bluuebunny/crossref_metadata_2025 huggingface dataset:
Hospitalization and post-discharge survival outcomes of adolescents and young adults with cancer.
Authors: Lazar Neto Felippe , Hidalgo Filho Cassio Murilo Trovo , Da Rocha Joao Wilson , Bonadio Renata Colombo , Hoff Paulo Marcelo
Published: June 2022

e18687

Background: Cancer incidence has increased among adolescents and young adults (AYA) over the last two decades. Younger patients often present with late diagnosis, aggressive disease, and are more likely to receive chemotherapy during cancer treatment. We investigated admission outcomes and post-discharge survival of AYA who were hospitalized after urgent admission. Methods: Retrospective cohort of patients with solid tumor diagnosis and age between 18 and 39 years, hospitalized after urgent admission to a tertiary, publicly-funded, cancer hospital in São Paulo, Brazil, from February 1st to December 31th 2021. We excluded patients with positive COVID-19 RT-PCR. We collected data on gender, cancer diagnosis, length of hospital stay, in-hospital mortality, chemotherapy infusion either before and during hospitalization; and last-follow up date and status. AYA admissions were compared to older adults (≥ 40 years [non-AYA]) admissions with chi-squared test. Overall survival (OS) after discharge between groups was analyzed with the log-rank test. Results: Of 4011 admissions, 312 were AYA. The median age was 34 (IQR 29-38) and most patients were female (63%). Compared to older adults (N = 3699), a higher proportion of AYA patients had breast cancer (25% vs 15%), central nervous system cancer (8.4% vs 2.6%), cervical cancer (12% vs 2.7%) and germinative cancer (4.5% vs 0.3%). The median length of hospital stay was 6 days (IQR 4-10). AYA were more likely to be under chemotherapy treatment during (11% versus 4%, p = 0.001) and within 30 days before hospitalization (32% vs 20%, p = 0.001). The overall in-hospital mortality rate was lower among AYA compared to older adults during the same period (12% vs 20%, p = 0.01). However, of those who died, a higher proportion were prescribed chemotherapy infusion before (38% vs 19%, p = 0.004) and during (15% vs 3.3%, p = 0.003) hospitalization; and a higher number of patients deceased on intensive-care unit beds, although the difference was not statistically significant (46% versus 36%, p = 0.2). Despite similar rates of 30-days readmissions (29% versus 26%, p = 0.3), AYA had better prognosis after discharge (mOS 295 days versus 181 days, p = 0.002). Conclusions: AYA patients had better hospitalization outcomes and were more likely to receive aggressive care near the end of life. Despite similar rates of early (≤ 30 days) readmissions, AYA had higher median overall survival after discharge compared to older adults. These finding should be taken into consideration when discussing hospitalization goals during admission of AYA with cancer.
Leveraging PrOFILE data to illustrate and benchmark the Institute of Medicine quality aims in global pediatric oncology.
Authors: Gonzalez-Guzman Miriam , Riley Elizabeth , Le Mai An , Forrest Heather , Friedrich Paola
Published: June 2022

e18706

Background: PrOFILE is a dynamic 360o evaluation of health service delivery that helps care teams and institutions committed to increasing childhood cancer survival define an improvement strategy. PrOFILE stands for Pediatric Oncology Facility Integrated Local Evaluation. As of December 2021, PrOFILE has been utilized in over 130 facilities from over 25 countries around the globe. The standard outputs are presented by module, which reflect the patient-care continuum. The Institute of Medicine (IOM) has proposed six aims for improvement to drive fundamental change in health care delivery. The IOM Committee recommends periodically evaluating progress and developing strategies for overcoming barriers.However, a tool to assist facilities to set a baseline and periodically assess progress does not exist. We evaluated the feasibility of leveraging PrOFILE data to identify (1) the status of each quality aim as defined by IOM and (2) the status compared to facilities in the same country or region. Methods: This study employed a multi-step mapping approach. We first mapped the 1,279 PrOFILE variables to the six IOM quality aims. Mapping was first performed independently by two authors, then reviewed by PrOFILE experts to achieve consensus. Each variable could only contribute to one aim. We then validated the mapping by running the previously collected data available from two cohorts (one with 13 and one with 17 facilities) and benchmarking institutional data to cohort data. Quality improvement experts and local stakeholders provided feedback on further use of the illustrations and benchmarks. Results: We identified 305 PrOFILE variables that reflect the IOM quality aims (Table). More PrOFILE questions could be used as proxy for safety, effectiveness, and timeliness aims, than patient-centeredness, efficiency, and equity (Table), however, all domains could be represented. Benchmarking the institution results to the regional or country cohort results allowed for context-relevant insightful benchmarking. Framing PrOFILE results utilizing the IOM six aims allowed local healthcare teams and relevant stakeholders to evaluate their baseline and set targets for improvement. Conclusions: This exercise demonstrates the feasibility of leveraging PrOFILE data to assess institutional alignment with the IOM quality aims. The results allow illustrating, benchmarking, and engaging with stakeholders in conversations aimed at improving delivery of pediatric oncology care in global real-world settings utilizing this perspective. Future PrOFILE reports will incorporate this feature, supporting establishing a baseline and tracking of progress over time.[Table: see text]
A real-world evidence of immunotherapy adoption in non-small cell lung cancer (NSCLC) treatment and its transition from platinum-refractory to the first line of therapy.
Authors: De Marchi Pedro , Nazareth Aguiar Pedro , Paes Rafael , Costa e Silva Matheus , Favato Barcelos Isabella , Taveira Gabriela Monte Tenorio , Montella Tatiane Caldas , Ferrari Bruno Lemos , Barrios Carlos H. , Ferreira Carlos G. M. , Dienstmann Rodrigo
Published: June 2022

e18714

Background: over the past few years, multiple clinical trials have shown that immune checkpoint inhibitors (ICI) are active in NSCLC treatment. In 2015, survival improvement was demonstrated with second line immunotherapy. More recently, benefit was proven in the first line setting, both with ICI alone or in combination with chemotherapy. How fast the medical community has incorporated these advances into its clinical practice needs to be evaluated, as well as ICI efficacy in a real-world setting. Methods: retrospective analysis of the Oncoclinicas Data Lake was carried out to extract and curate information on the use of ICI in NSCLC patients from 2015 onwards, as well as survival outcomes from start of treatment to death or last follow-up. Patients with actionable driver alterations were excluded from this analysis. Results: 767 patients were identified. Median age was 72 years, 54% were male. The number of patients treated with ICI increased dramatically in the period, from 13 in 2015 to 243 in 2020. Most patients (86%) received ICI in the second line or beyond in 2015, while in 2019 and 2020 the preference was immunotherapy in the first-line setting (60%). The transition from platinum-refractory to the first line was observed for both ICI single agents and ICI combinations. As of 2021, 75% of ICI + chemotherapy treatments take place in the first line setting and 54% of ICI monotherapy treatments are given in first line setting. Overall, median overall survival was 15.7 months for first line setting use of ICI (CI 95% 12.2-19.6) and 11.6 months for second line and beyond (CI 95% 8.9-14.2). Survival rates at 12 and 24 months for first line ICI use were 56% and 48.5% and for second line and beyond 35% and 25.5%, respectively. Conclusions: ICI was promptly incorporated into the treatment of NSCLC and its use has shifted from platinum-refractory to treatment-naïve setting, mostly with combination regimens. Our cohort shows real-world overall survival rates comparable with published literature, despite a more elderly population than clinical trials.
Is ECOG-PS ≥3 appropriate to guide rehabilitation referral decisions? Using patient-reported outcome measures to examine the prevalence of functional disability in patients with ECOG-PS 0-2.
Authors: Wood Kelley C , Hidde Mary , Kendig Tiffany , Ronnen Ellen A. , Carroll Rachel , Giri Smith , Williams Grant Richard , Pergolotti Mackenzi
Published: June 2022

e18724

Background: Outpatient physical or occupational therapy (PT/OT) can optimize cancer patients’ performance status and ability to complete instrumental activities of daily living (IADL). The American College of Sports Medicine recommends referral to PT/OT for those with Eastern Cooperative Oncology Group performance status (ECOG-PS) ≥3/5. However, ECOG-PS alone may not accurately indicate needs for PT/OT. We used functional patient reported outcome measures (F-PROM) to quantify the prevalence of functional disability for cancer patients with favorable ECOG-PS (0-2) starting a new line of systemic therapy. Methods: Patients with cancer at a multi-office community-based oncology private practice who were enrolled in a clinical trial (NCT04852575) completed a validated online geriatric assessment (the Cancer Aging Resiliency Evaluation) including F-PROM before starting a new line of systemic treatment. F-PROM included: Patient Reported Outcome Measurement System (PROMIS) - Cognitive Function (4 item, T-score = 41-80); impact of physical/emotional problems on social activities (social impact, 1-item); ability to walk one block (1-item); pain (0-10); and ability to perform nine IADL (3-point Likert scale). We extracted clinical characteristics from medical records, then used descriptive statistics and established F-PROM disability cut off to quantify the prevalence of functional disability. Results: Most patients (N = 86) were female (58%) and diagnosed with stage 3 or 4 (68%) breast (33%) or gastrointestinal cancer (24%). The mean±SD age was 64.3±10.7 years. ECOG was 0 (66%) or 1 (34%); none had ECOG-PS of >2. Across F-PROM, prevalence of disability ranged 24% (cognitive function) to 42% (social impact), see Table. IADL disability was reported by 31% of patients; median number of unique IADL disabilities was 3 (IQR = 1-4). Most common IADL disabilities were housework (29%), shopping (19%), ability to get to places out of walking distance (16%), and meal preparation (14%). Conclusions: Despite favorable ECOG-PS (0-1), 24 to 41% of patients starting a new line of systemic therapy in this study had one or more needs amendable to PT/OT. Future work should identify strategies to integrate F-PROM into routine oncology practice to identify rehabilitation needs and evaluate if subsequent PT/OT improves patient outcomes. Clinical trial information: NCT04852575. [Table: see text]
Real-world evidence of impact of atrial fibrillation (AF) on clinical and economic outcomes in patients with chronic lymphocytic leukemia (CLL).
Authors: Yang Keri , Liu Tom , Tang Boxiong , Chanan-Khan Asher
Published: June 2022

e18729

Background: While the incidence of AF in CLL has been increasing, the implications of AF in real-world CLL patients remain understudied. This study aimed to assess the impact of AF on clinical and economic outcomes in CLL patients. Methods: This retrospective observational study used the US IBM MarketScan® commercial claims/Medicare supplement database (2017-2020) to identify newly diagnosed CLL patients (≥18 years) and incidence of AF after index date, defined as the first CLL diagnosis date. Patients were followed for ≥3-months pre-index, and from index to last follow-up or death. In addition to patient characteristics, clinical outcomes (incidence of heart failure [HF], bleeding and stroke) and economic outcomes (costs and healthcare resource utilization [HRU]) were compared between CLL patients with AF (CLL+AF) and CLL patients without AF (CLL-AF). HRU was evaluated by inpatient, outpatient, ER, and pharmacy visits. Multivariable regression analyses were conducted to examine the association between AF and clinical outcomes. Results: Among a total of 16,800 newly diagnosed CLL patients included in the study, 20% developed AF. CLL+AF were significantly older than CLL-AF (median: 77 vs 62 years; P < .001). Compared to CLL-AF, CLL+AF also had significantly more comorbidities at baseline, as shown by higher Charlson comorbidity index (CCI) (median: 1.0 vs 3.0; P < .001) and more patients with previous AF history (0.3% vs 8.4%; P < .001). Further assessing clinical outcomes in CLL+AF vs CLL-AF, significantly higher incidence of HF (26.3% vs 3.0%; P < .001), bleeding (12.2% vs 4.8%; P < .001) and stroke (6.6% vs 1.2%; P < .001) were observed. For HRU, CLL+AF were reported to have significantly higher rates of ER visits (29.4% vs 12.9%; P < .001) and hospitalizations (42.2% vs 14.5%; P < .001) than CLL-AF. In CLL+AF, the average total AF-related costs were $13,520.21 within 30 days after AF diagnosis, and $22,304.82 within 60 days after AF diagnosis. Controlling for demographics and comorbidities, multivariable regressions reported statistically significant associations between AF and HF, as well as AF and stroke (Table). Conclusions: This real-world study reported significantly higher incidence of HF, bleeding and stroke incurred by CLL patients who developed AF compared with those who did not. The presence of HF, bleeding and stroke further increased HRU and costs. These findings highlight the importance of better disease management and treatment selection to prevent AF in CLL patients.[Table: see text]
Complementary and alternative medicine exposure in oncology (CAMEO) study: A multi-institutional cross-sectional analysis of patients receiving cancer treatment.
Authors: Hutten Ryan J. , Weil Christopher R. , Barney Brandon M. , Fagerlin Angela , Gaffney David K. , Gill David Michael , Whipple Gary , Rhodes Terence Duane , Scherer Laura , Suneja Gita , Tward Jonathan David , Werner Theresa Louise , Evans Jaden , Johnson Skyler B
Published: June 2022

e18739

Background: Compared to standard of care treatments, complementary and alternative medicine (CAM) use has been associated with decreased survival in cancer patients. CAM includes a broad range of treatments including vitamins/minerals, herbs/supplements, special diets, and mind/body interventions. An improved understanding of contemporary prevalence, predictors and intended goals of CAM use is needed to improve the cancer patient experience and guide shared decision-making regarding risks and benefits of their use. Methods: A cross-sectional survey of prospectively enrolled adult cancer patients treated at a large regional non-profit cancer center and an NCI-Designated Comprehensive Cancer Center between 2020 and 2021 was collected. Patients receiving cancer treatment were selected for analysis and grouped based on reported CAM use. Differences between CAM users and nonusers were assessed by chi-squared for categorical and two-sample t-test for continuous variables. Predictors of CAM use were identified with univariable and multivariable logistic regression. Results: Of 749 respondents, 83.31% had heard of or been recommended a CAM. Rates of CAM use during cancer treatment were highest for vitamins/minerals (56%), mind/body (52%), herbs/supplements (38%), special diets (30%), and other (12%). In the most common primary cancers, overall rates of CAM use were high (Breast: 84%, prostate: 66%, lung: 79%). Most patients (91%) use CAM in addition to conventional treatments. The intended goal of CAM therapy was most often management of symptoms (42%), treatment of cancer (30%), and mental health (15%). CAM users were younger than non-users (median age 62 years [y] vs 65y, p = 0.03). Females had higher rates of CAM use compared to males (86% vs. 78%, p < 0.01). Patients with incurable cancer had higher rates of CAM use than those with curable cancer (82% vs. 72%, p < 0.01). Predictors of CAM use on multivariable model include female gender (OR 2.5, p < 0.01) and incurable cancer (OR 2.5, p < 0.01). During cancer treatment, patients using CAM used multiple therapies and therapy types, including an average of 3.3 vitamins/minerals, 3.1 herbs/supplements, 2.5 mind/body exercises, and 1.6 special diets. Conclusions: CAM use is common among cancer patients receiving radiation, chemotherapy, and or surgery. Many patients are taking multiple CAM therapies during treatment with one third of patients using CAM with the intended goal of treating their cancer. This data provides details about and predictors of CAM use and provides information to guide patient-physician discussions.
Predicting major bleeding events in anticoagulated cancer patients with venous thromboembolism using real-world data and machine learning.
Authors: Muñoz Martín Andrés J. , Palacios María Luisa , Souto Juan Carlos , Obispo Berta , Aparicio Jorge , Garcia-Palomo Andres , Sanchez Antonio , Aguayo Cristina , Gutierrez Abad David , Viñuela-Benéitez Maria Carmen , Benavent Diego , Taberna Miren , Arumi Daniel , Hernández-Presa Miguel Ángel
Published: June 2022

e18744

Background: Evidence regarding the clinical predictors of bleeding risk in patients with cancer and venous thromboembolism (VTE) is lacking. Our aim was to develop a predictive model to assess the risk of major bleeding (MB) in anticoagulant-treated patients with active cancer during the first 6 months following VTE diagnosis. Methods: Observational, retrospective, and multicenter study based on the secondary analysis of unstructured clinical data in electronic health records (EHRs). Using the EHRead technology, based on Natural Language Processing (NLP) and machine learning (ML), data were collected from EHRs from 9 Spanish hospitals between 2014 and 2018. The study population comprised all adult cancer patients with a diagnosis of VTE under anticoagulant treatment and no history of MB. This population was downsampled to prevent bias and class imbalance. A total of 94 patient characteristics were explored, and Random Forest (RF) feature selection was performed to identify the most relevant predictors. Multiple algorithms were used to train different prediction models, which were subsequently validated in a hold-out dataset. The model with the best performance metrics (i.e., ROC-AUC) was selected as the final model. Results: Among a source population of 2,893,208 patients, 21,227 anticoagulant-treated patients with VTE and active cancer were identified from EHRs. Of these, 53.9% men, with a median age (Q1, Q3) of 70 (59,80) years. The median duration of follow up across all patients was 0.7 (0.11, 2.03) years. During the study period, estimated in-hospital prevalence of cancer-related VTE was 5.8 %. The most common type of VTE at baseline was deep vein thrombosis (68.2 % of patients), followed by pulmonary embolism (28.4%). The most frequent primary cancers were colorectal (10.1%) and lung cancer (8.5 %). Of all trained and validated models, the RF approach yielded the best performance, with a ROC-AUC = 0.7. The following predictors of MB were identified: hemoglobin levels, presence of metastasis, patient’s age, platelet count, leukocyte count, and serum creatinine levels. Conclusions: This is the first multicenter study to use NLP to extract the unstructured information from EHRs to develop a predictive model for MB in anticoagulated cancer patients with VTE. These results may improve the prevention and management of bleeding in these patients.
Post-acute sequelae of SARS-CoV-2 infection in patients with cancer.
Authors: Warner Jeremy Lyle , Pinato David J. James , Mishra Sanjay , Saliby Renee Maria , Hwang Clara , Gulati Shuchi , McKay Rana R. , Labaki Chris , Griffiths Elizabeth A. , Jani Chinmay , Yu Peter Paul , Portuguese Andrew Jay , Puc Matthew , Egan Pamela , Shah Sumit , Kasi Anup , Berg Stephanie A. , Flora Daniel Blake , Accordino Melissa Kate , Shah Dimpy P ,   COVID-19 and Cancer Consortium
Published: June 2022

e18746

Background: Most patients with cancer and COVID-19 will survive the acute illness. The longer-term impacts of COVID-19 on patients with cancer remain incompletely described. Methods: Using COVID-19 and Cancer Consortium registry data thru 12/31/2021, we examined outcomes of long-term COVID-19 survivors with post-acute sequelae of SARS-CoV-2 infection (PASC aka “long COVID”). PASC was defined as having recovered w/ complications or having died w/ ongoing infection 90+ days from original diagnosis; absence of PASC was defined as having fully recovered by 90 days, with 90+ days of follow-up. Patients with SARS-CoV-2 re-infection and records with low quality data were excluded. Results: 858 of 3710 of included patients (23%) met PASC criteria. Median follow-up (IQR) for PASC and recovered patients was 180 (98-217) and 180 (90-180) days, respectively. The PASC group had a higher rate of baseline comorbidities and poor performance status (Table). Cancer types, status, and recent anticancer treatment were similar between the groups. The PASC group experienced a higher illness burden, with more hospitalized (83% vs 48%); requiring ICU (29% vs 6%); requiring mechanical ventilation (17% vs 2%); and experiencing co-infections (19% vs 8%). There were more deaths in the PASC vs recovered group (8% vs 3%), with median (IQR) days to death of 158 (120-272) and 180 (130-228), respectively. Of these, 9% were attributed to COVID-19; 15% to both COVID-19 and cancer; 15% to cancer; and 23% to other causes. Conversely, no deaths in the recovered group were attributed to COVID-19; 57% were attributed to cancer; and 24% to other causes (proximal cause of death unknown/missing in 38% and 19%, respectively). Cancer treatment modification was more common in the recovered group (23% vs 18%). Conclusions: Patients with underlying comorbidities, worse ECOG PS, and more severe acute SARS-CoV-2 infection had higher rates of PASC. These patients suffered more severe complications and incurred worse outcomes. There was an appreciable rate of death in both PASC and non-PASC, with cancer the dominant but not only cause in fully recovered patients. Further study is needed to understand what factors drive PASC, and whether longer-term cancer-specific outcomes will be affected.[Table: see text]
The impact of COVID-19 on patients with cancer in the Oncology Care Model in the U.S. Oncology Network during performance period 8.
Authors: Wilfong Lalan S. , Ives Hope , Indurlal Puneeth , Staggs Stuart , Payne-De Bock Judi , Neubauer Marcus A.
Published: June 2022

e18747

Background: The COVID-19 pandemic had a profound impact on cancer care delivery throughout the nation. Data regarding the outcomes of patients on cancer therapy who had COVID-19 is lacking. The US Oncology Network had 14 practices participating in the Oncology Care Model (OCM) during performance period 8 (PP8) which enrolled patients from 1/2/2020 to 7/1/2020. OCM enrolls patients with Medicare undergoing treatment for a cancer diagnosis. Utilizing OCM claims files, we evaluated the impact of COVID-19 on outcomes and costs for patients enrolled in the OCM during the first stages of the pandemic. Methods: Utilizing claims and episode data from the OCM, we were able to identify episodes with patients who had a positive COVID-19 diagnosis. Episodes were flagged with COVID-19 based on the ICD-10 code U07.1 on claims files. We were then able to compare the total cost of care (TCOC), inpatient costs and death rate to those patients in the OCM that did not have a COVID-19 ICD-10 claim. Results: 2.5% of patient episodes in PP8 had a positive COVID-19 ICD-10 claim. TCOC per episode increased 36% per patient from $34,340 for those without COVID-19 to $53,605 for those with COVID-19, a difference of $19,265 per patient. Inpatient costs increased from $3,276 for those without COVID-19 to $12,226 for those with a COVID-19 diagnosis. 8.9% of patients without a COVID-19 diagnosis died during the episode vs 20.0% of those with a COVID-19 diagnosis. Other costs including the cost of drugs did not significantly differ between the two groups. Conclusions: A diagnosis of COVID-19 for patients in the OCM receiving cancer treatment during PP8 led to a significant increase in costs, especially the costs of hospitalization. The death rate more than doubled for patients with COVID-19 during an OCM episode. Patients with Medicare and cancer undergoing treatment were at high-risk for complications and death from COVID-19 during OCM performance period 8.
Clinical impact of SARS-CoV-2 delta variant infection in tumor patients and the impact of vaccination on different cancer treatment regimens.
Authors: Hempel Louisa , Piehler Armin , Gandorfer Beate , Veloso de Oliveira Julia , Philipp Patrick , Robert Sebastian , Axel Kleespies , Schick Cordula , Fleischmann Bastian , Schweneker Katrin , Milani Valeria , Schenk Kristina , Ebner Florian , Donhauser Lara , Zehn Dietmar , Hempel Dirk
Published: June 2022

e18750

Background: Data on SARS-CoV-2 infections in oncological patients in the outpatient settings are scarce. Methods: During the spread of the delta variant between April 2021 and September 2021, a total of 10.677 patients were tested for SARS-CoV-2 infection by RT-qPCR in seven outpatient clinics in Bavaria, Germany. Results: Within the tested patient cohort, 4.960 patients (46.5%) suffered from a malignant disease (74% solid tumors and 26% malignant hematological diseases). This group was compared with 5.717 patients (53.5%) without a malignant disease (33.1% with other hematological diseases and 66.9% patients without a hematological or oncological disease). During the observation period, 119 (2.4%) patients with malignancies were tested positive (88 patients with solid tumors; 31 patients with malignant hematological diseases) compared to 115 positive patients (2.0%) in the control group. 32 of 119 positively tested patients (26.9%) suffering from malignant disease required hospitalization and 9/32 patients (28.1%) died during the clinical course. Conclusions: These observations are in clear contrast to data from patients we evaluated during the pre-delta variants period between 15 and 26 April 2020 in the same seven outpatient clinics. In this period, a total of 1.227 patients were tested for SARS-CoV-2 by RT-qPCR. 78/1227 patients (6.3%) were tested positive in RT-qPCR and most showed mild symptoms of infection. None of the SARS-CoV-2 infected patients died. These data were analyzed when no vaccination was available. These data were evaluated during a period where no vaccine was available. Vaccination of patients with malignancies with BiontechPfizer's mRNA vaccines was started in April 2021. The response to the vaccine was tested by an antibody assay (Elecsys Anti-SARS-CoV-2 S-immunoassay, Roche) at the earliest four weeks after the second vaccination. To assess the response, we compared five patient cohorts: Patients who received (i) B cell depleting antibodies, (ii) checkpoint inhibitors (ICI), (iii) chemotherapy, or (iv) tyrosin kinase inhibitors (TKIs), and (v) healthy controls. The patients treated with ICI or TKI showed a comparable vaccination response to the healthy patients, while patients receiving Rituximab/Obinutuzumab showed no significant humoral vaccination response at all. The more severe disease course of patients infected by the SARS-CoV-2 delta variant compared to the initial waves of infections strongly underline the importance of vaccination in cancer patients.
Consequences of the COVID-19 pandemic on new cancer visits to a comprehensive cancer center in New York.
Authors: Garcia Katherine , Rohatgi Abhinav , Okpara Chinyere , Winner Megan , Weber Jeffrey S. , Braunstein Marc Justin
Published: June 2022

e18752

Background: Studies on cancer patients during the COVID-19 pandemic have shown a decrease in new diagnoses, delays in care, and a shift to later stage disease presentations. Considering that NY has been an epicenter for COVID-19 in the U.S., we investigated its impact on new cancer diagnoses at the two campuses of NYU’s Perlmutter Cancer Center and hypothesized that there would be a decrease in presentations during the peak outbreaks in NY. Methods: We conducted a single center, retrospective analysis of new cancer diagnoses before, during, and after the peak of the pandemic between Dec 1, 2019, and Aug 31, 2020. Following IRB approval, subjects were identified using our cancer center database, which includes both inpatient and outpatient visits. Subjects were included regardless of their treatment plan. New diagnoses before COVID-19 (Dec to Feb), at first peak (March to May), and during the initial recovery phase (June-Aug) were assessed. No COVID-19 vaccines were available during this time. Results: As summarized in Table, during the initial COVID-19 peak, there was a substantial decrease in new patient visits with statistically significant differences seen by age and certain cancer types including breast, skin, and hematologic malignancies. In all cancers, there was a decrease in the proportion of new patient visits among those over age 75 during the peak. When confining analyses to breast, skin, and hematologic cancers, we saw a significant increase in the proportion of younger new patients at the peak period. We also observed an association between age and stage, with an increase in new stage I diagnoses in the younger (age 18-54) population at peak. Telemedicine was most utilized by the younger population during both peak and recovery periods. Conclusions: In this retrospective analysis, we found that during the initial COVID-19 peak, prior to vaccine availability, outpatient visits for hematologic and solid malignancies decreased at our cancer center in NY. The decrease in the proportion of all cancer types in elderly patients during the peak was likely related to hesitancy among this vulnerable population to seek care. The widespread use of telemedicine also likely contributed to the increased incidence in new patient visits in younger patients. Lessons learned from this experience can help guide outreach to vulnerable populations during future outbreaks, particularly by fostering telemedicine use among the elderly.[Table: see text]
Real-world (RW) treatment patterns and clinical outcomes for chemotherapy-based regimens in first line (1L) MSI-H/dMMR metastatic colorectal cancer (mCRC).
Authors: Chase Monica , Amonkar Mayur , Myer Nicole , Wang Tongtong , Turzhitsky Vladimir , Spira Alexander I.
Published: June 2022

e18755

Background: Until the global approval of pembrolizumab for the treatment of first line (1L) MSI-H/dMMR metastatic CRC (mCRC), newly diagnosed patients were managed with standard of care (SOC) treatments like chemotherapy with or without an EGFR/VEGF inhibitor, independent of biomarker testing or status. This study assessed the RW SOC treatment patterns and outcomes among 1L MSI-H/dMMR mCRC patients. Methods: A retrospective observational study was conducted among patients ≥18 years diagnosed with stage IV MSI-H/dMMR mCRC (index event) who received care in the US community-based Oncology Network. Eligible patients were identified between 01-Jun-2017 to 29-Feb-2020 and followed longitudinally until 31-Aug-2020, last patient record, or date of death: whichever occurred first. Baseline demographics, clinical characteristics, treatment patterns and clinical outcomes were reported descriptively. Key clinical outcomes of interest were time to treatment discontinuation (TTD), rw-progression free survival (rwPFS) and overall survival (OS). Kaplan-Meier survival analysis was conducted for all time-to-event variables. Results: 150 MSI-H/dMMR CRC patients treated in the 1L setting were included, of which 38.7% were treated with chemotherapy and 61.3% with chemotherapy + an EGFR/VEGF inhibitor. Nearly 75% of patients had an ECOG PS of 0-1, and the time from diagnosis of metastatic disease to initiation of 1L treatment was 5.2 (0.1, 1157.4) weeks. The median duration of follow-up was 12.9 (0.1, 37.1) and 16.2 (0.8, 36.2) months among patients treated with chemotherapy and chemotherapy + EGFR/VEGF inhibitors, respectively. Within the chemotherapy group, 86% received FOLFOX while 14% received FOLFIRI. Within the chemotherapy + EGFR/VEGF group, the most common regimen was FOLFOX+bevacizumab (67%). Conclusions: The totality of RW clinical outcomes in 1L MSI-h/dMMR mCRC suggest that despite the availability of chemotherapy and EGFR/VEGF inhibitors, an unmet need still exists that may be addressed with the recent availability of pembrolizumab for select patients. This data further supports the rationale for biomarker testing and personalized treatment of 1L CRC. Patient characteristics and clinical outcomes are summarized in the table.[Table: see text]
Evaluation of flibanserin's benefits and tolerability in women with low libido and a history of breast cancer.
Authors: Javaid Somi , Brown Louise
Published: June 2022

e18761

Background: After cancer treatment, women with sexual problems are more likely to have a poor quality of life and lack self-esteem. The 2018 American Society of Clinical Oncology guidelines on interventions to address sexual problems in people with cancer lists flibanserin as a treatment option for premenopausal women with low libido and a history of cancer. However, flibanserin's clinical trials excluded women with a history of breast cancer; as a result, there is limited information on benefits and tolerability in this subset of women. This retrospective chart review study was conducted to address this knowledge gap. Methods: Structured data (partner and menopausal status, medications, medical history, and weight) were extracted from predefined fields in the clinic's electronic health record (EHR) system using on-demand reports. Free-text encounter notes served as the data source for unstructured data (benefits and tolerability). Patients with low libido (R68.82 or F52.0) plus a history of breast cancer and ≥1 flibanserin prescription submitted through the clinic’s EHR system (“Flibanserin Plus History of Breast Cancer” [FPHBC] patient), seen at the clinic between September 1, 2015, and August 31, 2021, are included in this analysis. Encounter notes were reviewed to ensure patients had a personal history of breast cancer and terms related to their benefits and tolerability coincided with their actual flibanserin usage. Patients were categorized as either FPHBC-User or FPHBC-Non- Users based on verified flibanserin usage. Results: Findings from the 20 FPHBC-Users are presented in the table below. Conclusions: Flibanserin was generally well-tolerated among FPHBC-Users and most women reported benefits in libido. Unexpected benefits included improved orgasm and other non-sexual benefits. The clinic consulted with all patients’ oncologists before initiating flibanserin which likely contributed to its safe use. It is important to acknowledge that flibanserin is just one component of care, and the benefits and tolerability reported here may or may not be related to treatment alone. Our findings may not generalize to all clinical practices, and more extensive studies are needed to verify these findings.[Table: see text]
Prognostic value of the SEER-Medicare myelodysplastic syndromes risk score for a contemporary cohort of patients with MDS.
Authors: Afzal Amber , Fiala Mark A. , Jacoby Meagan , Walter Matthew
Published: June 2022

e18762

Background: Prognostication of patients with myelodysplastic syndromes (MDS) using IPSS-R is not possible in administrative database analysis. In 2014, a claims-based prognostic scoring system, the SEER-Medicare MDS Risk Score (SMMRS) was developed to risk-stratify MDS patients for overall survival using ICD9 codes {Uno, 2014}. In 2015, ICD9 codes were replaced by ICD10 codes. In this study, we updated SMMRS with inclusion of both ICD-9 and -10 codes, and studied its predictive value for overall survival, leukemia-free survival and initiation of treatment among MDS patients. Methods: Patients with MDS were identified through ICD-O-03 codes in the SEER-Medicare database between 2007 and 2017. SMMRS was calculated using MDS subtype, age, comorbidities, cytopenias, transfusion-dependence, and recent hospital admissions. We analyzed the association of SMMRS with overall survival, leukemia-free survival (time from MDS diagnosis to leukemia), and initiation of treatment (hypomethylating agents /stem cell transplant) in Cox proportional hazards models while adjusting for potential confounders. Results: Patients with MDS (N = 12,710) had a median age of 80 years, half were males, and most were Caucasians. SMMRS stratified patients into low-risk (n = 3155), intermediate-1 risk (n = 3255), intermediate-2 risk (n = 3121), and-high risk (n = 3209) categories at diagnosis. The overall survival, leukemia-free survival and treatment initiation for patients in each SMMRS category is summarized in Table. The 5-year overall survival for the entire cohort was 20%. At 5 years, 10% of the MDS patients had transformed to leukemia, and 1/3rd had started MDS treatment. Conclusions: SMMRS based on ICD-9 and -10 codes predicts overall survival, leukemia-free survival and MDS treatment initiation by stratifying MDS patients into 4 risk-categories. It can be utilized to design/analyze future observational studies.[Table: see text]
Retrospective single system analysis of side effects experienced with mRNA (Pfizer-BioNTech and Moderna) vaccinations in immunocompromised cancer patients compared with CDC VAERS database between December 15th, 2020, through July 31st, 2021.
Authors: Danak Shivang , Fadel Celine , Rynarzewska Ania , Dalton Drew , Jones Louise , Johnson Andrew Thomas
Published: June 2022

e18782

Background: Immunotherapy is becoming a common therapy in cancer patients. Cancer patients on systemic therapy are a vulnerable population, making them highly susceptible to illness from any infection. The purpose of this study was to collect and analyze data reported by patients regarding the side effects of COVID-19 vaccines (Pfizer-BioNTech and Moderna) in cancer patients with solid tumors receiving immunotherapy. Due to the lack of studies and inclusion of cancer patients in the clinical trials for the vaccine, it is pivotal to investigate of the effects of the SARS-2-CoV vaccine on patients receiving immunotherapy to begin to bridge the current gap in knowledge. Methods: We performed a two-phased retrospective analysis of adult patients (age ≥18 years) who received either Moderna or Pfizer-BioNTech COVID-19 vaccinations and were currently on immunotherapy (December 15th, 2020, through July 31st, 2021). Phase 1 included a tertiary health system (n = 15,910) in Northeast Georgia. Phase 2 involved cross-tabulation with the VAERS CDC database to compare results at a national level (n = 374,667). The primary endpoints were severity of side effects, timing of side effects and the relationship between the vaccines. The method to evaluate outcome was the Pearson-Chi-Squared test. Results: Results showed that patients on immunotherapy were more likely to have at least one side effect in the tertiary health system (OR 6.727 [95% CI, 2.748 - 16.465] compared to least two side effects in the national dataset (X² = 7.032, p < 0.05). This difference was driven by the Moderna vaccine recipients, demonstrating a higher likelihood of experiencing two or more side effects (X² = 6.159, p < 0.05). Those receiving the Pfizer-BioNTech vaccine did not demonstrate statistically significant side effects. The most common reaction noted was weakness in both datasets, which was more likely to occur after the Moderna vaccine. Gender analysis showed no difference in side effects in those receiving immunotherapy. In terms of timing of side effects, patients on immunotherapy (M = 10.66, SD = 25.1) had a delayed side effect onset of 10 days vs. four days. (M = 4.72, SD = 15.5, p < 0.05). Conclusions: Both local and national datasets demonstrate cancer patients receiving immunotherapy compared to those that were on immunotherapy, were more likely to experience mild vaccine side effects, specifically weakness being the most common. There was no statistically significant increase in more serious adverse reactions. Additionally, side effect onset was delayed in patients on immunotherapy. These findings provide a foundation for understanding mRNA vaccines in patients on immunotherapy, with future research needs involving larger sample sizes.
Booster third dose of SARS-CoV-2 vaccine effectively lifts the waning immune response of solid cancer patients.
Authors: Janzic Urska , Bidovec-Stojkovic Urska , Katja Mohorcic , Fokter Dovnik Nina , Caks Marina , Debeljak Jerneja , Korosec Peter , Rijavec Matija
Published: June 2022

e18791

Background: Since cancer patients (pts) are at increased risk of severe morbidity and mortality due to COVID-19, SARS-CoV-2 vaccination is crucial to prevent severe disease course. The efficacy and longevity of vaccine protection, however, is still in question. Methods: In this prospective observational study we assessed immunogenicity of cancers patients on active treatment for solid cancers in two Slovenian Oncology Centres receiving SARS-CoV-2 vaccine by detection of anti-SARS-CoV-2 S1 IgG antibodies in serum; before, after first and second dose, 3 and 6 months (mo) after complete primary course of vaccination and 1 mo after the 3rd booster dose. Samples with ≥ 175 ng/ml were considered positive. Results: There were 125 pts included in the study, 112 completed the primary course of vaccination with 2 vaccine doses and 34 received the booster 3rd dose. Out of 34 pts receiving booster 3rd dose, the majority received mRNA based vaccines (88%) for the primary course of vaccination and all patients received mRNA based vaccines for the booster 3rd dose. Median time from 2nd to booster 3rd dose of vaccine was 6.75 mo, median age of pts was 66 yrs and 59% were male. Patients were receiving chemotherapy (ChT), immune checkpoint inhibitors (IO) or targeted therapy (TT) in 9%, 56% and 35%, respectively. They achieved seroconversion in 94% after the 2nd and in 97% after the 3rd booster dose. Overall, the median anti-SARS-CoV-2 S1 IgG titer was 11,191 ng/ml (mean 25,394; range 0 – 100,000) after complete primary course of vaccination and 1892 ng/ml (mean 6413; range 0 – 72,000) 6 mo after, P < 0.0001. However anti-SARS-CoV-2 S1 IgG antibodies increased significantly after the 3rd booster dose with median antibody value 51,310 ng/ml (mean 51,787; range 0 – 100,000), P < 0.001. Only one pt in this group got infected with SARS-CoV-2 and had a mild disease course. Conclusions: Cancer pts treated for solid malignancies achieve a high rate of seroconversion through the primary course of vaccination. However, significant waning of immunity against SARS-CoV-2 is observed 6 months thereafter, which can be potentiated with additional 3rd booster dose of vaccine.
Prevalence and risk factors of preoperative anemia in patients undergoing hysterectomy for gynecologic cancer.
Authors: Chokshi Sagar Kamlesh , Leiser Aliza L. , Aikins James K. , Ananth Cande
Published: June 2022

e18800

Background: Anemia is a common preoperative finding that is associated with increased morbidity and mortality in patients with gynecologic cancers. This study identified the prevalence and risk factors associated with anemia in women undergoing hysterectomy for gynecologic cancer. Methods: The National Surgical Quality Improvement Program (NSQIP) database was queried from 2014 to 2020 for women above the age of 18 who underwent an open or minimally invasive hysterectomy and had a postoperative diagnosis of endometrial, cervical, ovarian, or fallopian tube cancer. Prevalence rates of anemia (hematocrit less than 30%) were calculated, and odds ratio (OR) with 95% confidence interval (CI) were estimated from logistic regression models adjusted for comorbidities. Results: A total of 62,708 patients were included in the analysis and 3351 (5.3%) had anemia. Mean hematocrit was 38.9 (SD 4.9). Overall, endometrial cancer was the most common diagnosis (73.1%) and mean age for all patients was 61.2 years (SD 12.1). Patients were predominantly non-Hispanic White (74.4%). Non-Hispanic Black patients were 1.98 (95% CI, 1.76 – 2.22) times at increased odds of anemia compared to non-Hispanic White patients. Similarly, Hispanic ethnicity was associated with increased odds of anemia compared to non-Hispanic White women (OR, 1.31; 95% CI, 1.14 – 1.50). Underweight patients had 1.64 (95% CI, 1.27 – 2.12) increased odds of anemia compared to normal weight patients. Compared to patients that underwent minimally invasive surgery, those that had an open abdominal hysterectomy were at over 2.7-fold increased odds (OR, 2.77; 95% CI, 2.53 – 3.04) of anemia. Those who reported greater than 10% loss of body weight in the last 6 months were 2.33 (95% CI, 5.06 – 6.81) times at increased odds of anemia. Other clinical factors associated with increased odds of anemia included metastatic cancer, American Society of Anesthesiologists (ASA) physical status classification score of 3 or more, and 2 or more comorbid conditions. Conclusions: There are multiple risk factors associated with preoperative anemia in patients undergoing hysterectomy for cancer. Identification of high-risk patients may help clinicians appropriately screen for and treat anemia prior to surgery.
Assessing the immunomodulatory effect of testosterone on outcomes of patients with advanced solid tumors treated with immunotherapy using the National Cancer Database.
Authors: Jayakrishnan Thejus , Wei Wei , Sena Laura , Patil Pradnya Dinkar
Published: June 2022

e18805

Background: Androgens have been described to suppress immune responses to various benign and pathogenic antigens, accounting in part for sex-based differences in incidence and severity of autoimmunity, infection, and malignancy. We hypothesized that testosterone exposure alters immune tolerance to solid tumors and outcomes to cancer immunotherapy. In an attempt to isolate the effect of testosterone exposure on outcomes to treatment with immunotherapy, we utilized age as a surrogate for testosterone level and sought to test whether younger men with higher testosterone would have different outcomes following immunotherapy than older men with lower testosterone, relative to women. Methods: National Cancer Database (NCDB) was queried for patients with advanced non-small-cell lung cancer (NSCLC), renal cell carcinoma (RCC), or melanoma, who received immunotherapy as first-line systemic treatment. These patients were divided by quartiles for age (Q1 (youngest) through Q4 (oldest)) and a Multivariate Cox proportional hazard model was used to test the interaction between sex and age on survival outcomes for each cancer type while adjusting for the Charlson-Deyo comorbidity index. Results: The study included 23,741 NSCLC (median age 66 years, interquartile range (IQR) 59 – 74), 1741 RCC (62 y, IQR 55 – 69), and 5825 melanoma (64 y, IQR 54 - 73) patients. The majority of patients were male – 52.3%, 71.3%, and 68.2% for each cancer type respectively. The median overall survival (OS) following first-line immunotherapy declined with increasing age in each cancer type (Q1 > Q4). No significant interaction between age group and sex for any of the cancer types was identified (table). Notably, male patients in any group and cancer type did not have statistically longer OS following immunotherapy than female patients. Conclusions: This study did not show that age altered sex-based differences in outcomes to immunotherapy in patients with advanced solid tumors. It is possible that age is a poor surrogate for testosterone level in this patient population, that additional confounding factors were present, or that testosterone exposure does not modify outcomes to immunotherapy. Future studies will directly correlate serum testosterone levels with outcomes to immunotherapy in patients with advanced cancer.[Table: see text]