bluuebunny/crossref_metadata_2025_split huggingface dataset:
Chemotherapy at the end of life in colorectal and pancreatic cancer: Real-world data and trends over time.
Authors: Dunn Catherine , Lee Belinda , Shapiro Jeremy David , Wong Rachel , Gard Grace , Michael Michael , Hong Wei , Burge Matthew E. , Wong Vanessa , Thomson Ben , Ananda Sumitra , McLachlan Sue-Anne , Knowles Brett , Nikfarjam Mehdrad , Tie Jeanne , Jennens Ross , McKendrick Joseph James , Lee Margaret , Kosmider Suzanne , Gibbs Peter 
Published: June 2021

e18723 Background: Chemotherapy at the end of life (CEOL) is widely accepted as an indicator of aggressive care. However, the evidence is limited primarily to single-centre experiences, with no consensus regarding acceptable benchmarks for CEOL, nor how this may be changing over time and with novel treatment options. We describe ‘real world’ CEOL in two large, multisite Australian registries of metastatic colorectal cancer (mCRC) and both locally advanced and metastatic pancreatic cancer (PC). Methods: Data was analysed from the TRACC and PURPLE registries, two large prospective multisite Australian cancer registries collecting prospective demographic, tumour, treatment and outcome data for mCRC and PC respectively. We identified all decedents between May 2009 and November 2020, determined the proportion who died within 14 or 30 days of chemotherapy (14D / 30D), or within 30D after a new line of therapy, defined as the first cycle of a new treatment regimen. Using univariate analysis, we compared baseline demographic and clinicopathological variables and trends over time. Results: 1505 mCRC and 602 PC decedents were identified. 20.9% of decedents (21.6% mCRC and 19.3% PC) received chemotherapy within 30D, and 11.5% within 14D (12.3% mCRC and 9.6% PC). There were lower rates of 30D CEOL after the first cycle of a new line of therapy (4.3% mCRC and 5.7% PC). Rates of CEOL decreased over the study period for mCRC (median rate of initial 3-year period 28% versus 15% in last 3-year period), but remained largely static for PC (18.9% versus 17.9%). 30D CEOL was more likely with palliative than curative intent treatment (mCRC OR 1.6, 95% CI 1.14-2.25, p = 0.007, PC OR 5.3, 95% CI 1.6-17.8), and advanced rather than local disease in PC (PC OR 2.59, 95%CI 1.6-4.1, p < 0.001). There was a trend towards CEOL and poorer performance status (ECOG) across all groups, only significant for 30D CEOL mCRC (OR 1.51, 95% CI 1.04-2.2). There was no association between CEOL and patient age, gender, Charlson comorbidity score or lines of therapy. Conclusions: Real-world rates of CEOL are higher in our cohorts of mCRC and PC patients than historical benchmarks but comparable to contemporary reports, which may be due to a wider array of available active treatments. Overall rates are decreasing over time for mCRC but static for PC, which may reflect the poorer overall survival for PC and lack of new effective therapies. The lower rates of death after new lines of therapy may signify that CEOL is more likely with existing treatment regimens and that clinicians are less likely to initiate a new chemotherapeutic regimen at EOL.
Association of proton pump inhibitors with survival in Veterans with non-small cell lung cancer receiving immunotherapy.
Authors: Stokes William A. , Behera Madhusmita , Jiang Renjian , Gutman David , Giuste Felipe , Burns Abigail , Sebastian Nikhil , Ramalingam Selvi , Sukhatme Vidula , Lowe Michael C. , Ramalingam Suresh S. , Sukhatme Vikas , Moghanaki Drew 
Published: June 2021

e18729 Background: Proton pump inhibitors (PPI) can disrupt the gut microbiome and thereby modulate response to immunotherapy in cancer patients. In a recently published post-hoc analysis of 757 non-small cell lung cancer (NSCLC) patients receiving atezolizumab pooled from two prospective trials, overall survival (OS) and progression-free survival were significantly lower among the 234 patients receiving PPI. We investigated the impact of PPI in a larger cohort of NSCLC patients treated with ICI within the Veterans Health Administration. Methods: We conducted a nested cohort study of Veterans who were diagnosed with NSCLC between 2010 & 2018 and treated with ICI (immune checkpoint inhibitors). Exposure was defined as receipt of a PPI prescription within 90 days of an ICI infusion. Chi-square tests were used to compare characteristics of exposed versus unexposed Veterans. OS was measured from start of ICI. Cox proportional hazard multivariate (MV) regression was used to calculate hazard ratios (HR) corresponding to variables associated with OS. Results: We identified 3,634 Veterans receiving ICI with non-exclusive exposures to nivolumab (59.3%), pembrolizumab (35.1%), durvalumab (6.9%), and atezolizumab (3.3%). Their median age was 69, and a plurality had male gender (97.0%), white race (73.0%), comorbidity count ≥1 (60.4%), adenocarcinoma (47.8%), and stage IV disease at diagnosis (40.9%). In this nested cohort, 2,159 (59.4%) were exposed to PPI, predominantly omeprazole (1,264 or 85.6% of PPI group). Patients receiving PPI were more likely to be ≤71 years of age, to be white, to reside in rural areas, to have a higher comorbidity burden, to have adenocarcinoma histology, and to receive chemotherapy (all p≤0.04). On MV analysis, PPI use was not significantly associated with detriment in OS (HR 0.96 [0.89-1.04], p= 0.35). In the matched cohort analysis, median survival did not significantly differ between the 1,389 patients taking PPI and the 1,389 without PPI (median 10 versus 10 months, HR 0.98 [0.90-1.06], p= 0.59). Conclusions: In the largest analysis to date of concurrent PPI use in patients with NSCLC receiving ICI, there were no survival differences associated with concomitant PPI use. These results suggest that PPIs do not compromise ICI efficacy.
Comparison of population characteristics, treatment modes, and clinical outcomes of patients with advanced non-small cell lung cancer in clinical trials and in the real world received PD-1/PD-L1 inhibitor.
Authors: Ma Zhiyong , Wang Huijuan , Wei Chunhua , guo Wei Zhang , Yan Xiangtao , Zhang Mina , Zhang Xiaojuan , Niu Yuanyuan , Yang Jinpo 
Published: June 2021

e18733 Background: Although PD-1/PD-L1 inhibitors have become the standard treatment for patients with advanced non-small cell lung cancer (NSCLC), data from clinical trials are difficult to be verified in the real world. This study aims to compare the differences in population characteristics, treatment modes and clinical outcomes of advanced NSCLC patients received PD-1/PD-L1 inhibitors between the real-world (RWS) and the clinical study (RCT). Methods: This study enrolled 305 advanced NSCLC patients who received at least one PD-1/PD-L1 inhibitor treatment selected in the Affiliated Cancer Hospital of Zhengzhou University/Henan Cancer Hospital Information System and the Zero Krypton database during January 2016 to September 2019. The patients were divided into RWS group and RCT group. The PD-1/PD-L1 inhibitors included pembrolizumab, sintilizumab, nivolizumab, tislelizumab, carrelizumab, teriprizumab, durvalizumab and Atezolizumab. We performed paired analysis in clinical characteristics and treatment modes. Results: There were 155 cases in the RCT group and 150 cases in the RWS group. The RCT group consisted of higher proportion in male (79.4%) and squamous-carcinoma type (41.3%) than the RWS group, while more patients of brain metastasis (28%) and combination therapy (50.7%) in the RWS group. The ORRs were 42.4% and 20.6% respectively in the RCT and RWS groups receiving first-line treatment with PD-1/PD-L1 inhibitors, and the difference was statistically different. Moreover, the ORRs were 42.4% and 20.6% respectively in the RCT and RWS groups receiving PD-1/PD-L1 inhibitor as second-line treatment, without statistical difference. The progression-free survival (PFS) was 15.5 vs. 13.5 months in the RCT and RWS groups ( P= 0.91), and the median overall survival (OS) was 25.4 vs. 33.8 months respectively ( P= 0.24), with no statistical difference. After propensity match of baseline characteristics of the two groups of patients, it contained 108 patients in the RCT and RWS groups. The PFS was 13.3 vs. 13.3 months in the RCT and RWS groups ( P= 0.47), and the median OS was 21.1 vs. 23.2 months ( P= 0.58), with no statistical difference. Conclusions: Although more female, brain metastases and adenocarcinoma patients receiving PD-1/PD-L1 inhibitors in the real world, the clinical benefits were consistent with those in clinical trials. The results of propensity matching on the baseline characteristics of patients supported this conclusion.
Evaluating real-world overall survival (rwOS) across oncology data sources: Friends of Cancer Research non-small cell lung cancer pilot study.
Authors: Lasiter Laura , Baxi Shrujal , Belli Andrew J. , Boyd Marley , Christian Jennifer , Cohen Aaron B. , Espirito Janet L , Garrett-Mayer Liz , Hansen Eric , Izano Monika A. , Natanzon Yanina , Rivera Donna , Robert Nicholas J. , Small Mackenzie , Sweetnam Connor , Tymejczyk Olga , Wagner Joseph , Allen Jeff 
Published: June 2021

e18749 Background: Friends of Cancer Research and five data partners used electronic health record-sourced datasets to conduct parallel analyses in real-world data (RWD). The study assessed estimates of rwOS among patients taking platinum doublet chemotherapy (chemo) or pembrolizumab in combination with chemo (IO+chemo) in first-line treatment for metastatic non-small cell lung cancer (mNSCLC). Methods: The KEYNOTE-189 clinical trial was selected as a reference for cohort selection in the RWD. We applied select available KEYNOTE-189 eligibility criteria to compare rwOS in a homogenous real-world population. Analyses were conducted following a mutually developed statistical analysis plan that was harmonized across data partners. Twelve-month rwOS, and unadjusted and adjusted hazard ratios (HR) for death were calculated using time-to-event methods with patients censored at last structured activity prior to the data cutoff. Results: The five datasets included patients treated with chemo (range of n=155 to 1501) and IO+chemo patients (n=36 to 405, Table). Twelve-month rwOS estimates ranged from 45% to 58% in the chemo arm and 44% to 68% in the IO +chemo arm. The HR for death comparing IO+chemo to chemo varied across groups, ranging from 0.79 (95% CI: 0.68, 0.92) to 1.10 (95% CI: 0.70, 1.72). The HR for death adjusted for age, gender, performance status, and smoking status did not significantly alter results, ranging from 0.80 (95% CI: 0.69, 0.93) to 1.15 (96% CI: 0.71, 1.85). Conclusions: The systematic evaluation of reproducibility and performance of rwOS across five real-world cohorts and the impact of implementing consistent eligibility criteria and methods was useful to understand the consistency of results in real-world populations and relationship between treatments and outcomes in the absence of randomization. A well-articulated research question and a pre-specified analytic plan that includes covariate definitions are necessary preliminary steps to guide data harmonization, standardization, and analysis. A range of observed results highlights the complexity of real-world data, including differences in sample size, underlying patient variability across datasets, and missing covariate data. The harmonization process and observed results underscore the importance of a well-articulated research question and a pre-specified analytic plan to guide data harmonization, standardization, and analysis. [Table: see text]
Facility contextual effects influence the use of adjuvant immunotherapy in stage III melanoma.
Authors: Leonard Laura D. , Torphy Robert J. , Beaty Laurel , de Araujo Thiago B. , Colborn Kathryn , Ho Felix , Albuqueque Arthur , Lewis Karl D. , Gonzalez Rene , Medina Theresa Michelle , McCarter Martin , Stewart Camille L. , Gleisner Ana 
Published: June 2021

e18758 Background: There are now numerous effective adjuvant immunotherapy options for surgically resected stage III melanoma including novel checkpoint inhibitors and targeted therapies. Current guidelines recommend that the decision to treat stage III melanoma with adjuvant immunotherapy should be individualized and based upon disease burden, patient goals and anticipated therapy tolerance. We sought to assess the contribution of patient, tumor and facility factors on the implementation of immunotherapy in patients with surgically resected stage III melanoma. Methods: Using the National Cancer Database (NCDB), patients from 2012-2017 that underwent excision and were found to have a positive sentinel node were identified. A multivariable mixed effects logistic regression model with a random intercept for site was used to determine the effect of patient, tumor, and facility variables on the probability of immunotherapy. Reference Effect Measures (REM) were used to estimate the variation in immunotherapy use due to unmeasured facility factors (contextual effects) after adjusting for measured patient, tumor, and facility variables. Results: From 2012 to 2017, the percent of patients with stage III melanoma treated with adjuvant immunotherapy increased from 23.7% to 38.5% (p < 0.05). Overall, younger patients and patients with private insurance were more likely to receive immunotherapy. Tumor factors associated with increased use of adjuvant immunotherapy included increasing depth, mitotic rate ³1, ulceration, lymphovascular invasion (LVI), and undergoing a completion lymph node dissection (CLND). Additionally, treatment at a facility with a surgical volume <190 cases/year was associated with increased immunotherapy use. However, the width of the 90% REM range for unmeasured facility effects exceeded that of the measured facility, tumor, time, and patient demographics suggesting that contextual effects had a higher contribution to the variation in immunotherapy use. Conclusions: Our analysis suggests that uninsured patients and patients with government insurance (Medicaid and Medicare) are not receiving immunotherapy at the same frequency as privately insured patients with the same tumor characteristics treated at the same facility. Lastly, compared to known patient, tumor and facility factors, institutional contextual effects were the major drivers of the implementation of immunotherapy.[Table: see text]
Changes in chronic disease medication adherence following oral anticancer agent initiation in patients with multiple myeloma.
Authors: Gatwood Justin , Dashputre Ankur , Wallace Alex , Gatwood Katie S. , Farris Karen B. , Mackler Emily R. , Rizvi-Toner Amna , Rajpurohit Abhijeet , Farley Joel 
Published: June 2021

e18760 Background: Improvements in treatment options for multiple myeloma (MM) have led to double-digit increases in 5-year survival rates over the past 40 years. Such extended survival has increased emphasis for the management of comorbid chronic conditions. Initial analyses suggest that oral anticancer agent (OAA) initiation for MM may correspond to significant reductions in adherence to chronic disease medications. Methods: This was a retrospective cohort study of adults diagnosed with and being treated for MM between 2013-2018 using data from the IBM MarketScan Commercial Claims and Encounters databases and a 20% sample of Medicare claims data. Adults (18 years and older) were included if they were diagnosed with and had at least two claims for an OAA indicated for MM, had continuous enrollment for 12 months both before and after OAA initiation, and were previously diagnosed with two chronic conditions and had prescription fills for select chronic conditions. Medication adherence was determined using the proportion of days covered (PDC) metric and was compared for the 12 months before and after the OAA initiation by Wilcoxon signed-rank tests, McNemar’s tests, and difference-in-differences (DinD) models. Results: A slight majority of the 2,765 patients (total N from both databases) were male (52.3%), and hypertension (94.5%) and hyperlipidemia (69.2%) were the most common comorbid conditions. Mean OAA adherence in the first year of therapy was 55.8% (SD: 23.5) and 63.5% (SD: 26.9) for commercial and Medicare patients, respectively. PDCs for comorbid therapies declined in the first year after OAA initiation, irrespective of payer (table), and the proportion adherent to these therapies (PDC > 80%) also declined consistently. OAA adherence tended to align with the direction of changes in comorbid therapy adherence with those nonadherent to their OAA (PDC < 80%) demonstrating general declines in comorbid therapy PDCs post-OAA initiation (p<0.05 in 4 of 6 DinD models). Conclusions: Among adults with MM and multiple chronic conditions, the pre-OAA initiation level of adherence appears to dictate chronic disease medication use patterns after OAA initiation. The starting of OAA therapy facilitates an opportunity for providers to reinforce the need for total regimen adherence to improve the odds of positive cancer- and non-cancer-related outcomes. [Table: see text]
Retrospective study on the management of patients admitted for febrile neutropenia and considered to be at low risk at the Centre Hospitalier Universitaire de Québec.
Authors: Jean Tommy , Lemieux Julie , Soucy Geneviève , Caron Francis , Leblanc Dominique 
Published: June 2021

e18762 Background: Febrile neutropenia is a serious complication of chemotherapy leading to hospitalization in cancer patients. According to a practice guidelines published by ASCO (American Society of clinical Oncology) and IDSA (Infectious Diseases Society of American) in 2018, patients meeting the criteria for low-risk neutropenia according to the MASCC score (Multinational Association for Supportive Care in Cancer Score) could be treated as outpatient and thus avoid hospitalization. The objective of the study was to assess the number and proportion of patients who were hospitalized for febrile neutropenia in university hospital that would have met the low risk criteria of febrile neutropenia. We also wanted to know if these patients had experienced a favorable outcome during hospitalization. Methods: We performed a retrospective study including all patients admitted for febrile neutropenia in 3 hospitals in Quebec City during the period from January 1, 2018 to December 31, 2019. We excluded patients with leukemia, as well as stem cell transplant patients. The chart review retrospectively established the MASCC score for each patient. We also established according to predefined criteria whether the clinical course was favorable or unfavorable. Results: A total of 177 hospitalizations met our inclusion criteria. We found that 101/177 (57.1%) of hospitalized patients met the criteria for low-risk neutropenia according to the MASCC score (score of 21 and above). Of this number 74/177 (41.8%) presented all the criteria suggested for receiving outpatient treatment. In these patients 70/177 (39.5%) presented a favorable evolution during hospitalization and thus 4/177 (2.3%) presented an unfavorable evolution. Among these, 2 patients presented with infections considered major (2 bacteremia), 1 patient developed acute renal failure, and 1 other patient developed delirium. There was no death or admission to the intensive care unit in these 4 patients. Conclusions: According to this retrospective study, about 40% of patients admitted for febrile neutropenia filled the criteria of low risk febrile neutropenia and could be treated as outpatient. Given this represents a significant proportion of patients, a protocol for systematic follow-up of outpatient treatment with low-risk febrile neutropenia should be put in place.
Prevalence of lung cancer in Colombia and a new diagnostic algorithm using health administrative databases: A real-world evidence study.
Authors: Buitrago Giancarlo , Amaya-Nieto Javier , Torres Gabriel Fernando 
Published: June 2021

e18764 Background: Reliable, timely and detailed information of lung cancer mortality and costs from low- and middle-income countries is essential to policy design. We aimed to develop an electronic algorithm to identify lung cancer prevalent patient in Colombia using official databases and to estimate prevalence rates by age, sex, and geographic region. Methods: We performed a cross sectional study based on national claim databases in Colombia ( Base de datos de suficiencia de la Unidad de Pago por Capitación and Base de Datos Única de Afiliados) to identify lung cancer prevalent patients in 2017. Several algorithms based on the presence or absence of oncological procedures (Chemotherapy, radiotherapy and surgery), and a minimum number of months that each individual had lung cancer ICD-10 codes in the previous 3 years, were developed. After testing 16 algorithms, those with the closest prevalence rates to the ones reported by aggregated official sources (GLOBOCAN, National Cancer Institute and Cuenta de Alto Costo) were selected . We estimated prevalence rates by age, sex, and geographic region. Results: Two algorithm s were selected: i) it was defined as the presence of ICD-10 codes for 4 months or more (sensitive algorithm); and ii) adding the presence of at least one oncological procedure (specific algorithm). Estimated prevalence rates per 100,000 population were 15.3 and 9.7 for the sensitive and specific algorithms, respectively. These rates were higher in men (9.9), over 65 years old (37.1), who lived in Central and Bogota regions (14.7 and 10.9, respectively) (Table). Conclusions: Selected algorithms showed similar prevalence estimations to those reported by official sources and allowed us to estimate prevalence rates in specific aging, regional and gender groups for Colombia using national claims databases. These findings could be useful to identify clinical and economical outcomes related to lung cancer patients using national individual-level databases. [Table: see text]