bluuebunny/crossref_metadata_2025_split huggingface dataset:
Effect of healthcare fragmentation on breast, stomach, and colorectal cancer mortality in Colombia: A measurement estimated through administrative databases.
Authors: Rozo Agudelo Nicolás , Saldaña Espinel Laura Estefania , Patiño Benavidez Andres Felipe , Gamboa Garay Oscar Andres , Buitrago Giancarlo 
Published: June 2021

e18808 Background: Fragmentation in healthcare leads to adverse outcomes in cancer patients. Currently there is no fragmentation measurement that has been acknowledged to reliably assess healthcare fragmentation across different health systems. We aimed to measure cancer healthcare fragmentation through administrative databases in Colombia and to calculate its effect on breast, stomach and colorectal cancer mortality. Methods: We conducted a cohort study based on health administrative databases from 2013 to 2017. We combined data from two Colombian national health databases (Capitation Payment Unit database and Vital Statistics from DANE). We developed an algorithm based on ICD-10 codes and oncological procedures to select incident cases of breast, stomach and colorectal cancer. To measure healthcare fragmentation, we identified the number of providers between the dates of the first and last registered services. For patients who died during observation we adjusted the number of providers for survival time in days, otherwise survival time was set to 31 december, 2017. We categorized fragmentation in quartiles and evaluated its effect on mortality rate by Kaplan Meier estimates. Results: We identified three cohorts of patients based on primary tumor site. Age distribution was similar in stomach and colorectal cancer. Fragmentation measured as a continuous variable has a non-parametric distribution in all cohorts. The median of follow-up time ranged between 2.4 to 4.4 years. All-cause mortality rates were highest in stomach cancer, lowest in breast cancer. When measured as quartiles, fragmentation has a consistent dose-response effect increasing all-cause mortality rates. Conclusions: Healthcare fragmentation can be measured through algorithms applied to administrative databases in Colombia. Fragmentation is a predictor for all-cause mortality across different oncologic populations. This measurement based on real-world national administrative data could be used as an indicator of high-quality oncological healthcare for the Colombian healthcare system.[Table: see text]
Modeling Medicare’s Oncology Care Model bundles at more clinically granular levels: Evaluating the impact on provider performance.
Authors: Yue Andrew , Connor Nora , Gordan Lucio N. , Tran Lisa , Chaudhry Basit Iqbal 
Published: June 2021

e18854 Background: Aggregating different subtypes of cancers into bundles is an important methodology in oncology payment reform as an alternative to fee for service. However, expected resource utilization can vary significantly across cancer subtypes. We evaluated the impact that modeling Chronic Leukemia into a more clinically granular two part framework of chronic myelogenous leukemia (CML) and chronic lymphocytic leukemia would have on OCM results and the risk that the distribution of clinical subtypes at a practice would influence overall performance in the bundle. Methods: OCM episodes of chronic leukemia initiating between July 2016 and June 2019 were subdivided on the basis of individual ICD-10 coded diagnoses on cancer-related E&M visits. From a total of 4,658 episodes, we randomly sampled with replacement 3,500 episodes from 16 practices using empirical data distributions. Data models and mappings were developed based on clinical knowledge and exploratory data analyses to subdivide the OCM bundle of Chronic Leukemias into CLL and CML. Total cost of care and episode target prices were calculated through implementation of the OCM methodology. The distributional consistencies of episode target, cost, cost above target, and percent above target for the two diseases were evaluated by two-sample Kolmogorov-Smirnov (KS) tests. Results: The CML and CLL subtypes modeled from the aggregate OCM bundle demonstrated significantly different cost distributions relative to each other. As anticipated, treatments used in each subtype varied significantly marking different patterns of expected resource utilization. In our model, CLL episodes were on average 13.7% over target. Average CLL episode costs were $52.2K vs. an average target of $47.6K with 54% of episodes running over target. In contrast, CML episodes were 6.1% under target. Average CML episode costs were $45.2K vs. an average target of $50.3K with 43% of episodes running over target. Conclusions: Value based payment models in oncology such as OCM can be improved by modeling cancer bundles in more clinically granular ways that better reflect expected resource utilization for appropriate, standard of care. Insufficient clinical granularity in bundle construction can lead to provider performance being influenced by the distribution of patient subtypes at the practice. This can lead to inappropriate shifts of risk from payers to providers in value based models. Aggregate vs. subtype episode costs (mean, 5th, and 95th percentiles).[Table: see text]
Effect of induction intensity on survival in patients with acute myeloid leukemia.
Authors: Sahasrabudhe Kieran , Rebechi Melanie , Huang Ying , Behbehani Gregory , Bhatnagar Bhavana , Blachly James Stewart , Blaser Bradley Wayne , Borate Uma , Garzon Ramiro , Haque Tamanna Zohra , Larkin Karilyn T.M. , Long Meixiao , Mims Alice S. , Saad Ayman A. , Vasu Sumithira , Walker Alison R. , Wall Sarah Allison 
Published: June 2021

e19004 Background: Acute Myeloid Leukemia (AML) has traditionally been treated frontline with intensive induction chemotherapy in patients fit enough for this treatment. The FDA has approved several oral targeted therapies for AML in recent years. The survival impact of these agents vs induction chemotherapy is unknown. Methods: In this single-center, retrospective study, patients diagnosed with AML from 2015-2020 were included if they received treatment with either high intensity chemotherapy (HiC) or lower intensity targeted therapy (LITT). HiC was defined as a regimen containing cytarabine + anthracycline given on a “7+3” based schedule. Patients treated with liposomal cytarabine-daunorubicin were excluded. LITT was defined as venetoclax, gilteritinib, enasidenib, or ivosidenib alone or in combination with a hypomethylating agent. Patients fell into four groups: HiC only, LITT only, HiC followed by LITT, and LITT followed by HiC with assignment censored at transplant. Overall survival (OS) was estimated using Kaplan-Meier method and patients receiving any HiC vs LITT only were compared using log-rank test. Results: A total of 332 patients were included: 177 received HiC only, 116 LITT only, 32 HiC before LITT, and 7 LITT before HiC. Baseline characteristics and OS data are outlined in the table. The any HiC group had a lower median age and more patients with WBC >10 K/µL at diagnosis, as well as more patients receiving allogeneic hematopoietic cell transplant (HCT). OS was superior in the any HiC group vs LITT only group. Receipt of any HiC remained predictive of OS after adjusting for age (HR 0.65, 95% CI 0.44-0.96, p = 0.03); however, was no longer predictive of OS after adjusting for age and receipt of HCT. Conclusions: While HiC was associated with superior OS compared to LITT only treatment in univariable analysis, the survival benefit was no longer apparent after adjusting for age and receipt of HCT. The results suggest that intensity of AML treatment is less impactful on prognosis than ability to receive HCT. Differences in age were likely confounded by clinical trial eligibility and prescribing information specifically affecting patients receiving LITT. In the era of LITT, prospective randomized studies of intensity of AML therapy, particularly in non-favorable risk disease, are imperative to striking a balance between toxicity and cure for patients of all ages.[Table: see text]
Comparative study on iron content detection by energy spectral CT and MRI in MDS patients.
Authors: Zhang Yao , Xiao Chao , Li Jing , Song Lu-Xi , Zhao You-Shan , Han Shuang , Li Zhao-Wei , Guo Cha , Zhao Jun-Gong , Chang Chun-Kang 
Published: June 2021

e19032 Background: Myelodysplastic syndrome(MDS) patients may have iron overload due to long-term RBC transfusion or combined with abnormal iron metabolism.what are the differences of iron content detection by magnetic resonance imaging (MRI) and dual energy spectrum computed tomography (DECT)? What are the advantages and disadvantages of the two methods in the state of high and low iron deposition? Can the two methods complement each other? The purpose of this study was to compare the difference of liver/cardiac iron content detection in MDS patients by DECT and MRI under different adjust serum ferritin (ASF) levels. Methods: Liver and cardiac iron content were detected by DECT and MRI. Patients divided into different subgroups according to ASF. Compared the detection rate between DECT and MRI group, and correlation between liver/cardiac iron content detected by DECT/MRI and ASF in each subgroups. Results: The detection rate of iron overload(IO) in DECT group was lower than that of MRI group with ASF < 1000ng/ml subgroup,DECT and MRI had similar detection rates of moderate to severe IO with 1000≤ ASF < 5000ng/ml subgroup, detection rate of severe IO in MRI was lower than that of DECT with 5000ng/ml ≤ ASF subgroup. In patients underwent DECT and MRI examination at the same time, ASF was significantly correlated with hepatic VIC but not with liver iron concentration (LIC), and LIC correlated with ASF after removed these data of ASF > 5000 mg/L. LIC expression are not significantly different among 1000≤ ASF < 5000ng/ml and 5000 ng/ml ≤ASF subgroup. LIC and liver virtual iron content (VIC) were all significant correlation with ASF when ASF < 2500ng/ml, liver VIC was still correlation with ASF but LIC was not when 2500ng/ml≤ ASF. Neither cardiac VIC nor myocardial iron content (MIC) correlation with ASF in these subgroups. Conclusions: This study showed that MRI and DECT can be used complementary to each other. In high iron content, such as ASF ≥5000ng/ml, DECT detection is more reliable. In patients with low iron content, such as SF < 1000 ng/ml, MRI detection is more reliable. According to ASF, the appropriate detection method can be selected to evaluate the iron content more accurately.
Outcomes with venetoclax in myelodysplastic syndromes: A systematic review.
Authors: Khanam Razwana , Shahzad Moazzam , Pachika Pranali Santhoshini , Ahmed Zahoor , Ali Fatima , Masood Adeel , Shah Zunairah , Chattaraj Asmi , Chaudhary Sibgha Gull , Balusu Ramesh , Ahmed Nausheen , Khurana Sharad , Anwer Faiz , Abhyankar Sunil H. , McGuirk Joseph P , Mushtaq Muhammad Umair 
Published: June 2021

e19035 Background: Myelodysplastic syndromes (MDS) are clonal hemopoietic disorders causing cytopenia(s) and increased risk of transformation to acute myeloid leukemia (AML). Venetoclax is a B-cell lymphoma-2 (BCL-2) inhibitor that induces apoptosis in malignant cells. The FDA has approved venetoclax for the treatment of newly diagnosed adult AML patients unfit for intensive chemotherapy and its utility in MDS is being explored. We present a systematic review aimed to evaluate outcomes with venetoclax in MDS patients. Methods: We performed a literature search on 3 databases (Pubmed, Cochrane, and Clinicaltrials.gov) following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. We screened 62 studies using the Mesh terms ‘myelodysplastic syndrome’ and ‘venetoclax’. After excluding review, duplicate and non-relevant articles, 8 studies were included in the analysis. Quality evaluation was done using the NIH quality assessment tool. Pooled analysis was done using the ‘meta’ package (Schwarzer et al, R programming language) and proportions with 95% confidence intervals (CI) were computed. The Inter-study heterogeneity among the studies was assessed using the Q statistic proposed by Cochrane and the I2 index introduced by Higgins and Thompson. Results: We identified 313 patients from 8 studies (1 prospective, 3 retrospective, 2 ex-vivo, 2 clinical trials). Venetoclax was used in combination with hypomethylating agents (HMA) in 6 studies and with other agents in 2 studies. Most patients were pre-treated. Complete response (CR) with or without hematological recovery (CRi) was reported in 45% of patients (95% CI 0.26-0.66, I2= 90%, n = 292). Stable disease (SD) was seen in 18% patients (95% CI 0.08-0.37, I2= 85%, n = 223). Overall response rate (ORR) was 51% (95% CI 0.31-0.70, I2= 89%, n = 122). Hematopoietic stem cell transplant (HCT) was performed in 22% patients (95% CI 0.09-0.44, I2= 75%, n = 122). Twenty percent patients (95% CI 0.15-0.28, I2= 0%, n = 149) died. Common adverse events seen with venetoclax were cytopenias, gastrointestinal side effects and infections, often requiring drug interruption or dose. Conclusions: Despite heterogeneity of available literature, venetoclax seems to be a promising agent in treatment of MDS patients. Prospective clinical trial data is needed to ascertain safety and efficacy of venetoclax in MDS and impact on overall survival, in particular, in patients proceeding to HCT.[Table: see text]
Mitigating the risk of transfusion-transmitted bacterial infections in hematology oncology patients.
Authors: Alvarez Harold , Lanteri Marion , Koehne Guenther 
Published: June 2021

e19047 Background: Hospital acquired infections create major logistical, financial, and patient safety concerns within the healthcare system. Bacterial contamination (BC) of platelet components (PCs) can lead to transfusion-transmitted bacterial infections (TTBI), central line-associated bloodstream infections, and sepsis, with long-term complications and/or death. In the US, hematopoietic stem cell transplant (HSCT) recipients require transfusion support until engraftment and together with hematology/oncology (hemonc.) patients receive the highest number of PCs/patient. FDA’s Guidance recommends approaches to reduce BC risk including the use of enhanced bacterial culture screening (EBSC) or pathogen reduction (PR) of platelets. Methods: The Miami Cancer Institute (MCI) implemented PR-PCs for all allogeneic HSCT patients. Irradiation, CMV testing, and bacterial screening have been discontinued for PR-PCs. Transfusion outcomes are being monitored using active hemovigilance (HV) reporting. Results: Considering the fatality risk associated with BC of PCs (1:200,000 – 1:1,000,000) despite the use of optimal skin cleansing, initial sample diversion, and primary bacterial culture, 1/2,880 PCs are still contaminated (Bloch et al.); further steps towards BC mitigation are needed. As the UK and US reported a residual BC risk of 5.4-9.4/million PCs after implementation of EBSC, PR may represent an alternative approach with other cumulative benefits. Indeed, national HV data from France, Switzerland and Belgium reported no sepsis transfusion reactions since PR implementation (Benjamin et al.). In addition, the risk of TA-GVHD and other TTI including emerging infectious diseases (EID) may be decreased after the inactivation of pathogens and leukocytes (Lanteri et al.). At MCI, the percentage of transfused PR-PCs has been increasing steadily from 7.9% in July 2019 to 22.2% in January 2021. Over a 19 month-period, a total of 9,296 PC were transfused including 1,677 PR-PCs. While non-PR-PCs were all irradiated and bacterially screened, PR-PC were neither irradiated nor bacterially screened. No cases of TA-GVHD or TTI were reported. A total of 27 mild, non-life-threatening platelet transfusion reactions were reported including 22 (81.5%) after non-PR PCs transfusion and 5 (18.5%) after PR-PC transfusion. In addition, the early release of transfusion-ready fresh PR-PCs 24-48 hours after collection has proven invaluable in providing clinicians and patients with blood continuity during the COVID-19 pandemic. Conclusions: Though certain measures have improved blood safety, the risk of TTI associated with PC transfusion remains a concern for vulnerable hemonc. patients. Using PR-PC is especially important to consider when patients undergo extensive life-saving therapies such as bone marrow transplants.
Tislelizumab (BGB-A317) for relapsed/refractory (R/R) classical Hodgkin lymphoma (cHL): Long-term follow-up efficacy and safety results from a phase 2 study.
Authors: Song Yuqin , Gao Quanli , Zhang Huilai , Fan Lei , Zhou Jianfeng , Zou Dehui , Li Wei , Yang Haiyan , Liu Ting , Wang Quanshun , Lv Fangfang , Guo Haiyi , Yang Liudi , Huang Jane , Novotny William F. , Wang Yidi , Zhu Jun 
Published: June 2021

e19507 Background: Tislelizumab is a humanized IgG4 monoclonal antibody with high affinity/specificity for programmed cell death protein 1 (PD-1). It was engineered to minimize binding to Fc-γ receptors on macrophages, thereby decreasing antibody-dependent phagocytosis, a potential mechanism of T-cell clearance and resistance to anti–PD-1 therapy. Tislelizumab therapy was highly active in autologous stem cell transplant (ASCT)-failed or ineligible patients with R/R cHL ( Leukemia. 2020;34:533). Here we report results from up to 3 years follow-up. Methods: This asingle-arm, multicenter phase 2 study (NCT03209973) of 200 mg tislelizumab administered intravenously to patients (pts) with R/R cHL every 3 weeks until progressive disease (PD) or unacceptable toxicity. Patients were eligible if they: failed to achieve a response or progressed after ASCT, or: received ≥2 lines of prior systemic chemotherapy for cHL and were ineligible for ASCT. Primary endpoint was overall response rate (ORR) assessed by an independent review committee (IRC) per Lugano criteria ( J Clin Oncol. 2014;32:3059). Secondary endpoints were progression-free survival (PFS), duration of response (DOR), complete response (CR) rate, and time to response (TTR) per IRC, safety, and tolerability. Results: Pts (N=70) from 11 centers in China were enrolled and treated; characteristics have been previously reported. As of the data cutoff date (Nov 2, 2020), median follow-up was 33.8 months (range, 3.4-38.6). Pts still on treatment at the end of study (n=33; 47.1%) entered a long-term extension study. Efficacy data is presented in the Table below. In the 13 pts who received prior ASCT, 11 (84.6%) achieved CR. The most common treatment-emergent adverse events (AEs; ≥30%) were pyrexia (57.1%), upper respiratory tract infection (38.6%), hypothyroidism (37.1%), and increased weight (34.3%). Treatment-related grade ≥3 AEs (≥2 pts) were pneumonitis, hypertension, neutropenia, lipase increased, weight increased, and increased creatine phosphokinase (CPK; 2.9% each). Immune-related AEs were reported in 32 pts (45.7%), with grade ≥3 AEs in 8 pts (11.4%): pneumonitis (4) and skin adverse reactions, nephritis, lipase increased, and blood CPK increased (1 each). AEs led to treatment discontinuation in 6 pts (8.6%). Conclusions: Long-term follow-up of R/R cHL pts treated with tislelizumab further demonstrated the substantial therapeutic activity and continued PFS benefit. There were no new safety concerns identified for long-term treatment with tislelizumab. Clinical trial information: NCT03209973. [Table: see text]
Secondary hemophagocytic lymphohistiocytosis (HLH): Five years’ experience at the UTHealth McGovern Medical School at Houston, Texas.
Authors: Cervoni-Curet Frances Natalia , Rios Adan , Yohannan Binoy , Miao Hongyu 
Published: June 2021

e19578 Background: Secondary HLH in adults is associated to infections, malignancies, and autoimmune disorders. HLH in children has been the basis for the management and treatment of HLH in adults. Despite their clinical similarities there are fundamental differences. Children’s HLH is caused by gene mutations in granule-mediated cytotoxicity while secondary HLH does not have known apparent genetic causes. This may affect the clinical outcomes based in how we approach the diagnosis and management of secondary HLH in adults. Methods: We reviewed 49 cases of secondary HLH at our institution over a five-year period. Patients median age was 47 years, with 31 males, 18 females. Fifteen were Caucasian, 10 Asians, 8 African American and 15 Hispanics. One was not specified. Results: Fever, hyperferritenemia and cytopenia correlated with 100% elevation of sCD25R, the most important biomarker of HLH. Patients with these three criteria were urgently treated with dexamethasone-etoposide (HLH-94 protocol) or dexamethasone alone (autoimmune related) while completing identification of other criteria described in the pediatric population together with treatment of the secondary cause. Conclusions: Secondary HLH is not rare. Etoposide and dexamethasone (preferred dose:40 mg total/day initially) are the most important current therapeutic approaches. Secondary HLH must be treated urgently and independently of the secondary cause. Treatment should not be delayed awaiting results of sCD25R, NK-cell activity and presence of hemophagocytosis in the bone marrow (often absent). Further work needs to be done to elucidate the physiopathology of secondary HLH.[Table: see text]
Anti-PD-1 monotherapy in patients with malignant mesothelioma: A retrospective single institution experience.
Authors: Ali Atif , Holmes Hudson , Wang Hannah , Prather Lyndsey L. , Sabichi Anita Lyn , Burt Bryan M. , Ripley R. Taylor , Lee Hyun-Sung , Wang Daniel Ying 
Published: June 2021

e20564 Background: Malignant mesothelioma (MM) patients historically have poor outcomes, but immune checkpoint inhibitors have shown promising results in certain patients. We aimed to retrospectively assess efficacy and safety with use of anti-PD-1 monotherapy (aPD-1 Tx) in patients with MM at our institution from Dec 2015 to Dec 2020. Methods: We identified patients with MM treated with nivolumab or pembrolizumab. Clinical details including demographics, efficacy, and toxicity were collected. Efficacy was characterized based on overall response rate (ORR), progression-free survival (PFS) and overall survival (OS). Survival curves were generated using the Kaplan-Meier method, and intergroup comparisons were performed with the log-rank test. Univariable Cox regression analysis was used to determine whether variables were associated with survival. Results: We identified 61 patients treated with aPD-1 Tx for MM. Majority of patients (90%) had malignant pleural mesothelioma. Forty-two (69%) patients were male. The median age of initiation was 65 years (range: 30-84). Most patients (66%) had an ECOG performance status (PS) of 0-1. Known asbestos exposure was noted in 19 (31%) patients. Most patients had received prior chemotherapy (74%) and treated with nivolumab (89%). Only 66% of patients with known PD-L1 had positive expression ( > = 1%). There were 43 (70%) patients with epithelioid histology. Median follow-up was 22.2 months. ORR was 33% with stable disease in 25% of patients. In first-line aPD-1 Tx, ORR was 50%. PFS and OS at 12 months were 26% and 65%, respectively. The median PFS and OS were 5.1 and 15.6 months, respectively. PD-L1 positivity was not associated with improved PFS or OS. Univariable analysis demonstrated that ECOG PS 0-1 had significantly better OS with hazard ratio (HR) 0.40 (95% CI 0.20 – 0.83; p = 0.01). Immune-related adverse events (irAE) were seen in 33% of patients with 13 patients with grade 3 or higher (nephritis, pneumonitis, arthritis, leukocytosis, dermatitis, colitis, type 1 diabetes mellitus, tongue angioedema, and thrombocytopenia). One patient had grade 5 irAE due to severe thrombocytopenia. Patients who developed an irAE had significantly improved median OS (32.1 vs 12.1 months, p = 0.01). Conclusions: Anti-PD-1 monotherapy showed clinical efficacy and safety in malignant mesothelioma as both a first-line treatment and in pre-treated patients based on our real-world experience. The development of irAE may predict benefit, although fatal side effects can occur.