bluuebunny/crossref_metadata_2025_split huggingface dataset:
Trastuzumab biosimilar (Kanjinti) in breast cancer patients: One-center retrospective observational study.
Authors: Jagiello-Gruszfeld Agnieszka I. , Lemanska Izabela , Brewczynska Elzbieta , Pogoda Katarzyna , Dubianski Roman , Sienkiewicz Renata , Szombara Ewa , Jagielska Beata , Nowecki Zbigniew 
Published: June 2021

e13015 Background: The switch of anti-HER2 therapy from the reference drug Herceptin to a biosimilar has presented challenges to the clinics. Real world data on trastuzumab biosimilars are very limited or not available. In our clinic we perform observational retrospective study to confirm safety and efficacy Kanjinti. Methods: 195 patients (pts) with HER2-positive breast cancer were treated with Kanjinti from Jul.18. 2018 to Jan.29.2020. Cardiac events (↓LVEF) and other unexpected or serious adverse events were monitored in all pts. 34 pts received carboplatin, docetaxel pertuzumab and trastuzumab biosimilar in neoadjuvant setting, 99 received trastuzumab biosymilar in monotherapy or with other cytostatic drugs in neoadjuvant or adjuvant setting, and 62 received docetaxel, pertuzumab and Kanjinti in metastatic setting. Results: Pertuzumab was used in combination with Kanjinti in 49% of pts (32% in the 1st. line of palliative tretment and 17% in the neoadjuvant settings, respectively).Switching from Herceptin to Kanjinti was observed in 65% of MBC patients and 37% of EBC patients. Switching was done at a median of 4th cycle. 6 patients had a decline in LVEF. No other trastuzumab related adverse events was observed. Conclusions: The management of HER2 positive breast cancer in our clinic follows the international recommendations. This is the first real world safety data of Kanjinti from Poland. The 12-month follow-up treatment with Kanjinti an acceptable cardiac safety profile. In cases where there was a switch from Herceptin to Kanjinti or Kanjinti combined with pertuzumab, the safety profile was similar to that previously reported in other studies.
Patients’ perceptions of care coordination among NCORP therapeutic clinical trial participants: A matched case-control study.
Authors: Okado Izumi , Pagano Ian , Rhee Jessica , Berenberg Jeffrey L. , Holcombe Randall F. 
Published: June 2021

e13504 Background: Effective coordination of care (CC) is a critical component of high-quality cancer care; however, many patients with cancer continue to receive poorly coordinated care. CC experiences among therapeutic clinical trial (CT) participants are relatively unknown. We examined cancer patients’ perceptions of CC among CT participants using a validated Care Coordination Instrument (CCI). Methods: The study sample (N = 90) consisted of 45 CT participants and 45 matched non-participants from archival data from our prior CC studies. 171 patients who participated in therapeutic cancer clinical trials through the Hawaii Minority/Underserved NCI Community Oncology Research Program (NCORP) between 2015 and 2020 were contacted for study participation, and 26% completed the CCI. The CCI measures overall perceptions of CC and across 3 domains (Communication, Navigation, Operational). Paired t-tests were used to compare overall and domain scores between CT participants and non-participants. The two groups were matched by age, gender, cancer type (breast, GI, other), and clinical stage. Results: Among CT participants, the mean age was 61.7 ( SD = 9.4), and the majority were female (67%) and Asian (56%). The most common cancer types were breast (27%) and GI (16%), with 24% with stage III disease. CT participants reported significantly higher total CC scores than non-participants (62.5 vs. 55.8; p = .0008). Similar trends were found for Navigation ( p = .007) and Operational ( p = .001) domain scores. 29% of CT participants reported receiving high-intensity CC assistance from their clinical research associates (CRAs), and 27% indicated receiving moderate-level CC assistance. Responses to open-ended questions regarding CC revealed that CT participants received assistance with a variety of CC activities from their CRAs, including scheduling appointments and explaining test results and procedures. Conclusions: Patients who participate in therapeutic cancer clinical trials report more positive perceptions of CC compared to non-participants. Qualitative data suggest that significant care coordination support is provided by the clinical research associate. The results underscore the importance of CC support provided by CRAs who may be an unrecognized component of the healthcare delivery team. CC provided by CRAs may contribute to improved quality and value of cancer care for patients enrolled on therapeutic clinical trials.
Encouraging teamwork and innovative practices by creating proximity: A qualitative study of continuous improvements in the Quebec Cancer Network.
Authors: Tremblay Dominique , Touati Nassera , Usher Susan , Cournoyer Johanne 
Published: June 2021

e13509 Background: Quality cancer care relies on each profession keeping up with advances and best practices and spreading these across a complex multi-team system1. It requires enabling multiple providers and people living with cancer to bridge the distance between them and complement each other's contributions. The proximity framework2 provides a valuable way to understand conditions that increase the likelihood of knowledge sharing, innovation and collaboration. Methods: A qualitative study design of the Quebec Cancer Network was undertaken, with data collected from interviews with policymakers, managers, providers and users (N=22), observation of national and local level meetings (N=28) and document review. Interpretive Description using content analysis sought to identify actions that created proximity dimensions and the perceived influence these had on the development and spread of new approaches. Results: Deliberate actions taken within the network created different dimensions of proximity that impacted teamwork. Prescriptions from network leadership – including consistent promotion of the National cancer plan, patient participation in governance structures, shared quality indicators, and establishment of multidisciplinary committees at local level, created cognitive proximity: a shared mental model emphasizing patient-centred care and organizational proximity: shared standards across the network. Support for professional communities of practice created relational and institutional proximity, increasing trust and knowledge sharing. Local committees enhanced relational and cognitive proximity as providers came to appreciate and optimize each other's contribution to care. Conclusions: The combination of proximity dimensions created through communities of practice and prescriptions from the national level help develop and spread improvements that are tailored to - and take advantage of - networked team-based cancer care delivery. This reflects a balanced proximity where communities of practice pursue new knowledge and innovative practices that can be introduced in local committees to see how it fits with other contributions to solving a problem, thereby promoting recognition of interdependency within and between teams. Synergy between actions is essential to enhancing proximity. The proximity framework offers a complementary perspective to better understand opportunities for improving models of care. References: 1Weaver, S. J., et al. (2018). Unpacking care coordination through a multiteam system lens. Medical care, 56(3), 247-259. et al. Unpacking Care Coordination Through a Multiteam System Lens. Medical Care. 2018;56(3):247-59. 2Knoben, J., & Oerlemans, L. A. (2006). Proximity and inter‐organizational collaboration: A literature review. I nternational Journal of management reviews, 8(2), 71-89.
New drug approvals and their effect on performance for participants in the Oncology Care Model.
Authors: Bilbrey Larry Edward , Schleicher Stephen Matthew , Chaudhry Basit Iqbal , Yue Andrew , Blakely L. Johnetta 
Published: June 2021

e13525 Background: The Oncology Care Model (OCM) is an oncology-specific value-based care model that holds participating practices accountable for all costs of care. Medicare implements quantitative adjustments to model target costs in OCM, including a trend factor to reflect aggregate cost growth and a novel therapy adjustment for new indications. However, it is unclear how well these adjustments account for the emergence of new therapies that are evidence based and influence standard of care for an individual cancer type. We sought to investigate this by studying the impact that FDA approval for brentuximab vedotin (BV) in the first line setting in March 2018 had on OCM practice performance in Hodgkin’s Lymphoma (HL). Methods: We identified all HL OCM episodes attributed to Tennessee Oncology (TO), a large community oncology network of over 90 oncologists, during performance periods (PP) 3 through 6. HL episodes within the lymphoma bundle were identified through the use of individual ICD-10 coded diagnoses on claims for antineoplastic infusions and E&M visits. Using OCM performance data, our electronic health record, and claims data analytics software, we calculated average episode target costs, drug spending by drug type, and hospitalization costs to determine key determinants of OCM performance. Results: During the study period, there were 577 episodes of lymphoma attributed to TO, of which 28 were for patients with HL. TO’s OCM performance in HL was significantly under target in PP4 (under target by $13.5K) and significantly over target in PP5 (over target by $32.1K) after the updated BV FDA approval. Average episode spending on BV increased by over $45K during this timeframe, while OCM target cost increased only by approximately $19K. Despite the change in OCM performance, hospitalization costs and hospice utilization remained relatively stable. Conclusions: In the OCM, despite quantitative payment factors that in principle are intended to adjust target prices to reflect changing cost dynamics, significant gaps exist. These gaps can inappropriately shift risk to providers for the appropriate use of new indications, including those that change standard of care. The example of brentuximab vedotin in HL illustrates the difficulty in reaching performance benchmarks due to dynamics associated with the rising cost of drugs. Further methodological changes are needed in future oncology value-based care models to ensure accurate prediction of rapidly changing treatment costs for appropriate therapies. Hodgkin’s lymphoma OCM payment period cost and utilization comparison data.[Table: see text]
Cancer care system strengthening (Pendharkar model) offers uninterrupted care continuum during COVID19 pandemic.
Authors: Pendharkar Dinesh , Tripathi Chandramauli 
Published: June 2021

e13540 Background: District cancer care programme is operational in more than 150 districts of India. This programme has created nodal cancer units n government run district general hospitals offering cancer related services including chemotherapy and palliative care. During pandemic (COVID19), due lockdown, cancer patients were not able to access tertiary level specialised cancer centres. Aim of this presentation is to reaffirm the necessity of health system strengthening at peripheral level. Methods: With the aim of decentralization and task shifting, district cancer care programme is being implemented in 8 states of India. One general duty medical officers and paramedical staff is trained to assist cancer patients. The physician work under 24 x7 mentorship of oncology team. The government has created a physical cancer care unit with availability of some essential chemotherapy drugs as well. Cancer patients can access these units for assistance in diagnostics, follow-up, toxicity care, chemotherapy and palliative care. Results: We analysed data from few districts in year 2020. The number of patients vesting the units showed an increase during months of total lockdown. Data from 14 districts were analysed. It shows that number of outpatient visits and chemotherapy sessions were higher during strict lockdown. From January 2020 to December 2020 there were 19,273 outpatient visits, and 9,788 inpatient visits. During months of a strict lockdown-March, April, May, June the number increased.7,729 sessions of chemotherapy were performed and more than 2,230 new cases were registered during this year. Conclusions: The pandemic has brought new challenges and has compelled us to learn ways of care continuum. The most important has been the necessity of decentralisation of specialised care, its evenly and equitable distribution. District cancer care programme, as a measure of health system strengthening, which is being evolved in India has further emphasized the importance of such a system building.
Characteristics of the Multi Disciplinary Cancer Conference (Tumor Boards) in the COVID 19 era.
Authors: Simpson Lijo , Mathew Anju , Wojciechowski Robert 
Published: June 2021

e13561 Background: Cancer centers in the US are required to discuss a minimum of 15% analytic cases and prospective presentation (minimum 80%) in the multidisciplinary case conference (tumor board, MDCC), per the Commission on Cancer accrediting standards. Tumor board discussion have been shown to improve treatment decision making and patient outcomes. These meetings were in person meetings in the Pre-COVID era. The COVID 19 pandemic and the subsequent requirements for social distancing forced hospitals to move most MDCCs to a virtual format. We report on the large scale utilization of a propriety Care-Coordination platform OncoLens to run MDCCs across the country. Methods: Technology quality metrics were collected from the ongoing daily usage of the platform including time characteristics, care team utilization metrics, average attendance, quality metrics collected for accreditation and clinical trials matching on the OncoLens platform. Results: The virtual platform was accessible to around 8000 providers across the United States. On average per month there were 250 virtual meetings with over 290,000 meeting minutes. Conferences ranged from 30 minutes to 4 hours. 75% of users used the web application 25% of users utilized their smart phones .System uptime was 99.99%. Hospitals were able to conduct General and Site specific conferences. Virtual attendance of the required specialties of Medical Oncology, Radiation Oncology, Surgery, Pathology and Radiology was attained, with the average conference attendance being 14. On average hospitals required 2 administrative training sessions. Most of the case presentations were prospective. This format does enable cancer programs to collect quality metrics around Cancer program accreditation by the American College of Surgeons. A wide variety of common and rare cancer types were discussed in the virtual format. 66% of patients discussed potentially matched to clinical trials during the discussion. Conclusions: The shift of MDCCs to a mostly virtual environment occurred quickly in response to the COVID 19 pandemic. It took an average of 2 training classes to get the cancer care team on board with the use of new technology. It is possible to have high quality discussions and attain metrics for Commission On Cancer accreditation utilizing a virtual platform.
Cooperative group and pharmaceutical sponsored clinical trials: Perceptions of U.S. community oncologists.
Authors: Swain Richard Scott , Zettler Marjorie E. , Jeune-Smith Yolaine , Feinberg Bruce A. , Gajra Ajeet 
Published: June 2021

e13571 Background: Many community-based oncologists in the US participate in clinical trials. These trials largely fall into two categories: trials run by cooperative (co-op) groups, funded and supported by the National Cancer Institute and trials developed, and supported by the pharmaceutical (pharma) industry. This study aimed to assess participation in, and perceptions regarding, co-op versus pharma trials among US community oncologists. Methods: We invited healthcare providers (HCP) across the continental US to attend 4 virtual meetings held between September and November 2020. Participants submitted their demographic information and responses to targeted questions regarding their opinions about co-op- and pharma-sponsored trials via a web-based pre-meeting survey. We evaluated participant HCP practice demographics and survey responses using descriptive statistics. Results: Of 259 surveyed participants, HCPs specialized in hematology-oncology (57%) and medical oncology (40%) with mean (median) 19 (18) years’ clinical experience. Most HCPs (178; 69%) reported participating in clinical research, and of these, 137 (77%) participated in co-op-led and 156 (88%) participated in pharma-led clinical research. HCPs preferred participating in both pharma and co-op (49%), pharma only (22%), and co-op only (11%) trials, while 18% preferred not to participate. Co-op trials were considered more prestigious to lead (86%), less likely to imply a conflict of interest (59%), and to address more pertinent questions (58%), while pharma trials had perceived advantages of better compensation (61%) and superior efficiency (48%). Co-op trials were perceived as not being financially sustainable (69%) and slower to accrue patients (85%) than pharma-led trials. Relatedly, in a hypothetical scenario of competing trials with identical design, the majority (60%) of HCPs preferred enrolling a loved one in a co-op trial. HCPs practicing in facilities with academic affiliation (34%) and in non-academic (66%) settings reported similar perceptions about co-op- and pharma-led trials; though, HCPs in academic settings were more likely to participate in clinical research compared to those in non-academic settings (82% vs. 62% [ P=0.001], respectively). Conclusions: In our survey of experienced HCPs, co-op-led clinical trials were perceived generally more favorably than pharma-led trials, even with concerns regarding cost, feasibility, and slower recruitment. However, despite their preference for co-op trials, HCPs were more likely to participate in pharma-led trials. Almost a third of surveyed HCPs are not participating in clinical trials and a fifth do not wish to. These findings can inform stakeholders (co-op trial leadership, pharma drug development teams, and patient advocacy groups) regarding appropriate education, design, and messaging regarding future clinical trials in oncology.
Implementation of the Vinehealth application, a digital health tool, into the care of patients living with brain cancer.
Authors: Gvozdanovic Andrew , Mangiapelo Riccardo , Patel Rayna , Kirby Georgina , Kitchen Neil , Miserocchi Anna , McEvoy Andy , Grover Patrick , Thorne Lewis , Fersht Naomi , Williams Norman R. , Marcus Hani , Kosmin Michael 
Published: June 2021

e13582 Background: Cancers of the brain lead to significant neurocognitive, physical and psychological morbidities. Digital technologies provide a novel platform to capture and evaluate these needs. Mobile health (mHealth) applications typically focus on one aspect of care rather than addressing the multimodal needs of the demographic of these patients. The Vinehealth application aims to address this by tracking symptoms, delivering machine learning-based personalised educational content, and facilitating reminders for medications and appointments. Where mHealth interventions traditionally lack the evidence-based approach of pharmaceuticals, this study acts as an initial step in the rigorous assessment of a new digital health tool. Methods: A mixed methodology approach was applied to evaluate the Vinehealth application as a care delivery adjunct. Patients with brain cancer were recruited from the day of their procedure ± 7 days. Over a 12-week period, we collected real-world and ePRO data via the application. We assessed qualitative feedback from mixed-methodology surveys and semi-structured interviews at onboarding and after two weeks of application use. Results: Six participants enrolled of whom four downloaded the application; four completed all interviews. One patient set up their device incorrectly and so couldn't receive the questionnaires; excluding this patient, the EQ-5D-5L and EORTC QLQ-BN20 completion rates were 100% and 83% respectively. Average scores (±SD) at onboarding and offboarding were EQ-5D-5L: 2.07±1.28 and 1.73±1.22, and QLQ-BN20: 13.33 and 22.5. In total: 212 symptoms, 174 activity, and 47 medication data points were captured, and 113 educational articles were read. Participants were generally optimistic about application use. All users stated they would recommend Vinehealth and expressed subjective improvements in care. Accessibility issues in the ePRO delivery system which impacted completion rate were identified and have subsequently been fully addressed. Conclusions: This feasibility study showed acceptable patient use, led to a subjective improvement in care, and demonstrated effective collection of real-world and validated ePRO data. This provides a strong basis to further explore the integration of the Vinehealth application into brain cancer care. This study will inform the design of a larger, more comprehensive trial continuing to evaluate improvements in care delivery through data collection, educational support and patient empowerment.
A nurse-led telephone triage for the prevention and control of COVID-19 spread in an oncology department.
Authors: Calvetti Lorenzo , Simionato Francesca , Cappetta Alessandro , La Russa Francesca , Cimenton Roberta , Gasparin Barbara , Corà Francesco , Aprile Giuseppe 
Published: June 2021

e13617 Background: After the results of the Nurse-led Telephone Triage (NTT) study ( Calvetti L, et al. ASCO 2020), the system has been implemented to prevent unnecessary hospitalizations of cancer patients. With the pandemic outbreak, a dedicated SARS-CoV-2 2019 (COVID-19) NTT protocol was added to monitor cancer patients (CPs) receiving active medical treatment. We report on the impact of NTT in limiting accesses and minimizing the risk of spread of the infection through the Department of Oncology. Methods: CPs on active medical treatment were educated to call the NTT in case of any symptoms suspected for COVID-19 infection to the Oncology Department of Vicenza, Italy, during the COVID-19 pandemic (February 22 2020 to January 31, 2021). Each event assessment was performed by trained oncology nurses with the supervision of a medical oncologist on duty and in case of suspected COVID-19 infection a testing pathway for COVID-19 was activated. Primary endpoint of this study was to compare incidence of COVID-19 and related deaths in both CPs on active medical treatment and health workers with the rate in the overall population of Veneto region. Results: From February 22 2020 to January 31, 2021 1,154 patients received systemic anticancer treatment (versus 1,022 patients in the same 2019 – 2020 period). Total consultations at NTT were 587; 97 patients reported symptoms suspected for COVID-19 infections. The COVID-19 testing pathway was launched in 60 CPs and a positive test was reported in 25 CPs (2.2% incidence compared to 6.5% in the overall Veneto region population). Two COVID-19 related deaths were reported (8% death rate). In the same period, 2/54 (3.7%) health workers tested positive for COVID-19. Patients who tested positive had a median treatment delay of 25 days. Conclusions: The NTT system in the clinical practice provided a useful tool for monitoring and limiting hospital-acquired COVID-19 infection among both CPs on active treatment and health workers.