bluuebunny/crossref_metadata_2025 huggingface dataset:
Electronic patient-reported outcomes in a cohort of patients with lung cancer treated in the community with shorter versus longer course PD1/PDL1 therapy.
Authors: Kolodziej Michael A. , Kwiatkowsky Lavi , Travis Patrick M. , Blau Sibel , Kuthiala Sejal , Telivala Bijoy Pankaj , Calkins Geoffrey , Parrinello Christina
Published: June 2023

e18810

Background: PD1/PDL1 (IO) therapy has been extensively studied as monotherapy and in combination with other IO therapy, chemotherapy and targeted agents. The side effect profile in the clinical trial setting in lung cancer has been extensively cataloged. However, patient-reported symptoms in the real world have not been evaluated and may help inform reasons for patient discontinuation of therapy or adverse clinical events. Methods: Patients from 3 community oncology practices were eligible for inclusion in the study if they had a primary diagnosis of lung cancer, started IO therapy (either monotherapy or in combination with chemotherapy) between Sep 2020 and June 2022 (with follow-up through Dec 31, 2022), and submitted at least 2 ePRO reports during treatment. We examined ePRO reports submitted by patients using a proprietary commercially available ePRO tool. Reports were categorized as high risk if they exceeded a clinical threshold for severity defined by the practices. We also examined the reporting profile by therapy type, and further stratified by time on treatments ( < 6 versus 6+ months of therapy). Results: There were 172 patients included in the analysis. Over this time frame, 68 patients received IO monotherapy and 104 received IO plus chemotherapy. Of these patients, 51% were male and 64% were 65+ years of age. Overall, 68 patients received less than 6 months of therapy and 104 patients received more than 6 months of therapy. There were 3159 reports submitted (1087 within the first 60 days of treatment) with a median of 13 reports per patient. Patients receiving IO plus chemotherapy reported more severe symptoms (symptom severity of 3 or greater on a 5-point scale) within the first 60 days of treatment than those receiving IO monotherapy (51% vs 34%, p = 0.03, Chi square). Regardless of treatment type, patients receiving < 6 months of therapy were more likely to report severe symptoms during this time period as compared to those on treatment for 6 months or longer (Table). 50% of reports triggered an alert based on severity, 22% led to a phone call and 1.3% an emergent office visit. Conclusions: ePROs can identify common side effects in lung cancer patients receiving IO monotherapy and IO/chemotherapy combinations. Early symptoms may define a population at high risk of early discontinuation. Aggressively managing these patients might result in a longer duration of therapy and better clinical outcome. [Table: see text]
Effect of pandemic-related reductions in cancer care delivery on different US health systems.
Authors: Janczewski Lauren M , Cotler Joseph , Merkow Ryan P , Palis Bryan E , Nelson Heidi , Mullett Timothy , Boffa Daniel J
Published: June 2023

e18811

Background: The Covid-19 pandemic caused unprecedented challenges in the diagnosis and evaluation of cancer. At the same time, cancer treatment was potentially impacted by significant constraints on patients and hospitals; however, the extent and differential influence on different hospital types is unknown. Our objective was to assess the patterns of treatment utilization to better characterize the impact of the first year of the Covid-19 pandemic on the US healthcare system. Methods: The National Cancer Database (NCDB) was queried for patients treated for any type of malignancy diagnosed from 2018-2020. Autoregressive models were used to forecast expected findings for 2020 based on observations from the prior two years. Descriptive univariate statistics using chi-squared tests were performed to compare observed-to-expected findings for treatment utilization and losses in provided care in 2020. Results: Overall, 1,229,654 patients underwent treatment for any newly diagnosed cancer in the NCDB in 2020, representing a 16.8% reduction compared to what was expected. Stratified by treatment modality, 146,805 fewer patients than expected underwent surgery, 80,480 fewer received radiation and 68,014 fewer received chemotherapy. Reductions in treatment were examined by hospital type. Academic hospitals experienced the greatest reduction in provided care (-105,093 patients, -19%) compared to community programs (-72,432 patients, -14%) and integrated networks (-40,827 patients, -13%). However, there were fewer hospitals in the academic cohort which exaggerated the impact on each hospital. Thus, academic hospitals lost approximately 484 patients per hospital while community hospitals lost 99 patients and integrated networks lost 110 patients per hospital. The losses in provided care were most dramatic in terms of surgical care, as academic hospitals operated on 314 fewer patients per hospital (-20%) than expected while community hospitals on average operated on 69 fewer patients (-16%) and integrated networks 71 fewer patients (-14%). Conclusions: The impact of the first year of the Covid-19 pandemic on cancer treatment was heterogenous, resulting in nearly twice the number of missed surgical patients, compared to other treatment modalities. While all hospital types were affected by the pandemic, cancer care at academic hospitals experienced disproportionate reductions, with each hospital losing more than 4 times the number of treated patients than other hospital types. Continued efforts to recover from the strain of the pandemic on the US healthcare system will need to consider the complex influence of treatment declines across hospital types and different cancer service lines.
Exploring the association between medical marijuana cardholder status and antiemetic overuse.
Authors: Baltz Alan , Peng Cheng , Gressler Laura Elisabeth , Bhatti Sajjad Akbar , Lewis Kanna
Published: June 2023

e18812

Background: The conscientious prescribing of antiemetics by chemotherapy-induced nausea and vomiting (CINV) risk was highlighted in the American Society of Clinical Oncology (ASCO) “Choosing Wisely” recommendations. The pharmacologic properties of medical marijuana (MMJ) and increased availability through legislation may allow for decreased incidence of CINV, however, little is known about the effects of MMJ legislation on the use of antiemetics. The objective is thus to assess the association between MMJ cardholder status in Arkansas and antiemetic overuse among cancer patients. Methods: A retrospective cohort was derived from the linked Arkansas All Payers Claims Database (APCD; 2013-2020) and MMJ card holder data (2013-2019). The cohort of interest consisted of individuals aged 18 and older with a chemotherapy claim in outpatient setting within 12 months of a cancer diagnosis. Exposed individuals had access to MMJ through an MMJ card. The primary outcome of interest was antiemetic overuse, as characterized by the ASCO recommendation. Antiemetic use was identified using prescription claims and coded as present if an antiemetic prescription was identified between two weeks prior to two days following chemotherapy receipt. Logistic regression, adjusted for baseline demographic and prescription characteristics, were used to calculate the adjusted odds ratios (aOR) and 95% confidence intervals (CI) of experiencing antiemetic overuse. Results: Within Arkansas, 22,139 individuals without a MMJ card received 167,084 chemotherapy cycles and 161 individuals with a MMJ card received 2,775 chemotherapy cycles. Antiemetic overuse was identified in 6.59% versus 5.87% of chemotherapy cycles among non-MMJ cardholders and MMJ cardholders respectively. The calculated aOR of antiemetic overuse among individuals with a MMJ card was .671 (95%CI:.567-.794) when compared to individuals without a MMJ card. Conclusions: The findings indicate that MMJ cardholders are significantly less likely to experience antiemetic overuse than individuals without MMJ cards. Increased awareness of ASCO’s recommendation and further investigation into the use, effectiveness, and safety of cannabis for the use of CINV mitigation is needed to inform patient and provider decision-making.
Real-world data on incidence of acute adverse reactions (AARs) reported in clinical practice.
Authors: Ferrari Laura A. , Dotti Katia F. , Mariani Gabriella , Redaelli Valentino I. , Re Barbara , Cataldo Erika , De Braud Filippo G.
Published: June 2023

e18814

Background: AARs are a significant concern in cancer treatment practice. The exact mechanisms underlying AARs are not fully understood. Their occurrence, even if rare, is unpredictable.This study updates the incidence of AARs in our large cohort of administrations as well as the impact on AARs of the increased number of targeted therapy drugs entered the clinical routine.Several new oncologic drugs have been rapidly developed in the last decade and many of them approved through a fast-track process.Medical Day Hospital of the Fondazione IRCCS Istituto Nazionale dei Tumori provides parenteral treatments for adult oncologic and hematological outpatients of the Medical Oncology Department, with a yearly average of 20,000 treatments, 25% of which are represented by investigational new drugs. Methods: A retrospective analysis of the AARs occurred between January 2020 and December 2022 was conducted.Overall, 61,096 treatments were performed. Therapeutic schemes included chemotherapies, targeted therapies, or both.Excluding the 14,667 investigational treatments, we analyzed 46,429 therapeutic regimens recorded in our database corresponding to 55,895 preparations of non-investigational drugs. Sixty % (33,580) of these preparations were chemotherapies and 40 % targeted therapies (22,315).All patients receiving chemotherapies were premedicated with steroids, while targeted therapies premedication was not always used.As part of the pharmacovigilance program, AARs occurring during injections of approved drugs were registered and reported to AIFA and Eudravigilance.It’s noteworthy that Covid-19 emergency interfered only marginally ( < 10 %) with the amount of administrations performed during that period. Results: A total of 496 AARs out of 55,895 administrations were registered (0,9 %), of which 358 (72 %) were reported with chemotherapies and 138 (28 %) with targeted therapies.The great majority of AARs reported was not severe. Fourteen reactions ( 3% ) were classified as severe, six of them in the targeted therapy group.In order of frequency, among chemotherapies, reactions were more often associated with oxaliplatin, liposomal doxorubicin, etoposide, paclitaxel, vinflunin, docetaxel, cabazitaxel, fludarabine, cisplatin (relative incidence ≥ 1,5 %), while among targeted therapies with rituximab and isatuximab (2,5 % respectively) and TDM1, panitumumab, daratumumab, durvalumab (≥ 0,5 %). Conclusions: This single institutional study suggests useful informations to support safe management of current oncological treatments.Compared to published data, our findings show a low incidence of AARs.Better recognition of potential risk factors and recommendations about premedications, infusions rate and infusion reactions’ management could improve treatment outcome and healthcare drug delivery-related cost.
Cancer therapy-associated thrombosis: A patient- reported outcomes (PROs) analysis.
Authors: Kosmidis Paris A. , Deligianni Elena , Kosmidis Thanos
Published: June 2023

e18819

Background: Cancer patients have a higher rate of thrombotic events (TEs) compared to the general population. Site, stage and treatment related factors, among others, contribute to this increased risk. Regarding treatment, various anticancer agents have been linked with increased risk of TEs. However, despite the incidence and impact of TEs, available data is inadequate, and most PRO-based analyses focus on individual agents. This analysis aims to utilise PROs to identify correlations between several anticancer agents and the incidence of TEs. Methods: CareAcross is an online interactive platform which collects Patient Reported Outcomes and provides support to cancer patients based on their condition and needs. Specific cancer treatments are among the collected data. Additionally, breast and lung cancer patients engaging with the platform were asked to report, among others, whether they have had a TE during their cancer journey. Data was aggregated and anonymised in order to evaluate the likelihood of TEs for each cancer treatment. Results: Based on data captured as of February 2023, 2011 breast (13% metastatic) and 573 lung (51% metastatic) cancer patients from 8 (mostly European) countries had provided real world data on cancer treatments and TEs. Among them, 144 (7.2%) breast cancer and 97 (16.9%) lung cancer patients reported TEs. Breast cancer treatments with higher than average association with TEs included aromatase inhibitors (8.1% of 569), tamoxifen (8.0% of 462), trastuzumab (9.0% of 221), CDK4/6 inhibitors (8.7% of 126). Among lung cancer treatments, cisplatin was associated with higher incidence than carboplatin (20.0% of 110 vs 13.4% of 112); others included pembrolizumab (21.8% of 78), pemetrexed (13.2% of 68), alectinib (29.4% of 34), osimertinib (12.1% of 33), afatinib (29% of 31). The Table provides a summary for this subset of anticancer agents. Conclusions: Based on the analysis of PROs from the CareAcross platform, it is confirmed that lung cancer patients have a higher risk of TEs compared to breast cancer patients. Moreover, certain anticancer agents appear to be linked with increased risk of TEs. In breast cancer, aromatase inhibitors and tamoxifen show similar association; in lung cancer, cisplatin appears to be a stronger factor compared to carboplatin. Finally, it is worth mentioning that some immunotherapies and targeted agents in lung cancer were found to have strong association with TEs. More PROs would improve the accuracy of these findings. [Table: see text]
Analysis of hospitalizations of patients with Kaposi sarcoma: A national population-based study.
Authors: Kanemo Philip Onyekaoso , Olafimihan Ayobami Gbenga , Akhiwu Ted , Edigin Ehizogie , Ibrahim Muhammad Bilal , Ijeli Anthonia , Aihie Osaigbokan , Castillo Dan Ran , Riaz Muhammad Nauman
Published: June 2023

e18821

Background: Kaposi sarcoma (KS) is a type of soft tissue sarcoma due to infection with human herpes virus 8 (HHV-8) and can be associated with acquired immunodeficiency syndrome [AIDS]. Recent national population data are scarce on reasons for hospitalizations, epidemiology, and hospitalization outcomes of patients with KS in the United States (U.S). Methods: Data were abstracted from the National Inpatient Sample (NIS) Database. This database is the largest collection of inpatient admission data in the U.S. It is a 20-percent stratified sample of all discharges from U.S. community hospitals, excluding rehabilitation and long-term acute care hospitals. The numbers in the databases are weighted to optimize national estimates. Hospitalizations for patients with KS were obtained by searching for hospitalizations that contained ICD-10 code “C46” as a principal or secondary diagnosis. The principal diagnosis is the main reason for the admission, while any other diagnosis other than the principal, are secondary diagnosis. The reason for hospitalization (or principal diagnosis) was recorded in descending order of frequency based on the ICD-10 code organ system category and specific principal diagnosis. The total number of KS discharges, baseline demographic characteristics, hospital length of stay (LOS), and total hospital charges were recorded. STATA 16 was used for analysis. Since NIS contains de-identified data, Institutional Review Board (IRB) review was waived. Results: There were 32 million discharges included in the 2020 NIS database. Of those, 2,785 hospitalizations were for patients aged ≥18 years, who had either a principal or secondary ICD 10 code for KS. Patients were mainly males (91%), black (40%), mean age of 48 years, inpatient mortality of 9.3%, mean LOS of 9 days, and mean total hospital charge of 132,476 U.S dollars. The 5 most common reasons for hospitalization by ICD 10 code categories were infections (52.4%), cardiovascular (6.5%), respiratory (6.1%), neoplasm and hematologic (5.6%), and skin (5.6%). The 5 most common specific principal diagnoses for hospitalizations were Human immunodeficiency virus [HIV] disease (29.1%), sepsis (12.7%), left leg cellulitis (2.7%), pneumonia (2.2%), and Acute kidney injury (1.8%). Conclusions: Hospitalizations for KS patients are mostly black middle-aged men, with high inpatient mortality, long LOS, and significant hospital charges. Infections and HIV were the most common reasons for hospitalizations. Management of underlying HIV and measures for prevention, early detection, and prompt treatment of infections in the outpatient setting are important in preventing hospitalizations of these patients.
Treatment patterns of triple-class refractory (TCR) multiple myeloma (MM) across the United States (US), Canada, and western Europe: A real-world observational chart review study.
Authors: Goyal Ravi K. , Frugier Gaelle , Rombi Julien , Esterberg Lizzi , Davis Keith L. , Hlavacek Patrick , Ren Jinma , Schepart Alex , Aydin Didem , DiBonaventura Marco
Published: June 2023

e18827

Background: Most patients with MM eventually become refractory to the three main therapy classes used to treat the disease: proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), and anti-CD38 monoclonal antibodies (mAbs). The objective of the present study was to describe the management of patients who have become TCR and how treatment strategies vary across countries. Methods: A retrospective chart review study was conducted across the US, Canada (CA), the UK, France (FR), Germany (DE), Spain (ES), Belgium (BE), the Netherlands (NL), and Sweden (SE). Oncologists/hematologists were recruited to abstract medical chart information from eligible patients (eg, diagnosed with MM, clinician-reported refractoriness to ≥1 IMiD, ≥1 PI, and ≥1 anti-CD38 antibody treatment) into an electronic case report form. Patients had to initiate their first (index) therapy after becoming TCR between 11/1/2015 and 12/31/2019. Chart abstractions were performed from February through October 2022. Demographics, baseline clinical characteristics, and treatment patterns were descriptively analyzed. Results: A total of 718 patients with TCR MM were included (61.4% male; median age at index = 64.2 years); 25.8% had an ECOG score of 2 and 28.7% had high cytogenetic risk [ie, t(4:14), t(14:16), and/or del(17p)]. Patients received a median of 3 treatment lines prior to their index therapy (19.4% were penta-exposed). In the post TCR setting, the most frequently used treatments included IMiDs (52.5%), PIs (40.8%), chemotherapy (CT; 27.3%), and mAbs (16.3%). Treatment class usage also varied significantly by country (Table 1). Conclusions: Our global chart review indicated that many patients reach TCR status after only a few lines of therapy and, after this point, retreating with IMiDs, PIs, and mAbs was common practice. The diversity of treatment classes used in this setting underscores the challenges across countries with managing a TCR population due to the lack of a clear standard of care. [Table: see text]
Health care provider and hospital decision-maker perceptions and beliefs on global environmental sustainability in the operating room.
Authors: Gorgun Emre , Dehipawala Sumudu , O'Hara Matthew , Naoumtchik Elena , Gangoli Gaurav , Ricketts Crystal , Tommaselli Giovanni
Published: June 2023

e18832

Background: Human health is intrinsically linked to the environment’s health; therefore, it is essential for the surgical oncology community, healthcare providers (HCPs) and hospital leadership alike, to incorporate environmentally sustainable practices, while continuing to provide high quality care. Hospital operating rooms (ORs) have a serious environmental impact due to a high rate of greenhouse gas (GHG) emissions, medical waste generation, and energy consumption. An evidence-based understanding of the environmental impact of ORs, as well as sustainability initiatives undertaken to decrease this impact, are crucial for generating and implementing appropriate policies and guidelines. This systematic literature review (SLR) aimed to determine the perceptions and beliefs of HCPs and decision-makers related to environmental sustainability in OR settings globally. Methods: An SLR was conducted following the Preferred Reporting Items for Systematic and Meta-Analyses (PRISMA) guidelines. Embase and PubMed searches were conducted to identify relevant studies published between January 2011 and November 2022. Results: The analysis incorporated thirty-four studies focused on the perceptions and beliefs of OR HCPs and decision-makers on sustainability initiatives. The majority of HCPs across all studies indicated a willingness to engage in these sustainability initiatives such as recycling, while noting frequent barriers that prevent participation, such as lack of awareness and education, hospital funding, facilities to carry out recycling processes, and guidance at the hospital level. One study noted that robotic and laparoscopic procedures, when compared to open procedures, generate greater quantities of waste and GHG emissions. In a survey of 400 anesthesiologists, the lack of support from the hospital and inadequate education were identified as the main barriers to OR recycling by more than 60% of respondents. Common sustainability initiatives suggested by HCPs included creating a sustainability steering committee, reducing overall OR waste via recycling and waste segregation, education and training dedicated to environmental sustainability and enforcement of rules and mandates for sustainability initiatives. Conclusions: HCPs are aware of potential opportunities to make ORs more environmentally sustainable and HCPs are willing, but not necessarily able, to participate in these efforts. Existing literature shows that HCPs have suggestions for how to minimize the environmental impact of the OR. Oncologists interested in adopting more sustainable practices can use this research as a guide for key themes and barriers to acknowledge when designing and implementing their own initiatives. More research is needed on the implementation and impact of sustainability initiatives on the environment.
Male breast cancer survival data and clinicopathological characteristics: A single-centre experience.
Authors: Tzouda Vasiliki , Zouki Dionysia , Kardara Vasiliki , Gouveris Panagiotis , Papaxoinis George , Tourkantonis Ioannis , Grivas Anastasios , Demiri Stamatina G , Tryfonopoulos Dimitrios
Published: June 2023

e18837

Background: Male breast cancer represents an uncommon entity accounting for less than 1% of all breast cancers. Although the understanding of biology, clinical presentation and management are evolving, a large knowledge gap still remains. Due to disease’s rarity, there is a significant paucity of data and most clinicians confront male cases by extrapolating from breast cancer in women. In this study we aim to report our institutional experience across a 17-year period about male breast cancer patients treated at the same centre. Methods: Clinical, histopathological, treatment and survival data of male breast cancer patients diagnosed between 2006 and 2022 at Second Department Medical Oncology in Saint Savvas Anticancer Hospital were identified and analyzed. Results: A total number of 24 male breast cancer patients were detected. The median age at diagnosis was 63 years. All participants had invasive ductal carcinoma. None of them presented with metastatic disease, while the majority had stage II disease (62,5%). All, except two cases, underwent mastectomy with either axillary or sentinel lymph node dissection. Regarding hormone receptors, 96% were ER positive and 25% were PR negative, while 79% were negative for HER-2 overexpression. As far as HER-2 low status is concerned, 42% (10 out of 24) were categorized as low expressors. From genetic point of view, data were available only for 9 cases, 2 of which were BRCA-2 mutant. Adjuvant chemotherapy (anthracycline and taxane based mainly) was administered in 75% (18 out of 24) of patients. At the time of last follow up (January 2023), only 5 participants presented disease progression, with metastatic lesions in bones, liver and lymph nodes. The median disease-free survival (DFS) was 48 months. In our cohort 5 deaths were recorded and the median overall survival (OS) was 58,5 months. Conclusions: Male breast cancer is a unique entity that remains understudied. Our institutional data provide a useful overview about this rare disease in Greece. Ongoing effort is required to conduct clinical trials or to include male patients in large, randomized cohorts in order to improve medical care.
Evolution of cancer treatment costs in the last 36 months in a self-funded health care in Brazil.
Authors: Reis Neto Joao Paulo , Busch Juliana Martinho , Stefani Stephen
Published: June 2023

e18838

Background: In Brazil, cancer, in addition to being one of the main causes of illness and death, represents one of the highest public and private healthcare expenses. Regardless of the population profile, the direct costs of cancer pose as a real threat to the health system's sustainability. The objective of this study is to analyze the evolution of the use and costs of chemotherapy, targeted therapy, hormone therapy and immunotherapy. Methods: Retrospective cohort consisted of all health plan beneficiaries diagnosed with cancer and who received pharmacological treatment in the last 36 months (September/2019 to August/2022). Based on Period 1 (P1, Sep/2019 to Aug/2020), we analyzed the evolution in the other periods (P2 and P3, Sep/2020 to Aug/2021 and Sep/2021 to Aug/2022, respectively) of the use of chemotherapy and the costs involved (per capita and per patient treated). We also analyzed the evolution of expenses with oral antineoplastic agents and their proportion in relation to other routes of administration. The most prescribed therapies were analyzed. Microsoft Excel and Qlik Sense were used for relative and absolute frequencies, means and standard deviation (95% confidence intervals, significance when p < 0.05). Results: During the study period, 982 beneficiaries (683, 601 and 572, respectively in P1, P2 and P3) underwent treatment with antineoplastic agents (mean age 68 years, 50.7% women). In P1, 1.6% of the total exposed received some type of chemotherapy. In the following intervals, the percentage increased to 1.7% and 2.1%, P2 and P3, respectively. Although the cost per patient treated increased by 4.7% in 36 months, the annual expense per patient, that is, the entire portfolio of the plan and not just those diagnosed with cancer, increased by 40.5%. Should be noted that the variation that occurred in P2 in relation to P1 was 7.8%, however, in P3 compared to P2, 30.3%. The proportion of patients receiving oral antineoplastics in relation to those treated remained stable (53.6%, 54.7% and 52.3%, P1, P2 and P3, respectively). Ten active principles with the highest financial consumption and corresponding to more than half of the total expenses: nivolumab, daratumumab, bevacizumab, trastuzumab, pembrolizumab, pertuzumab, enzalutamide, atezolizumab, paclitaxel and brentuximab vedotin. Conclusions: Molecular and immunological therapies have revolutionized cancer treatment and improved patient outcomes and survival, however, new treatment options represent an additional challenge. In this study, the cost of cancer treatment has increased 40.5%, especially in the last period, which coincides with the expansion of the list of mandatory coverages and due to the resumption of procedures after COVID-19. Minimizing the financial impact of the new technologies, through responsible management focused on the patient and based on the best scientific evidence, is fundamental for maintaining the sustainability.
COVID-19 and prevalence of venous thromboembolism among cancer patients: A nationwide inpatient sample analysis.
Authors: Ibrahim Muhammad Bilal , Litvin Rafaella , Noor Hiba , Khan Ali Husnain , Ishaya Michelle , Obeidat Khaldun , Kanemo Philip Onyekaoso , Olafimihan Ayobami Gbenga , Turk Ekrem , Aryal Badri , Anwar Muhammad Tayyab , Jamshed Aneeza , Batra Kunnal
Published: June 2023

e18839

Background: Cancer, as well as immunosuppression from chemotherapy, aggravates thromboembolism risk. The risk is likely amplified in an additive fashion with COVID-19 infection, which confers a higher risk of VTE risk with viral sepsis, endothelial inflammation, and microthrombi formation. Numerous studies have shown the heightened risk of pulmonary embolism among severe COVID-19 patients. We sought to evaluate further the extent of COVID-19-associated coagulopathy and associated outcomes. Methods: National Inpatient Sample 2020 was used to identify non-elective hospitalizations of patients with a secondary diagnosis of any cancer. These were stratified into two cohorts based on the presence of the primary diagnosis of COVID-19. Primary outcomes include venous thromboembolism, PE, and VTE without PE in cancer patients with and without Covid-19 infection. The secondary outcomes examined were in-patient mortality, the average length of stay (LOS), and total hospital charge (THC). Multivariate analysis was performed to obtain the odds ratio. All weighted analysis was conducted through STATA 17. Results: Out of 1,734,735 non-elective admissions of patients with cancer, 36,295 (2%) were admitted for COVID-19. Our analysis showed statistically non-significant increased odds of venous thromboembolism(aOR:1.09 CI 0.99-1.20) in cancer patients with COVID. There was, however, a significant increase in the odds of pulmonary embolism(aOR 1.7, CI: 1.51- 1.91) among cancer patients with Covid-19. There were decreased odds of VTE without PE(aOR: 0.67 CI: 0.57-0.78). There was a statistically significant increase in odds of mortality (aOR: 2.8 CI: 2.63-3.0), length of stay(aOR:1.85 CI: 1.65- 2.05), total hospital charges($83,201 vs. $78,869 p: < 0.01) in cancer patients with COVID-19 compared to cancer patients without COVID-19. Conclusions: This study shows that COVID-19 in cancer patients has deleterious effects, including an increased risk of pulmonary embolism and poor in-hospital outcomes. The finding of a lower incidence of non-PE VTE in patients with cancer is likely related to limitations with coding in NIS, in which lower complexity codes might be omitted in patients with multiple diagnoses. With significantly increased mortality and economic burden, these findings emphasize the significance of thrombotic prophylaxis and vaccination in cancer patients. [Table: see text]
Cardiovascular comorbidities and cardiovascular events in patients with metastatic prostate cancer.
Authors: Saidi Mohammed Alaeddine , Soumeyya Ghomari , Sedjelmaci Sarra
Published: June 2023

e18851

Background: Prostate cancer (PCa) is globally the second most frequently diagnosed cancer in men. Patients with metastatic disease require cancer treatment for several months or even years. These treatments can have different side effects including adverse cardiac effects because of decreased serum testosterone levels. Methods: We conducted an observational study of men who were diagnosed with metastatic PCa from January 1, 2013, through December 31, 2018, with follow-up through December 31, 2022. We documented comorbid conditions, medications, tumor characteristics, type and duration of systemic treatment received. We also documented fasting glucose, total cholesterol, HDL, LDL and triglyceride levels at diagnosis. A cardiovascular event was defined as the first occurrence of hypertension, myocardial infraction, atrial fibrillation, heart failure, sudden cardiac death, acute thrombo-embolism and stroke. Cox proportional hazards models were used to assess association between cancer treatment and incident cardiovascular disease (CVD). Results: The cohort included One hundred and twenty one men who were diagnosed with metastatic prostate adenocarcinoma with a mean age at diagnosis of 68.9 years. 84.2% had bone-only metastasis. 69.4% had at least one CVD-Risk Factor. 53.4% Hypertension, 28.2% Dyslipidemia, 12.3% Diabetes. 15 men (12.3%) had pre-existing CVD. 3.3% stroke, 4.1% myocardial infraction, 2.4% heart failure, 2.4% atrial fibrillaton. 24.2% were under statin therapy and 22.0% under aspirin. Androgen deprivation therapy (ADT) was used for all patients, including 9.9% goserelin, 3.3% leuprolide and 86.8 triptorelin. 70.2 % had received concomitant treatment: 22.3% bicalutamide, 60.3% abiraterone, 68.8% docetaxel, 4.1% cabazitaxel. Men were observed for a median of 5.6 years (range = 33 days to 10 years). Cardiovascular adverse events occurred in 14 patients (11.5%) on ADT alone and in 23 (19.0%) on combination therapy. 26 (21.4%) Hypertension, 1 (0.8%) myocardial infraction, 1 (0.8%) atrial fibrillation, 2 (1.6%) had heart failure, 1 (0.8%) sudden cardiac death, 5 (4.1%) acute thrombo-embolism, 1 (0.8%) stroke. In subgroup-analyses of different combination treatments, Cardiovascular events were found to be significantly associated with combination of abiraterone with ADT (HR = 1.31, 95 % CI: 1.13 to 1.37; P < 0.001). For men with a history of pre-existing CVD, CV events were more pronounced, 23.9% vs. 6.6% for men without pre-existing CVD. Conclusions: Metastatic prostate cancer patients often have pre-existing CVD and CVD-Risk Factors. Addition of abiraterone to ADT increase the risk of cardiovascular events. Physicians should monitor their patients in order to early detect any abnormality, and should encourage them to adopt a healthier lifestyle.
Real world outcomes of veterans 18-45 years old with acute lymphocytic leukemia.
Authors: McKinnell Zoe , Hammudi Mustafa , Tuerff Daniel , Hamilton Colleen , Antonio Martha , Diao Guoqing , Liu Shanshan , Subrahmanyam Ramesh , Jain Maneesh Rajiv
Published: June 2023

e18852

Background: Age is a strong prognostic factor in acute lymphocytic leukemia (ALL), with children doing better than adults with the same disease. One hypothesis for this age-based disparity is differences in treatment regimens. Current NCCN guidelines say it is acceptable to treat young adult patients with either pediatric or adult regimens. We conducted a retrospective study of all veterans with ALL diagnosed between the ages of 18-45 since the year 2000 to evaluate the effect of different treatment regimens on overall survival. We also evaluated other disparities that exist among young adults with ALL including race and enrollment in clinical trials. Methods: Electronic medical record data from the Veterans Affairs Corporate Data Warehouse was used to identify patients with an ICD 9 or 10 code for ALL. All patients were chart checked to confirm ALL diagnosis and excluded if they were diagnosed before 2000, had childhood ALL, or if induction protocol was not recorded. 260 patients were included in the final analysis, including 130 treated with a pediatric-inspired regimen. Kaplan-Meier and Cox regression analyses were used to compare overall survival between patients treated on a pediatric-inspired regimen and patients treated on an adult regimen. Multivariate analysis was performed with controls for age, ALL subtype (B, T, mixed phenotype), Ph status, cytogenetic risk (based on modified MRC-ECOG study), obesity (BMI > 30), and race. Hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated using multivariable Cox regression to estimate associations with risk of 5-year death. Results: Patients treated on a pediatric regimen had statistically significant survival gains, with a HR of 0.41, p < 0.001, after controlling for obesity, Ph status, ALL subtype and cytogenetic risk. Pediatric-regimen survival gains were similar for patients ages 30-45 (HR 0.5, p = 0.037). White patients had significantly improved OS compared to people of color (HR 0.55, p = 0.013) after controlling for the aforementioned covariates. Black patients were far less likely (23%) to receive a transplant than non-Black patients (46%). Only 7% of patients were treated on a clinical trial. Patients ages 30-45 were 83% less likely to be enrolled in a clinical trial and 24% less likely to receive a pediatric-regimen than younger adults. Conclusions: This data demonstrates that treatment with a pediatric regimen significantly improves overall survival in patients up to the age of 45. The data also suggests ongoing shortcomings in treatment for young adults with ALL, especially 30 to 45 yos, including persistently high use of adult induction regimens, low rates of referral to clinical trials, and significant racial disparities in bone marrow transplants for Black patients. [Table: see text]
Trends in breast cancer death by stage at diagnoses in 2000-2018.
Authors: Kahn Adriana Matutino , Marczyk Michal , Silber Andrea , Rozenblit Mariya , Sanft Tara B. , DiGiovanna Michael , Schellhorn Sarah , Krop Ian E. , Lustberg Maryam B. , Winer Eric P. , Pusztai Lajos
Published: June 2023

e18855

Background: Approximately 40-45,000, women die from breast cancer each year, most of which are due to metastatic recurrence of stage I-III cancers. Stage I and II cancers are considered highly curable, but they also include most patients. The goal of this analysis is to examine the contribution of stage I, II, III, and IV disease to annual breast cancer-specific death and assess time trends. Methods: Data from patients diagnosed with stage I-IV breast cancer between 1975-2018 (N = 1,545,502) were obtained from The Surveillance, Epidemiology, and End Results (SEER) Program. After filtering for the female sex, one primary site only, surgery performed, known AJCC stage > 0, and survival data available we included N = 1,018,331 patients. We estimated the year of breast cancer-specific death (BCSD) by adding time to BCSD to a year of diagnosis for each patient. We summarized the proportion of BCSD by stage at diagnosis in each year between 2000 and 2017. All temporal trends were assessed by fitting the linear model with interactions between stage and year, then running the ANOVA to test model coefficient significance. For each year of diagnosis, Kaplan-Meier curves were fitted to patient data grouped by stage, and 5-year survival was estimated. Results: The study population included 24% ER-, 73% ER+ (the rest unknown) cancers; 35% HER2-, 6% HER2+ (the rest unknown); 24% were < 50 and 76% > 50 years of age; 60% received adjuvant chemotherapy. Over time, the frequency of stage I cancers increased from 49% in 2000 to 54% by 2017 (slope = 0.37 [95% CI: 0.32; 0.42]), and stage II and III decreased from 35.2% to 34.9% (slope = - 0.09 [-0.15; -0.04]) and from 14% to 10% (slope = -0.23 [-0.29; -0.18]), respectively. Five-year breast cancer-specific survivals remained stable for stage I cancers and increased significantly for stage II (slope = 0.002 [0.001;0.003]), stage III (slope = 0.006 [0.005;0.007]) and IV cancers (slope = 0.011 [0.010; 0.012]). The contribution of stage I cancers to annual breast cancer death increased and reached 23% in 2017, while death from stage III disease decreased to 30%. Since 2003, > 50% of breast cancer deaths are from stage I-II cancers. Conclusions: The prevalence of stage I breast cancers increased in the past 20 years, and despite excellent overall prognosis, stage I-II cancers account for over 60% of all BCSD. To substantially reduce breast cancer death, we need to better identify the minority of Stage I-II patients who remain at risk for recurrence and death. [Table: see text]
Real world data on off-label use of consolidation durvalumab in newly diagnosed stage II and recurrent non-small cell lung cancer patients treated with definitive chemoradiotherapy.
Authors: Wise Corey , Mangurian Mark , Marur Shika , Pozotrigo Melissa , Toler Andrew , Bobolts Laura Rose , Norden Andrew D. , Marur Shanthi
Published: June 2023

e18857

Background: Consolidation durvalumab is approved for treatment of newly diagnosed, unresectable stage III non-small cell lung cancer (NSCLC) who have not progressed after definitive chemoradiotherapy (CRT) and the NCCN guidelines has since included stage II NSCLC who have not progressed after definitive CRT. Methods: A retrospective, observational real-world study was conducted to identify and describe the off-label use of consolidation durvalumab in NSCLC after completion of CRT between June 2018-June 2021. Data sources included claims data and electronic medical records submitted with prior authorization (PA) requests to OncoHealth, a digital health company that reviews PA requests for cancer treatment. With a data cut-off of 12/22/2022, real-world Time to Progression (rwTTP) and real-world Time to Next Treatment (rwTTNT) were evaluated. All endpoints were measured from the start of consolidation durvalumab treatment; rwTTP spanned until earliest date of clinician-reported progression and rwTTNT spanned until initiation of subsequent treatment. Results: Among 326 patients identified to have received durvalumab after definitive CRT, 45 (13.8%) received off-label treatment. The median age was 71 years (range: 53 to 88), 51% male, 53% former smokers, 29% Stage I, IIA or IIB, 71% locoregional recurrent disease; 58% squamous histology, 47% had undergone prior surgery +/- adjuvant chemo, 27% received prior radiation only and 98% received concomitant platinum-based chemotherapy prior to durvalumab. Median time to initiating durvalumab after CRT was 47 days. After a median follow up of 13.1 (range: 7.0-50.7) months, 33% (n = 15) had progression of disease. The median rwTTP was 14.0 (range: 4.2-32.9) months and median rwTTNT was 14.7 (range: 6.0-33.0) months. Conclusions: In the real world, off-label use of consolidation durvalumab was based on clinical justification and extrapolation of results from PACIFIC trial. The results of rwTTP and rwTTNT outcomes suggest patients with early stage or recurrent disease achieved clinically meaningful benefit from treatment approach used in the PACIFIC trial. With additional patients and longer follow up, real-world data could shed light on the appropriateness of expanding off-label use of durvalumab consolidation.
Characterizing of adverse events across 30,000 peer reviewed case report publications.
Authors: Khabbaha Suad , Dempsey Sarah Carder , Anema Aranka , Singh Sonal , Thorlund Kristian
Published: June 2023

e18858

Background: Pharmacovigilance suffers from considerable underreporting. This is particularly the case for novel oncology therapeutics where regulatory approval is supported by clinical trials with small sample sizes and limited follow-up to observe later treatment-related adverse events. More recently approval of oncologic therapies based on Real World Evidence, using study designs such as historical controls further complicates the task of assessing the clinical significance of AE. Furthermore, causation is rarely confirmed outside controlled settings such as clinical trials, and particularly absent in conventional RWE sources. Methods: We evaluated the ability of published case reports to serve as a source of pharmacovigilance for novel oncology therapeutics as well as the prevalence of reporting of clinician confirmed causality. We assessed structured patient journey data extracted from approximately 30,000 peer reviewed oncology case reports published since 2015 and available from the OpenCaseTM database. The reviewed cases covered hematological cancers (myelomas, leukemias, and lymphomas) and solid cancers (lung, breast, colorectal, and bladder) and represented case reports from over 125 nations. Adverse events and key patient journey data were extracted using state-of-the-art natural language processing (NLP) models with validated accuracy of over 92%. Results: A total of 58.5% reported at least one adverse event after or during a treatment period. Of these, the median number of reported adverse events were 4 (IQR: 2 - 8). There were 12,551 unique AEs after normalizing with the MedDRA database using a state-of-the-art AI model. The ten most frequently reported AEs were pain, fever, weight loss, fatigue, post-op complications, fatigue, anemia, infection, bleeding, and dyspnea, ranging from 897 to 2606 occurrences. Clinical confirmation of causation (i.e., treatment-related adverse event) was available for at least one adverse event in over half of the case reports. The majority of these were related to immune checkpoint inhibitors, but toxicity due to chemotherapies and complications due to surgery were also common. Conclusions: In conclusion, our study suggests that peer reviewed oncology case reports represent a rich source of reported adverse events, often with clinically confirmed causality, which could substantially augment adverse events reporting of oncology therapeutics.
Cancer ontology understanding among community oncologists: Insights from a survey linked to implementation of mCODE-informed electronic health record (EHR).
Authors: Dienstmann Rodrigo , Christtanini Koyama Fernanda , Costa e Silva Matheus , Mega Livia , Laloni Mariana , Ferreira Carlos G. M. , Ferrari Bruno Lemos
Published: June 2023

e18860

Background: Real-world data (RWD) will help recognize the gaps between evidence and practice, re-shaping clinical assessments. Data collected at the source in oncology-tailored EHRs are expected to facilitate generation of high-quality RWD. In the process of implementing a new EHR informed by mCODE standards in our network of oncology clinics, we defined mandatory variables amenable to structured data capture. However, medical knowledge about cancer ontology has not been methodically investigated. Methods: Online survey with 4 multiple-choice questions that illustrate in clinical cases the most important concepts and terminologies related to cancer diagnosis, treatment, and patient outcome. The questionnaire was shared with ~ 300 medical oncologists from our institution through mobile messaging app in December 2022. Physicians signed electronic informed consent for anonymized data analysis. Results: In total, 203 oncologists agreed to participate and 152 completed the survey. Most oncologists (75%) correctly define “therapy intent” (palliative versus curative) and corresponding “treatment line”. Many (51%) do not understand that “disease stage” is static (defined at the time of diagnosis) and does not change to stage IV if patient presents with relapsed/recurrent disease. A significant proportion of oncologists (66%) wrongly define “response status” to a given therapy as stable/progressive disease in a patient that had major clinical/radiological response but presents with unconfirmed tumor marker increase and no clear change in bone metastases by imaging. However, most oncologists (88%) can correctly define “reason for therapy discontinuation” as “planned interruption” in the end of adjuvant chemo-immunotherapy. When stratifying physicians according to self-defined knowledge of disease ontology, we found that 27% of those with moderate/deep understanding of mCODE scored 4 correct answers in the questionnaire as compared to 8% with 4 correct answers if mCODE knowledge was null or vague (P value < 0.001, odds ratio 5.1, CI95% 1.8-15.8). Conclusions: Overall understanding of cancer-specific data dictionaries is low among community oncologists. With the new EHR system we are nudging physicians not to update the “stage at diagnosis” status at the time of disease relapse/recurrence by creating a “current cancer status” element with mandatory completion (linked to prescriptions/ pharmacy claims). Also, “response status” as assessed by physicians must be cross-checked with other data sources (tumor markers, imaging results, physician notes and reason for therapy discontinuation) given inconsistent definition of “clinical benefit versus progressive disease” among physicians. In addition, we will constantly educate oncologists and monitor their EHR data entry behavior for successful execution of RWD projects.