bluuebunny/crossref_metadata_2025 huggingface dataset:
Prognostic testing and treatment patterns in Black patients (pts) with chronic lymphocytic leukemia (CLL) from the informCLL prospective, observational registry.
Authors: Barrientos Jacqueline Claudia , Mato Anthony , Sharman Jeff Porter , Brander Danielle M. , Gutierrez Meghan E. , Wu Linda , Panjabi Sumeet , Young Alex , Upasani Sandhya , Naganuma Maoko , Ghosh Nilanjan
Published: June 2022

e18559

Background: Real-world data on practice patterns in Black pts with CLL are limited. We evaluated treatment (tx) patterns and prognostic biomarker testing in Black pts enrolled in the informCLL registry. Methods: Pts who initiated FDA-approved tx for CLL/SLL (index tx) were enrolled from October 2015 to June 2019. Baseline (BL) characteristics, FISH testing rates, BL factors associated with FISH testing, and patterns of index tx are summarized by line of therapy (LOT; previously untreated [1L] and relapsed/refractory [R/R]). Results: Of 1462 enrolled pts (overall registry population), 106 (7%) were Black (Table). Community-based practices enrolled 87% of Black pts, similar to the overall population (93%). Black pts were predominantly enrolled in the South (69%). Among Black pts, median age was 66 y, 65% had ECOG status ≥1, 64% had Rai stage III-IV, and median time from diagnosis to tx on registry was 40 mo (7 mo for 1L). In the overall population, median age was 71 y, 53% had ECOG status ≥1, 51% had Rai stage III-IV, and median time from diagnosis to tx was 41 mo (19 mo for 1L). FISH testing was performed in 25% of Black pts, similar to the testing rate in the overall population (28%). In a multivariate analysis, BL factors significantly associated with FISH testing were shorter time from initial diagnosis to tx, better ECOG status, earlier LOT (1L), community practice setting, and prior malignancy (p<0.05 for all); race was not a predictive factor. As in the overall population, ibrutinib was the most frequent tx among Black pts in 1L (50%) and R/R (67%), followed by chemoimmunotherapy (CIT; 1L, 43%; R/R, 15%). In 1L pts, tx with ibrutinib generally increased over time (2016, 31%; 2017, 57%; 2018, 63%; 2019, 55%) while CIT use persisted (56%; 36%; 38%; 36%, respectively). In R/R pts, use of ibrutinib decreased over time while CIT remained consistent and tx with other novel agents increased. Conclusions: Black pts with CLL tended to be younger, with worse ECOG status, more advanced disease, and shorter time to 1L therapy than the overall informCLL registry population. While ibrutinib was the most common tx in Black pts, CIT use in 1L remained persistent. Similar to the overall registry population, prognostic testing rates were suboptimal in Black pts. These results highlight the importance of prognostic testing and the need to more closely monitor disease status in Black pts as they will tend to require initial CLL therapy more rapidly than other pts. Clinical trial information: NCT02582879. [Table: see text]
Tackling healthcare inequities through a social media-based platform to connect solid tumor patients with COVID-19 to clinical trials.
Authors: Leyfman Yan , Sandeep Samarth , McGregor Kirk , Rizk Peter , Khoury Carlo , Park Chandler H.
Published: June 2022

e18560

Background: COVID-19 has contributed to healthcare inequity amongst minorities and lower socioeconomic populations, while complicating present anti-cancer treatment regimens. Due to their immunocompromised status, cancer patients are at an increased risk of severe SARS-CoV-2 infection. While sentiment analysis via SM has seen vast growth among healthcare professional, deeper connection and management has been lacking. Given the higher usage of SM impressions and the increase in healthcare disparities especially at the intersection of oncology and COVID-19, the aim of this study was to develop a platform that can: (1) show that the relationships highlighted within these tweets can be realized in biomolecular interactions—specifically within the interaction between solid tumors and COVID-19; (2) use SM data to connect patients with clinical trials. Methods: To determine this relationship, ontologies, which are groupings of terms and related identifiers, such as genes, were created for general search terms, utilizing the Human Phenotype Ontology. They were then combined with “COVID-19” and used as search terms in Twitter’s Standard Search tool. The keywords with the most matches were then queried through clinicaltrials.gov and European Bioinformatics Institute’s (EBI) Protein Search Tool to find relevant clinical trials and proteins. Finally, the proteins found by the EBI protein search were run through the SwissModel Tool to find relevant protein structures before being used in binding using Polar+’s Binding Platform from Iff Technologies, which provides K values related to 50% inhibition for each medication or immunotherapy. This produced a set of disease-specific keywords that are related to top tweets, clinical trials, protein structures, and binding concentration values in relevant biomolecular pathways for the keyword set “Tumor COVID-19”. Results: The example shown in Table is produced via our platform, with keywords with tweet numbers greater than 95% of all tweets with connected keywords used. Conclusions: By utilizing SM with highly relevant keywords, this platform can combat healthcare inequity by connecting patients and their tweets to clinical trials and enhance literacy about their medical conditions, while providing a greater understanding of the biomolecular pathways involved.[Table: see text]
Measuring the long commute: Experiences of a multi-ethnic cohort of patients enrolled in a financial reimbursement program for cancer clinical trials.
Authors: Medina Sheyla P , Zhang Sylvia , Nieves Elena , Dornsife Dana , Johnson Robert G. , Spicer Darcy V. , Borno Hala
Published: June 2022

e18568

Background: Financial reimbursement programs (FRP) aim to address patients’ out-of-pocket expenses associated with clinical trial participation. The study aims to explore patients’ experience in therapeutic clinical trials (TCT) after enrollment in FRP at two academic medical centers in California and identify barriers and opportunities to improve TCT participation. Methods: From May 2019 to January 2020, adult patients with a diagnosis of cancer and eligible for a TCT were recruited from oncology clinics. Eligible participants for the FRP had a household income ≤ 700% of the current HHS Poverty Guidelines. Semi-structured interviews were conducted in patients’ preferred language. Qualitative analysis was performed comparing experiences by site and by preferred language. An iterative process of coding was used to identify themes on interview transcripts. Results: 53 patients were interviewed (20, UCSF; 33, USC). Median age was 59 (IQR 46 - 65) and 59% were female. Nearly half (49%) identified as Latinx/Hispanic compared to 32% Non-Hispanic White, 10% Asian, 4% Black, 1% Native American, and 4% Other. A third were non-English speakers (68% English, 26% Spanish, 6% Korean/Other), 42% had a college education or more, and 55% were retired/unemployed. The majority of patients (66%) had metastatic disease. Patients described their commute to the TCT sites which involved complex logistics and commute time ranging from one hour to 4.5 hours as well as numerous out-of-pocket costs. Prominent barriers to TCT participation included financial toxicity, fears of the process itself or the low likelihood of cure, and systemic factors affecting enrollment. Despite these barriers, most patients would participate in a TCT regardless of financial hardship. Patients proposed modifications to TCTs including decentralization, recruitment strategies, education and peer counseling as well as vouchers and established rates for out-of-pocket expenses. While English-speaking patients were varied on willingness to discuss financial concerns with their doctors, the majority of non-English speakers reported that they would speak with their physician about financial concerns associated with treatment. Conclusions: Patients’ experiences with TCTs demonstrate a combination of financial and logistical stressors that may be lessened by financial reimbursement programs. FRPs have the potential to address inequities in clinical trial access among vulnerable populations.
Factors influencing the initiation of adjuvant endocrine therapy in patients with Estrogen receptor-positive ductal carcinoma in situ: A single institution experience.
Authors: Farag Fady , Levy Julia , Cole John T.
Published: June 2022

e18569

Background: Ductal carcinoma in situ (DCIS) is a non-obligate precursor to invasive ductal breast cancers. The aim of treatment in DCIS is to prevent local recurrence as almost half of recurrences can be invasive. Few studies have specifically addressed how provider recommendation and patient’s demographic factors contribute to medication initiation in women with DCIS. The objective of this study is to evaluate whether disparities exist pertaining to prescription of adjuvant hormonal therapies. Methods: This single-center retrospective study included 111 patients diagnosed with DCIS between 2020 and 2021. Data collected included race, type of insurance, prescribing providers, and socioeconomic status. We used zip codes to identify the poverty levels in these areas as published in the United States Census Bureau and stratified the patients into quartiles accordingly. Chi-Square statistics were used to calculate significance levels. Results: The average age was 62.8. 63 (56.8%) patients received adjuvant hormonal therapy, and 48 (43.2%) did not. White patients comprised 53.1% of the population, while African Americans were 45%. Among the white patients, 52.5% took hormonal therapy, while 62% of African Americans received hormonal treatment. Majority had Medicare insurance (49.5%), or a commercial insurance (42.3%). 62% of Medicare patients received hormonal therapy and 52.5% of commercial insurance users received adjuvant treatment. 34% lived in areas with the percentage below poverty line greater than 21.9%, 27% lived in areas with the percentage below poverty line between 16.4-21.9%, 38.7% % lived in areas with the percentage below poverty line between 10.6% and 16.4%, and 9% lived in areas with the percentage below poverty line was less than 10.6%. Providers were grouped into either breast oncologist or general oncologists. Breast oncologists prescribed hormonal treatment to 56.8% of their patients, and general oncologists to 56.7% of their patients. There was no statistical significant correlation between the intake of hormonal therapy and race (P = 0.6), insurance (P = 0.5), socioeconomic (P = 0.58) or providers (P = 0.99). Conclusions: In this single-center study, we didn’t find that patients’ demographics or providers influenced the decision to initiate adjuvant hormonal therapy in DCIS.
Using a standard implementation science framework to improve clinical trial enrollment for a community Tennessee oncology center.
Authors: Jain Neha M , Lammers Philip Edward , Savona Michael R. , Osterman Travis John , Goorha Salil
Published: June 2022

e18586

Background: Recommendations for clinical trial consideration are ubiquitous across all cancers. However, it is challenging to identify patients from underrepresented communities and offer them opportunities to enroll in clinical trials due to a multitude of reasons including social determinants of care, distance from clinical resources, lack of resources, etc. As part of the Leukemia & Lymphoma Society (LLS) Influential Medicine Providing Access to Clinical Trials (IMPACT) study, Vanderbilt-Ingram Cancer Center (Nashville, TN) partnered with Baptist Cancer Center (BCC, Memphis, TN) to improve accrual of trials for patients with Hodgkins lymphoma. BCC has an active NCI Community Oncology Research Program (NCORP) grant with 12 affiliated sites spread across Arkansas, Tennessee, and Mississippi and provides care for underrepresented minority, and underserved communities. Methods: We chose the Consolidated Framework for Implementation Research (CFIR), as a conceptual model to guide assessment of the existing process and inherent opportunities. We created a secure REDCap survey to identify timepoints in the existing clinician workflow and research sites that provide the best opportunities to discuss clinical trials with the patient. Retrospective data was collected for 67 patients diagnosed with Hodgkins lymphoma, who received care at six sites affiliated with BCC. A manual chart review was performed to extract data from the electronic medical record. Results: We observed that 73% of the patients from 2 sites already had an established diagnosis of Hodgkins lymphoma at the time of referral to the medical oncologist. By contrast, only 33% of patients from the remaining 4 sites had an established diagnosis at the time of referral. In these cases, the diagnosis was established after pathological testing ordered by the oncologist was performed. Conclusions: Using our analysis, we identified 2 sites from a large healthcare network that would benefit greatest from implementing pre-screening for clinical trials before the first visit with a medical oncologist. Further, we determined that efforts/resources for trial screening at the remaining 4 sites would be best served after pathological evidence of disease was established. Clinical trial enrolment is a multi-step process and needs substantial human and financial resources. Implementation science interventions can help to guide judicious use of resources while improving patient care in rural and underserved communities.[Table: see text]
Disparities in pegasparagase-induced toxicity in Hispanic patients with acute lymphoblastic leukemia.
Authors: Boulter Alexis Chen , Sovich Justin Lin , Kainthla Radhika , Sadeghi Navid , Jones Amy Little
Published: June 2022

e18590

Background: Hispanic individuals experience the highest incidence of acute lymphoblastic leukemia of any racial or ethnic group in the United States. While Hispanic individuals are known to have disproportionately increased mortality and higher therapy-related toxicity rates in ALL, there is a paucity of data regarding ethnic differences in rates of toxicity related to pegasparagase, a backbone of ALL treatment regimens. In our safety-net hospital system, we sought to evaluate disparities in rates of pegasparagase-induced hepatotoxicity between Hispanic and non-Hispanic patients. Methods: Pegasparagase infusions administered in adult ALL patients from 2011-2020 at Parkland Memorial Hospital in Dallas, Texas, were identified using the electronic medical record. Retrospective review of demographic, clinical, and socioeconomic data was conducted. For each infusion, dosing, timing, transaminase trends, and toxicity data were gathered. Statistical analysis was completed with Excel Analysis ToolPak and R Statistical Software. Accounting for baseline characteristics (age, BMI, sex, metabolic comorbidities, and baseline hepatic function), multiple linear regression models were constructed for peak transaminase and bilirubin levels. ANOVA testing, adjusted R2 values, and AIC were utilized to compare the contribution of race, ethnicity, and socioeconomic variables to modeling. Results: 47 individual patients received pegasparagase during the study period with 196 infusions evaluated. The mean age was 30 years, 29% were female and 73.4% white Hispanic. There were 64 grade 3-4 pegasparagase-related toxicities (54 hepatotoxicity, 4 pancreatitis, 6 thrombosis). 83.3% of grade 3-4 hepatotoxicity events were in Hispanic patients, and 16.7% in non-Hispanics. The median time from infusion to grade 3-4 toxicity was 18 days. Hispanic ethnicity was significantly associated with severe hepatoxicity (P = 0.0004). An interaction was identified with insurance status and primary language which significantly strengthened the impact of ethnicity and race on hepatotoxicity severity (P = 0.005, P = 0.02). Conclusions: In our safety-net population, Hispanic ethnicity was associated with significantly higher grades of hepatotoxicity when compared to non-Hispanic patients. Uninsured status and primary Spanish language use were not only independently associated with increased toxicity but also strengthened the effect of Hispanic ethnicity on the severity of liver dysfunction related to pegasparagase. These findings propose that Hispanic patients may benefit from closer monitoring during treatment with pegasparagase-containing regimens and highlight the need for further studies to improve risk-stratification of Hispanic patients when selecting ALL therapy.
Utilization and financial coverage of blood based next generation sequencing for solid tumors: A study from Augusta-Georgia.
Authors: Lampkin Erica , Karki Nabin Raj , Matosz Sabrina , Casey Mycal , Leurinda Christian , Abdel Karim Nagla Fawzy
Published: June 2022

e18592

Background: There is an increasing trend of integrating molecular profiling to devise treatment plans for solid malignancies. Tumor testing for specific clonal abnormalities is being supplanted by broad multigene panel testing from blood specimen, aptly labelled liquid biopsy. Due to varying utility across malignancies in differing contexts and issues of access and affordability, their adoption is not uniform. We attempt to characterize the pattern of utilization across tumor types and financial coverage schemes in an academic cancer institute in southeastern United States. Methods: All blood based next generation testing samples ordered by providers affiliated to Georgia Cancer center between January 1, 2017, and December 31, 2021, via Guardant platform for all solid tumors was included in this analysis. Guardant360 and Guardant360CDx assays tested for upto 83 cancer related genes in circulating cell-free DNA in patients of solid tumors. Primary cancer diagnosis, insurance information and turnaround time was obtained from Guardant. Results: 296 tests were sent from January 1, 2017, through December 31, 2021. The total number of tests performed in year 2017, 2018, 2019, 2020 and 2021 were 1, 3, 28, 99 and 165 respectively. Billing information was available for all cases, clinical information was available for 262 cases. Average turnaround time was 8.5 days overall. 221 Guardant360 was sent with average turnaround time of 10 days. 41 Guardant360CDx was sent with average turnaround time of 7 days. The frequency of malignancies in the order of dimensioning frequency were lung 50.7%, prostate 12.1%, breast 6.9%, kidney 3.8% and colorectal 3.4%. The remaining 22.1% comprised of pancreatic, melanoma, glioblastoma, and bladder malignancies. The test was covered by private insurance/employee health plan in 53.4% (158/296), Medicare in 31.1% (92/296) and Medicaid in 10.5% (31/296) (table). 4.7% (14/296) qualified for free of charge testing (financial indigent) and 0.3% (1/296) were self-pay (table). Conclusions: There is an increase in the utilization of liquid biopsy to perform comprehensive genomic analysis. The distribution of tumor types is not entirely explained by the incidence and availability of targeted therapies for each type. Private insurers accounted for most of the tests being done. The disparities in utilization of this platform across different tumor types and payment models deserve further exploration. T[Table: see text]
Enrollment disparities in non-Hodgkin lymphoma clinical trials.
Authors: Boisclair Stephanie , Sandoval-Sus Jose David , Kolitz Jonathan E. , Rhodes Joanna Meehan
Published: June 2022

e18594

Background: Disparities in cancer clinical trials limit the real-world reproducibility of their results while remaining inapplicable to excluded patients (pts) like those living with chronic viral infections. Non-Hodgkin lymphoma (NHL) has an incidence distributed heterogeneously among races and is associated with chronic viral infections such as HIV, Hepatitis B (Hep B) and Hepatitis C (Hep C). Given these epidemiological characteristics, we assessed demographic representation in NHL clinical trials to identify areas for improvement. Methods: Clinicaltrials.gov was queried for NHL trials and specified for completed, interventional, phase 2, 3 & 4 trials, with results and with recruitment in the US. Trials including malignancies other than NHL, with enrollment outside of the US or lacking reported demographics on clinicaltrials.gov or trial publications were excluded. SEER 21 and the 2020 US census were used to calculate incident cases for each specified subgroup. Enrollment fraction (EF) was defined as the number of trial enrollees divided by the estimated US cases in each subgroup. We compared EF between subgroups utilizing odds ratios (OR) with p-value < 0.05 deemed significant. Results: Of 176 trials meeting criteria, 64 (36.4%) reported ethnicity and 79 (44.9%) reported race. EF of Black, Asian/Pacific Islander, American Indian and Hispanic (HSP) pts were significantly lower compared to White and non-HSP pts (Table). Racial minorities were less likely to be enrolled in relapsed/refractory trials (OR 0.31 - 0.57 p < 0.008) compared to White pts but all were equally likely to be enrolled in front-line trials. HSP pts had a lower EF compared to non-HSP pts in both relapsed/refractory and front-line trials (OR 0.57, 0.46 p < 0.0001). Black and HSP pts were also less likely to be enrolled in hematopoietic stem cell transplant (HSCT) trials (OR 0.27, 0.74, p < 0.003). Women had a significantly lower EF compared to men (Table). 150 trials had inclusion/exclusion criteria specific for chronic viral infections: 141 (94%) excluded pts with HIV, 108 (72%) with chronic Hep B and 103 (69%) with Hep C. Conclusions: Our study demonstrates underrepresentation of not only women, but also of Black, Asian/Pacific Islanders, American Indian and HSP pts in NHL trials, especially in relapsing/refractory and HSCT trials. Moreover, pts living with chronic viral infections are systematically excluded by trial criteria. It is essential that trials reporting on safety, toxicity and efficacy represent the true patient population to limit ascertainment bias and improve external validity of results.[Table: see text]
Are we providing adequate information? patient-specific clinical trial information at NCI-designated cancer center websites.
Authors: Velazquez Manana Ana I. , Idossa Dame , Meza Kelly Jasmin , Rodriguez Vargas Juan J. , Duma Narjust
Published: June 2022

e18602

Background: Disparities persist in the recruitment and enrollment of diverse populations to cancer clinical trials (CT). Barriers to CT participation are numerous and include structural inequities that limit access, stringent eligibility criteria, financial barriers, provider bias, and patient knowledge. While national societies recommend patient educational materials should be written ≤6th grade reading level, most CT online information available is complex. We evaluated the accessibility, readability, and content of patient-specific CT information from NCI-designated cancer center websites (CCW). Methods: We conducted a qualitative review of CT information in 64 clinical NCI CCW. We reviewed each CCW’s patient-specific CT information to evaluate content, reading level, and navigation. Readability was evaluated using validated measures [i.e., Flesch-Kincaid Grade Level (FKGL), Gunning Fog Index (GFI), Coleman-Liau Index (CLI), and Simple Measure of Gobbledygook (SMOG) Grade Level] and an average readability score. Data was summarized using descriptive statistics. Results: Most CCW made CT information easily accessible, 62 had a CT-specific website of which 61% required only 1-click from the homepage and 5% required ≥3 clicks. Common patient-specific information included definition of CT (89%), CT phases (66%), guidance on how to decide if you should enroll in a CT (59%), risks and benefits of participation (53%), informed consent (48%), and financial considerations (30%). Only 16% of CCW contained CT information for patients with limited or no English proficiency (14% Spanish, 8% Chinese). CT educational content required a reading level of ≥10th grade (Table). 44% of websites included links to outside educational resources, such as the NCI. None of the websites included CT-specific supportive resources (i.e., transportation, navigation, financial assistance, etc.). Most CCW included a CT search bar (77%), yet when searching for a specific cancer type (i.e., breast cancer) 53% yielded a top search result that was disease agnostic or for a different cancer type. 72% included CT descriptions, 58% their eligibility criteria, and 29% included pre-screening forms or links to CT-specific inquiries. Conclusions: Most NCI designated CCW contain CT information at a high literacy level with suboptimal search options and very limited resources/information in other languages. Our findings highlight missed opportunities to develop and advertise CT-specific supportive services and to disseminate CT education materials that meet the literacy and language needs of the increasingly diverse US population.[Table: see text]
Successful biosimilar adoption in oncology: strategic approach to system standardization.
Authors: Limvorasak Suwicha , Dobbs Crystal Leung , Kim James , Posadas Edwin Melencio , Teaford Hilary , Diniz Marcio A. , Rogatko Andre , Vinson Bruce , Sakamoto Leanne , Patel Vipul , Figlin Robert A. , Shane Rita , Reckamp Karen L.
Published: June 2022

e18605

Background: In the United States, therapeutic substitution with oncologic biosimilars offer opportunities to reduce the rising costs of cancer care while improving access to safe and effective treatment. Current challenges include integration into clinical practice, state laws for biosimilar interchangeability and payer reimbursement policies. Methods: We developed an approach to standardize biosimilar utilization across our oncology enterprise by leveraging the electronic health record to integrate with clinical algorithm pathways and financial information. Institutionally preferred biosimilars drugs were selected through the oncology Pharmacy & Therapeutics committee as part of the formulary process. Physicians were permitted to opt-out of substitution within the electronic order sets. Patients were divided into two groups based as 1) main medical center 2) affiliated sites to assess feasibility of the enterprise-wide substitution, defined as an 80% compliance rate at the main medical center and a 75% compliance rate at the affiliates sites. This provided a minimum detectable difference of 5.7% and 8.9%, respectively using an exact one-sided Binomial test with 80% of power at 2.5% significance level with Sidak correction. Results: Between January and December 2021, a total of 811 cancer patients who initiated treatment with bevacizumab, rituximab or trastuzumab were identified, of whom 535 were eligible for this analysis (age 18-96; 61% female, 39% male). The overall substitution rate to biosimilars was 83% (76%-97%) compared to baseline of 55%, representing a 51% improvement. The conversion rate was higher at the main medical center compared to the affiliated sites (85% vs. 81%). Among 92 patients who did not have substitution to biosimilars, the most common reasons were off-label indication (35%), patient assistance program (17%), payer preferred alternative brand (15%) and clinician preferred reference brand (12%). Four patients (< 1%) were not converted due to infusion reactions possibly related to biosimilars. Based on the wholesale acquisition cost, we estimate reduction in direct spending of $1.2 million per month or an average 23% cost savings. Conclusions: This real-world data suggest use of an integrated electronic health record to standardize biosimilar utilization in oncology and reduce costs. This approach leverages existing infrastructure for successful biosimilar adoption in oncology while preserving quality and safety.[Table: see text]
Protocol requirements and logistical intensity of early-phase clinical trials (EP-CTs).
Authors: Durbin Sienna , Lundquist Debra , Healy Megan , Lynch Kaitlyn , Bame Viola , Martin Tristan , Johnson Andrew , Turbini Victoria , Juric Dejan , Jimenez Rachel , Nipp Ryan David
Published: June 2022

e18609

Background: EP-CTs are increasingly important options for patients with cancer and often involve intensive monitoring. Characterizing the time burden and logistical intensity of EP-CT protocols could help patients and clinicians make informed decisions about trial participation. Methods: We retrospectively reviewed the electronic health records of consecutive patients enrolled in EP-CTs at Massachusetts General Hospital from 2017-2019 to obtain baseline characteristics (demographics and clinical factors), EP-CT investigational agent (immunomodulatory [IM], targeted inhibitor [TI], antibody drug conjugate [ADC]/chemotherapy prodrug), and logistical intensity (visit frequency required per protocol and presence of extended visits). We defined visit frequency as the number of visits required per protocol within the first 28 days on trial. We defined an extended visit as six or more hours required in clinic on at least one day during the first 28 days on study. We evaluated associations among patient characteristics, investigational agents, logistical intensity, and time spent on trial. Results: Among 421 patients (median age = 63.0 years, 56.9% female, 97.6% metastatic disease), 43.2% were enrolled in IM EP-CTs, 43.0% TI, and 13.8% ADC/chemotherapy prodrug investigational agents. Patients enrolled on ADC/prodrug trials had the highest burden of metastatic disease (mean sites: 2.8 [ADC] vs 2.4 [TI] vs 2.3 [IM], p = 0.007) and oldest age (mean years: 64.0 [ADC] vs 61.7 [IM] vs 58.5 [TI], p = 0.003). However, those on ADC trials had the most days spent on trial (mean days: 78.3 [TI] vs 102.2 [IM] vs 131.8 [ADC], p = 0.003). Patients enrolled on TI trials had the highest required visit frequency compared with those enrolled on other trials (mean visits: 5.5 [TI] vs 5.3 [ADC] vs 5.0 [IM], p = 0.027). Additionally, those on TI trials were most likely to have an extended visit (82.3% [TI] vs 58.2% [IM] vs 29.3% [ADC], p < 0.001) and least likely to receive first in human therapy (38.1% [TI] vs 74.1% [ADC] vs 74.2% [IM], p < 0.001). Conclusions: In this cohort of patients participating in EP-CTs, we found that those enrolled on TI trials had the highest per protocol visit frequency and greatest likelihood of required extended visits. Those on ADC trials spent the most days on trial despite having the highest average age and burden of metastatic disease. These data highlight the time burden and logistical intensity of EP-CTs, underscoring certain trials as especially time intensive, which may help inform trial selection and participation.
Navigation of patients with locally advanced head and neck squamous cell carcinoma during cisplatin-based chemoradiation: A cohort study.
Authors: de Castro Gilberto , de Souza Priscila Rangel , Nunes Lenira Corsi Ruggiero , Souza Rosilene Josefa , Dias Tamara Aparecida Vieira , dos Reis Nathalia , Goes Samira S , Moravia Renata Alvim , Moreira Paulo Thadeu Fantinato , Lopez Rossana Veronica Mendoza , da Silva Maria Rita
Published: June 2022

e18613

Background: Cisplatin(DDP)-based chemoradiation (CCR) is currently used to treat locally advanced head and neck squamous cell carcinoma (LAHNSCC), either as an exclusive modality or in the adjuvant setting. Acute, treatment-related toxicities are frequent. In this prospective cohort study, we evaluated the impact of patient (pt) navigation in multidisciplinary care by nurses on adherence to consultations and procedures, number and duration of hospital admissions, admissions to the emergency department, and treatment-related toxicities. Methods: In this prospective, uni-institutional cohort study, pts diagnosed with LAHNSCC (oral cavity, oropharynx, hypopharynx, and larynx) were consecutively included at the beginning of CCR, after informed consent. The navigation program included: (1) referral to multidisciplinary care (Nutrition, Psychology, Social Work); (2) monitoring attendance at multidisciplinary clinical visits; (3) monitoring of possible hospital and emergency admissions; and (4) diagnosis and monitoring of treatment-related toxicities, graded according to CTCAE v5.0. To observe an effect size of 0.50 with a power of 80% and a type I error of 0.05, 64 pts would be needed. Here we present the analysis of the first 26 pts included, with outcomes compared to 130 LAHNSCC pts treated with CCR at the same institution in 2019. Accrual was stopped. Results: 26 pts were included between Mar/2021 and Sep/2021, with a median age of 57 years, being 77% men, with KPS ≥ 80% in 25 pts (96%), and with a primary tumor in the oral cavity or oropharynx in 18 patients (69%). CCR was administered in the adjuvant setting in 9 pts and as an exclusive treatment in 17 pts. 10 pts (39%) experienced DDP discontinuation (mainly for toxicity) in the navigation group, compared to 67% in the control group (p = 0.008); and the duration of radiotherapy was 48d and 49d, respectively (p = 0.483). No grade 4 adverse events were observed in navigated pts. The median number of absences (any visit or treatment) was 1.0 (control) and zero (navigation, p < 0.001). Admission to the emergency department occurred in 6 navigated pts (23%) as compared to 100 control pts (77%, p < 0.001), while hospitalizations occurred in 1 (3.8%) and 50 (38.5%, p < 0.001), respectively, lasting 4.9±9.7d and 1±0.39d (p = 0.001). Conclusions: The navigation program provided better outcomes in comparison to the control group, in terms of a lower number of missed appointments, a higher number of chemotherapy cycles administered, lower frequency of severe toxicities, lower frequency of attendance at emergency and hospitalization services, as well as reduced length of hospital stay.
Impact of neuroendocrine tumor diagnosis (NET) on quality of life.
Authors: Roy Arya Mariam , Kaur Jasmine , Iyer Renuka V.
Published: June 2022

e18614

Background: With longer median survival for NET patients, the impact of symptoms and treatments on QOL and financial well-being throughout the disease course need to be evaluated to understand the true burden of the disease on patients. Current HRQOL data are during active treatments and this prospective biobank was established to capture this information throughout the disease course. Methods: At Roswell Park Comprehensive Cancer Center, with Institutional Review Board (IRB) approval a NET biobank was established in April 2019 for collecting clinical tissue samples, patient demographics, treatment outcomes, access to care and self-reported HRQoL outcomes. Using previously developed HRQoL questionnaires, we examined the impact of the NET on the quality of life of NET patients and data of 144 patients enrolled to date in the biobank is presented here. Linear regression was used to assess the association of baseline characters with QoL variables. The analysis was done with STATA/IC 16.0. Results: A total of 144 patients are enrolled. Males were 27% (n = 39) and females were 73% (n = 105). The mean age of diagnosis was 54 +/- 0.79, with those between 45 to 65 (72%, n = 103). These patients were enrolled through support groups and social media from 30 different states in the US (135) and 9 pts from Canada. After the diagnosis, 27% of patients had to quit their job. Impact on major HRQoL variables are summarized in Table. Only 21% of patients reported that they feel knowledgeable about NET and got the majority of their support from their primary care (60%) and oncologist (57%). When asked about the most pressing need from their care team, 57% of patients requested their care team had more information about available clinical trials. Sex, age groups did not have statistically significant association on the impact of NETs on the HRQoL of patients. Conclusions: NET diagnosis affects the HRQoL of patients including their social, emotional, and financial well-being. A national biobank capturing data on various demographic, risk factors, treatment sequence, symptoms, HRQoL parameters, financial toxicity is a valuable resource to better understand the needs of this patient group.[Table: see text]
Systematic assessment of online health information related to drug therapy for non-small cell lung cancer.
Authors: Xu Yu-Hui , Zheng Yi-Fan , Yang Hui-Min , Chen Xiao , Tang Ke-Jing
Published: June 2022

e18626

Background: Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. Patients increasingly use the internet for drug therapy information that may influence decision-making, drug adherence, and self-management. However, online drug therapy information is prone to quality and readability issues. We systemically assess online drug therapy information for patients with NSCLC in terms of quality, suitability, reliability and readability. Methods: NSCLC online drug therapy websites were searched with three terms using three major engines (Google, Yahoo and Bing). Validated tools were used to assess the content in terms of quality (DISCERN), suitability (Suitability Assessment of Materials [SAM]), reliability (Journal of the American Medical Association [JAMA] benchmarks and the Health on the Net [HON] code), readability (Flesch-Kincaid Grade Level). The scores were compared in drug therapy and affiliation subgroups. Results: A total of 52 websites were included. The median quality score was 48.8 (interquartile range [IQR], 39.5-57.0), or fair (39-50). The quality scores were not statistically significant between different subgroups. The median suitability score was 43.8% (40.6%-46.4%), or adequate (40%-69%). The commercial websites showed the highest median suitability score of 45.2%, which was significantly higher than that of non-profit websites ( P < 0.05). The average readability was at a grade of 10.6 level using the Flesch-Kincaid scale which was significantly higher than the traditionally recommended grade-six level ( P＜0.001). The median reliability scores of commercial websites were observably higher than non-profit websites ( P＜0.05). Around 40% of websites were HON code accredited. Conclusions: Most online resources for NSCLC have fair quality, adequate suitability, and poor readability. Reliability was of a moderate level. Therefore, healthcare providers should be cautious when referring patients to online health information and the online information for NSCLC has great room for improvement.[Table: see text]
Impact of readmission for patients with cancer in a public health system.
Authors: Hidalgo Filho Cassio Murilo Trovo , Lazar Neto Felippe , Da Rocha Joao Wilson , Bonadio Renata Colombo , Hoff Paulo Marcelo
Published: June 2022

e18633

Background: Patients with cancer have high mortality during hospitalization and poor prognosis after discharge. However, most evidence comes from developed countries where early diagnosis is common and a higher number of treatment options are available. In addition, socioeconomic disparity is also known to impact on cancer prognosis. We aimed to investigate the impact of hospitalizations, early readmissions, and Human Development Index (HDI) among cancer patients in a public tertiary hospital in Brazil. Methods: A retrospective study was conducted including patients admitted at a Brazilian tertiary cancer center from February 1st to November 30th of 2021. Data was collected from patients' electronic health records. COVID-19 diagnosed patients were excluded. We evaluated 7-day and 30-day readmission rate, and post-discharge survival. We retrieved patients' home address region HDI from the latest Brazilian Census and investigated if it would affect hospitalization and post-discharge outcomes. Overall survival (OS) after discharge was compared between groups with log-rank test and categorical variables proportions with chi-square test. Results: A total of 3711 patients were included during the period. The median age was 64 years (IQR 53-72); nearly half were female (51%). The most common cancer diagnosis was breast cancer (538, 15%) followed by prostate (308, 8.4%), colon (298, 8.1%) and lung (269, 7.3%). The median hospitalization length was 6 days (IQR 4-11). The overall in-hospital mortality rate was 20% (n = 734). Patients initially admitted to the Intensive Care Unit (ICU) had a higher mortality compared to wards (44% vs 17%, p < 0.001). Of those discharged, 9.9% and 28% of the patients were readmitted within 7 and 30 days, respectively. The median overall survival (mOS) of the discharged patients was 182 days (95% CI 160-201 days). Early readmission within 7 and 30 days were associated with poorer overall survival after discharge (Table, p < 0.001). We have not found any association between the HDI and in-hospital mortality, rate of readmissions or overall survival after discharge. Conclusions: Early readmission is an important prognostic factor and should be taken into consideration when discussing post-discharge treatment objectives. HDI does not seem to affect neither hospitalization nor survival outcomes in a publicly funded cancer center.[Table: see text]
Medically integrated dispensing (MID) clinical and cost outcomes compared to specialty pharmacies (SP).
Authors: Leach Joseph W. , Eckwright David , Champaloux Steven W. , Forsberg Paul , Weiss Arno , Jorgensen Christopher , Gleason Patrick P.
Published: June 2022

e18645

Background: Oral oncolytics MID offers potential care and cost advantages compared to a centralized SP model. A pharmacy benefit manger and 3 health plans created a pilot program to enable and encourage oncology practice MID with the goal of improving care, enhancing the provider and patient experience, and reducing drug waste. This study assesses clinical outcomes and drug waste differences between MID and central SP dispensing using real-world pharmacy claims data. Methods: The MID pilot program was implemented early 2021 within 3 oncology practices across 3 plans commercially insured lives. Members were required to have continuous enrollment for the adherence and discontinuation (d/c) measures. Adherence was measured using the CMS industry standard proportion of days covered with a > / = 80% cut point. D/c was measured in new initiators defined as no claim evidence of the drug in the previous 90 days with discontinuation defined as having a > / = 45-day therapy gap within the first 180 days. Dose changes were defined as a new unit strength being dispensed for a previously filled drug. Each measure used a unique drug list: 3 CDK4/6i for adherence; 10 highly utilized oral brand and generic oncolytics for d/c; and 26 oral oncology brand drugs having multiple strengths and labeled dose change directions for dose change waste. The adherence and waste measures assessment end date was Dec 31, 2021 and for d/c was Jan 28, 2022. Statistical testing: adherence- Fischer’s exact test; d/c- chi-square; and waste– t-test. Results: For adherence, individuals were followed for an average of 243 days, range 21-333 days, without a statistical difference between MID and SP follow-up. CDK4/6i adherence was 82% (9 of 11) for MID and 73% (421 of 574) for SP, p = 0.74. D/C was 29% (15 of 52) for MID and 48% (360 of 753) for SP, p = 0.01. Waste occurred in 29% (6 of 21) of MID dose changes and 50% (315 of 627) of SP dose changes, p = 0.05; resulting in an average cost of $937 and $2,733 per dose change at the MID and SP, respectively, for an SP average dose change additional cost of $1,796. Conclusions: MID demonstrated numerically higher adherence, significantly lower d/c rate with MID having a number need to treat of 5 to prevent one less d/c event, and significantly lower waste expense with an estimated savings of $1.1 million, if all 627 individuals with a dose change at SP had used a MID. These real-world findings have resulted in a national PBM network to encourage MID use.
A multiphase continuing education and quality improvement initiative to tailor treatment plans for patients with follicular lymphoma.
Authors: Kim Joseph , Fenske Timothy S. , Gracie-King Linda , Viens Marc David , Ocana Victor , Chandra Abhinav Binod , Penberthy David , McCurdy Tori
Published: June 2022

e18651

Background: Data support the need for increasing shared decision-making (SDM) conversations to align treatment decisions with patient values and preferences (Kehl KL et al. JAMA Oncol. 2015). Combining certified interprofessional continuing education and quality improvement (QI) methods may accelerate how cancer clinicians translate evidence into real-world clinical practice when diagnosing and treating patients with follicular lymphoma (FL). This initiative was supported by educational grants from Genentech, a member of the Roche Group and Bristol Myers Squibb and managed by AXIS Medical Education and Q Synthesis. Methods: The project collaborators invited three community hospital-based cancer centers to participate in this 18-month longitudinal, multiphase CME/CE and QI initiative. Each cancer center performed a baseline assessment by reviewing how their clinicians diagnosed and treated patients with FL. This process involved chart reviews, focus group discussions, and online surveys. Each cancer center developed problem statements, aim statements, and implemented improvement projects around prognostic scoring, the use of molecular diagnostics, SDM, and treatment planning. Clinicians also participated in two live virtual continuing education interventions, co-moderated by an academic clinician with a focus in lymphoma (T.F.), as well as the medical director of the activity (J.K.) and received reinforcement messages following those activities. Results: Members of the multidisciplinary cancer care team from three cancer centers in AZ, TN, and VA participated in this initiative. Across all three cancer centers, the following educational outcomes were observed: 61% increase in knowledge about the concept of POD24 (early disease progression within 24 months of initiating therapy); 50% increase in knowledge and practice skills regarding tailored treatment planning based on patient risk factors and prognostic scores; 33% increase in knowledge around the benefits of incorporating SDM when developing treatment plans, and an 18% increase in knowledge about risk-based treatment plans. The QI projects resulted in a 56% improvement in prognostic scoring (incorporating tumor grade and stage), a 25% increase in documenting tumor burden, and a 22% increase in the use of molecular diagnostics. Conclusions: This multiphase education and QI program enabled cancer clinicians to improve monitoring patients for POD24 and risk assessment, incorporate molecular testing, engage in SDM conversations with patients, and formulate tailored treatment plans for patients with FL.