bluuebunny/crossref_metadata_2025 huggingface dataset:
Review of time to treatment for head and neck cancer patients at a rural Maine cancer center.
Authors: Harb Antoine Joseph , Curtis Adam
Published: October 2020

292

Background: Time to Treatment (TTT) for head and neck (H&N) malignancies were reviewed for all patients treated at Northern Light Cancer Institute, from 2013 to 2017. A total of 297 cases were identified. Methods: TTT was defined as time of tissue diagnosis by biopsy to the first treatment day. Data was compared to a comprehensive study of 51,655 cases conducted by Murphy et al (JCO, 34; 2, Jan 10, 2016). Median days to treatment were compared by tumor site and treatment modality. Comparison of the distribution of cases where TTT exceeded the critical time point of 67 days (determined by Murphy) was also made. The primary mode of treatment was a combination of chemotherapy and radiation (concomitant) in 39.5% of patients. Other treatment modalities included radiation only (17.2%), and surgery, either as stand-alone treatment, or followed by subsequent additional treatment (32.4%). These treatment modalities comprise 89.1% of all cases. Results: We identified 82 (27.7%) patients with oral cancer, 99 (33.5%) with oropharyngeal malignancy and 92 (31.1%) with laryngeal cancer. Median TTT was 40 days (compared to 34 days found by Murphy) for chemo-radiation patients, 42 (versus 31) for radiation only, and 34 (versus 17) for surgery. TTT for surgery patients was significantly shorter than the other two treatment modalities (p < 0.05). There were no significant differences in TTT based on primary site. All comparisons to Murphy (treatment and primary site) were significantly lower than our median values (p < 0.05). Median TTT over 5 years maintained the same relationship between the treatment modalities. 29.2% of our patients were treated within 30 days, 50% from 31-52 days, 10.6% from 53-67 days, and 10.2% beyond 67 days, compared with 59.5, 23.3, 8.3, and 9% respectively found by Murphy. Conclusions: TTT for H&N cancers has been relatively stable over the 5-year time course examined. The majority of our patients (50%) are treated in the 31-52 day timeframe compared with the first 30 days (59.5%) with Murphy. Our data suggest similar percentages (10.2 versus 9%) after which patients had poorer outcome. Further efforts should be entertained to make sure patients are seen sooner in the oncology clinic.
Evaluation of a centralized toxicity view in the electronic health record (EHR) for physician-recorded Common Terminology Criteria for Adverse Events (CTCAE).
Authors: Levin-Epstein Rebecca , Ma Martin , Jiang Naomi Y. , Valle Luca Faustino , Yoon Stephanie , Jablonsky David , Steinberg Michael L. , Kishan Amar Upadhyaya , Wu Allan D. , Raldow Ann C.
Published: October 2020

296

Background: Patients’ treatment-related acute and late toxicities are essential clinical data, yet this information is widely dispersed among notes in the EHR. This lack of structure impedes clinician ability to efficiently and comprehensively integrate toxicity information into clinical management. We aimed to consolidate toxicity data to improve clinician efficiency in accessing this information, and to evaluate the utility of this tool in radiation oncology. Methods: We developed an auto-updating flowsheet view (“Synopsis”) in the Epic EHR that longitudinally integrates physician-graded CTCAE toxicity selected using a SmartForm embedded in EHR notes. Physicians timed themselves performing 4 tasks to assess acute and post-treatment toxicity information for patients seen in follow-up, alternating with vs. without use of Synopsis. Wilcoxon Rank-Sum testing compared recorded task times with and without Synopsis. A survey was sent to physicians regarding qualitative utility of Synopsis. Results: Six physicians reviewed 98 patients seen in follow-up (49 with Synopsis, 49 without Synopsis) at median 8.1 months (Synopsis) and 6.5 months (no Synopsis) since completion of radiation (p = 0.88). Use of Synopsis was associated with significantly faster assessment of: overall toxicity history (median 50 vs. 93 seconds, p = 0.0007), highest acute toxicity during treatment (median 19 vs. 40 seconds, p = 0.0002), highest post-treatment toxicity (11 vs. 65 seconds, p < 0.0001), and longitudinal review of a single symptom (8 vs. 61 seconds, p < 0.0001). Among 10 physician survey respondents, 100% reported that Synopsis improved efficiency and 30% reported it led to a change in management. All physicians felt it was important to understand a patient’s toxicity history, but 80% reported that time required with the note-based EHR structure was prohibitive; with use of Synopsis, 90% reported that this task was now feasible. Specific domains most improved included ability to: identify high-grade toxicities (100%), contextualize new symptoms (80%), summarize treatment-related toxicity (80%), navigate in the EHR to a time of high-grade toxicity (60%), evaluate the success of an intervention (30%), and decide whether to discuss a reported new symptom (30%). Conclusions: A centralized toxicity view in the EHR improves clinician efficiency in evaluating longitudinal toxicity data and enhances clinician ability to comprehensively integrate toxicity information into patient care.
Mobile health tool for monitoring cancer treatment complications.
Authors: Sanyal Amit , Heun James M. , Janssen Clemens walter , Sweeney Jessica
Published: October 2020

297

Background: Side effects after cancer treatment are ubiquitous, seen in up to 98.3% of patients in one Phase III lymphoma trial. Additionally, cancer patients are at a greater risk of mortality from infections such as coronavirus disease 2019 (COVID-19), prompting recommendations for routine screening. Current care delivery model, reliant on self- triaging of symptoms by patients results in delayed management and avoidable emergency room visits and hospitalizations. Technology based symptom monitoring allows early identification of complications, reduces symptom burden, cost of care and enables early detection of relapse. We studied utility of a mobile-health tool for toxicity monitoring and COVID-19 screening. Methods: We developed an application that periodically delivers disease specific toxicity questionnaires to patients following cancer treatment. Based on NCI- PRO-CTCAE form builder, the questions are delivered through SMS or e-mail. Responses crossing pre-specified thresholds are flagged for manual care team follow-up. Patient and staff experience as well as medical interventions are captured. Results: Currently, 68 patients with different malignancies are enrolled. Median age 60 years (range 24-85), 35 males, 31 females. 72.35% patients rated user experience at 4 or higher (1-5 scale, 5 highest). Aggregate provider rating was 3.25 (1-5 scale, 5 highest). Of 639 captured responses, 157 reported fatigue, 145 no symptoms, 57 nausea/vomiting or diarrhea, 52 numbness/tingling and 48 shortness of breath. 76 responses were flagged for nurse follow-up calls. These resulted in 72 successful outpatient symptom management, 2 hospitalizations for neutropenic fever, 1 MRI diagnosis of radiation necrosis and 1 diagnosis of lymphoma progression. 92% of patients received a follow up within one business day. Median time between response recorded and follow up completed was 55 minutes. Of 1299 responses recorded by COVID-19 screening, 1175 reported no symptoms. All positive responses (47 cough, 52 diarrhea, 5 fever and 20 dyspnea) were false positives. Study is ongoing with recent implementation of a distress screening and survivorship modules. Conclusions: Electronic capture of symptoms using connected technology is feasible and can be used to screen cancer patients for treatment related complications as well as pandemic related illnesses.
Toxicity of high-dose methotrexate administration at the Sidney Kimmel Cancer Center (SKCC): A retrospective review to guide establishment of an outpatient treatment program.
Authors: Sokol Kelsey , Yuan Kelley , Fendler Katlin , Burdette Samantha , Galanis Patricia , Piddoubny Maria , Delengowski Anne , Gung Carol , George Mercy , Alpdogan Onder , Martinez-Outschoorn Ubaldo , Porcu Pierluigi , Binder Adam
Published: October 2020

30

Background: High-dose methotrexate (HDMTX) is administered for the treatment of primary central nervous system (CNS) lymphoma (PCNSL), leptomeningeal metastases, and osteosarcoma, as well as CNS prophylaxis in patients with high-risk lymphoma and leukemia. Treatment is typically administered in an inpatient setting to enable aggressive hydration, urinary alkalinization, and frequent lab monitoring given the risk of acute kidney injury. Multiple pediatric centers have published experiences with outpatient administration of HDMTX. We aim to determine the toxicity rate in adult patients at SKCC receiving HDMTX to identify a population in which to pilot an outpatient HDMTX program. Methods: We performed a retrospective review of all patients receiving inpatient HDMTX at SKCC between January 1, 2018 and October 31, 2019. Results: Seventy-three patients (52% male) with median age of 60 years (range 22-81) received 255 cycles total of HDMTX. Diagnoses include PCNSL/vitreoretinal lymphoma (n=22), diffuse large B-cell lymphoma (n=17), B-cell acute lymphoblastic leukemia (n=16) and other diagnoses (n= 18). Thirty-one cycles were administered as CNS prophylaxis and 224 cycles as treatment, with a median prophylactic dose of 3.5 g/m2 (range 1-3.5) and median treatment dose of 3.5 g/m2 (range 0.25-12). The most common toxicity was acute kidney injury at a median day 3 of the cycle (range 1-7). See the table for details. Conclusions: Acute kidney injury occurred more often in the treatment group compared to prophylaxis group. Of all patients with AKI in the treatment group, 45% had a diagnosis of PCNSL. In the prophylactic group, only 21% of patients (3/14) experienced AKI of which all resolved. Of all AKI events, 90% were Grade 2 and 90% resolved. Based on these results, we plan to pilot an outpatient HDMTX program in patients receiving prophylactic HDMTX to determine its effect on patient quality of life and cost of care. [Table: see text]
Reducing burdens of site feasibility assessments for conducting clinical trials.
Authors: Kurbegov Dax , Hurley Patricia A. , Waterhouse David Michael , Nowakowski Grzegorz S. , Kim Edward S.
Published: October 2020

300

Background: Current methods to assess site feasibility for industry-funded clinical trials are onerous and delay patient access to novel treatment options and high-quality clinical trials. Industry sponsors and contract research organizations (CROs) often probe for unnecessary and/or duplicative information. These burdens prolong trial start-up times and are a barrier to site participation in oncology trials. The American Society of Clinical Oncology (ASCO) Research Community Forum convened a task force to identify ways to improve the site feasibility assessment process. Methods: Data were collected in 3 steps: 1) survey to assess site burdens, 2) collation of sample feasibility questionnaires (FQs), and 3) stakeholder meeting to discuss potential solutions. The task force then developed recommendations for process improvements and obtained stakeholder feedback through a survey. Results: 113 oncology practices (66 community, 47 academic) reported completing a median 5 FQs and 2 pre-study site visits (PSSVs) per month. FQs took a median 2 hours to complete whereas PSSVs took a median 4 hours to complete. Most considered FQ (81%) and PSSV (91%) content redundant to information previously provided, and FQs similar between different sponsors (86%). The median time from first contact to first patient enrolled was 6 months. The 40 respondents to the stakeholder survey represented 19 academic- and 9 community-based sites, 8 industry sponsors, and 4 CROs. Most preferred a model with a short FQ plus a PSSV when there was not a prior relationship. If there was a prior relationship, either a PSSV or teleconference was preferred. All stakeholders identified time savings, expedited start-up, fewer staff resources, and cost savings as the greatest benefits. The greatest barriers to adoption were buy-in from sponsors and CROs, and insufficient information about site capabilities. Conclusions: Site feasibility assessments for industry-sponsored trials are important to ensure patient safety and access to high quality clinical trials. However, current methods are inefficient and time and resource intensive. This initiative provided insights about challenges for sites and the viability of a fundamental change to site feasibility assessments. ASCO recommendations are forthcoming on improving processes, standardizing and minimizing questions, and using portals that are effective across all trials and clinical research scenarios.
The success of the Rapid Diagnostic Clinic (RDC) detecting new cancers in patients with non-localizing symptoms.
Authors: Sindhar Jan , Martin Sabine , Rahman Loay , Zheng Sifan , Mukadam Yaseen , Ali Sunnyath , Steward Lindsay , Wheeler Daniel , Moss Charlotte L , Jones Geraint , Russell Beth , Van Hemelrijck Mieke , De Michele Luigi , Bhattacharjee Saoirse
Published: October 2020

303

Background: Rapid Diagnostic Clinics (RDC) are being set up across the UK allow primary care physicians to refer patients with symptoms concerning for cancer that do not fulfil tumour-specific two week wait urgent referral criteria. Guy’s RDC was established to address the high cancer related mortality in our network. There is little data assessing the effectiveness of RDC models is available in a British population. Methods: We evaluated all patients referred to Guy’s RDC pilot scheme between December 2016-June 2019 (n=1,341) to assess the rate and type of cancer diagnosed and clinical outcomes. Results: Of 1341 patients, 96 cancers were diagnoses (7.2%). Most common were lung (16%), haematological (13%) and colorectal (12%). A third were at early stage (I-II) and 40% received radical treatment. Median time to cancer diagnosis 28 days (IQR 15-47) and treatment 56 days (IQR 32-84). 75% of patients were suitable for anti-cancer treatment: surgery (26%), systemic (24%) and radiotherapy (14%). We plan to present updated data on > 2000 patients referred until June 2020. Overall 6% of patients were diagnosed with pre-malignant conditions. Conclusions: RDCs provide a streamlined pathway for complex vague symptoms patients which are challenging for primary care. The 7% rate of cancer diagnosis exceeds many tumour specific urgent pathways which supports the need for rapid tailored diagnostics. The detection of pre-malignant conditions in 6% allows surveillance and intervention to potentially improve long-term outcomes. RDCs are likely to be pivotal in the cancer recovery phase of the COVID-19 pandemic.
Finding value in social media: A collaborative online communication platform linking providers to education and an online tumor board across a large community of oncology practices.
Authors: Daniel Davey B. , Blakely Johnetta , Schleicher Stephen Matthew , Allen Duncan , Marsden Mary Catherine , Arrowsmith Mary Margaret , Grothey Axel , Schwartzberg Lee S.
Published: October 2020

305

Background: Clinical collaboration across fragmented and often small clinic sites can be challenging. As a potential solution, OneOncology, a national community oncology network, launched OneCommunity, a secure, interactive online platform used across our network of six practices and over 130 clinic sites. One feature is a “virtual” tumor board where physicians can post complex cases at any time and obtain input from disease-specific experts from within the network. Members can also post, comment and disseminate information about policy and education updates affecting oncology. Methods: OneCommunity launched on December 15, 2019 and all 442 members of OneOncology were allowed access. We tracked numbers of membership, tumor board cases, policy updates and questions, views and responses per post, and response time for tumor board and policy posts during the study period from launch through June 11, 2020. Results: In the first six months of use, 277 providers signed up and logged into the platform. 71 individual patient cases were presented across 10 specialty tumor boards. The mean time to first response was 35 hours ( < 1 hour, 297 hours), median time was 20 hours, and 73% of postings had a response within 48 hours of original posting. The most robust tumor boards were breast, GI, and lung cancers. There was also a set of general posts that was nonspecific to patients including policy, COVID updates, and educational reviews. The average number of responses for tumor boards was significantly greater than general posts (3.5 vs. 1.8, p < 0.05). The number of views for both types of posts, however, were high (406 vs. 346, p < 0.05). Conclusions: An online communication platform is feasible and allows physicians to receive treatment suggestions for complex cases relatively quickly and across geographies. Tumor board cases received more interaction than policy and education updates. The platform lends itself to rapidly adding other aspects of cancer care such as COVID-19. Future applications include a network wide real-time molecular tumor board.
Managing outpatient oncology visits during COVID-19 pandemic: Addressing patients' concerns and precautionary measures.
Authors: Al Mutairi Nashmia , Al Harbi Mohammad , Shehata Hussam , Mohammed Rashid Noridayu , Jazieh Abdul-Rahman
Published: October 2020

35

Background: Implementation of precautionary measures in response to COVID-19 pandemic involve patients pre-visit screening of patients to detect any potential risk of infection and proper patient flow to the clinic and adherence to social distancing. Our study evaluates our center experience with the pre-visit screening calls and plans to optimize the process. Methods: As precautionary measure to COVID-19 pandemic, all patients scheduled for oncology outpatient visit were called by a nurse to screen them for any acute respiratory infection (ARI) and triage their visit into physical visit or virtual visit. Patients with high ARI score were directed for proper isolation and COVID-19 testing process and recommended to have virtual clinic visit with their oncologists. Those who have low ARI score and require in person clinic visit receive confirmation of appointment during the call with visit instructions. A tally of all responses and decision were maintained for process monitoring. Results: Between March 23, and June 13, 2020, 1,905 patients had pre-visit screening calls. Nurses could not reach 82 (4%) patients and 23 patients expired per family member report. Out of 1800 patients who responded to call, 1392 (77 %) had confirmed physical appointment, 179 (10%) switched to virtual appointments. Sixteen out of the 19 patients who have high ARI score have swab done. All patients were tracked to assure proper management of their symptoms and continuity of oncological care. A total of 229 (12.7%) patients refused to come due to COVID-19 concerns and all were rescheduled based on primary oncologists decision. A quality improvement project was initiated to understand the concerns of patients who refused to come and address them properly. Conclusions: Pre-visit screening call is a critical intervention, not just in assuring adherence to infection control measures, but in identifying patients concerns and addressing them. There is a need for implementation of updated patient education and awareness approach about the risk of COVID-19 infection and the importance of adherence to their cancer treatment plans.
Better treatment at what cost? A study of myeloma spending.
Authors: Naipaul Rohini , Mow Elena , Mercer Rebecca , Yeung Lyndee , Gavura Scott , Kouroukis C. Tom
Published: October 2020

60

Background: Multiple myeloma represents less than 1.5% of new cancer cases in Canada. Currently, the estimated median overall survival is at least 5-6 years, primarily driven by therapeutic advances over the past decade. As treatment protocols routinely use doublet and triplet combinations, there are increasing concerns about the ability of health systems to afford growing costs of treatment. To inform system planning in Ontario, we examined trends in costs and utilization of myeloma drugs funded by Ontario’s New Drug Funding Program (NDFP) and the Ontario Drug Benefit program (ODB). Methods: NDFP primarily funds IV cancer drugs while ODB funds take-home cancer drugs (THCD). Treatment volumes and government costs, including drug costs and pharmacy fees where applicable, were obtained from ODB and NDFP claims data. Based on the available data, trends were examined from the 2010/11 to the second quarter of the 2019/20 fiscal year. Results: A total of 7 myeloma drugs (3-IV cancer drugs, 4-THCD) were examined. Over 9 years (2010/11 - 2018/19), spending on publicly-funded myeloma drugs increased by 303% while treatment volumes increased by 116%. Between 2014/15 and 2018/19, bortezomib spending decreased by 72%, largely due to generic pricing policies, while lenalidomide spending increased by 158%, likely due to new indications. By 2018/19, these 7 drugs accounted for 17% of the total cancer drug costs under Ontario's publicly funded programs. NDFP spending on IV cancer drugs by the second quarter of 2019/20 has surpassed the annual expenditures in 2018/19 due to the addition of daratumumab. Conclusions: Since 2010/11, growth in Ontario's public expenditures on myeloma drugs has outpaced savings from pricing policies and this growth is mainly driven by the high cost of the novel agents.
Healthcare resource utilization and economic burden of cytokine release syndrome (CRS) and neurologic events (NE) in patients (pts) with relapsed/refractory multiple myeloma (RRMM) receiving idecabtagene vicleucel (ide-cel, bb2121) in KarMMa.
Authors: Hari Parameswaran , Nguyen Andy , Pelletier Corey , McGarvey November , Gitlin Matthew , Parikh Kejal
Published: October 2020

61

Background: Incidence, healthcare resource utilization (HRU), and management costs associated with CRS and NE were assessed among pts in the KarMMa trial (NCT03361748) treated with ide-cel, a BCMA-directed CAR T cell therapy for RRMM. Methods: HRU occurring from onset to resolution of CRS and/or NE and consistent with trial management guidelines were identified from the clinical trial database. Costs associated with CRS or NE by grade (Gr) were applied using public databases and literature on United States national average costs from the health system perspective and aggregated across duration of events. Results: Of 128 pts treated with ide-cel, 107 had CRS with or without NE including 84 (65.6%) with CRS only and 23 (18.0%) with both; no pts had NE only. All cases of CRS with NE occurred concurrently (≥1 d of overlap). Most pts with CRS and/or NE had Gr ≤2 events (96/107, 89.7%); none had both Gr ≥3 CRS and NE. Of the 23 pts with both, 22 (95.6%) had CRS before or on the same day as NE. Among the 15 pts who had CRS before NE, NE developed a median of 2 days after CRS onset. Of the 107 pts with CRS with or without NE, 67 (62.6%) received tocilizumab, 26 (24.3%) received both tocilizumab and corticosteroids, and 19 (17.8%) received intensive care. Only 5 pts (4.7%) required dialysis or intubation, all of whom had Gr ≥3 events. Management costs for CRS with or without NE were largely driven by hospitalizations (Table). Median costs ranges were $18,497-$23,285 for Gr ≤2 CRS, $33,183 for Gr ≤2 CRS with NE, and $60,588-$121,535 for Gr ≥3 CRS with or without NE. Overall median costs for Gr ≤2 vs Gr ≥3 CRS with or without NE were $21,693 vs $99,894. Conclusions: In KarMMa, CRS or NE events were primarily Gr ≤2. An increase in HRU and management costs were associated with more severe CRS or NE with a sharp increase in Gr ≤2 vs Gr ≥3. Clinical trial information: NCT03361748 . [Table: see text]
Prevalence of financial and health insurance literacy and their association with financial hardship in cancer patients.
Authors: Khera Nandita , Zhang Nan , Warsame Rahma M. , Hilal Talal , Padman Rema , Shah Nilay , Griffin Joan M.
Published: October 2020

70

Background: The prevalence of health insurance literacy (HIL) and financial literacy (FL) in cancer patients is not well described. Further, a better understanding of the association between these constructs and the domains of financial hardship (FH) can guide potential interventions. Methods: We examined the prevalence of HIL and FL and FH in cancer patients on active treatment at our institution. HIL and FL were assessed using Health Insurance Literacy Measure (HILM) and 5 questions from the National Financial Capability Study respectively. COST FACIT and National Health Interview Survey (NHIS) questions were used to examine overall FH and its 3 domains (material, behavioral and psychological hardship). Pearson correlation coefficient was used to describe the relation between the COST score and FH domains assessed by NHIS questions. Logistic regression analysis was performed to determine the associations of overall FH (measured by COST FACIT) with FL and HIL. Results: Among 256 patients approached, 202 completed questionnaires. Median age was 67 (range 22 to 91) years. 51% were male, 93% Whites and 5% were Hispanic. 69% had a solid tumor with 37% stage IV. Median number of lines of treatment was 4 (range 1 to 18). 21% were currently employed, 59% had ≥college degree, 41% had private insurance and 42% had monthly income≥$7000. 50% participants answered at least 4/5 FL questions correctly, indicating high FL. Being male, White, having insurance, higher education and income ≥$7000 were associated with higher FL. 72% of participants had high HIL, and they were more likely to be Non-Hispanic, married and have received more lines of treatment. FL significantly correlated with HIL (r = 0.29, p < .001). 65% patients endorsed FH based on NHIS questions (10% behavioral, 20% material, and 62% psychological hardship). 48% patients had FH based on a COST score < 28 (Median score), which correlated with material (r = -0.59, p < .001), psychological (r = -0.55, p < .001) and behavioral FH (r = -0.42, p < .001). The association between FH and HIL was not significant (OR 0.78; p = 0.08), though higher FL was associated with lower FH (OR 0.69; p = 0.02). Conclusions: Despite high FL and HIL (as compared to national standards), the prevalence of FH in our relatively affluent patient cohort was high, driven mainly by psychological hardship. We did not find strong association between the HIL and FH unlike in the reported literature. Our findings behoove us to develop tailored interventions to address unique domains of the FH in a diverse population.
Healthcare resource utilization and total cost of care in older patients with acute myeloid leukemia ineligible for intensive chemotherapy.
Authors: LeBlanc Thomas William , Seetasith Arpamas , Choi Michelle E , Surinach Andy , To Tu My , Montez Melissa , Ma Esprit
Published: October 2020

72

Background: Limited data are available on the economic burden of care for older patients with AML ineligible for intensive chemotherapy. This study aimed to evaluate healthcare resource utilization (HRU) and total cost of care (TCC) in this population. Methods: A retrospective observational study of Surveillance, Epidemiology, and End Results data (Jan 1, 2010 – Dec 31, 2015) linked to Medicare claims (up to Dec 31, 2017). Patients were ≥ 60 years old; newly diagnosed with AML; had ≥ 12 months of continuous Part A and B coverage before diagnosis; and initiated treatment on a hypomethylating agent: azacytidine (AZA) or decitabine (DEC) ≤ 90 days after diagnosis, or best supportive care (BSC). HRU (hospitalization, monitoring, transfusions, office visits, emergency department [ED] visits) and TCC reported in per patient per month (PPPM) were evaluated. Results: Among 3,905 patients identified, 877 (22%) received AZA, 899 (23%) received DEC, 2,129 (55%) received BSC. At a mean follow-up of 4.1 month (mo), mean TCC in BSC was $22,479.48 PPPM (standard deviation [SD]: $20,183.72). Hospitalization was the main cost driver (83.7% of TCC) in BSC, followed by Part B services and transfusions. At a mean follow-up of 11.9 vs. 13.0 mo, and mean treatment duration both at 5.4 mo, the mean TCC was $15,805.76 PPPM (SD: $19,368.16) in AZA vs. $20,518.71 PPPM (SD: $23,400.68) in DEC. All HRU decreased after AZA or DEC treatment initiation, except an increase in hospitalizations after treatment discontinuation (Table). During treatment on AZA and DEC, the main cost driver was hospitalization (60.7% vs. 60.9%) followed by drug costs and transfusions. After treatment discontinuation, hospitalization remained the main cost driver (77.2% vs. 78.9%) followed by transfusions and Part B services. Conclusions: This study quantifies the sizeable TCC in older patients with AML ineligible for intensive chemotherapy with hospitalization as the primary cost driver. Novel treatments that reduce hospitalizations, transfusions, and Part B services could lower the burden to the overall healthcare system. [Table: see text]
Cost-health literacy training in fellowship: A QI initiative.
Authors: Fischer Katrina , Anand Sidharth , Walling Anne M. , Larson Sarah Marie , Glaspy John
Published: October 2020

80

Background: Limited cost-health literacy is a significant factor in the physicians ability to discuss and navigate patient financial concerns. Because these skills are not formally taught during training, the cost-health literacy of graduate medical trainees is unknown. This study describes a QI initiative to measure and improve upon the cost-health literacy skills of oncology fellows as it pertains to objective knowledge and self-perceived cost communication practices. Methods: All oncology fellows (n = 19) at the University of California, Los Angeles were invited to participate in QI project during the fall of 2019. Fellows participated in a case-based curriculum over three months, consisting of a group didactic on financial toxicity (45 minutes) and an interactive case based learning scenario that highlighted financial toxicity risk factors and areas for intervention (30 minutes). We concluded with a group discussion (30 minutes) to review and consolidate strategies, identfying internal and external resources that enable physicians to navigate financial toxicity in direct patient care. A cost-health literacy survey was administered at baseline and at the conclusion of the curriculum to evaluate the impact of the program. Results: Of 19 participants, 17 participated and 16 completed both the pre and post survey. These 16 were included in the analysis. After the intervention, participants were more likely to report comfort discussing out of pocket costs (50% v 19%, p = 0.005) and to feel they could help a patient experiencing financial toxicity (62% v 6%, p = 0.005). Fellows were more likely to report awareness of resources that were available to them to help patients manage financial toxicity (69% v 19%, p 0.003) but were no more likely to report asking patients about their subjective distress due to treatment related costs (57% v 50%, p = 0.759). Conclusions: We can teach and improve upon cost-health literacy skills through participation in a targeted, brief curriculum. Further studies are warranted to determine how this approach can be applied in other settings and how it objectively impacts cost communication practices.
Comparison of perspectives and practices to mitigate financial toxicity between advance practice providers and attending oncologists.
Authors: Ragavan Meera Vimala , Parikh Divya Ahuja , Patel Manali I.
Published: October 2020

82

Background: Characterizing the oncology provider’s role in addressing the growing epidemic of financial toxicity faced by cancer patients is of increasing importance. Advance practice providers (APPs) increasingly serve as primary providers for many cancer patients, but no studies to date have examined their perspectives and practices in addressing financial toxicity, nor compared them to that of attending physicians. Methods: We developed an 18-question electronic, anonymous survey informed by an extensive literature search regarding perspectives on the provider’s role and current practices in addressing financial toxicity. We emailed the survey to 75 attending physicians and 117 APPs at our institution’s cancer center. Responses during the study period 12/12/2018-1/31/2019 were analyzed. Results: 32 attending physicians and 28 APPs completed the survey. Response rates were higher among attending physicians (42%) compared to APPs (24%). Attending physicians were more likely than APPs to agree that providers should openly discuss cost (75% vs. 36%, p = 0.002). APPs were more likely to agree that providers should defer cost conversations to a third party (57% vs. 31%, p = 0.04) and make the same treatment recommendation regardless of cost (50% vs. 25%, p = 0.022). Use of cost-effectiveness (CE) guidelines was higher among APPs compared to attending physicians (71% vs. 31%, p = 0.0019). Awareness of out of pocket costs, frequency of referrals to financial counselors, and ranking of top barriers to cost conversations (price transparency, knowledge of resources, and time) were similar between attending physicians and APPs. Conclusions: While APPs and attending physicians differed considerably in their perspectives on the role oncology providers should take in mitigating financial toxicity, they were more consistent in current practices and identification of barriers to cost conversations. APPs were interestingly more likely to use CE guidelines than attending physicians. Higher response rates among attending physicians may reflect inherently stronger opinions regarding the provider’s role in addressing financial toxicity. Future studies should explore these differences to better inform provider-level interventions to reduce financial toxicity.
Utilization of a multisite financial reimbursement program to promote racial/ethnic diversity and inclusion in therapeutic cancer clinical trials: The iMPACT Study.
Authors: Borno Hala , Zhang Sylvia , Nieves Elena , Dornsife Dana , Johnson Robert G. , Spicer Darcy V.
Published: October 2020

85

Background: A lack of racial/ethnic diversity among cancer therapeutic clinical trial (TCT) participants remains a critical problem. The significance of costs, both direct and indirect, associated with cancer TCT participation are increasingly understood. Here, we report findings observed in the IMproving Patient Access to Cancer clinical Trials (IMPACT) study, a pilot feasibility study investigating the feasibility and efficacy of offering a financial reimbursement program (FRP) during cancer TCT discussion with or without additional outreach in improving enrollment and diversity. Methods: Participants for this study were recruited at two Comprehensive Cancer Centers (CCCs) from April to September 2019. Patients were randomized 1:1 to receive a brochure about a FRP at time of consent for a TCT or receive brochure and outreach through a scripted follow-up phone call regarding the FRP. Results: No difference in TCT enrollment was observed between study arms. Among 170 patients approached to participate, 132 (78%) provided consent. The participant mean age was 57 years old (std dev = 14 years). Among participants 57% were male and 49% were white. The remaining major racial/ethnic groups were Black (5%) Asian (13%) and Hispanic (26%). The proportion of non-whites was greater among IMPACT study (43%) compared to CCC TCT (28%) participants. Among FRP participants, 24% reported a household income < $25,000 and 14% from $25,001 to $56,000. Conclusions: This study observed that offering an FRP as part of TCT discussion is feasible and effective at CCCs. An outreach phone call is not required in order to influence enrollment in TCT. FRP recipients are racially/ethnically diverse and low socioeconomic status.
Feasibility of and associated cost savings from transitioning to therapeutic biosimilar use in a large community oncology network.
Authors: Young Garrett , McGee Kathy , Owens Leah , McCullough Stacey , Arrowsmith Edward , Poole Stacey L , Marsden Mary Catherine , Lyss Aaron J. , Schleicher Stephen Matthew , Richey Sylvia S. , Dickson Natalie R. , Schwartzberg Lee S.
Published: October 2020

9

Background: The use of biosimilar drugs in the treatment of cancer offer an opportunity for oncology providers to decrease total cost of care while preserving quality. However, it remains unclear whether providers and patients may resist biosimilar use due to concerns over safety and efficacy. Our national network of 5 practices with over 100 clinics committed to a conversion to therapeutic biosimilars for trastuzumab and bevacizumab after their introduction in July 2019. Methods: Common steps to foster therapeutic biosimilar conversion included frequent communication from medical directors to providers and staff, incorporation of biosimilars into default treatment regimen orders, providing clinical teams lists identifying candidates for conversion, and tracking reasons why biosimilar switch did not occur. Most practices prioritized converting patients initiating new treatments, then later transitioning patients receiving maintenance therapy. This phased approach was taken to ensure that prior authorization and patient consent could be obtained prior to conversion. Rates of biosimilar use were calculated by comparing the number of administrations for which a biosimilar was given to the total number of administrations for which a biosimilar could have been given. Cost savings were calculated by comparing the difference in Medicare allowed rates for each originator and biosimilar drug pair at the time of administration. Results: Biosimilar use increased over time at all practices, from 0% to an average of 67% for trastuzumab and 78% for bevacizumab. The decrease in cost attributed to the use of biosimilars in the study period totaled over $4.4 million. Challenges to biosimilar use included physician preference for the originator drug, difference in preferred agents across payers, and challenges with biosimilar drug storage. Patients rarely had concerns over efficacy and safety. Conclusions: Therapeutic biosimilar adoption in a large oncology network is feasible and can lead to significant cost savings. [Table: see text]
“When offered to participate”: A systematic review and meta-analysis of patient agreement to participate in cancer clinical trials.
Authors: Unger Joseph M. , Hershman Dawn L. , Till Cathee , Minasian Lori M. , Osarogiagbon Raymond U , Fleury Mark , Vaidya Riha
Published: October 2020

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Background: Patient participation in clinical trials (CTs) is vital for knowledge advancement and outcomes improvement. The rate of CT participation for adult cancer patients is between 5%-8%; many CTs fail due to poor accrual. Although patient decision-making is a common focus of studies examining barriers to CT participation, the rate of trial participation for patients actually offered a CT is unknown. Methods: We conducted a systematic review and meta-analysis using PubMed, Web of Science, and Ovid Medline search engines to identify studies over 20 years (1/1/2000-1/1/2020) that examined CT participation. Studies must have been conducted in the United States and specified the number of patients offered a CT and the number enrolled. We conducted a meta-analysis of single proportions using random effects. Rates were examined for both treatment trials and cancer control (CC) studies. We also compared the rates of enrollment between Black, Hispanic, and Asian patients versus White patients. Clinical care setting (academic vs community) was examined as a potential moderator. Results: We screened 3,241 unique citations and identified 35 (30 treatment and 5 CC) studies among which n = 9,759 patients were offered CT participation. Overall, 55.0% (95% CI: 49.4%-60.5%) of patients offered a CT agreed to enroll. Trial participation rates did not differ between treatment (55.0%, 95% CI: 48.9%-60.9%) and CC trials (55.3%, 95% CI: 38.9%-71.1%, p = .98); however, participation rates were significantly higher at academic centers (58.4%, 95% CI: 52.2%-64.5%) versus community centers (45.0%, 95% CI: 34.5%-55.7%, p = .04). In common studies, Black patients agreed to participate at similar rates (58.4%, 95% CI: 46.8%-69.7%) compared to White patients (55.1%, 95% CI: 44.3%-65.6%, p = .88). Results were also similar comparing White versus Hispanic or Asian patients. The main reasons for non-participation were treatment choice or lack of interest. Conclusions: More than half of all cancer patients who are offered CTs do participate; results were consistent between major race/ethnicity groups. This finding upends several conventional beliefs about cancer clinical trial participation, including that Black patients are less likely to agree to participate and that patient decision-making is the primary barrier to participation. Policies and interventions to improve CT participation should focus more on modifiable systemic structural and clinical barriers, such as improving access to existing trials and broadening trial eligibility.
Access to palliative care services for limited English proficient patients with advanced NSCLC.
Authors: Leung Bonnie , Wong Selina , Malli Kiran , Ho Cheryl
Published: October 2020

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Background: More than a quarter of people living in British Columbia, Canada speak languages other than English in their homes. Immigrants often encounter communication challenges with their health care providers (HCPs), have poor health literacy, and have a limited understanding on navigating the health care system. NSCLC patients with limited English proficiency (LEP) may receive less palliative care services despite high symptom burden and significant needs due to these factors. The study goals were to observe the difference in access to community palliative home care (CPHC) and rate of completing a Do Not Resuscitate (DNR) form between NSCLC patients who are English proficient (EP) and LEP. Methods: All patients with advanced NSCLC referred to BC Cancer–Vancouver Centre in 2016 and received medical care were included (N=176). Patients seen with a medical interpreter were considered to be LEP. Demographics and clinical information were collected retrospectively. UVA using X2 test and Fisher’s exact test were used to compare EP and LEP patients. Mann-Whitney test was used to compare the median time from CPHC referral and signed DNR to death between EP and LEP patients. Results: Language of communication: English 65%, Cantonese 22%, Mandarin 6%, Korean 1%, Tagalog 1%, and other 5%. Baseline characteristics: median age 69 EP vs 76 LEP, female 44% EP vs 65% LEP, non-squamous 68% EP vs 72% LEP and squamous 14% EP vs 6% LEP. There was no difference in the rate of CPHC referral (87% EP vs 80% LEP, p=0.342) and signed DNR form (92% EP vs 89% LEP, p=0.549). The median time from CPHC referral to death was 10 weeks EP vs 15 weeks LEP (p=0.039). The median time from signed DNR to death was 5 weeks EP vs 6 weeks LEP (p=0.806). There was no statistically significant difference in location of death between the two groups: acute care 20% EP vs 24% LEP, home 27% EP vs 13% LEP, hospice 36% EP vs 39% LEP, and tertiary palliative care unit 17% EP vs 24% LEP (p=0.251). Conclusions: EP and LEP patients with NSCLC had similar rates of CPHC service referrals and end of life planning. This suggests assistance of medical interpreters at the time of oncology visits help message delivery between LEP patients and HCPs. LEP patients had earlier referrals to CPHC prior to death which may reflect an enhanced awareness and effort by HCPs to have earlier conversations with patients who may have language and cultural barriers with discussing goals of care. Good communication improves patients and their family’s understanding of the goals and scope of palliative care services and allow HCPs to better understand the patients’ wishes.
Everybody’s a Critic
Authors: Foster Hal
Published: October 2020

How did critique become a bad object when, only a few decades ago, it seemed to be the cutting edge of cultural practice? This essay notes some of the recent vicissitudes of the critical enterprise, including the charges that it is destructive, cynical, or simply rote. Rather than a dismissive line, “everybody’s a critic” might suggest the arrival of a truly demotic criticism.
Boundless Mystification
Authors: Tally Robert T.
Published: October 2020

In Marxist literary criticism—for example, as represented by Fredric Jame-son’s influential study, The Political Unconscious—the interpretation of texts has frequently involved ideology critique, by which the critic attempts to disclose both the ideological content or structural limitations of a given text while also being attuned to the text’s utopian or revolutionary potential. In recent decades, Marxist criticism in particular and what is taken to be the hermeneutics of suspicion more generally have come under attack by literary scholars who favor various forms of postcritique, including surface reading and thin description. This essay suggests that postcritique, and all that it involves, contributes to the radical dismantling of higher education caused by rampant neoliberalism. The vocation of ideology critique and of Marxist criticism is, this essay contends, the most appropriate response to a society so utterly mystified as our own.
Ras, PI3K and mTORC2 – three's a crowd?
Authors: Smith Stephen F. , Collins Shannon E. , Charest Pascale G.
Published: October 2020

The Ras oncogene is notoriously difficult to target with specific therapeutics. Consequently, there is interest to better understand the Ras signaling pathways to identify potential targetable effectors. Recently, the mechanistic target of rapamycin complex 2 (mTORC2) was identified as an evolutionarily conserved Ras effector. mTORC2 regulates essential cellular processes, including metabolism, survival, growth, proliferation and migration. Moreover, increasing evidence implicate mTORC2 in oncogenesis. Little is known about the regulation of mTORC2 activity, but proposed mechanisms include a role for phosphatidylinositol (3,4,5)-trisphosphate – which is produced by class I phosphatidylinositol 3-kinases (PI3Ks), well-characterized Ras effectors. Therefore, the relationship between Ras, PI3K and mTORC2, in both normal physiology and cancer is unclear; moreover, seemingly conflicting observations have been reported. Here, we review the evidence on potential links between Ras, PI3K and mTORC2. Interestingly, data suggest that Ras and PI3K are both direct regulators of mTORC2 but that they act on distinct pools of mTORC2: Ras activates mTORC2 at the plasma membrane, whereas PI3K activates mTORC2 at intracellular compartments. Consequently, we propose a model to explain how Ras and PI3K can differentially regulate mTORC2, and highlight the diversity in the mechanisms of mTORC2 regulation, which appear to be determined by the stimulus, cell type, and the molecularly and spatially distinct mTORC2 pools.
Construction of Structure-Controlled Perovskite Ultra-Thin Layers on Au(100) Single-Crystal Surface via Self-Assembled Monolayer of 4-Aminothiophenol
Authors: Takahari Mami , Kondo Toshihiro
Published: October 2020

In order to control a crystal configuration of MAPbBr3 (MA = CH3NH3+) perovskite ultra-thin layers, the Au(100) single-crystal, the self-assembled monolayer (SAM) of 4-aminothiophenol (4-ATP), and the layer-by-layer alternating immersion were employed as a substrate, a linker between the perovskite thin layer and gold substrate, and a preparation method, respectively. Structure and crystal configuration of the constructed MAPbBr3 perovskite ultra-thin layers on 4-ATP SAM modified Au(100) were investigated by X-ray photoelectron spectroscopy (XPS), scanning tunneling microscopy (STM), and grazing incidence surface X-ray diffraction (GISXRD). As a result, we succeeded to construct the structure-controlled MAPbBr3 perovskite ultra-thin layers on the 4-ATP SAM modified Au(100) surface with an atomic dimension.