bluuebunny/crossref_metadata_2025_split huggingface dataset:
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.