Risk Scores for Occult Cancer in Patients with Venous Thromboembolism: A Post Hoc Analysis of the Hokusai-VTE Study

2018 ◽  
Vol 118 (07) ◽  
pp. 1270-1278 ◽  
Author(s):  
Noémie Kraaijpoel ◽  
Nick van Es ◽  
Gary Raskob ◽  
Harry Büller ◽  
Marc Carrier ◽  
...  

AbstractVenous thromboembolism (VTE) may be the first sign of an undiagnosed cancer. In patients with unprovoked VTE, the risk is approximately 5% in the year following VTE diagnosis. Cancer-specific screening is therefore often considered in these patients, but the optimal screening strategy remains controversial. Recently, two risk classification scores have been proposed that may help in identifying patients at high risk of occult cancer in whom extensive screening may be warranted. In the present post hoc analysis of the Hokusai-VTE study, we evaluated the performance of the Registro Informatizado de Pacientes con Enfermedad TromboEmbólica (RIETE) and Screening for Occult Malignancy in Patients with Idiopathic Venous Thromboembolism (SOME) scores for occult cancer in patients with acute VTE. A total of 8,032 patients were included in the analysis of whom 218 (2.7%; 95% confidence interval [CI], 2.4–3.1) developed cancer between 30-day and 12-month follow-up. The c-statistics of the RIETE and SOME scores were 0.62 (95% CI, 0.57–0.66) and 0.59 (95% CI, 0.55–0.62), respectively. In patients classified as ‘high risk’, the cumulative incidence of cancer diagnosis during follow-up was 2.9% (95% CI, 2.1–3.9) for the RIETE score and 2.7% (95% CI, 1.9–3.7) for the SOME score, corresponding to hazard ratios of 1.8 (95% CI, 1.3–2.5) and 1.5 (95% CI, 1.04–2.2), respectively. In conclusion, the performance of both scores was poor. When used dichotomously, the scores were able to identify a group of patients with a significantly higher risk of occult cancer, although it remains unknown whether this translates into improved clinical important outcomes.

2018 ◽  
Vol 164 ◽  
pp. S224
Author(s):  
N. Kraaijpoel ◽  
N. van Es ◽  
G.E. Raskob ◽  
H.R. Büller ◽  
M. Carrier ◽  
...  

Blood ◽  
2016 ◽  
Vol 127 (16) ◽  
pp. 2035-2037 ◽  
Author(s):  
Ryma Ihaddadene ◽  
Daniel J. Corsi ◽  
Alejandro Lazo-Langner ◽  
Sudeep Shivakumar ◽  
Ryan Zarychanski ◽  
...  

Key Points It remains unclear whether a subgroup of high-risk patients could potentially benefit from a more extensive screening strategy. Age, prior provoked VTE, and smoking status may be important predictors of occult cancer detection in patients with first unprovoked VTE.


Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 1230-1230
Author(s):  
Nathan Cantor ◽  
Marc Carrier ◽  
Marc A. Rodger ◽  
Gabrielle Veillet-Lemay ◽  
Elham Sabri ◽  
...  

Abstract Background: The diagnosis of an unprovoked (i.e., in the absence of any risk factors) venous thromboembolism (VTE) may be a sign of an underlying cancer. Previous estimates of the incidence rate of occult cancer in patients with unprovoked VTE are as high as 5-10%. However, screening methods to detect cancer early in these patients are of limited clinical value and previous identification of risk factors focused on short-term cancer diagnosis. Therefore, this study will assess the long-term incidence and risk factors of cancer in unprovoked VTE patients. Methods: This retrospective study is a post-hoc analysis of the REVERSE (Recurrent Venous Thromboembolism Risk Stratification Evaluation) study. Patient data was collected following an initial six-month course of anticoagulation therapy and were followed for a mean time period of 5.0 years (range 1 month-8 years). We performed univariable analysis to test the strength of association between each potential predictor variable and occult cancer diagnosis. Furthermore, using forward model selection we created a multivariable model with optimal predictive value for cancer diagnosis. Results: Among 663 patients presenting with unprovoked VTE, 38 (5.7%) subsequently developed a new cancer diagnosis during the follow-up period. The most common types of cancers diagnosed were prostate (21%) and colorectal cancer (16%). Univariate analysis revealed age > 65 (OR 2.59; 95% CI 1.31-4.49, P= 0.0036), elevated D-Dimer (OR 2.71; 95% CI 1.38-5.31, P=0.026) and pulmonary vein obstruction (PVO) score (OR 4.34 95% CI 1.26-14.92, P=0.023) as the strongest predictors of occult cancer. Only D-Dimer (Adj.-OR 2.72 95% CI 1.39-5.32) remained in the multivariate model and no other factor significantly improved the model's fit. Conclusion: Patients with an unprovoked VTE remain at an elevated risk of developing cancer following anticoagulation therapy. Age > 65 years old, elevated D-Dimer, and PVO in pulmonary embolism patients are among potential risk factors for developing occult cancer. More studies are needed to validate these potentially important risk factors. Disclosures Carrier: BMS: Honoraria, Research Funding; Leo Pharma: Research Funding; Pfizer: Honoraria; Bayer: Honoraria. Rodger:Biomerieux: Research Funding. Kovacs:Daiichi Sankyo Pharma Development: Research Funding; Bayer: Research Funding.


2018 ◽  
Vol 170 ◽  
pp. 8
Author(s):  
Nathan Cantor ◽  
Gabrielle Veillet-Lemay ◽  
Elham Sabri ◽  
Marc Carrier ◽  
Michael Kovacs ◽  
...  

2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 300-300
Author(s):  
Summer Wilmoth ◽  
Leah Carrillo ◽  
Elana Martinez ◽  
Raymundo Mendoza Mendoza ◽  
Lauren Correa ◽  
...  

Abstract Objectives Hispanics are disproportionally affected by obesity, cancer, and other obesity-related chronic diseases. Building a Healthy Temple (BHT) was a multi-component, faith-based lifestyle intervention implemented in 27 low-income, predominately-Hispanic congregations in San Antonio, TX between 2012 and 2017. One aim of BHT was to assess program effectiveness at improving health-conducive church environment/policy and sustainability of these improvements at follow-up. Methods A key macro-level program component of BHT was the formation of a Health Ministry Committee to initiate church-wide health-conducive environment/policy changes. The Congregational Health Index (CHI) was used to assess church nutrition (17 items) and physical activity (PA, 5 items) environment/policy at baseline, end of program, and follow-up (6 months or more post-intervention). Data were expressed as % of the maximum scores. Friedman test and post hoc analysis were performed with Wilcoxon signed-rank tests and significance of pairwise comparisons, adjusted with Bonferroni correction. Results Eighteen churches completed all 3 CHI assessments. Percentage of total nutrition and PA environment/policy scores for baseline, end of program, and follow-up were 38% (35–45), 64% (53–75), and 69% (64–77), respectively. Post hoc analysis shows significant improvements in nutrition and PA environment/policy scores at end of program (Z = –3.73, P < 0.001) and follow-up (Z = –3.73, P < 0.001) as compared to baseline, as well as significantly higher scores at follow-up compared to end of program (Z = –3.18, P = 0.001). Conclusions Study findings reveal the importance of utilizing congregation-wide macro-level interventions to create health-conducive enviroment/policy changes to facilitate and sustain healthy lifestyle changes in predominately-Hispanic faith community settings. Funding Sources Baptist Health Foundation San Antonio & Cancer Prevention Research Institute of Texas.


Author(s):  
Osman Öcal ◽  
Kerstin Schütte ◽  
Juozas Kupčinskas ◽  
Egidijus Morkunas ◽  
Gabija Jurkeviciute ◽  
...  

Abstract Purpose To explore the potential correlation between baseline interleukin (IL) values and overall survival or objective response in patients with hepatocellular carcinoma (HCC) receiving sorafenib. Methods A subset of patients with HCC undergoing sorafenib monotherapy within a prospective multicenter phase II trial (SORAMIC, sorafenib treatment alone vs. combined with Y90 radioembolization) underwent baseline IL-6 and IL-8 assessment before treatment initiation. In this exploratory post hoc analysis, the best cut-off points for baseline IL-6 and IL-8 values predicting overall survival (OS) were evaluated, as well as correlation with the objective response. Results Forty-seven patients (43 male) with a median OS of 13.8 months were analyzed. Cut-off values of 8.58 and 57.9 pg/mL most effectively predicted overall survival for IL-6 and IL-8, respectively. Patients with high IL-6 (HR, 4.1 [1.9–8.9], p < 0.001) and IL-8 (HR, 2.4 [1.2–4.7], p = 0.009) had significantly shorter overall survival than patients with low IL values. Multivariate analysis confirmed IL-6 (HR, 2.99 [1.22–7.3], p = 0.017) and IL-8 (HR, 2.19 [1.02–4.7], p = 0.044) as independent predictors of OS. Baseline IL-6 and IL-8 with respective cut-off values predicted objective response rates according to mRECIST in a subset of 42 patients with follow-up imaging available (IL-6, 46.6% vs. 19.2%, p = 0.007; IL-8, 50.0% vs. 17.4%, p = 0.011). Conclusion IL-6 and IL-8 baseline values predicted outcomes of sorafenib-treated patients in this well-characterized prospective cohort of the SORAMIC trial. We suggest that the respective cut-off values might serve for validation in larger cohorts, potentially offering guidance for improved patient selection.


2018 ◽  
Vol 143 (6) ◽  
pp. 1541-1548 ◽  
Author(s):  
Lise M.A. De Strooper ◽  
Johannes Berkhof ◽  
Renske D.M. Steenbergen ◽  
Birgit I. Lissenberg‐Witte ◽  
Peter J.F. Snijders ◽  
...  

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 2054-2054
Author(s):  
David Brachman ◽  
Peter Nakaji ◽  
Kris Smith ◽  
Theresa Thomas ◽  
Christopher Dardis ◽  
...  

2054 Background: Recurrent GBM (rGBM) is a diffuse disease, and resection (R) alone does not provide durable local control (LC) or prolong overall survival (OS). Hypothesizing R plus immediate radiation (RT) may achieve durable LC and secondarily improve OS by permitting time for subsequent potentially effective but biologically slower treatments to have an impact, we prospectively evaluated R combined with a novel surgically targeted radiation therapy (STaRT) device utilizing Cs-131 embedded in bioresorbable collagen tiles. Methods: From 2/13-2/18 patients (pts) with locally recurrent GBM were treated on a prospective single arm trial (ClinicalTrials.gov, NCT#03088579) of maximum safe resection and immediate RT (GammaTile, GT Medical Technologies, Tempe AZ). Upon resection the at-risk areas of the surgical bed were lined with the GammaTile (GT) device, delivering 60-80 Gy at 5 mm. Follow up treatments were not specified but captured; no pt. underwent additional local therapy without progression, and no pt. was lost to follow up. We present study specified endpoints of local control (LC), overall survival (OS), and adverse events (AE), and a post hoc, hypothesis-generating analysis of outcomes by receipt of systemic (Sys) therapy. Results: 28 locally recurrent GBM were treated, 20 at first progression (range 1-3). Median age was 58 years (yrs.) (range 21-80), KPS 80 (60-100), female: male ratio 10:18 (36/64%). MGMT was methylated in 11%, unmethylated in 18%, and unknown in 71%. For all pts., median OS was 10.7 months (mo.) (range.1-42.3), and radiographic LC was 8.8 mo. (range.01-34.5). LC (defined as < 15 mm from surgical bed) was maintained in 50% of pts., and no first failure was local. 12 mo. OS was 75% for pts. < 50 yrs. vs. 43% for > 50 yrs. (HR.46, p =.009). MGMT, KPS, and sex were non-predictive. After R+GT, 17 pts. received > 1 cycle of systemic therapy (Sys), either as adjuvant or salvage, alone or in combination . Sys was bevacizumab (BEV) in 15 pts., temozolomide (TMZ) in 12, and lomustine (CCNU) in 8 (N > 17 as some pts. received > 1 Sys). Post hoc analysis disclosed a 15.1 mo. OS for pts. receiving > 1 cycle of Sys (Sys+, N = 17) vs. 6.5 mo. for no Sys (Sys-, N = 11) (hazard ratio (HR).38, p =.017)). LC was 11.4 mo. for Sys+ and 2.1 mo. for Sys- (HR.44; p =.16)). Median OS (mo.) for BEV+ vs. BEV- was 16.7/4.5 (HR.38, p =.017), for TMZ+ vs. TMZ- 17.5/6.7 (HR.40, p =.025) and for CCNU+ vs. CCNU- 17.5/7.9 (HR.61, p =.25), respectively. Three attributed AE occurred, 1 dehiscence requiring surgery and 2 radiation brain effects, medically treated. 4 unrelated deaths occurred < 60 days post-op, all in the Sys- cohort, impacting their opportunity for subsequent treatment. Conclusions: In this study local treatment alone was insufficient to achieve prolonged OS. Post hoc analysis suggests R+GT coupled with Sys may have potential to impact OS in rGBM patients. GT was FDA cleared in 2020 for use in newly diagnosed malignant and all recurrent intracranial neoplasms. Clinical trial information: NCT#03088579.


2019 ◽  
Vol 7 (1) ◽  
pp. e000718 ◽  
Author(s):  
Andrea Cardona ◽  
Aaron O'Brien ◽  
Matthew C Bernier ◽  
Arpad Somogyi ◽  
Vicki H Wysocki ◽  
...  

IntroductionType 2 diabetes mellitus (T2D) confers high atherosclerotic cardiovascular disease (ASCVD) risk. The metabolite trimethylamine N-oxide (TMAO) derived via gut flora has been linked to excess ASCVD.Research design and methodsWe analyzed data, biospecimens, and major adverse cardiovascular events (MACEs) from the prospective multicenter randomized Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial to assess its value in 330 high-risk individuals with T2D without evident atherosclerotic disease at enrollment.ResultsIncident cardiovascular events occurred in 165 cases; 165 controls matched by age, sex, and treatment arm experienced no incident events during follow-up. Cases and controls (mean age 64.5 years) had similar mean glycated hemoglobin (HbA1c) (8.2%) and mean 10-year ASCVD risk (23.5%); groups also had similar use of statins and antihypertensive medications at baseline and follow-up. Baseline plasma TMAO levels did not differ between groups after adjusting for ASCVD risk score, HbA1c, and estimated glomerular filtration rate, nor did TMAO distinguish patients suffering incident MACE from those who remained event-free.ConclusionsTMAO’s prognostic value for incident ASCVD events may be blunted when applied to individuals with T2D with poor glycemic control and high baseline ASCVD risk. These results behoove further translational investigations of unique mechanisms of ASCVD risk in T2D.


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