recommendations. PD-L1 biomarker testing was performed amongst the highest proportion of patients in this study and nearly 50% of all patients received immunotherapy, including checkpoint inhibitors. Targeted therapy was used in 14.2% of this population, suggesting that patients with actionable biomarkers may not be receiving targeted treatment for their disease, potentially due to gaps in testing among patients in this dataset.
Real-world patterns of pain medication use among patients with metastatic pancreatic ductal adenocarcinoma (mPDAC).
Authors: Laursen Ashley Ann , Surinach Andy , Wang Shu , Cockrum Paul , George Ben
Published: September 2021

302

Background: Helping patients manage cancer-related pain is an important aspect of supportive care. 80% of patients with mPDAC suffer from abdominal and/or back pain. Pancreatic cancer-related pain is typically treated pharmaceutically using pain medicines, which include opioids or narcotics. Previous studies have found that the presence of pain was associated with impaired survival in pancreatic cancer patients. The goal of this study was to assess the treatment patterns of pain medication usage and their association with duration of therapy (DOT) among patients with mPDAC treated in the real-world setting. Methods: This retrospective observational study utilized the IBM MarketScan Commercial and Medicare supplemental claims data. Data were analyzed for adult patients who were diagnosed with mPDAC and received treatment between January 2015 and March 2020. Patient characteristics and DOT were assessed. Opioid use during treatment including the number of prescriptions filled and average daily dose in morphine equivalents were summarized. Yearly and regional trends of opioid use were assessed. Results: There were 2,841 patients (median age: 61 years, IQR: 56-66) included in the study treated with first line (1L) therapies of interest. 55.6% (n = 1,579) of patients were male and 72.0% (2,046) had commercial insurance. The overall DOT in 1L was 78 days (IQR: 38 – 157). 54.3% of patients filled at least one prescription for opioids during treatment. The mean number of prescriptions filled during treatment was 2.2 (SD: 4.0) and the mean daily dose was 39.5mg morphine equivalents (SD: 134.6) The median DOT among patients who received at least one pain prescription was 92 days (IQR: 44 – 176) while those who did not receive pain medication experienced a DOT of 64 days (IQR: 29 – 135). Among the 1,248 patients who received second line treatment the median DOT was 60.5 days (IQR: 29 – 127). 50.6% (n = 632) filled at least one opioid prescription during treatment. Median DOT among patients who received pain medication was 73.5 days (IQR: 42 – 141) and 47.5 days (IQR: 15 – 103.5) among those who did not. Across lines of therapy opioid use remained stable during the study period ranging from 54.2% among patients treated in 2015 to 51.1% among those who initiated treatment in 2019. No regional differences were observed in prescription patterns within the four US census regions (range: 50.2 – 54.4%). Conclusions: In this real-world cohort of patients with mPDAC nearly half were prescribed at least one opioid during treatment. Patients who received opioids experienced a longer duration of therapy compared to those who did not. Further studies are needed to understand the association of pain control with improved clinical outcomes among patients with mPDAC.
Impact of antibiotic (ATB) exposure prior to immune checkpoint inhibitor (ICI) treatment on overall survival (OS): A population-based study.
Authors: Eng Lawson , Sutradhar Rinku , Niu Yue , Liu Ning , Liu Ying , Kaliwal Yosuf , Powis Melanie Lynn , Liu Geoffrey , Peppercorn Jeffrey M. , Bedard Philippe L. , Krzyzanowska Monika K.
Published: September 2021

303

Background: ICIs are a common therapeutic option for many solid tumors. While prior studies have shown that ATB exposure may negatively impact ICI outcomes through gut microbiome changes, many were small studies with heterogeneity in ATB classes and exposure windows. Here, we performed a population level retrospective cohort study to evaluate the impact of ATB exposure prior to ICI on OS. Methods: We used administrative data to identify a cohort of cancer patients > 65 years of age receiving ICIs from June 2012 to October 2018 in Ontario, Canada and deterministically linked with databases to obtain socio-demographic and clinical co-variates and ATB prescription claims. Multivariable cox-proportional hazard models evaluated the impact of ATB exposure both within 1 year and 60 days prior to starting ICI on OS, adjusted for age, gender, body mass index, comorbidities, autoimmune history, hospitalization in the past year and treatment facility level at start of ICI therapy. Results: Among 2737 patients, median age 73; 43% received Nivolumab, 41% Pembrolizumab and 13% Ipilimumab; 53% were lung cancer, 34% melanoma. Median ATB treatment duration for patients receiving ATB within 1 year (59%) and 60 days (19%) prior to ICI were 14 days (SD = 32) and 9 days (SD = 13) respectively. Median OS estimate was 306 days. Any ATB exposure within 1 year prior to ICI was associated with worse OS (aHR = 1.12 95% CI [1.12-1.23] p = 0.03). A non significant dose effect was seen based on weeks of ATB exposure 1 year prior to ICI (aHR = 1.01 per week [1.00-1.02] p = 0.10). ATB class analysis identified fluoroquinolone exposure within 1 year (aHR = 1.26 [1.13-1.40] p < 0.001) and 60 days before ICI (aHR = 1.20 [0.99-1.45] p = 0.06) were associated with worse OS; with a dose effect based on total weeks of exposure over 1 year (aHR = 1.07 per week [1.03-1.11] p < 0.001) and 60 days (aHR = 1.12 per week [1.03-1.23] p = 0.01). Subgroup analysis showed similar results for patients receiving anti-PD1 ICIs, where patients exposed to fluoroquinolone both 1 year (aHR = 1.28 [1.15-1.44] p < 0.001) and 60 days (aHR = 1.19 [0.98-1.44] p = 0.08) before ICIs had poorer OS with dose effects observed based on weeks of fluoroquinolone exposure. Similarly, subgroup analyses based on disease site identified that lung cancer patients exposed to fluoroquinolones 1 year before starting ICIs (aHR = 1.22 [1.06-1.39] p = 0.005) and melanoma patients exposed to fluoroquinolones 60 days before starting ICIs (aHR = 1.66 [1.12-2.47] p = 0.01) had poorer OS. Conclusions: Exposure to ATBs and specifically fluoroquinolones prior to ICI therapy is associated with worse OS. Interventions aimed at altering the gut microbiome may be required to help improve outcomes for patients on ICIs with prior ATB exposure.
Treatment initiation with bone-targeting agents among patients with bone metastasis secondary to solid tumors or patients with multiple myeloma.
Authors: Tran Oth , Hatfield Mark , Moynihan Meghan , Shah Neel , Costa Laurie A. , Saad Hossam , Despiegel Nicolas
Published: September 2021

309

Background: Recent real-world evidence is lacking regarding the initiation of bone-targeting agents (BTAs), and time to treatment with BTAs after a diagnosis of bone metastasis secondary to solid tumors (BM-ST) or multiple myeloma (MM), in both the commercially insured and Medicare Supplemental populations. Methods: Patients aged >18 and newly diagnosed with BM-ST or MM during 11/1/2016-6/30/2019 (earliest diagnosis = index date) were selected from the IBM MarketScan Commercial and Medicare Databases. Patients were continuously enrolled in the 12 months before and 6 months after the index date and had no prior evidence of BTA use, skeletal-related events (SREs), osteoporosis or Paget’s disease. Initiation of and time to BTA treatment (i.e., denosumab, zoledronic acid, ibandronate or pamidronate) were reported during the variable follow-up period. SREs prior to BTA use were reported and included spinal cord compression, pathological fractures, surgery and radiation to bone. Results were stratified by tumor type (BM-ST and MM) and payer (commercial and Medicare). Results: The analysis included 8,769 commercially insured patients (70% BM-ST and 30% MM [mean age 55 and 54]) and 4,100 Medicare patients (74% BM-ST and 26% MM [mean age 76 and 75]). Across payers, the most common comorbidities were pain and hypertension. BTA initiation for BM-ST and MM patients was 46% and 24% among the commercial cohort, and 33% and 18% among the Medicare cohort. Among BM-ST commercial and Medicare cohorts, respectively, the proportion initiating BTA varied by solid tumor type: 64% and 45% of breast, 43% and 37% of prostate, and 47% and 34% of lung. Mean (SD) time to BTA initiation for BM-ST and MM patients was 3.0 (4.2) and 3.7 (5.2) months for the commercial cohort, and 3.1 (4.7) and 2.9 (3.3) months for the Medicare cohort. Among patients with BTA initiation, the proportion of BM-ST and MM patients with SREs prior to BTA treatment was 33% and 31% for the commercial cohort and 23% and 26% for the Medicare cohort. Across payers, the majority of first SREs were radiation to bone for BM-ST patients and pathological fracture for MM patients. Conclusions: For commercial patients, about one-half of BM-ST patients and a quarter of MM patients initiated BTA treatment; for Medicare patients, these proportions decreased to a third and a fifth, respectively. On average, BTA initiation occurred within about 3 to 4 months from first diagnosis. The proportion of commercial and Medicare patients with SREs prior to BTA initiation was a third and a quarter, respectively. Results generated from this study should be supplemented by the evaluation of the relationship between bone protection treatment patterns and outcomes associated with BM-ST and MM.
Validation of self-reported incident cancer diagnoses in the U.S. Health and Retirement Study: A tool for population-based cancer and aging research.
Authors: Mullins Megan , Kler Jasdeep , Eastman Marissa , Kabeto Mohammed , Wallner Lauren P. , Kobayashi Lindsay
Published: September 2021

312

Background: Population aging and improving cancer survival rates are resulting in a growing population of older cancer survivors in the United States (US). As a result, there is an increasing need for longitudinal, population-representative data for interdisciplinary cancer research among older adults. The US Health Retirement Study (HRS) is an ongoing population-representative cohort of US adults over age 50 that contains rich interview and biomarker data on health during aging. Interviews have collected self-reported cancer diagnoses since 1998, but these self-reports have not been validated. We compared first incident cancer diagnoses self-reported in HRS interviews against diagnostic claims from linked Medicare records. Methods: We examined the validity of first incident cancer diagnoses self-reported in biennial HRS interviews from 2000 through 2016 against ICD-9 and ICD-10 diagnostic claim records among 8,242 HRS participants aged ≥65 with 90% continuous enrollment in fee-for-service Medicare, using the claim records as the gold standard. We calculated the sensitivity, specificity, and k for first incident cancer diagnoses (all cancers combined, excluding non-melanoma skin cancer, and each of bladder, breast, colorectal/anal, uterine, kidney/renal, lung/bronchus, and prostate cancers) cumulatively over the follow-up, and at each biennial study interview. Results: Self-reports of first incident cancer diagnosis (agnostic of site) between 2000 and 2016 had 73.2% sensitivity and 96.2% specificity against Medicare claims (k = 0.73). For site-specific self-reports, sensitivities ranged from 44.7% (kidney) to 75.0% (breast), and specificities ranged from 99.2% (prostate) to 99.9% (bladder, uterine, and kidney). Results were similar in sensitivity analyses restricting to individuals with 100% continuous fee-for-service Medicare enrollment and when restricting to individuals with at least 24 months of Medicare enrollment. Conclusions: Self-reported cancer diagnoses in the HRS have reasonable validity for population-based research on cancer and aging across cancer types. Apart from breast cancer, cancer site specific analyses will greatly benefit from the improved validity of self-report with Medicare claim linkage.
Perceptions of barriers to patient financial hardship screening differ by provider role within gynecologic oncology outpatient care.
Authors: Dholakia Jhalak , Pisu Maria , Huh Warner King , Liang Margaret Irene
Published: September 2021

317

Background: Although approximately half of patients with gynecologic malignancy experience financial hardship (FH) during treatment, best practices to identify and assist patients with FH are lacking. To develop such practices, we assessed oncology provider and staff perspectives about FH screening and provision of assistance. Methods: An anonymous survey was conducted electronically within the Gynecologic Oncology outpatient office at a Comprehensive Cancer Center. Potential barriers to patient FH screening and follow-up were assessed within 2 domains: 1) logistic barriers to incorporating FH screening and follow-up into outpatient workflow and 2) perceived patient barriers to FH screening. Responses were elicited on a 5-point Likert scale from ‘very’ to ‘not at all’ significant and dichotomized into significant and not significant barriers. Results: Of 43 providers approached, 37 responded (86% response rate) of which 14 were physicians (MD)/nurse practitioners (NP) and 23 were other staff members (i.e., clinical and research nurses, social workers, pharmacists, care coordinators, lay navigators, and financial counselors). Altogether, 38% worked in their current position for >5 years (n=14), 11% for 3-5 years (n=4), and 51% for <3 years (n=19). For logistic barriers to implementing FH screening and follow-up, the most frequently reported significant barriers included lack of personnel training (69%) and lack of available staff (62%), training regarding follow-up (72%), and case tracking infrastructure (67%). The most frequent significant perceived patient barriers were lack of knowledge of whom to contact (72%), concerns about impact on treatment if FH needs were identified (72%), and lack of patient readiness to discuss financial needs (62%.) Compared to MD/NP, staff members more often indicated the following as significant barriers: difficulty incorporating FH screening into initial visit workflow (31 % vs. 57%, p=0.03), overstretched personnel (29% vs 73%, p=0.005), and patient concerns about influence on treatment (62% vs 86%, p=0.01). Conclusions: Care team members identified barriers to patient FH screening across logistic and patient-centered domains, although MD/NP less so than other staff possibly reflecting different exposures to patient financial needs during clinical encounters or burden of workflow. Implementation of universal FH screening, dedicated personnel, convenient tracking mechanisms, and multi-disciplinary provider and staff training may improve recognition of patient FH and facilitate its integration into oncology care plans.
Physician satisfaction with electronic medical records (EMRs): Time for an intelligent health record?
Authors: Gajra Ajeet , Simons Dewilka , Jeune-Smith Yolaine , Valley Amy W. , Feinberg Bruce A.
Published: September 2021

318

Background: EMRs are devised to improve the quality and efficiency of healthcare delivery and to reduce medical errors. Despite the widespread use of EMRs, various factors can limit their effectiveness in improving healthcare quality. General EMR use has been cited as a factor contributing to increased workload and clinician burnout in oncology and other specialties. The objective of this qualitative research study was to identify barriers perceived by medical oncologists and hematologists (mO/H) in utilizing EMR software and factors associated with levels of satisfaction. Methods: Between January and April 2021, mO/H from across the U.S. were invited to complete a web-based survey about various trends and critical issues in oncology care. Demographics about the physicians and characteristics of their practices were captured as well in the survey. Responses were aggregated and analyzed using descriptive statistics. Results: A total of 369 mO/H completed the survey: 72% practice in a community setting; 47% identified as a hospital employee; they have an average of 19 years of clinical experience and spend on average 86% of their working time in direct patient care, seeing 17 patients per day on average on clinic days. Most (99%) of mO/H surveyed use an EMR software at their practice, with Epic (45%) and OncoEMR (16%) being the most common. Regarding satisfaction, 16% and 50% reported feeling highly satisfied and satisfied, respectively, with their current EMR, and 3% and 11% reported feeling very dissatisfied or dissatisfied, respectively. Some (19%) stated that they have considered changing their EMR, and 68% are unsure how EMR licensing fees for their practice are paid. EMR pain points most commonly experienced were: time-consuming, e.g., too many steps/click (70%); interoperability, e.g., difficulty sharing information across institutions or other EMR software (45%); data entry issues, e.g., difficulty entering clinical information, scheduling patient visits and reminders, or ordering multiple labs (38%); and poor workflow support (31%). The most useful aspects/features of their EMR software reported were availability of information, e.g., preloaded protocols, chemotherapy regimens and pathways (64%); data access (64%); and multiple access points, including remote access (37%). Conclusions: Satisfaction with EMR were generally positive among the mO/H surveyed. However, there are multiple deterrents to the efficient use of current EMR systems. This information is essential in the design of next-generation EMR (an Intelligent Medical Records system) to allow for incorporation of aspects most useful to the end-users, such as pathway access, preloaded information on cancer management as well as ease of access and portability, and a user experience that minimizes clicks and reduces physician time with EMR.
Sentiment analysis of tweets on prior authorization.
Authors: Prasanna Shivika , Premnath Naveen , Angraal Suveen , Sedhom Ramy , Khera Rohan , Parsons Helen , Hussaini Syed , Johnson Pamela T , Lou Emil , Beg Muhammad Shaalan , Subbiah Ishwaria Mohan , Rao Praveen , Gupta Arjun
Published: September 2021

322

Background: Natural language processing (NLP) algorithms can be leveraged to better understand prevailing themes in healthcare conversations. Sentiment analysis, an NLP technique to analyze and interpret sentiments from text, has been validated on Twitter in tracking natural disasters and disease outbreaks. To establish its role in healthcare discourse, we sought to explore the feasibility and accuracy of sentiment analysis on Twitter posts (‘’tweets’’) related to prior authorizations (PAs), a common occurrence in oncology built to curb payer-concerns about costs of cancer care, but which can obstruct timely and appropriate care and increase administrative burden and clinician frustration. Methods: We identified tweets related to PAs between 03/09/2021-04/29/2021 using pre-specified keywords [e.g., #priorauth etc.] and used Twarc, a command-line tool and Python library for archiving Twitter JavaScript Object Notation data. We performed sentiment analysis using two NLP models: (1) TextBlob (trained on movie reviews); and (2) VADER (trained on social media). These models provide results as polarity, a score between 0-1, and a sentiment as ‘’positive’’ (>0), ‘’neutral’’ (exactly 0), or ‘’negative’’ (<0). We (AG, NP) manually reviewed all tweets to give the ground truth (human interpretation of reality) including a notation for sarcasm since models are not trained to detect sarcasm. We calculated the precision (positive predictive value), recall (sensitivity), and the F1-Score (measure of accuracy, range 0-1, 0=failure, 1=perfect) for the models vs. the ground truth. Results: After preprocessing, 964 tweets (mean 137/ week) met our inclusion criteria for sentiment analysis. The two existing NLP models labeled 42.4%- 43.3% tweets as positive, as compared to the ground truth (5.6% tweets positive). F-1 scores of models across labels ranged from 0.18-0.54. We noted sarcasm in 2.8% of tweets. Detailed results in Table. Conclusions: We demonstrate the feasibility of performing sentiment analysis on a topic of high interest within clinical oncology and the deficiency of existing NLP models to capture sentiment within oncologic Twitter discourse. Ongoing iterations of this work further train these models through better identification of the tweeter (patient vs. health care worker) and other analytics from shared content.[Table: see text]
CONTINUUM: A single-arm pilot care transition intervention for hospitalized patients with advanced cancer.
Authors: Lage Daniel E , Schmelkin Alane , Cohn Julia , Miller Laurie , Kuhlman Caroline , Krueger Elizabeth A. , Olivier Kara Marie , Haggett Dana , Ritchie Christine , Greer Joseph A. , El-Jawahri Areej , Nipp Ryan David , Temel Jennifer S.
Published: September 2021

33

Background: Patients with advanced cancer are frequently hospitalized and experience burdensome transitions of care after discharge. Interventions to address patients’ symptoms, support medication management, and ensure continuity of care after discharge are lacking. We sought to demonstrate the feasibility and acceptability of CONTINUUM (CONTINUity of care Under Management by video visits) for this population. Methods: We conducted a single-arm pilot trial (n = 50) of CONTINUUM at Massachusetts General Hospital (MGH). The intervention consisted of a video visit with an oncology nurse practitioner (NP) within 3 business days of hospital discharge to address symptoms, medication management, hospitalization-related issues, and care coordination. Prior to discharge, we enrolled English-speaking adults with advanced breast, gastrointestinal, genitourinary, or thoracic cancers experiencing an unplanned hospitalization who were receiving ongoing oncology care at MGH and being discharged home without hospice services. We defined the intervention as feasible if ≥70% of approached and eligible patients enrolled and if ≥70% of enrolled patients completed the intervention within 3 business days of discharge. At 2 weeks after discharge, patients rated the ease of use of the video technology and stated whether they would recommend the intervention. NPs completed post-intervention surveys to assess fidelity to the intervention protocol. Results: From 01/07/21 to 05/28/21, we enrolled 50 patients (75% of patients approached). Of the enrolled patients (median age = 65 years; 62% and 22% had advanced gastrointestinal or thoracic cancers, respectively), 78% of enrolled patients received the intervention within 3 business days of discharge. Patient rating of the ease of use of video technology was a mean of 7.6 out of 10, with 72% stating they “agreed” or “strongly agreed” that they would recommend the intervention. NP post-intervention surveys revealed that visits primarily focused on symptom management (56%), followed by addressing post-hospital care issues (21%). Of the 30 patients with 30-day follow-up, 43% were readmitted within 30 days of discharge, and 17% died within 30 days of discharge. Conclusions: We found that CONTINUUM, which consists of an NP-delivered video visit soon after hospital discharge addressing patients’ symptoms, medications, and care coordination, represents a feasible and acceptable approach to provide post-discharge care for hospitalized patients with advanced cancer. Future studies will test the efficacy of the intervention for reducing hospital readmissions. Clinical trial information: NCT04640714.
Oncologists’ knowledge and perspectives on the use of biosimilars.
Authors: Peipert John , Kaiser Karen , Kircher Sheetal Mehta , Greene George J. , Shaunfield Sara , Hauner Katherina KY , Cella David , Mroczek Dan
Published: September 2021

35

Background: Despite the increasing availability of biosimilar cancer treatments, little is known about oncologists’ knowledge and concerns about biosimilar use in the United States. We conducted a survey of oncologists to examine their knowledge, attitudes, and experience with biosimilars. Methods: Using the ASCO Survey Research Pool (10-6-20 to 11-16-20), clinical oncologists completed a 29-question survey designed with structured input from clinical and health care system experts and literature review. Results: Of the 269 respondents, most ( n= 236, 88%) treated with biosimilars and reported that biosimilars were required at their institution. The table summarizes participants’ knowledge, barriers to use, preferences for and access to information around biosimilars, and interest in training. Conclusions: Despite high uptake of biosimilars, knowledge about basic features of biosimilars was low, and oncologists in community and private practice settings were more often concerned about safety and efficacy than those in academic practices. This information provides targets for future education about biosimilars.[Table: see text]
Physician-pharmacy integration and oral cancer drug use and quality.
Authors: Kakani Pragya
Published: September 2021

39

Background: Public reports suggest increasing integration of in-house specialty pharmacies by independent and system-based oncology practices. Understanding the impact of such integration has important implications for state-level regulations limiting physicians’ ability to launch pharmacies in certain states and policies governing pharmacy network design. In this analysis, I document the growth of in-house pharmacies and estimate the impact of this growth on oral cancer drug use and quality. Methods: I used 2006-2017 data from Medicare Fee-for-Service and Part D claims, pharmacy names and characteristics from health plan pharmacy network lists and the National Plan and Provider Enumeration System, and a unique Health System and Practice Dataset, developed by National Bureau of Economic Research and Harvard University researchers, that tracks practice ownership relationships. I first linked physician organizations and pharmacies that they operate using a novel claims-based algorithm combining information on pharmacy characteristics, similarities in names of practices and pharmacies, and the share of total pharmacy spending attributable to a single practice or system. I then used an event study approach to compare oral oncolytic use and quality at practices launching a pharmacy between 2009 to 2014 compared with matched controls. Outcomes included total spending on oral oncolytics, use of oral drugs when an intravenous equivalent exists (capecitabine and 5-fluoruracil), timeliness of new prescription fills (# days from first fill to last office visit), medication adherence, and early discontinuation of lenalidomide, tyrosine kinase inhibitors, aromatase inhibitors, tamoxifen, enzalutamide, and abiraterone. Results: The number of independent or system-based oncology practices with an in-house pharmacy filling any oncology prescriptions increased from 135 in 2006 to 442 in 2017. In that time, the share of Medicare Part D spending on oral oncolytics filled at in-house pharmacies increased from 4% in 2006 to 27% in 2017. The launch of an in-house pharmacy was not associated with an overall increase in spending on oral oncolytics, but was associated with a 4.5 percentage point (p =.01) increase in the use of capecitabine relative to 5-fluorouracil, within 2 years of launch. In-house pharmacies were associated with a modest decrease in the time to fill an initial prescription (2.4 days, p <.001) within 2 years of launch, but no improvements in adherence or reductions in early discontinuation. Conclusions: There has been substantial growth in the use of in-house pharmacies in oncology in recent years. Having an in-house pharmacy only had modest effects on cost and quality. Policymakers should therefore approach claims that in-house pharmacies meaningfully impact cost and quality with caution.
Impact of a hospital specialty pharmacy in partnership with a free-standing care coordination organization on time to delivery and receipt of oral anticancer drugs.
Authors: Beauchemin Melissa Parsons , Lichtenstein Morgan RL , Raghunathan Rohit R. , Doshi Sahil D , Law Cynthia , Accordino Melissa Kate , Elkin Elena B. , Wright Jason Dennis , Hershman Dawn L.
Published: September 2021

43

Background: Most oral anti-cancer drugs (OACD) prescriptions require extensive coordination between providers and payers, which can delay drug receipt. Specialty pharmacies are intended to facilitate communication between multiple entities to deliver OACDs with increased efficiency. In 2018, our cancer center partnered with Shields Health Solutions (SHS), a freestanding organization providing care coordination to implement a hospital-based specialty pharmacy. We evaluated the rate of failed drug receipt (FR) and time to drug receipt (TTR) before and after specialty pharmacy implementation. Methods: We prospectively collected data on all new OACD prescriptions for adult oncology patients at a large, urban cancer center from 1/1/2018 to 12/31/2019. In fall 2018, a specialty pharmacy was opened to facilitate drug procurement for patients. We collected patient demographic, clinical, and insurance data, OACD name, date prescribed, delivery date, and interactions with payers and financial assistance groups. For prescriptions received, TTR was the number of days from OACD prescription to patient receipt of the drug. FR was defined as failure to receive a prescribed OACD. We excluded OACD prescriptions for a washout period of two months during pharmacy initiation. We used multivariable logistic regression to examine factors associated with TTR > 7 days and FR before and after specialty pharmacy implementation. Results: In total, 883 patients were prescribed 1145 new OACDs. The majority of prescribed drugs were targeted treatment (56%, N = 646) and 72% (N = 819) required prior authorization (PA). Of all prescriptions, 86% (N = 999) were successfully received with an overall median TTR of 7 days. Adjusted analyses showed that patients were more likely to receive their drugs in less than 7 days after specialty pharmacy implementation (OR: 1.4 95% CI 1.04 – 1.81), p = 0.03). In an unadjusted analysis, patients were more likely to receive their initial medications after specialty pharmacy implementation, compared to before specialty pharmacy implementation (89% vs. 84%, p = 0.04). Multivariable analysis showed a trend toward more patients receiving drugs after specialty pharmacy implementation (OR: 1.42, 95% CI 0.98 – 2.03, p = 0.06). Conclusions: The implementation of a hospital-based specialty pharmacy in partnership with SHS decreased TTR. This difference is in part attributable to improved care coordination and communication. A centralized approach may improve overall efficiency due to fewer clinical practice disruptions.
Impact of COVID-19 pandemic on oncologists’ professional and personal lives: A pre-vaccine study.
Authors: Gajra Ajeet , Jeune-Smith Yolaine , Fortier Stephanie , Feinberg Bruce A.
Published: September 2021

45

Background: The COVID-19 pandemic has adversely impacted healthcare workers globally, leading to high rates of burnout, especially among frontline workers. We conducted a study to assess the pandemic’s impact on community-based medical oncologists and hematologists (mO/H) in the U.S. before the widespread distribution of vaccines. Methods: Between October and December 2020, mO/H participated in a compensated, online survey addressing the impact of COVID-19 on oncologists’ professional and personal lives and other issues in oncology; demographic, clinical, and practice-based questions were also asked. Results are presented using descriptive statistics. Results: A total of 259 geographically diverse mO/H, with a median of 18 (1-42) years in practice, completed the survey. At the time of the study, local trends in COVID-19 cases were reported as increasing, stable, or decreasing by 29%, 51%, and 20%, respectively. The summative view of the pandemic was “proud of my work as a physician in the frontlines” (37%), “a challenge to get through” (35%), and “no significant impact” (23%). Over half reported a moderate to severe impact on their professional (60%) and personal lives (65). The top 3 factors adversely impacting professional life were: concern of transmitting COVID-19 to patients or staff (52%), difficulty providing patient care (45%), and loss of income (41%). The top 4 factors adversely impacting personal life were: concerns of safety for self and family (84%), a sense of anxiety (50%), loss of family income (24%), and a sense of depression/doom (22%). Fifty percent agreed or strongly agreed that they had increased burnout at work since the beginning of the pandemic. However, workload was assessed as stable (51%) or reduced (33%) during the pandemic. The top 3 factors contributing to burnout were: loss of face-to-face patient interaction (46%), financial loss by practice (42%), and reduced patient volume (35%). The factors thought to impact income were: use of virtual patients visits (38%), pay cuts from the employer (33%), and cancellation of elective procedures (31%). Overall, 41% reported receiving funds from government-based programs (e.g., CARES act) during the pandemic. While about half (52%) did not believe that the pandemic would impact their retirement, some felt that the pandemic would likely hasten (17%) or delay (17%) their plans to retire. Conclusions: This study confirms greater feelings of burnout among U.S. community-based mO/H in the wake of the pandemic and offers insight into drivers of professional and personal dissatisfaction. While mO/H have concerns about loss of income, notably, loss of in-person patient interaction is also a key factor impacting their professional satisfaction. Given the high baseline rate of burnout among mO/H, it is critical to prevent, mitigate and control additional risks imposed by pandemic-related factors.
Limited benefit and high financial burden of drugs used to manage cancer-associated anorexia/cachexia syndrome (CACS).
Authors: Gupta Arjun , Nshuti Leonce , Grewal Udhayvir Singh , Sedhom Ramy , Parsons Helen , Blaes Anne Hudson , Virnig Beth A. , Lustberg Maryam B. , Subbiah Ishwaria Mohan , Nipp Ryan David , Dy Sydney M. , Dusetzina Stacie
Published: September 2021

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Background: To date, drugs used for CACS have limited efficacy and may have unwanted side effects. Despite this, clinicians commonly prescribe certain drugs for CACS, adding financial burden to patients through out-of-pocket costs near or at the end of life. We sought to describe the range of costs of the multiple drugs commonly used to manage CACS. Methods: We reviewed oncology, nutrition, and supportive care guidelines (ASCO, ESMO, ESPEN, MASCC) and compiled a list of drugs recommended for CACS. We also included drugs commonly used off-label in clinical practice as identified by study authors. Using GoodRx.com, we extracted available formulations (e.g., tablet [tab] vs capsule [cap] vs oral disintegrating tablet [ODT] vs solution [sol]), and brand name vs generic products for each drug. We identified the average retail price, and the lowest price with coupons, for each formulation using the most commonly used dosage for a 2-week period (typical fill). The average retail price is the cash price for consumers without prescription drug coverage. The lowest price represents a discounted, best case scenario of out-of-pocket costs for patients without prescription drug coverage. We collected data using the zip code 10065 in May 2021 to describe the range of costs of these drug formulations. Results: We included 7 drugs available in 20 formulations (Table). For a 2-week fill, the least expensive options included generic olanzapine 5 mg tab (once daily) and generic mirtazapine 15 mg tab (once daily), costing $4.50 per fill. Brand-name solutions were costly, ranging from $605.50 (megestrol acetate, Megace ES) to $1,156.30 (dronabinol, Syndros). Costs between formulations of the same drug/dosage varied widely: for olanzapine 5 mg, the lowest price varied from $4.50 [generic, tab] to $238.40 [Zyprexa zydis, brand-name, ODT]. Conclusions: We found that the costs of drugs used for CACS are highly variable, ranging from < $5 to > $1000 per fill. Overall there is limited data supporting use of drugs for managing CACS. Thus, our findings can help guide patient-clinician discussions about the risk/benefit ratio of a prescription for managing CACS, while highlighting the importance of seeking less expensive formulations when possible.[Table: see text]
Improvements in access to cancer clinical trials facilitated by comprehensive genomic profiling in non-small cell lung cancer.
Authors: Lee Woojung , Spencer Scott , Carlson Josh John , Dinh Tam , Dayer Victoria , Cummingham Rachel , Kaa Kathleen , Martucci Gary , Hynes Maggie , Veenstra David Leroy
Published: September 2021

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Background: The use of comprehensive genomic profiling (CGP) in cancer patients could lead to additional enrollment in clinical trials that study novel genetic biomarkers, potentially reducing treatment costs for payers and improving health outcomes for patients. Our objective was to estimate the number of additional clinical trials in which patients with non-small cell lung cancer (NSCLC) could potentially enroll due to the use of CGP vs. a comparator panel of 50 genes or less. Methods: Clinical trials in NSCLC that started between 2015 - 2020 were identified from the Aggregate Analysis of ClinicalTrials.gov (AACT) database. Trials with unknown status or study sites outside the United States only were excluded. We abstracted information on required genetic alterations based on the study eligibility criteria. We calculated the incremental number of trials available to patients due to results generated by CGP (FoundationOne CDx, 324 genes) vs. a commercially available comparator panel that was 50 genes or less (Oncomine Dx Target Test, 23 genes) by phase and calendar year. The additional trials were characterized by disease severity, type of therapy, and setting. Results: Enrollment eligibility was dependent on genetic variant status in 35% (250/709) of all identified NSCLC trials. There were 29 (248 vs. 219) additional clinical trials available to patients through the use of CGP, 12% of all gene-specific trials for NSCLC. We identified 45 uses of genetic markers in the 29 additional clinical trials. The most frequent genetic marker in the incremental trials was microsatellite instability, accounting for 44% of all identified markers (20/45). The incremental number of trials available to patients due to the use of CGP did not vary significantly over time but varied by phase – most of the additional clinical trials were in phase 1 or 2 (28/29, 97%). Most of the incremental trials were in metastatic disease (22/29, 76%) and were conducted in academic or advanced community settings (18/29, 62%). The most frequently studied type of intervention in these studies was targeted monotherapy (8/29, 28%), followed by immuno-monotherapy (7/29, 24%). Conclusions: Clinical trials in NSCLC initiated over the past 5 years have consistently included CGP-specific genes or markers in eligibility criteria. Patients with NSCLC have the potential to benefit from the use of CGP as compared to smaller gene panels through improved access to clinical trials.[Table: see text]
Barriers to participation and success in value-based care (VBC) models.
Authors: Gajra Ajeet , Simons Dewilka , Jeune-Smith Yolaine , Valley Amy W. , Feinberg Bruce A.
Published: September 2021

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Background: The enactment of the Medicare Access and CHIP Reauthorization Act (MACRA) in 2015 initiated the transition from a fee-for-service to a fee-for-value payment system in healthcare. Two government-sponsored VBC models (Oncology Care Model [OCM] and Merit-Based Incentive Payment System [MIPS]) were introduced in 2016 and 2017. Several commercial payers followed suit with similar value-based contracts. Implementing and complying with the performance metrics of these models comes with challenges. This qualitative research study sought to assess participation in both government-sponsored and commercial-insurance-sponsored VBC models among oncology providers and their perceptions regarding the ability to perform successfully. Methods: Between February and April 2021, medical oncologists/hematologists (mO/H) from across the U.S. were invited to complete a web-based survey about various trends and critical issues in oncology care. Demographics about the physicians and characteristics of their practices were captured as well in the survey. Responses were aggregated and analyzed using descriptive statistics. Results: A total of 307 mO/H across the U.S. completed the survey: 73% practice in a community setting; 47% identify as hospital employees. The participants spend a median of 90% of their working time in direct patient care, have a median of 16 years of clinical experience, and see a median of 20 patients per day on clinic days. Half participate in a government-sponsored VBC model (21% MIPS and 28% OCM), and 20% participate in a commercial VBC model. A third reported that it is difficult to perform favorably in VBC models (37% government and 35% commercial). Primary challenges deterring favorable performance were navigating the payer landscape and reimbursements (27%), identifying cost-reduction opportunities (20%), tracking costs across an episode (18%), and clinical decision support and compliance (17%). One-third are not satisfied with currently available technology to effectively support their performance in VBC models. Almost half would like to see more seamless integration into practice workflows (49%) and interoperability across platforms including EHRs (42%), and 24% would like artificial intelligence or machine learning features integrated into solutions tools. Conclusions: Oncology practices find it challenging to perform favorably in government and private payer-sponsored VBC models. They are generally dissatisfied with current technology and see an unmet need for interoperability and artificial intelligence to better support their performance in these programs. Further research is needed to determine how best to design and implement VBC programs.
Institutional chart review on same-day pegfilgrastim administration in small cell lung cancer (SCLC) patients receiving myelotoxic chemotherapy.
Authors: Choi Briana , Alrawashdh Neda , Vraney Jamie , McBride Ali , Abraham Ivo
Published: September 2021

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Background: Pegfilgrastim administration is recommended at least 24 hours after the end of chemotherapy (CTX) treatment for prevention of chemotherapy-induced (febrile) neutropenia (CIN/FN). Published studies have found no differences in the risk of FN between same-day and next-day pegfilgrastim administrations in certain cancers. To evaluate the efficacy and safety of same-day compared to next-day pegfilgrastim administration in SCLC patients, we evaluated our own institutional data. Methods: Using ICD-9 and ICD-10 codes for SCLC, electronic health records were reviewed retrospectivey for the period 11/1/2013-8/31/2018 at the University of Arizona Cancer Center (UACC). Inclusion criteria were age 18 or older, biopsy confirmed SCLC diagnosis, treated at UACC, and pegfilgrastim administration on the same day as CTX. Outcomes collected in the first cycle and all cycles of CTX were: FN incidence, CIN grade 3/4, and treatment delay or hospitalizations due to CIN/FN. Results: Out of 1,181 patient records, 34 patients met inclusion criteria. The median age was 67.5 years, 23.5% of patients had stage 3 or 4 SCLC while 50% had 0-1 ECOG status. 44.1% of patients had a risk based on the type of CTX. Average baseline absolute neutrophil count was 5.55x109cells/L (SD=1.27x109cells/L). A total of 104 CTX cycles were given. Outcomes are summarized in the Table below. After the first cycle, the incidence rate of CIN grade 3/4 was 5.88%, but 0% for all other outcomes. Conclusions: After the first cycle, there were s of FN and no patients experienced treatment delays or hospitalizations related to CIN/FN; only two cases for CIN grade 3/4 were observed. Across all cycles, CIN grade 3/4 was observed in 17 cycles. In only two cycles, treatment was delayed or patient was hospitalized due to CIN/FN, not involving same patients. FN was observed in only 3/104 cycles. All observed rate were comparable or lower than known rates for next-day pegfilgrastim administration. Future studies including randomized trials should be further evaluated.[Table: see text]