bluuebunny/crossref_metadata_2025_split huggingface dataset:
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

55 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

59 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

70 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

71 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]