bluuebunny/crossref_metadata_2025 huggingface dataset:
Real-world experience of checkpoint inhibitors across India: CRSF 2020-01.
Authors: Goyal Gautam , Chandrasekharan Arun , Avaronnan Manuprasad , Talreja Vikas , Bhosale Bharatsinha Baburao , Kothari Rushabh , Mondal Tanmoy , Pande Nikhil , Talele Avinash , Poladia Bhavesh Pradip , Agarwala Vivek , Karpe Ashay
Published: June 2023

e18862

Background: There are limited data available from India on the real-world use of checkpoint inhibitors. Hence we did this analysis across India to study the pattern of use and outcomes with checkpoint inhibitors. Methods: This was a retrospective multicentric protocol. Patients who received immunotherapy from January 2016 to October 2021 were included. The baseline demographic, previous treatment, response, date of progression, date of death and status were noted. SPSS version 20 was used for analysis. Descriptive statistics were performed. Kaplan Meier method was used for estimation of progression-free survival (PFS) and overall survival (OS). COX regression model was used to identify factors impacting OS. Results: We identified 308 patients in the study. The median age was 58.5 years (Interquartile range 51-66 years) and there was a male preponderance (249, 80.8%). The 3 commonest sites of use were head and neck cancer in 144 patients (46.8%), lung cancer in 81 (26.3%) and renal cell carcinoma in 31(10.1) patients. The ECOG PS was 0-1 in 215 (70%), 2 in 71 (23.1), 3-4 in 21(6.8%) and not documented in 1(0.3%) patient. The two most common checkpoint inhibitors used were nivolumab and pembrolizumab 255 (82.8%) and 37(12%) patients respectively. These were used in curative setting in 6 patients (1.9%) and palliative in rest all. 43(14%) patients received them as first-line in, 129 (41.9) as second-line and beyond the second line in 130 (42.2%) patients. The response rate was 24% (n = 74). The median PFS was 4.067 (95%CI 3.45-4.67) and the median OS was 10.0 months (95%CI 6.2-13.8). Among the factors tested for impact on OS the ECOG PS 0-1 ( HR-0.493 95%CI 0.324-0.749; P = 0.001), non head and neck site of the disease (HR-2.134 95%CI 1.164-3.911) and reception of immunotherapy in first line setting (HR -0.533 95%CI 0.295-0.963: P = 0.037) had an favorable impact on OS. Conclusions: Checkpoint inhibitors provide similar efficacy as those seen in pivotal studies in real-world settings.
Development of a multiphase patient-reported outcomes dashboard to support population health and drive quality improvement in ambulatory oncology.
Authors: Zhang Sunyi , Manni Michael , Whittaker Sarah , Barwick Paige , Finn Brian , Schindler Mary , Verzino Gabe , Sirohi Niren , Johnson Jason , Haakenstad Ellana K , Lakhani Hakim , Hassett Michael J. , McCleary Nadine Jackson
Published: June 2023

e18864

Background: The Patient Reported Data (PRD) Program at Dana-Farber Cancer Institute (DFCI) has implemented a portfolio of electronic questionnaires including patient-reported outcome measures (PROMs) and risk screeners in routine practice. Over 141,906 questionnaires have been completed by over 60,158 patients across solid tumor, liquid tumor, and supportive care (see table). We are now prepared to share this data internally in an accessible and actionable format via the development of an Outcomes Dashboard. Methods: PRD and the DFCI Clinical Operations & Business Analytics team created a roadmap for iterative dashboards to be developed with Tableau 2022.1, a business analytics platform. The development team included a business analyst, data scientist, and content experts. The goal of our roadmap was to balance rapid delivery of data with the resources needed to develop more complex dashboards incorporating PRD with other data. The Outcomes Dashboard roadmap consists of four phases. Phase 1 focuses on creating a core dashboard and displaying aggregate PROMs-derived scores and risk scores with filters and stratification by patient demographics and clinical encounter data. Phase 2 adds clinical outcomes data including hospitalizations and treatment adherence. Phase 3 adds non-scored questionnaire data such as social determinants of health. Phase 4 incorporates oncology treatment data including treatment route, goals, class, and other characteristics. Results: Data was generated using Microsoft SQL Server Management Studio and loaded into Tableau to create visualizations with data refreshed daily. Dashboard Phase 1 is complete and will be released in spring 2023. Dashboard users will include executive leaders, operations, clinicians, and others. The dashboard will be used to identify differences and disparities in care delivery and outcomes by disease type, treatment, and other characteristics; highlight opportunities for interventions to improve quality and care delivery; identify areas for future research; and help fulfill emerging regulatory requirements. Conclusions: By making aggregate PRD and associated outcomes available in an accessible format, we aim to drive quality improvement and enable population health management. Future efforts will include educating users, assessing uptake of the dashboard, and partnering with stakeholders to develop clinical interventions to improve outcomes. [Table: see text]
Real-world clinical outcomes in patients (pts) with HR+/HER2- metastatic breast cancer (mBC) treated with chemotherapy (CT) in the United States (US).
Authors: Tolaney Sara M. , Punie Kevin , Kurian Allison W. , Ntalla Ioanna , Verret Wendy , Sadetsky Natalia , Sjekloca Nikoleta , Stokes Michael , Jhaveri Komal L.
Published: June 2023

e18871

Background: HR+/HER2- mBC remains incurable, despite progress made with endocrine therapy (ET) + CDK4/6i in prolonging survival. After resistance to ET-based treatment, options are limited to CT and a decrease in survival is observed with every subsequent line of treatment received. This study describes real-world outcomes in pts with HR+/HER2- mBC initiating CT or previously treated with CT in the US. Methods: This retrospective, observational cohort study used the ConcertAI Patient360™ curated dataset of electronic medical record data from the US. Pts (≥18 years) diagnosed with HR+/HER2- mBC and initiating their first CT from January 2011 to June 2021 were included. Real-world outcomes were assessed for all pts who initiated treatment with a first CT, and those who were subsequently treated with a second, third, and fourth CT. Index date was defined as the CT start date of each systemic therapy line. Results: In total, 1545 pts met the eligibility criteria and were included for analysis. Pts were primarily female (99%) and White (76%); median age was 61 years (IQR, 52-69) and 68% had visceral metastases. Most pts (80%) were treated in a community setting and 41% received their first CT in 1L; 58% and 44% had prior exposure to ET and CDK4/6i in the mBC setting, respectively. The median time from mBC diagnosis to first CT was 12 months (IQR, 1.4-30.8). Among all pts included, 57%, 31% and 17% were subsequently treated with a second, third, and fourth CT, respectively, during the study period. Capecitabine and paclitaxel were the most used as the first (45% and 29%), second (35% and 30%), and third (25% and 22%) CT, while gemcitabine (22%) and eribulin (20%) were used most as fourth CT. Clinical outcomes assessed are summarized in the table. Median real-world overall survival (rwOS; 95% CI) from time of mBC diagnosis was 48.5 months (45.5-51.5). Median rwOS from first CT treatment start date was 23.3 months (21.3-25.4). In pretreated pts with 1, 2, or 3 prior lines of CT, median rwOS from each index date was 16.5 months (14.8-18.3), 11.8 months (10.4-13.1), and 9.1 months (7.3-11.2), respectively. Conclusions: Among pts with HR+/HER2- mBC in this analysis, CT choice and real-world clinical outcomes per systemic therapy line were comparable to existing literature. Outcomes decreased as pts advanced CT lines, indicating that in this setting the unmet need remains high. More efficacious treatment options are needed for ET-resistant, chemo-naïve pts and pts pretreated with CT with HR+/HER2- mBC. [Table: see text]
Navigating how to choose an oncologist as part of the cancer journey.
Authors: Francis Ann , Teschner Taylor , Warde Prem R. , Johlie Melissa , Buthe Lynn , Johnson Kjel Andrew
Published: June 2023

e18877

Background: Being diagnosed with cancer and having to navigate what to do next is overwhelming. One of the initial actions that needs to be taken is choosing an oncologist. It is essential that each patient finds an oncologist they trust and who will work with them through their diagnosis and treatment. CVS Health conducted this study to gain insight into 1) how cancer patients select an oncologist and what factors weigh into choosing an oncologist and 2) treatment cost concerns. Methods: In August 2022, we conducted an online survey with consumers selected from a national online panel. Patients (n = 126) were included if they had cancer, employer health insurance and currently undergoing or having completed chemotherapy infusion, oral chemotherapy, hormone therapy or immunotherapy. Patients answered a series of questions designed to understand how they selected their oncologist. Descriptive statistics and percentages are reported. Results: Oncology diagnoses included breast (48%), colon or rectal (8%), leukemia (8%), melanoma (7%), basal cell (6%), ovarian (6%), endometrial (6%), testicular (6%), prostate (5%), lung (4%) and < 3% of other cancers (patients could choose multiple diagnoses). Most (79%) patients completed treatment; 75% received or were receiving chemotherapy infusion, 63% surgery, 60% radiation therapy, 29% hormone therapy and 22% oral chemotherapy. 68% of patients responded that someone suggested/referred them to their oncologist. Of these patients, 43% stated a specialist (other than an oncologist) referred them to their oncologist, 34% said their primary care physician (PCP) referred them, while hospital/treatment center, family member/friend, insurance company and other made up the rest. 38% of respondents received a second opinion. Most (89%) patients remained with the same oncologist throughout their treatment. When selecting an oncologist, most patients identified experience (93%), being a respected oncologist (90%), reputation (86%), being in network (77%), quality measures (74%) and treatment recommendations (73%) as “Very Important” factors when choosing an oncologist. 38% of patients began to worry about medical bills when diagnosed; however, 30% were never concerned. Over half (56%) of patients reported treatment cost as the most concerning bill. 82% of patients reached their deductible during treatment, with half (54%) expecting to hit their deductible less than 3 months into treatment. 75% of respondents reported hitting their out-of-pocket maximum; 39% hit it less than 3 months into treatment. Conclusions: Specialists and PCPs are integral in referring patients to oncologists. While patients are less likely to choose their oncologists directly, they report that experience, reputation, and quality of care are essential qualities in an oncologist. Cost was not an important factor when choosing an oncologist, however, patients are concerned with medical bills, specifically treatment costs.
Clinical factors associated with prescribing patterns of bone modifying agents in men with metastatic castration-resistant prostate cancer.
Authors: Kobe Christopher , Nguyen Charles B. , Kumbier Kyle E. , Bauman Jordan , Burns Jennifer A. , Tsao Phoebe A. , Sparks Jordan B. , Caram Megan Veresh
Published: June 2023

e18878

Background: Bone metastases occur in up to 90% of men with metastatic prostate cancer and cause skeletal-related events (SREs) such as fracture and spinal cord compression. Although bone modifying agents (BMAs) have been shown to decrease the risk of SREs in men with metastatic castration-resistant prostate cancer (mCRPC), BMAs are not widely used in this patient population. In this retrospective study, we report the prescribing patterns of BMAs and predictors of BMA use in a large national cohort. Methods: We used the VA corporate data warehouse to identify patients with mCRPC who were treated with first-line mCRPC therapy (abiraterone, enzalutamide, docetaxel, or ketoconazole) between 2010 and 2017. BMA prescribing frequency and patterns were analyzed. Multivariable regression analysis was used to evaluate clinical and disease-specific factors associated with BMA use which are presented as adjusted odds ratios (OR) with 95% confidence intervals (CI). Results: In the final cohort of 4,079 patients, the median age at mCRPC diagnosis was 73 years (IQR 66-81). 29% of patients in the cohort were Black. Diagnosis codes identified bone metastases at mCRPC diagnosis in 48% of the cohort (ICD-9 and 10 coding for sites of metastases are known to underestimate the actual incidence of metastases). Only 48% of patients received a BMA following initiation of treatment for mCRPC, 47% of which had already received a BMA 6 months prior to mCRPC diagnosis. For those who were new BMA starts, the median time to BMA administration from mCRPC treatment was 3.4 months (IQR 1.2-8.8). Factors associated with BMA use were having an ICD-9 or 10 diagnosis code for bone metastases at time of mCRPC treatment (OR 1.28, 95% CI 1.10-1.48), concurrent corticosteroid use (OR 1.90, 95% CI 1.53-2.38), and docetaxel use as first-line mCRPC therapy (OR 1.78, 95% CI 1.45-2.18). Factors associated with decreased BMA use were Charlson comorbidity index score of ≥ 2 (OR 0.75, 95% CI 0.62-0.90), advancing age (OR 0.86 per 10 years, 95% CI 0.79-0.94), and decreased eGFR (eGFR 30-59, OR 0.81, 95% CI 0.68-0.96; eGFR 0-29, OR 0.23, 95% CI 0.14-0.37). Having a diagnosis code for a SRE before mCRPC diagnosis (e.g., bone fracture and cord compression) did not impact BMA use, but the incidence of those events was low. Conclusions: Less than half of this VA cohort received a BMA after starting therapy for mCRPC. Key factors associated with BMA use were corticosteroid use and first-line docetaxel use, which likely represented more aggressive disease. Notably, patients who were older and had more comorbid conditions were less likely to receive a BMA despite being highest risk for frailty and SREs. Future quality improvement efforts aimed at increasing BMA use may address the needs of the geriatric mCRPC patient population.
Real-world outcomes in patients (pts) with metastatic triple-negative breast cancer (mTNBC) treated with sacituzumab govitecan (SG) in 2L+ in the United States (US).
Authors: Kalinsky Kevin , Spring Laura , Yam Clinton , Taylor Aliki , Sjekloca Nikoleta , Kaushiva Alpana , Lai Catherine , Ntalla Ioanna , Nanda Rita
Published: June 2023

e18879

Background: Pts with mTNBC have poor prognosis and limited treatment options. SG is an anti—Trop-2 antibody-drug conjugate approved in multiple countries for pts with mTNBC who received at least 1 prior systemic therapy and in the US for pts with pretreated HR+/HER2- mBC. In the pivotal phase 3 ASCENT study (NCT02574455), SG demonstrated superior efficacy over single-agent chemotherapy and a manageable safety profile in pts with mTNBCardia A, et al. NEJM. 2021). This study is, to our knowledge, the first to describe real-world treatment patterns and dosing with SG and its impact on clinical outcomes in pts with mTNBC in the US. Methods: This retrospective, observational cohort study used the ConcertAI Patient360™ dataset with additional curated electronic medical record data from the US. Pts (≥18 years) diagnosed with mTNBC as defined according to the current American Society of Clinical Oncology/College of American Pathologists guidelines (HER2 IHC0, 1, or 2/ISH-negative; ER/PR <1%) and initiating treatment with SG (index date) in 2L+ from April 2020 to May 2022 were included. Real-world clinical outcomes with SG and use patterns were assessed. Kaplan-Meier method was used to determine real-world overall survival (rwOS). Results: In total, 230 pts met the eligibility criteria and were included for analysis. All pts were female; 64% were White and 26% Black; median age was 60 years (IQR, 49-69); 71% of pts presented with ECOG performance status ≤1; 71% had visceral metastases and 7% had brain metastases at baseline. The median time from mBC diagnosis to SG treatment initiation was 11.8 months (IQR, 7.6-19.2). Most pts (66%) were treated in a community setting; 34%, 28%, 19%, and 20% of pts were treated with SG in the 2L, 3L, 4L, and 5L+ setting, respectively. Between 2020-2022, there was a trend in the distribution of SG use shifting to earlier line settings, see Table. Median starting dose was 10 mg/kg (IQR, 9.8-10.1). Median follow-up duration was 7.2 months (IQR, 3.9-11.1). Median rwOS (95% CI) from index date was 10 months (8.3-11.1) among all pts. Median rwOS (95% CI) was 13.9 months (9.79-not estimable) and 8.4 months (7.7-10.3) among pts treated with SG in 2L and in 3L+ setting, respectively. Analyses on real-world patterns of SG use are ongoing and additional results will be provided. Conclusions: Pts who were treated with SG in routine clinical practice were older, more ethnically diverse, and presented with worse performance status than pts enrolled in the ASCENT trial but demonstrated a similar survival benefit. The proportion of pts treated with 2L SG increased from 2020 to 2022, reflecting an expected dynamic of post approval drug uptake in routine practice. [Table: see text]
Factors that determine selection of a cancer treatment location.
Authors: Francis Ann , Teschner Taylor , Warde Prem R. , Johlie Melissa , Buthe Lynn , Johnson Kjel Andrew
Published: June 2023

e18880

Background: Cancer patients, who are already overwhelmed by their diagnosis and other decisions that need to be made, are also confronted with decisions regarding treatment options. Understanding factors that influence a cancer patient’s decision to select a treatment location are needed to optimize treatment decision-making and avoid financial toxicity. This study aimed to gather feedback from cancer patients to understand what factors influence their decision to choose a cancer treatment location. Methods: We conducted an online cross-sectional survey of 126 current and former cancer patients. We asked what factors influenced their decision to select their current or former cancer treatment center. The survey was conducted in 2022; descriptive statistics and percentages are reported. Results: Most patients were White (87%), female (74%), college-educated (70%) and resided in the suburbs (57%); hypertension (32%) was the most common comorbidity. The most common cancers were breast (48%), followed by colon or rectal (8%) and leukemia (8%). Roughly half of the patients selected the location for screening (51%), while someone else selected locations for diagnosis and staging (63%), treatment plans (64%) and treatment (45%). Of those who indicated that someone else chose their screening, diagnosis and staging, treatment plan and treatment locations, most reported their oncologist decided the diagnosis and staging (57%), treatment plan (86%) and treatment locations (90%). The wait time to receive treatment (89%) and distance from home or work (86%) were the two most important factors when selecting a cancer treatment location. Over half (57%) of patients said they would be “very willing” or “somewhat willing” to change treatment locations for a $0 copay/coinsurance offer. However, only 38% of respondents would be willing to change locations for a $0 copay/coinsurance offer if it meant they would have to change oncologists. 48% of patients were willing to drive 41-100 miles to a treatment location for a $0 copay/coinsurance offer. 74% of patients received an infusion as part of treatment; over half (57%) preferred to receive the infusion in a suite at a cancer center/clinic. Conclusions: While primary care physicians and oncologists share almost equally in selecting screening locations, oncologists are most often responsible for recommending a treatment location for the other three steps (diagnosis and staging, treatment plan and treatment) in the cancer treatment journey. When offered a $0 copay/coinsurance program during treatment, patients were willing to change locations, highlighting the impact of cost on selecting a cancer treatment location. However, patients were less likely to change locations if that meant changing their oncologist, highlighting the importance of trust and comfort in one’s oncologist.
Understanding the information needs of lymphoma and CLL patients: A comparison of Asia-Pacific and Europe.
Authors: Bates Cherie D. , Watson Amanda , Warwick Lorna
Published: June 2023

e18884

Background: Effective communication between healthcare providers and patients has improved patient outcomes and satisfaction. This study aims to evaluate the impact of healthcare provider-patient communication on patient satisfaction and outcomes in patients diagnosed with lymphoma and chronic lymphocytic leukaemia (CLL). The study utilises data from the Lymphoma Coalition (LC) 2020 Global Patient Survey (GPS) to compare the information experiences of patients in the Asia-Pacific (APAC) and European regions diagnosed with lymphoma and CLL. Methods: We analysed a subset of patients from APAC region (n = 3021) and the European region (n = 4343) and examined the demographic characteristics of both groups. Statistical analyses, including chi-square tests and logistic regression, were performed using IBM SPSS v27 software to assess patients' information experiences. Results: The findings of this study reveal that patients in APAC experienced a lower likelihood of receiving sufficient information at the time of diagnosis and expressed challenges in comprehending treatment options and managing treatment-related side effects. Notably, compared to patients in Europe, patients in APAC reported a greater need for information related to self-care (42% vs 14%) and treatment options (68% vs 50%). Conclusions: This study highlights APAC patients with lymphoma & CLL require more information, reflective of their health literacy levels, from their healthcare professionals. It is recommended that healthcare providers provide tailored information to improve patient outcomes and satisfaction. [Table: see text]
Beyond the binary: Analysis of esophageal cancer hospitalizations in the transgender population, a national inpatient sample study.
Authors: Yadukumar Lekha , Singh Yuvaraj , Dasu Neethi , Khalid Yaser , Gogtay Maya
Published: June 2023

e18888

Background: Transgenders are individuals with a gender identity that differs from their sex at the time of birth. Over > 1.6 million adults identify themselves as transgender in the US, of which 39% are women and 36% are men. While gender differences in cancer prevalence have been well established between men and women, very few studies evaluate the prevalence of cancer in patients who identify as transgender people. We aimed to evaluate the trends of esophageal cancer admission hospitalizations in the transgender population compared to the general population. Methods: This was a retrospective analysis of the data obtained from the Nationwide Inpatient Sample database. Data were sampled from 2015 to 2020 utilizing the ICD-10 codes of esophageal cancer and patients( > 18 years) who identified as transgender. The primary outcome was in-hospital mortality. Secondary outcomes were the length of stay (LOS) and total costs in the hospital, respectively. A multivariate logistic regression analysis was used to estimate the odds ratio. Results: A total of 212,425 patients with esophageal cancer were admitted between 2015- 2020, of which 97,950 were transgender. The mean age was 33 vs. 34 years in the general population. Both groups were predominantly Caucasian (65% vs. 68%), followed by African Americans (15.2% vs. 5.2%). Median household income (MHI) in transgender people was commonly in the lower quartile (27.8%). In cisgender patients, 37% had a MHI in the 26th-50th followed by 26% in the 76th-100th percentile. Inpatient mortality in transgender patients with esophageal cancer was OR = 5.1[1.8-8.3] (p < 0.05). The average LOS was higher in the transgender population by 2.15 days [1.1-3.1](p < 0.05). Increased LOS in teaching hospitals by 1.3 days [1.08- 1.59] (p < 0.001) and larger hospitals by 1.4 days [0.51- 2.28] (p < 0.001) was observed. The total cost of admission was significantly different in teaching hospitals ($27,774, p < 0.001). Conclusions: We found a significant difference between the inpatient outcomes of transgender and the general population. Despite the markedly low representation of transgender people in the national cancer registries, they experienced an increased mean length of stay and mortality compared to cisgenders with esophageal cancer. Further investigation is required to determine the cause of disparity in healthcare utilization amongst the gender-diverse population. [Table: see text]
Adverse events during chimeric antigen receptor T-cell (CAR-T) therapy for hematologic malignancies (HM): Real-world, US patient experience.
Authors: Kish Jonathan , Liu Rachael , Vennam Srinivasa , Lussier Courtney , Pfeffer Daniel , Nayak Pratibha
Published: June 2023

e18891

Background: CAR-T therapy represents the most significant advancement in the treatment of HM in the past 5 years. Life-threatening complications such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) may occur leading to significant morbidity and mortality. We aimed to describes the frequency of CRS and ICANS and the time to onset of each post CAR-T therapy administration in real-world, U.S. patients. Methods: Patients (pts) with HM who received any FDA-approved CAR-T therapy were identified from a U.S. EMR database containing de-identified healthcare data for > 40M patients from > 500 hospitals and 30 healthcare systems (including academic centers). Confirmation of CAR-t treatment was based on ≥1 procedure code for general administration of CAR-T therapy (e.g., XW033C3, introduction of engineered autologous chimeric antigen receptor t-cell immunotherapy into peripheral vein) or a specific approved CAR-T (I.e., XW033K7, introduction of idecabtagene vicleucel immunotherapy into peripheral vein) between 2017 and 2022. Diagnosis of CRS or any ICAN was based ≥1 related ICD-10 diagnosis code (e.g., CRS = D89.83X). Frequency of occurrence of CRS, symptoms of CRS, ICANS symptoms, and severity of CRS or ICANS is described (severity based on validated clinical algorithm). Time to CRS and ICANS was calculated as the interval from CAR-T administration to first reported diagnosis, respectively. Results: 212 pts met the study criteria including 77 b-cell lymphoma, 64 multiple myeloma, 47 follicular lymphoma, 13 mantle cell lymphoma and 11 acute lymphoblastic leukemia pts. The majority were male (54.7%); median age was 60 years. Overall, 100 (47.2%) pts were diagnosed with CRS (any grade) while 82 (38.7%) pts experienced any ICAN symptoms. The top three CRS symptoms were fever (57.5%), hypotension (31.1%) and tachycardia (21.2%). The top three ICANS symptoms were obtundation (18.4%), confusion (12.7%), and delirium (12.7%). Of CRS pts, 25.0% experienced severe symptoms, including renal insufficiency (10.0%), atrial fibrillation (9.0%), ventricular tachycardia (7.0%), and cardiac failure (2.0%). The median time to development of CRS was 2 days (range 0-23 days). Of pts. experiencing ICANS, 72.0% experienced any mild symptom and 53.7% experienced any severe symptom, including obtundation (47.6%), aphasia (13.4%), and seizures (1.2%). The median time to development of ICANS post CAR-T therapy was 6 days (range 0-26 days). Conclusions: Our study is the first real-world, U.S. evaluation of the frequency and time to toxicities associated with CAR-t therapy across multiple hematologic malignancies. While well-described in RCTs these data highlight the need for the continued development of clinical and therapeutic approaches to minimize their impact on the effectiveness of CAR-T.
COVID-19 vaccination in patients with cancer: Results from survey based observational study.
Authors: Polimera Hyma Vani , Pomerantz Lauren Danielle , Guare Emma , Zhu Junjia , Joshi Monika
Published: June 2023

e18897

Background: COVID‐19 (C19) disproportionately affects those with comorbid medical conditions, leading to significantly higher mortality rate. Cancer(ca) is a well-studied risk factor for developing severe C19 disease. However, ca patients (pts) were largely excluded from clinical trials evaluating the safety and efficacy of 3 FDA-approved C19 vaccines (vax). We aim to study this highly vulnerable pts’ behavior and outcomes regarding C19 vax. Methods: A prospective and observational single center study. Adult ca pts (18-89 years) seen in clinics from Nov 2021-Sept 2022 were randomly interviewed using telephone surveys after a verbal consent. Type of ca and therapy data were collected from pts’ medical records. The survey included C19 disease status, vax status positive (vax+) or negative (vax-), reason for vax status, s.e, impact on ca Rx or ca progression. Our primary objectives were to assess the rate of vaccination in the adult ca pts and identify barriers to vaccination. Secondary objectives were determining factors associated with vax acceptance vs. hesitancy, identifying s.e of C19 vax, and effect of C19 vax on clinical outcomes in ca pts. Results: N = 170 [Males 82 (48.2%) and females 88 (51.8%)]. The median age was 65 years. Among 170 pts, 58.2% had solid malignancy, 40% had hematologic malignancy, and 1.8% had both solid and hematologic malignancy. Refer to Table 1 for outcomes data. Overall, 146 (85.9%) pts received C19 vax. C19 infection positive (C19+) in 49 (28.8%) pts. Of them 9 (18.4%) pts required hospitalization. The vax rate of prior C19+ pts was 73.5% compared to 90.9% in C19 infection negative (C19-) pts (p = 0.0013). Demographic factors were not significantly associated with vaccine uptake. A total of 50% pts developed s.e from vax. However only one patient (0.68%) reported a delay in ca treatment due to C19 vax and believed that vax affected the ca outcome. Conclusions: Our results demonstrate that majority of the ca pts were vaccinated against C19 and tolerated it well, with minimal side effects. Prior C19 infection significantly decreased vax uptake. Vaccination did not have notable adverse effect on ca outcomes. Oncologists should discuss the importance of C19 vax in the context of ca to avoid misconceptions and hesitancy. Clinical trial information: NCT04953065 . [Table: see text]
A powerful random forest-based pipeline for accurately identifying the structural variants on panel sequencing data.
Authors: Zhuang Guiwu , Chen Yu-Long , Tang Hongzhen , Wang Wei , Wang Peng , Gao Edmond , Fang Shencun
Published: June 2023

e18898

Background: Numerous studies have reported that the identification of structural variants (SVs) can provide ideal targets for cancer targeting therapy. However, on the one hand, the current algorithms exhibited different performances in detecting different types and sizes of SVs; on the other hand, the whole-genome/exome sequencing for detecting SVs is costly, and only a portion of SVs can be used to guide the clinical treatment of cancer patients. Therefore, developing a powerful, highly accurate, and cost-effective pipeline to detect SVs for clinical application is urgently required. Methods: Based on simulated sequencing data, four common SV detection tools (Delly, Lumpy, SvABA, and Manta) were used to select the best performance one. This tool will be used for detecting SVs in panel sequencing data. Then, Integrative Genomics Viewer (IGV) was used to annotate these SVs as true positive (TP) and false positive (FP) SVs. These annotated TP and FP SVs were used as input in the random forest classifier (RFC) to train a model for predicting the true or false positive SVs. Two independent testing cohorts and standards were used to validate this constructed pipeline. In addition, IHC/FISH experiments were performed to further validate these predicted TP SVs. Results: In the simulation data, the detection tool with the highest SVs identification sensitivity was Delly. By Delly, a total of 1,303 SVs in 384 tumor samples were detected. Based on annotated TP and FP SVs, an RFC model was constructed in the training cohort, which predicted 334 and 560 TP and FP SVs, respectively. The accuracy rates (AR) were 99.85% and 100% of TP and FP SVs, respectively. The predicted TP and FP SVs by constructed pipeline also showed a high accuracy rate in cohort 1 (98.96% and 99.24% of TP and FP SVs, respectively), cohort 2 (98.48% and 100% of TP and FP SVs, respectively), and standards (the mean accuracy rate was 90%). Finally, based on these TP SVs predicted by the constructed pipeline, FISH/IHC experiment results further verified the robustness of this pipeline (the man accuracy rate was 95.83%). Conclusions: The constructed random forest-based pipeline can robustly and accurately identify SVs based on panel sequencing data, which will be helpful for clinical decision-making.
Assessing the willingness to participate in future clinical trials.
Authors: Shaver Amy L. , Nikita Nikita , Banks Joshua , El Khoury Christiane , Melillo Rebecca J. , Song Yawei , Lu-Yao Grace L. , Leader Amy
Published: June 2023

e18899

Background: Sidney Kimmel Cancer Center at Jefferson in Philadelphia, PA conducts a bi-annual survey to identify and describe their catchment area. Since patient participation is critical to the future of cancer clinical trials yet less than 6.3% of cancer patients participate nationally, the most recent survey included questions related to willingness to participate in future clinical trials. Survey items included the willingness to participate in future clinical trials and offer insight into reasons to and not to participate. Methods: A cross-sectional study was conducted among adult residents in southeastern Pennsylvania and New Jersey from July 2022 to August 2022 and included 2,744 respondents. Survey questions were included to elucidate reasons for or against willingness to participate, cancer attitudes or beliefs, health literacy, and numeracy. Characteristics were summarized with frequency counts and percentages. Frequency counts were weighted. Weights were calculated by iteratively adjusting the marginal values of select demographic characteristics to match the population totals of each surveyed county based on population totals obtained from American Community Survey data. Results: The weighted sample represented the 3,889,048 residents of the catchment area. Survey respondents self-identified as Hispanic (9.3%), non-Hispanic (NH) White (57.8%), NH Black (19.0%), and NH Other (14.0%). Only 50.8% of the population expressed willingness to participate in a future clinical trial. Over 50% of Hispanics, NH Backs, and NH Whites were willing to participate in future trials (Table). Those who did were more likely to be married (51.4%) and NH White (61.1%), see table. When asked the reason for future participation the strongest response was the possibility of learning more about my health or medical condition (67.4%). The weakest reason was similar between both my family (12.4%) and my doctor (14.2%) who would want me to participate. The strongest reason against participation is “worry about experiencing side effects” (52.6%). Conclusions: The results shed light on the need to ask catchment members when designing recruitment methods. Future endeavors involving community engagement and education may improve willingness to participate. [Table: see text]
Incidence of solid malignancies (SM) among patients with Waldenström macroglobulinemia (WM): Analysis of the SEER database (2000-2019).
Authors: Taneja Alankrita , Mishra Rahul , Arun Kumar Sumukh , Iyer Ajay , Hillengass Jens
Published: June 2023

e18902

Background: WM is an indolent disease with a median survival of ~ 16 years following diagnosis. We aimed to study the incidence of various SM among patients with WM, which can help in their targeted surveillance. Methods: We used SEER 17 registry to identify adult [ > 20 years(y)] patients(pts) with an index diagnosis (dx) of WM between 2000- 2019. We included ICD-O-3 codes 9671/3 (Lymphoplasmacytic lymphoma) and 9761/ (Waldenstrom macroglobulinemia) to identify index dx. Only first of the two codes was used if both were mentioned for same pt. Pts were grouped based on age at WM dx ≤60y (young) and > 60y (old) for analysis. We used ICD-O-3/WHO 2008 codes assigned to site of SM to identify subsequent diagnosis ( > 2months after index diagnosis) of SM. We included the first SM site, for pts with > 1 subsequent SM. We analyzed SM sites with > 15 patients. We excluded patients with diagnosis made from death certificate or autopsy. Follow up period was till December 2019. Demographics and treatment details were extracted using SEER Stat v 8.4.0.1 software. Statistical analyses were performed using R 4.2.2. Chi-squared test was used to calculate difference between categorical variables. Kaplan Meier method and log rank test were used to estimate overall survival (OS). Results: We identified 8099 patients with a dx of WM, of which 794 (9.8%) had subsequent SM. WM and SM were diagnosed at median (IQR) ages of 70 (62-76)y and 74 (67-81)y, with a median gap of 41 (20-79) months. Majority of WM survivors with SM were males (517/794, 65.1%), white (91.4%) and old ( > 60y) (79.2%) at WM diagnosis. Ten SM sites, each with > 15 pts were identified (Table). Most common site of SM in young WM females was breast, while it was lung and bronchus(LB) in the older group. In males, prostate, and LB were two most common sites in each age-groups. 1% of older male patients developed breast cancer. (Table1) Of note, thyroid was a common site, 9.3% of SM, in young WM female cohort. Cecum and most of brain cancers were noted among pts with old age at WM dx. Overall survival was poorest for LB. Conclusions: There was a 10% incidence of SM in WM survivors during 2000-2019. LB cancer carried worst OS among WM survivors and was the most prevalent, second to gender specific cancer, among patients with relatively younger onset WM. [Table: see text]
Effect of COVID-19 on mortality in patients admitted for DVT/PE with pre-existing cancer diagnosis at the beginning of the COVID-19 pandemic: A national inpatient sample study.
Authors: Campbell Andrew , Abuhelwa Ziad , Hamouda Danae M.
Published: June 2023

e18903

Background: Coagulopathy and thrombosis are commonly associated with both cancer and Coronavirus Disease 2019 (COVID-19) infection. Thus, it is thought that cancer patients with COVID-19 carry an even higher risk for thrombosis than each disease individually. Cohort studies using the COVID-19 and Cancer Consortium (CCC19) registry data have identified risk factors for development of in-hospital VTE and PE in patients with cancer and COVID-19, however the risk of in-hospital mortality and length of stay in this population remains unknown. Using newly-available data from the National Inpatient Sample in 2020, we compared rates of in-hospital mortality and length of stay between patients with and without COVID-19 infection admitted for DVT and PE with known diagnosis of cancer. Methods: The National Inpatient Sample was analyzed to identify all adult admissions with primary diagnosis of DVT and PE and secondary diagnosis of solid tumor or hematologic malignancy from April to December 2020. These patients were then stratified based on secondary diagnoses of COVID-19 infection. Rates of inpatient mortality and hospital length of stay were compared to non-COVID patients. The cases for COVID-19 infection, thrombotic events, and cancer were selected based on ICD-10 (International Classification of Disease) codes. ICD-10 codes used for solid tumor malignancies included breast, lung, prostate, colon, pancreas, liver, and rectal cancer. ICD-10 codes for hematologic malignancy included leukemia, lymphoma, and multiple myeloma. Chi square tests were utilized to check the significance of association between mortality, LOS and COVID-19 infection in the population admitted for DVT and PE. Results: There were a total of 13,856 patients admitted for DVT/PE with secondary diagnosis of solid tumor or hematologic malignancy from April to December 2020. Among this population, 80 patients (mean age 61 years) also had a secondary diagnosis of COVID-19 infection. Overall in-hospital death rate for cancer patients with DVT/PE was 5.2% (n = 720). Less than 1% (n = 5) of those patients had a secondary diagnosis of COVID-19 infection (P = 0.8547). Mean LOS with COVID-19 diagnosis was 4 days (95% CI 2.7 - 5.3) and without COVID diagnosis was 4.75 days (95% CI 4.5 - 5, P = 0.4483), showing no statistically significant difference. Conclusions: There was no statistically significant difference of mortality or LOS between COVID-19 and non-COVID-19 infected patients admitted for DVT or PE with secondary diagnosis of malignancy.
Estimated value-based pricing for blood-based colorectal cancer screening test versus multi-target stool DNA test.
Authors: Kisiel John B. , Fendrick A. Mark , Borah Bijan J. , Ebner Derek W. , Ozbay A. Burak , Vahdat Vahab , Estes Chris , Limburg Paul J.
Published: June 2023

e18911

Background: Stool-based colorectal cancer (CRC) screening with the multi-target stool DNA (mt-sDNA) test is a guideline endorsed strategy for average-risk individuals age ≥45 years and provides a reference for value-based pricing (VBP); maximum price at which a willingness-to-pay threshold is reached. Blood-based tests (BT) are an emerging screening option. Using recent reported BT performance data from the ECLIPSE study (Guardant Health, Inc.)1, the potential VBP of BT compared with multi-target stool DNA (mt-sDNA) was analyzed. Methods: Using the validated CRC-AIM model, we simulated a cohort of 2 million average-risk individuals who received screening with BT at 1, 2, or 3-year intervals or triennial mt-sDNA between the ages of 45-75 years. For BT, CRC sensitivity, advanced adenoma sensitivity, and specificity were based on reported clinical trial data (83%, 13%, and 90%, respectively). Adherence assumptions for BT and mt-sDNA screening were modeled at perfect (100%) or real-world mt-sDNA adherence (RWE). Key outcomes were life-years gained (LYG) per 1000 individuals vs no screening, and VBP of BT vs mt-sDNA ($895 vs $508) was assessed at a willingness-to-pay (WTP) threshold of $50,000 per quality-adjusted life-year. Results: The triennial mt-sDNA was more effective and less costly vs BT at all intervals with both perfect and RWE adherence at the current price. Compared with mt-sDNA screening, LYG of screening with BT was lower (320 vs. 241-314) and the VBP should be at most $49 and $11 and no-cost at the 1-, 2-, and 3-year intervals, respectively (Table), when perfect adherence is assumed. With RWE adherence, the LYG with mt-sDNA was 306 compared to 229-284 with BT across all intervals. To be comparable to RWE triennial mt-sDNA screening, the maximum VBP for BT would need to be $13 at the 1-year interval and no cost for 2- and 3-year interval. Conclusions: Compared to annual, biannual, and triennial BT, triennial mt-sDNA was more effective at all intervals and 44% to 102% less costly. The maximum price of BT should not exceed $49 to be considered a cost-effective option compared to mt-sDNA when WTP is 50,000. [Table: see text]
Practice efficiency of treatment with epcoritamab versus glofitamab in relapsed/refractory diffuse large B-cell lymphoma.
Authors: Meyer Kellie , Huang Danmeng , O'Day Ken , Lahue Betsy J. , Wang Anthony , Mutebi Alex , Brodkin Samantha , Jun Monika P.
Published: June 2023

e18919

Background: Bispecific antibodies are an emerging class of immunotherapies with demonstrated efficacy in the treatment of relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL). Since epcoritamab is administered subcutaneously, it provides an opportunity for reduced healthcare provider (HCP) and patient burden compared to intravenous (IV) glofitamab. This study assessed HCP and chair time saved treating R/R DLBCL patients with epcoritamab versus glofitamab. Methods: An efficiency model was developed to comprehensively capture time and resources utilized in the administration of epcoritamab and glofitamab from the perspective of institutional decision makers in the United States. The model was informed by the administration process and dosing schedules outlined in the pivotal publications as well as published literature examining HCP’s tasks and the time required to complete these tasks. A 6-month time horizon as was adopted as the base case due to its relevance in the Enhancing Oncology Model, and scenario analyses were performed examining various time horizons. Results: Treating patients with SC epcoritamab compared to IV glofitamab was estimated to reduce HCP time by 29% (45.4 hours for 19 doses of epcoritamab vs. 63.9 hours for 10 doses of glofitamab) and chair time by 38% (55.8 vs. 90.6 hours) per patient over a 6-month time horizon. Time saved for epcoritamab was mainly driven by glofitamab’s infusion time and required pre-treatment with obinutuzumab. For 100 hypothetical patients treated with SC epcoritamab vs. IV glofitamab, a savings of 3,478 chair hours was generated, which could free up capacity to treat 62 additional patients. In the scenario analyses examining different time horizons, the capacity savings advantage of epcoritamab over glofitamab remained. Conclusions: In this model, the use of SC epcoritamab improved practice efficiency compared to IV glofitamab. For institutional decision makers, reduced chair time may increase the total number of treated patients and lead to reduced waiting lists.
Impact of economic inequality on Kaposi sarcoma of the lung: A retrospective cohort.
Authors: Guevara Nehemias , Francis-Morel Garry , Perez Esmirna , Bustamante Alvarez Jean Gabriel
Published: June 2023

e18920

Background: Kaposi Sarcoma of the lung is a rare entity; it is unclear if a below-average household income has an impact on outcomes. Methods: This is a retrospective cohort study of patients with Kaposi Sarcoma of the lung that were admitted to acute care from 2016 to 2020. Data is derived from the National Inpatient Sample (NIS). We compared outcomes in 2 cohorts: those with household income < $50,000 versus those with > $50,000. The primary endpoint was differences in all-cause in-patient mortality. Secondary endpoints included differences in length of stay (LoS) and admission cost. Results: A total of 460 patients met inclusion criteria; 40% had income < $50K, and 60% > $50K (p < 0.001). There was a trend to male predominance (100% of < $50K, 95% > $50K; p 0.147) with a mean age of 39 (35 for < 50K, 41 for > 50K; p 0.015). Black patients were the most afflicted group (46%; 71% of < $50K, 29% > $50K; p < 0.001), followed by White patients (33%, 20% of < $50K, 43% of > $50K; p < 0.001). Additionally, patients with household income < $50K (40%; p < 0.001) and hospitals located in the South (43%, 48% of < $50K, 40% of > %50K; p < 0.001) and West (32%, 11% of < $50K, 46% of > 50K; p < 0.001) represented the largest group. Majority of patients were under Medicaid insurance coverage, however there was no relationship between Medicaid coverage and mortality (p = 0.709, CI 0.16-3.42). There was no difference in distribution based on primary payer, hospital bed size, hospital teaching status, and hospital ownership (p > 0.05). No differences in mortality were noted among groups (p 0.845). No differences in LoS were seen (p 0.560), but younger patients were more likely to have shorter LoS (p 0.033). Ultimately, no differences in hospitalization costs were noted (p 0.426). Furthermore, from the 460 patients with Kaposi lung sarcoma, 5 were post-transplant patients, and 130 were patients with HIV; in this sub-group of analysis, were no differences between ages. The mean age in patients with lung transplants was 39.5, and the HIV group was 40 years. The black population was the most affected, with an income below $50 000. Conclusions: Income did not impact mortality in patients admitted for Kaposi sarcoma of the lung. Black patients and patients with income < $50,000 represented the largest group. Nevertheless, more research is needed for better stratification and to elucidate many factors that play a role in the mortality of patients with Kaposi sarcoma of the lung.