bluuebunny/crossref_metadata_2025_split huggingface dataset:
APPs provide high-quality specialty care in virtual clinic.
Authors: Toth Sara , Long Christine L , Townsend Sydney , Mikan Sabrina Q. , Hoegger Blake , Patt Debra A. , Books Holly 
Published: September 2022

390 Background: In our team-based approach to care delivery, Advanced Practice Providers (APPs) are a critical component of the care delivery team. In our statewide oncology practice APPs are not available at each site, limiting our ability to provide program visits that enhance patient care and limiting our flexible staffing capacity. APP program visits - Advance Care Planning (ACP), Treatment Review and Coordination (TRC) and Genetics – had limited availability due to the capacity of existing APP staff. We sought to provide both enhancements in patient care with program visits and offer flexible staffing capacity across our statewide practice by using a centralized virtual care clinic model providing high quality specialty care via Telemedicine. Methods: Four APPs were identified and trained to provide full-time telemedicine services statewide under a single collaboration agreement with the Virtual APP Medical Director. Local sites went through a brief onboarding process with the Virtual APP clinic and then submitted requests for appointment coverage by the Virtual APP (VAPP) team. The VAPPs had the same core oncology training, with a few differentiated skills which were matched with coverage requests aligning with their skill sets. To ensure continuity of care, virtual APP clinic notes were visible statewide in the practice EHR, and local providers were alerted by chart message of significant patient concerns. Results: In the first 3 months of service, the VAPPs completed 1,040 appointments for 12 clinics. The VAPPs conducted 50% Program visits and 50% established patient visits (follow-up, on treatment and urgent care). Conducting the Program visits virtually allowed patients to invite family members from any location to join the appointments virtually. The Urgent Care capability was not used frequently in the first 90 days of service, but may still grow in the future. Conclusions: The Virtual APP program ensured oncology patients received high quality, timely care through 1,040 completed visits. This prevented delays in care, resolved staffing challenges, expanded care, and supports virtual care in oncology. This program ensures APPs are available when and where needed and allows them to efficiently serve multiple clinics. The VAPPs provided education, assessment, prevention, and management of toxicities in a flexible manner.
Impact of statewide telemedicine support model in a community oncology practice.
Authors: Townsend Sydney , Hoegger Blake , Ortega Lance , Patt Debra A. , Books Holly , Mikan Sabrina Q. 
Published: September 2022

391 Background: While there was broad adoption of telemedicine during the COVID-19 pandemic, optimizing the interaction for patients and the clinical team remained a challenge. We sought to optimize delivery of telemedicine services to provide more efficient and effective patient care. Target areas of concern for improvement were scheduling, staffing, communication, technical challenges with operating the platform, a high cancellation rate, and limited copay collections. Methods: A team of 8 virtual Patient Service Coordinators (VPSCs), 8 virtual Medical Assistants (VMAs), and an RN clinical manager was created to work remotely from home to serve Providers at 8 clinics. VPSCs performed check-in duties, demographics, copay collection and technology trouble-shooting with patients. VMAs performed medical intake (medication reconciliation, depression screenings, and vital signs) with real-time EMR input. VMAs stayed in-touch with patients to communicate Provider delays. Standardized communication pathways connected virtual teams with in-clinic teams. The clinics selected to participate in the TMS program were conducting 29% - 50% of E&M visits by telemedicine. The goal of the TMS program was to reduce stress and burnout, as well as relieve in-clinic staff of telemedicine duties giving them capacity to address in-clinic COVID related staff shortages. Results: The TMS Program supported 15,500 visits (11/15/21 – 5/31/22) and increased upfront expected copay collection from 9% pre-program to 100% post program. The program reduced the time for first contact on video from 18 minutes to 1 minute and reduced the telemedicine cancellation rate by 3%. The supported TM cancellation rate was 7% lower than in-person visit cancellation rate. A geographically distributed work from home team was able to support a 66% increase in visits during inclement weather days which allowed visits to be completed that would have otherwise been canceled due to clinic closures. Additionally, the TMS program relieved workload for in-clinic staff and the VPSC and VMA positions proved highly desirable to the eligible workforce. Conclusions: The TMS Program improved patient connectivity and experience, increased upfront co-pay collection, decreased burden on in-clinic staff, allowed continuity of care during inclement weather, and was an attractive work option for staff. Due to its success, the program moved past pilot phase into an operational program.
Implementation of a telemedicine-based genetic counseling program in a large community oncology practice.
Authors: Rao Smita K. , Blakely L. Johnetta , Small Kate , Schleicher Stephen Matthew , Dickson Natalie R. 
Published: September 2022

393 Background: Genetic testing is an integral part of cancer care. To optimally facilitate testing, genetic counselors (GC) provide interpretation and direction for treatments in certain applicable solid tumors. A telemedicine (TM) genetic counseling program was initiated in 2019 at Tennessee Oncology, a large community oncology practice spanning over 30 clinical sites throughout Tennessee and Georgia. Methods: Appropriate patients were identified and referred through the Electronic Medical Record (EMR) for genetic testing based on current National Comprehensive Cancer Network (NCCN) guidelines. All counseling sessions were scheduled over TM to the patient’s home to enhance convenience, broaden access, and decrease no-show rates. Physician education regarding result-dependent appropriate screening recommendations per NCCN for mutation positive patients were provided through email communication and dedicated GC notes in the EMR. Results: Between 2019 and 2021, GC referrals per year grew from 195 to 840. Of these referrals, 84.6% of patients completed GC consultations, all of which were facilitated through TM. Of completed consultations, 81.4% underwent testing. Average time from referral to GC consultation was 8-13 business days. The no-show rate was low (< 7%). This program started at 1 clinic in 2019 and is now offered for patient care in 16 clinics across the state. Conclusions: Our program illustrates how remote GC programs are an effective choice for scaling genetics care across a large community oncology practice. Deep integration of TM-based genetic counseling within the EMR helps identify high-risk patients, improves test adoption, patient keep-rate and turn-around-time therefore helping to better patient outcomes. This quality assurance program is an important part of comprehensive cancer care that we can provide to our patients and their families.
Utilization, user characteristics, and adverse outcomes of bevacizumab products in oncology in a distributed research network.
Authors: Ko Jenice , Mendelsohn Aaron , Daniels Kimberly , Gomez-Lumbreras Ainhoa , Marshall James , McDermott Cara L. , Pawloski Pamala A. , Yee Gary C. , Lockhart Catherine 
Published: September 2022

400 Background: Bevacizumab (Avastin), an anti-angiogenic agent, was approved for various oncologic indications in 2004 in the US. Two biosimilars, bevacizumab-awwb (Mvasi) and bevacizumab-bvzr (Zirabev), were on the market 2017 and 2019, respectively. Real-world data on adverse events for bevacizumab biosimilars is limited. Methods: We conducted a retrospective cohort study using the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) distributed database to evaluate utilization patterns, patient characteristics, and prespecified adverse events of interest for the originator bevacizumab relative to its biosimilars in oncology among users 21 years of age and older between January 1, 2010, to December 31, 2020. Oncology indications included colon, lung, and gynecologic (cervical, uterine, and ovarian) cancers. Adverse events (AEs) of interest were arterial thromboembolism (ATE), congestive heart failure (CHF), gastrointestinal perforation, stroke and acute myocardial infarction (AMI), and venous thromboembolism (VTE). The study analyzed biosimilars collectively, which include bevacizumab-awwb and bevacizumab-bvzr. Results: Both bevacizumab originator and biosimilar users for colon cancer were mostly male (55%), had a mean age of 61 years, and a mean Charlson/Elixhauser combined comorbidity score from 7.0 to 8.0. Among patients with lung cancer users, 53% were female with an overall mean age of 64 years and comorbidity scores from 6.4 to 7.5. Patients with gynecologic cancers had mean age of 63 years, and comorbidity scores from 6.1 to 6.7. Overall, oncologic bevacizumab use increased by 19% over time. Of the 24,044 total episodes from 2010 to 2020, AEs included ATE (2,560 events, 11%), CHF (2,092 events, 9%), gastrointestinal perforation (2,858 events, 12%), stroke/AMI (399 events, 2%), and VTE (4,447 events, 19%). AE rates were comparable between the originator and biosimilars: 7% and 8% for ATE, 5% and 4% for CHF, 9% and 8% for gastrointestinal perforation, 0.6% and 1% for stroke and AMI, and 10% and 8% for VTE, respectively. From 2019 to 2020, biosimilar use increased from 6% to 49% of total bevacizumab utilization for patients with colon cancer, from 2% to 36% for patients with lung cancer, and from 2% to 38% for patients with gynecologic cancers. Conclusions: Bevacizumab utilization increased across all oncology indications evaluated during the study period. From 2019 to 2020, utilization for biosimilars relative to the originator increased. As there are limited data available on bevacizumab biosimilar use in real world settings, future research should be conducted to see if utilization for biosimilar products continues to rise as well as safety over time.
Clinical symptoms and conditions leading to metastatic non–small cell lung cancer diagnosis in patients with and without targeted mutations.
Authors: Apple Jon , Shah Anne , Subramanian Janakiraman , ASLAM SAAD , Engel-Nitz Nicole , Weber Laura A , White John 
Published: September 2022

401 Background: This study compares patient characteristics, clinical conditions, the prevalence and timing of lung cancer symptoms, and diagnostic procedures from onset to mNCSLC diagnosis for patients with and without targetable mutations. Methods: This was a retrospective claims analysis of Medicare Advantage and commercially insured adult mNSCLC patients (11/01/2012 - 01/31/2020) with continuous health plan enrollment (24 months pre-index and ≥2 months post-index) around the index date (mNSCLC diagnosis). Patients on targeted therapy post-diagnosis were assigned to the targeted group (TG); non-targeted group (NTG) otherwise. Twenty pre-specified lung cancer related symptoms, baseline comorbidities, and diagnostic procedures were examined in the pre-index period. Results: The study comprised 2,940 patients (TG: 390; NTG: 2,550); TG had lower mean age (65.8yrs vs 69.2yrs; p < 0.001), more females (59.5% vs 50.6%; p = 0.001), and lower tobacco use (55.9% vs 92.5%; p < 0.001). Mean TG Charlson score was 1.37 in the TG vs 1.93 in the NTG; p < 0.001. There were no significant differences in prevalence of any lung cancer related symptoms (TG 81.8% vs NTG 83.5%; p = 0.4). When comparing the 20 individual, pre-specified lung cancer related symptoms (cough, dyspnea, hemoptysis, etc.), there were also no significant differences between the study cohorts. For patients with symptoms, the mean times from the first symptom to mNSCLC diagnosis were similar (TG: 339.3 days; NTG: 363.1 days; p = 0.13)(Table). There were significant differences in the proportion of patients with comorbidities between study cohorts (TG 64.4% vs NTG 73.5%; p < 0.001). Among patients within TG, there was higher prevalence of pleural effusion (22.1% vs 12.6%; p < 0.001) and lower prevalence of COPD (17.7% vs 50.8%; p < 0.001). For diagnostic procedures, patients in TG had fewer imaging procedures than NTG (Chest x-ray 67.7% vs. 74.1%; p = 0.008, CT scan 57.2% vs 63.5%; p = 0.016, PET scan 19.0% vs 27.1%; p < 0.001); and a longer mean time from first symptom to first imaging procedure (TG: 220 days; NTG: 184 days; p = 0.015)(Table). Conclusions: Patients with and without targetable mutations may differ by some patient characteristics, but they may not differ by presentation and type of lung cancer related symptoms leading up to diagnosis.[Table: see text]
The treating oncologist as a potential barrier to enrollment in molecular targeted trials.
Authors: Paydary Koosha , DeLuca Alli , Aggarwal Rahul Raj , Wall Lauren , Stadler Walter Michael 
Published: September 2022

407 Background: It has been hypothesized that the rarity of molecular inclusion criteria hampers trial accrual. In this study, we attempted to address this challenge in the context of a SETD2-mutation targeted trial. Methods: Patients who received molecular sequencing services from Tempus were analyzed for the presence of SETD2 molecular variants that matched trial enrollment criteria, and resided within 50 miles from the treatment center or were receiving treatment at clinical sites with strong referral histories. A written notification was issued to the ordering physician whenever a likely match was identified, and additional phone and email outreach follow up, including reasons for not pursuing the clinical trial, was conducted. Results: Over one year, 38 eligible patients were identified, none of which were enrolled. The most common reason for not being enrolled was cohort closure following initial identification and outreach. More specifically, cohort closure occurred < 2 months, 2-4 months, 4-6 months and > 6 months following identification of the mutation in 5, 8, 2 and 7 patients, respectively. Physicians for additional potential patients cited trial consideration as a future option, presence of prohibitive comorbidities, lack of interest, and patient death in 6, 3, 2 and 1 patients, respectively. Physicians for 4 patients did not respond to multiple follow up attempts. In regards to individual follow up, physicians received 0-1, 2-3, and 4 or more follow up outreach notifications regarding trial availability for 14, 19, and 5 patients respectively. Conclusions: Despite identification of a large number of potential trial candidates for a molecular targeted therapeutic trial through use of matching algorithms and extensive treating physician follow up, no patients were enrolled. This raises the hypothesis that the biggest barrier to enrollment, as in other settings, is treating physician motivation and that AI algorithms for identifying potential subjects are insufficient. Larger target populations than anticipated, better coordination between outreach efforts and enrollment status, and directed patient outreach may be necessary.
An exploratory comparative effectiveness analysis of febrile neutropenia incidence among patients with cancer receiving granulocyte colony stimulating factors.
Authors: Pawloski Pamala A. , Lockhart Catherine , Vazquez-Benitez Gabriela , DeFor Terese A , Mendelsohn Aaron , Marshall James , Moyneur Erick , McDermott Cara L. ,   BBCIC G-CSF Comparative Effectiveness Research Team
Published: September 2022

408 Background: We conducted an exploratory comparative effectiveness analysis comparing various G-CSF (pegfilgrastim/filgrastim) products to each other in incidence of febrile neutropenia (FN) among patients with breast, lung, colon, pancreatic, ovarian cancers or non-Hodgkin’s lymphoma (NHL) in the Biologics and Biosimilars Collective Intelligence Consortium’s (BBCIC) Distributed Research Network. Methods: We included patients aged > = 20 years who, in 2015-2019, per insurance claims, received any pegfilgrastim or filgrastim products as febrile neutropenia (FN) prophylaxis during the first cycle of chemotherapy posing a high or intermediate FN risk per National Comprehensive Cancer Network guidelines. We compared the FN risk starting at day 5 following day 1 of chemotherapy receipt between products using Poisson regression model with standardized inverse probability weights and robust variance to estimate the Relative Risk (RR) and 95% Confidence intervals (CI). Results: A total of 15,941 patients received a pegfilgrastim product in cycle 1 of chemotherapy: 15,115 (95%) pegfilgrastim, 484 (3%) pegfilgrastim_cbqv, 342 (2%) pegfilgrastim_jmdb. 565 patients received a filgrastim product: 284 (50%) filgrastim, 201 (36%) filgrastim_sndz, 80 (14%) tbo-filgrastim. FN events by product were: 346 pegfilgrastim (2.3% of users), 11 pegfilgrastim_cbqv (2.3%), 8 pegfilgrastim_jmdb (2.3%), 13 filgrastim (4.6%), 5 filgrastim_sndz (2.5%), 2 tbo-filgrastim (2.5%). We found no difference in FN incidence when comparing pegfilgrastim_cbqv to pegfilgrastim (RR 0.83, 95% CI 0.41-1.69), pegfilgrastim_jmdb to pegfilgrastim (RR 1.03, 95% CI 0.56-1.92), and pegfilgrastim_jmdb to pegfilgrastim_cbqv (RR 1.11, 95% CI 0.45-2.74). Similarly, we found no difference in FN incidence when comparing filgrastim_sndz to filgrastim (RR 0.46, 95% CI 0.17-1.28), tbo-filgrastim to filgrastim (RR = 0.30, 95% CI 0.06-1.36), or tbo-filgrastim to filgrastim_sndz (RR 0.54, 95% CI 0.10-2.77). Adverse events were rare, with similar rates observed among all products. Conclusions: We observed no significant difference in FN incidence among patients when comparing various G-CSF products, including when biosimilars were compared to their reference counterparts.
Duration of first-line immune checkpoint inhibitor treatment in U.S. patients with melanoma, non–small cell lung cancer, and renal cell carcinoma.
Authors: Rawji Alia , Henk Henry J. , DaCosta Byfield Stacey , Malin Jennifer 
Published: September 2022

411 Background: By 2018, Immune Checkpoint Inhibitor (ICI) drugs had gained FDA approval for the treatment of several cancers including melanoma, non-small cell lung cancer (NSCLC), and renal cell carcinoma (RCC). Recommendations for treatment duration for ICI therapy varies and is often used until either progression of disease or intolerance from toxic effects. Blumenthal et al showed that there is a positive correlation between real-world time to discontinuation (rwTTD) and progression free survival. We report the rwTTD of ICI drug use in first-line of therapy (LOT1) among enrollees diagnosed with melanoma, NSCLC, and RCC between 2015 and 2018, as well as ICI utilization in second-line therapy. Methods: A cohort of patients treated for these 3 cancers between 2015 and 2018 was identified using de-identified data from the Optum Labs Data Warehouse and clinical information from the Optum Cancer Guidance Program’s electronic prior authorization (ePA) platform. De-identified administrative claims data were then linked to ePA information at the patient level to identify details of treatment received and duration of treatment. Eligible patients were enrolled in a commercial or Medicare Advantage (MA) plan and required to initiate treatment within 6 months of diagnosis, enrolled at least 6 months prior to diagnosis date (in order to ensure this was the LOT1) and at least thirty days after start of first identified treatment regimen (in order to identify the full treatment regimen). ICI regimens are defined as those with an ICI drug received within the first 30 days of the LOT1 start date. Duration of ICI use was defined as number of days from LOT1 start to date of last ICI administration in LOT1. We estimate rwTTD accounting for censoring via SAS PROC LIFETEST. Results: In this population, we identified 844 eligible patients with these 3 cancers who received LOT1 ICI therapy from 2015 - 2018. NSCLC is the most common cancer treated with an ICI (N = 598). Median rwTTD varied between 172 and 191 days across these 3 cancers. 68% of melanoma patients remained on LOT1 ICI treatment at 90 days decreasing to 30% at 1 year, while 74% of NSCLC remained on LOT1 ICI for at least 90 days and 40% of RCC patients for 1 year. We observed that of individuals who had an ICI in LOT1, 18% of those with NSCLC moved on to an ICI in LOT2, 39% of those with Melanoma, and 25% of those with RCC. Conclusions: Median rwTTD and the percent of patients remaining on ICI treatment at 90 and 180 days in LOT1 was similar among the three cancers. However, RCC patient are more likely to remain on LOT1 ICI (40%) than those being treated for Melanoma and NSCLC.[Table: see text]
COVID-19 admissions among patients with cancer, characterization, and at-home monoclonal antibody treatment.
Authors: Laughlin Amy Iarrobino , Steyl Allison , Emsley Beth Ingle , Warner Terra , Ledford Andrea , Basaly Richard M , Baker Sara Y , Shoup Margo , Nanda Akash , Avgeropoulos Nicholas George 
Published: September 2022

414 Background: Cancer patients are at risk for severe Covid-19 infection. We characterized Covid-related hospitalizations across a large health system in Central Florida. We then used this analysis to target at home treatment for Covid-19. Methods: Retrospective chart review was conducted for all Covid-related admissions in cancer patients 1/2021-7/2021 at Orlando Health. Cancer type, discharge, vaccination and treatment status were collected. Distribution of cancer type among patients admitted was compared to the population treated at the cancer institute using chi-square test. Casirivimab and imdevimab monoclonal antibody (intravenous or subcutaneous) was provided at home through partnership with a home health agency. All patients received follow-up for patient satisfaction and resolution of symptoms. Results: 104 patients with Covid-related admissions were identified. 83% were diagnosed with solid and 17% with hematologic malignancy. The most common cancers were breast, genitourinary, lung, head and neck and upper gastrointestinal cancers. Proportion of patients with hematologic malignancies (lymphoma, leukemia, myeloma) were significantly higher among Covid admissions compared to the population of patients treated at the cancer institute (19/104 versus 320/4127, p < 0.01). 9% of patients died in hospital. 91% were discharged alive, 72% to home. 78% were unvaccinated (15% two, 7% one dose). 30% were on active treatment within 90 days, 52% received cytotoxic agents, 48% received targeted therapy or immunotherapy. Oncology clinics caring for hematologic malignancy patients were then targeted to offer Covid treatment at home.18 patients requested treatment from 8/17/21-10/25/21. 13 patients were treated at home, 1 went to the emergency room before receiving therapy and 4 were denied by insurance. Patients and providers were highly satisfied, with net promoter scores of 85 (n = 13) and 100 (n = 7) respectively. No infusion reactions occurred. Follow-up with all patients indicated resolution of symptoms, no patients were hospitalized for Covid after 7 days. Conclusions: Covid admissions among cancer patients at a large health system were consistent with published reports noting increased risk for patients with hematologic malignancies. Identification of this population translated to a targeted approach to offering monoclonal antibody treatment at home. In this small cohort, at home treatment was safe and associated with high patient and provider satisfaction.