THU0214 LONG-TERM EFFECTIVENESS OF METHOTREXATE WITH STEP DOWN GLUCOCORTICOID BRIDGING (COBRA SLIM) VERSUS OTHER CONVENTIONAL DMARD REGIMENS AS INITIAL RA THERAPY: 5-YEAR OUTCOMES OF THE CARERA TRIAL.

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 332-333
Author(s):  
V. Stouten ◽  
R. Westhovens ◽  
D. De Cock ◽  
S. Pazmino ◽  
J. Joly ◽  
...  
Keyword(s):  
High Risk ◽  
Risk Group ◽  
Low Risk ◽  
Remission Induction ◽  
Avant Garde ◽  
High Risk Patients ◽  
Early Ra ◽  
Risk Patients ◽  
Step Down

Background:The treat-to-target Care in Early Rheumatoid Arthritis (CareRA) trial demonstrated that remission induction with csDMARD combinations and step-down glucocorticoids (GCs) was not superior over methotrexate (MTX) monotherapy with step-down GCs (Cobra Slim) in RA patients with a high-risk profile (1). Moreover, Cobra Slim showed benefit over a tight step-up with MTX in monotherapy (TSU) in RA patients with a low-risk profile.Objectives:To compare the long term outcomes up to 5 years of different initial intensive treatment strategies in participants of the CareRA-plus study.Methods:In the CareRA trial, patients with DMARD naïve early RA were stratified in a high- or low-risk group based upon the presence of serummarkers, disease activity and erosive status. High-risk patients were randomised to Cobra Classic (MTX+sulphasalazine with highly dosed GC remission induction scheme), Cobra Avant-Garde (MTX+leflunomide with moderately dosed GC scheme) or Cobra Slim. Low-risk patients were randomised to Cobra Slim or TSU. Patients completing this trial were eligible for the CareRA-plus observational study. Here, patients were evaluated 6-monthly over 3 years. Therapy adaptation was left to the treating physician. Efficacy was assessed by DAS28-CRP and HAQ and compared between the originally allocated treatment arms. The 5-year evolution from CareRA baseline of DAS28-CRP and HAQ was assessed via linear mixed models. All adverse events (AEs), considered to be clinically relevant by investigators, and DMARD/GCs therapy were registered.Results:Of 322 eligible patients, 252 (78%) were included in CareRA-plus, of which 203 (81%) completed the study. Characteristics and outcomes at the CareRA closing visit (year 2) did not differ between patients entering CareRA-plus or not. DAS28-CRP<2.6 at year 5 in high-risk patients was 72%, 77% and 64% in the Classic, Slim and Avant-Garde group respectively (p=0.403). In the longitudinal analyses, all treatment arms in the high-risk group had comparable DAS28-CRP (p=0.921) and HAQ scores over time (p=0.540). In the low-risk population, 83% of patients in the Slim and 82% in the TSU arm had DAS28-CRP<2.6 at year 5 (p=0.945). Low-risk patients starting Cobra-Slim had lower DAS28-CRP scores over 5 years than those receiving TSU (p= 0.002). HAQ score over time did not differ (p=0.129). In high-risk patients, the total numbers of AEs throughout CareRA-plus, were 70 in 36 Classic, 95 in 48 Slim and 80 in 36 Avant-Garde patients (p=0.182). In the low-risk group there were 18 AEs in 10 Slim and 36 in 17 TSU patients (p=0.048). During the 5-year study, biologics were initiated in 22% of all patients: 23% of Classic, 23% of Slim high-risk, 25% of Avant-Garde, 17% of Slim low-risk, and 15% of TSU patients. At the year 5 visit, 71%, 61% and 50% of high-risk patients were on csDMARD monotherapy (mostly MTX) in Classic, Slim and Avant-Garde respectively. Of the low-risk group, 65% in COBRA-Slim and 62% in TSU were taking a single csDMARD. At the year 5 visit, 9% of all participants received chronic oral GC therapy (>3 months).Conclusion:All intensive treatment strategies resulted in excellent long-term clinical outcomes. Initial Cobra Slim therapy showed comparable 5-year effectiveness as Cobra Classic and Avant-Garde in high-risk early RA patients and better efficacy and safety than conservative step up treatment in low-risk patients.Figure 1.Mean disease activity by DAS28-CRP or mean functionality by HAQ index scores for high-risk or low-risk patients.References:[1]Stouten, V. et al. Effectiveness of different combinations of DMARDs and glucocorticoid bridging in early rheumatoid arthritis: two-year results of CareRA. Rheumatology (Oxford). (2019)doi:10.1093/rheumatology/kez213.Disclosure of Interests: :Veerle Stouten: None declared, Rene Westhovens Grant/research support from: Celltrion Inc, Galapagos, Gilead, Consultant of: Celltrion Inc, Galapagos, Gilead, Speakers bureau: Celltrion Inc, Galapagos, Gilead, Diederik De Cock: None declared, Sofia Pazmino: None declared, Johan Joly: None declared, Delphine Bertrand: None declared, Kristien Van der Elst: None declared, Patrick Verschueren Grant/research support from: Pfizer unrestricted chair of early RA research, Speakers bureau: various companies

scholarly journals Effectiveness of different combinations of DMARDs and glucocorticoid bridging in early rheumatoid arthritis: two-year results of CareRA

Rheumatology ◽  
2019 ◽  
Vol 58 (12) ◽  
pp. 2284-2294 ◽  
Author(s):  
Veerle Stouten ◽  
René Westhovens ◽  
Sofia Pazmino ◽  
Diederik De Cock ◽  
Kristien Van der Elst ◽  
...  
Keyword(s):  
High Risk ◽  
Risk Group ◽  
High Risk Group ◽  
Low Risk ◽  
Avant Garde ◽  
Early Ra ◽  
Risk Patients ◽  
Step Down ◽  
N 93

AbstractObjectivesTo investigate whether MTX should be combined with an additional DMARD and bridging glucocorticoids as initial treatment for patients with early RA to induce an effective long-term response.MethodsThe Care in early RA study is a two-year investigator-initiated pragmatic multicentre randomized trial. Early RA patients, naïve to DMARDs and glucocorticoids, were stratified based on prognostic factors. High-risk patients were randomized to COBRA-Classic (n = 98): MTX, sulfasalazine, prednisone step-down from 60 mg; COBRA-Slim (n = 98): MTX, prednisone step-down from 30 mg; or COBRA-Avant-Garde (n = 93): MTX, leflunomide, prednisone step-down from 30 mg. Low-risk patients were randomized to COBRA-Slim (n = 43); or Tight Step Up (TSU) (n = 47): MTX without prednisone. Clinical/radiological outcomes at year 2, sustainability of response, safety and treatment adaptations were assessed.ResultsIn the high-risk group 71/98 (72%) patients achieved a DAS28-CRP < 2.6 with COBRA-Slim compared with 64/98 (65%) with COBRA-Classic and 69/93 (74%) with COBRA-Avant-Garde (P = 1.00). Other clinical/radiological outcomes and sustainability of response were similar. COBRA-Slim treatment resulted in less therapy-related adverse events compared with COBRA-Classic (P = 0.02) or COBRA-Avant-Garde (P = 0.005). In the low-risk group, 29/43 (67%) patients on COBRA-Slim and 34/47 (72%) on TSU achieved a DAS28-CRP < 2.6 (P = 1.00). On COBRA-Slim, low-risk patients had lower longitudinal DAS28-CRP scores over 2 years, a lower need for glucocorticoid injections and a comparable safety profile compared with TSU.ConclusionAll regimens combining DMARDs with glucocorticoids were effective for patients with early RA up to 2 years. The COBRA-Slim regimen, MTX monotherapy with glucocorticoid bridging, provided the best balance between efficacy and safety, irrespective of patients’ prognosis.Trial registrationClinicalTrials.gov, http://www.clinicaltrials.gov, NCT01172639.

Two-year cost-effectiveness of different COBRA-like intensive remission induction schemes in early rheumatoid arthritis: a piggyback study on the pragmatic randomised controlled CareRA trial

2020 ◽  
Vol 79 (5) ◽  
pp. 556-565 ◽  
Author(s):  
Sofia Pazmino ◽  
Annelies Boonen ◽  
Veerle Stouten ◽  
Diederik De Cock ◽  
Johan Joly ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Cost Effectiveness ◽  
High Risk ◽  
Risk Group ◽  
Low Risk ◽  
Remission Induction ◽  
Avant Garde ◽  
Risk Patients ◽  
Step Down ◽  
Randomised Controlled

ObjectivesTo evaluate the cost-effectiveness of treat-to-target strategies among recently diagnosed patients with rheumatoid arthritis (RA) using methotrexate (MTX) and a step-down glucocorticoid (GC) scheme (COBRA Slim) compared with (1) this combination with either sulphasalazine (COBRA Classic) or leflunomide (COBRA Avant-Garde) in high-risk patients and (2) MTX without GCs (Tight-Step-Up, TSU) in low-risk patients.MethodsThe incremental cost-utility was calculated from a healthcare perspective in the intention-to-treat population (n=379) of the 2-year open-label pragmatic randomised controlled Care in early RA trial. Healthcare costs were collected prospectively through electronic trial records. Quality-adjusted life years (QALYs) were estimated using mapping algorithms for EuroQoL-5 Dimension. Multiple imputation was used to handle missing data and bootstrapping to calculate CIs. Robustness was tested with biological disease-modifying antirheumatic drugs at biosimilar prices.ResultsIn the high-risk group, Classic (∆k€1.464, 95% CI −0.198 to 3.127) and Avant-Garde (∆k€0.636, 95% CI −0.987 to 2.258) were more expensive compared with Slim and QALYs were slightly worse for Classic (∆−0.002, 95% CI −0.086 to 0.082) and Avant-Garde (∆−0.009, 95% CI −0.102 to 0.084). This resulted in the domination of Classic and Avant-Garde by Slim. In the low-risk group, Slim was cheaper (∆k€−0.617, 95% CI −2.799 to 1.566) and QALYs were higher (∆0.141, 95% CI 0.008 to 0.274) compared with TSU, indicating Slim dominated. Results were robust against the price of biosimilars.ConclusionsThe combination of MTX with a GC bridging scheme is less expensive with comparable health utility than more intensive step-down combination strategies or a conventional step-up approach 2 years after initial treatment.Trial registration numberNCT01172639.

scholarly journals Methotrexate in combination with other DMARDs is not superior to methotrexate alone for remission induction with moderate-to-high-dose glucocorticoid bridging in early rheumatoid arthritis after 16 weeks of treatment: the CareRA trial

2014 ◽  
Vol 74 (1) ◽  
pp. 27-34 ◽  
Author(s):  
P Verschueren ◽  
D De Cock ◽  
L Corluy ◽  
R Joos ◽  
C Langenaken ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
High Risk ◽  
Disease Activity ◽  
Early Rheumatoid Arthritis ◽  
Remission Induction ◽  
Avant Garde ◽  
High Risk Patients ◽  
Risk Patients ◽  
Secondary Endpoints ◽  
Step Down

ObjectivesTo compare the efficacy and safety of intensive combination strategies with glucocorticoids (GCs) in the first 16 weeks (W) of early rheumatoid arthritis (eRA) treatment, focusing on high-risk patients, in the Care in early RA trial.Methods400 disease-modifying antirheumatic drugs (DMARD)-naive patients with eRA were recruited and stratified into high risk or low risk according to classical prognostic markers. High-risk patients (n=290) were randomised to 1/3 treatment strategies: combination therapy for early rheumatoid arthritis (COBRA) Classic (methotrexate (MTX)+ sulfasalazine+60 mg prednisone tapered to 7.5 mg daily from W7), COBRA Slim (MTX+30 mg prednisone tapered to 5 mg from W6) and COBRA Avant-Garde (MTX+leflunomide+30 mg prednisone tapered to 5 mg from W6). Treatment modifications to target low-disease activity were mandatory from W8, if desirable and feasible according to the rheumatologist. The primary outcome was remission (28 joint disease activity score calculated with C-reactive protein <2.6) at W16 (intention-to-treat analysis). Secondary endpoints were good European League Against Rheumatism response, clinically meaningful health assessment questionnaire (HAQ) response and HAQ equal to zero. Adverse events (AEs) were registered.ResultsData from 98 Classic, 98 Slim and 94 Avant-Garde patients were analysed. At W16, remission was reached in 70.4% Classic, 73.6% Slim and 68.1% Avant-Garde patients (p=0.713). Likewise, no significant differences were shown in other secondary endpoints. However, therapy-related AEs were reported in 61.2% of Classic, in 46.9% of Slim and in 69.1% of Avant-Garde patients (p=0.006).ConclusionsFor high-risk eRA, MTX associated with a moderate step-down dose of GCs was as effective in inducing remission at W16 as DMARD combination therapies with moderate or high step-down GC doses and it showed a more favourable short-term safety profile.EudraCT number:2008-007225-39.

Effectiveness of methotrexate with step-down glucocorticoid remission induction (COBRA Slim) versus other intensive treatment strategies for early rheumatoid arthritis in a treat-to-target approach: 1-year results of CareRA, a randomised pragmatic open-label superiority trial

2016 ◽  
Vol 76 (3) ◽  
pp. 511-520 ◽  
Author(s):  
Patrick Verschueren ◽  
Diederik De Cock ◽  
Luk Corluy ◽  
Rik Joos ◽  
Christine Langenaken ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
High Risk ◽  
Low Risk ◽  
Treat To Target ◽  
Remission Induction ◽  
Open Label ◽  
Avant Garde ◽  
Superiority Trial ◽  
Risk Patients ◽  
Step Down

ObjectivesCombining disease-modifying antirheumatic drugs (DMARDs) with glucocorticoids (GCs) is an effective treatment strategy for early rheumatoid arthritis (ERA), yet the ideal schedule and feasibility in daily practice are debated. We evaluated different DMARD combinations and GC remission induction schemes in poor prognosis patients; and methotrexate (MTX) with or without GC remission induction in good prognosis patients, during the first treatment year.MethodsThe Care in ERA (CareRA) trial is a 2-year investigator-initiated randomised pragmatic open-label superiority trial comparing remission induction regimens in a treat-to-target approach. DMARD-inexperienced patients with ERA were stratified into a high-risk or low-risk group based upon presence of erosions, disease activity, rheumatoid factor and anticitrullinated protein antibodies. High-risk patients were randomised to a COBRA Classic (MTX + sulfasalazine + prednisone step-down from 60 mg), COBRA Slim (MTX + prednisone step-down from 30 mg) or COBRA Avant Garde (MTX + leflunomide + prednisone step-down from 30 mg) scheme. Low-risk patients were randomised to MTX tight step-up (MTX-TSU) or COBRA Slim. Primary outcome was the proportion of patients in 28 joint disease activity score calculated with C-reactive protein remission at week 52 in an intention-to-treat analysis. Secondary outcomes were safety and effectiveness (ClinicalTrial.gov identifier NCT01172639).Results98 COBRA Classic, 98 COBRA Slim (high risk), 93 COBRA Avant Garde, 47 MTX-TSU and 43 COBRA Slim (low risk) patients were evaluated. Remission was achieved in 64.3% (63/98) COBRA Classic, 60.2% (59/98) COBRA Slim (high risk) and 62.4% (58/93) COBRA Avant Garde patients at W52 (p=0.840); and in 57.4% (27/47) MTX-TSU and 67.4% (29/43) COBRA Slim (low risk) patients (p=0.329). Less adverse events occurred per patient with COBRA Slim (high risk) compared with COBRA Classic or COBRA Avant Garde (p=0.038). Adverse events were similar in MTX-TSU and COBRA Slim (low risk) patients (p=0.871). At W52, 76.0% patients were on DMARD monotherapy, 5.2% used GCs and 7.5% biologicals.ConclusionsMTX with a moderate-dose GC remission induction scheme (COBRA Slim) seems an effective, safe, low-cost and feasible initial treatment strategy for patients with ERA regardless of their prognostic profile, provided a treat-to-target approach is followed.Trial registration numbersEudraCT-number 2008-007225-39 and NCT01172639; Results.

P3609Temporal trends of the management and outcomes of patients after myocardial infarction according to the risk for recurrent cardiovascular events

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
T Grinberg ◽  
T Bental ◽  
Y Hammer ◽  
A R Assali ◽  
H Vaknin-Assa ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
High Risk ◽  
Cardiovascular Events ◽  
Risk Group ◽  
Temporal Trends ◽  
High Risk Group ◽  
Low Risk ◽  
Intermediate Risk ◽  
High Risk Patients ◽  
Risk Patients

Abstract Background Following Myocardial Infarction (MI), patients are at increased risk for recurrent cardiovascular events, particularly during the immediate period. Yet some patients are at higher risk than others, owing to their clinical characteristics and comorbidities, these high-risk patients are less often treated with guideline-recommended therapies. Aim To examine temporal trends in treatment and outcomes of patients with MI according to the TIMI risk score for secondary prevention (TRS2°P), a recently validated risk stratification tool. Methods A retrospective cohort study of patients with an acute MI, who underwent percutaneous coronary intervention and were discharged alive between 2004–2016. Temporal trends were examined in the early (2004–2010) and late (2011–2016) time-periods. Patients were stratified by the TRS2°P to a low (≤1), intermediate (2) or high-risk group (≥3). Clinical outcomes included 30-day MACE (death, MI, target vessel revascularization, coronary artery bypass grafting, unstable angina or stroke) and 1-year mortality. Results Among 4921 patients, 31% were low-risk, 27% intermediate-risk and 42% high-risk. Compared to low and intermediate-risk patients, high-risk patients were older, more commonly female, and had more comorbidities such as hypertension, diabetes, peripheral vascular disease, and chronic kidney disease. They presented more often with non ST elevation MI and 3-vessel disease. High-risk patients were less likely to receive drug eluting stents and potent anti-platelet drugs, among other guideline-recommended therapies. Evidently, they experienced higher 30-day MACE (8.1% vs. 3.9% and 2.1% in intermediate and low-risk, respectively, P<0.001) and 1-year mortality (10.4% vs. 3.9% and 1.1% in intermediate and low-risk, respectively, P<0.001). During time, comparing the early to the late-period, the use of potent antiplatelets and statins increased among the entire cohort (P<0.001). However, only the high-risk group demonstrated a significantly lower 30-day MACE (P=0.001). During time, there were no differences in 1-year mortality rate among all risk categories. Temporal trends in 30-day MACE by TRS2°P Conclusion Despite a better application of guideline-recommended therapies, high-risk patients after MI are still relatively undertreated. Nevertheless, they demonstrated the most notable improvement in outcomes over time.

Screening Efectiveness with SERUM Galactomannan in High and Low Risk Patients for Fungal Infection in the Post ALLO-HTC

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 5452-5452
Author(s):  
Fabio Augusto Ruiz Gómez ◽  
Valentin García Gutierrez ◽  
Elia Gomez ◽  
Pilar Herrera Puente ◽  
Isabel Page Herráez ◽  
...  
Keyword(s):  
High Risk ◽  
Fungal Infection ◽  
Hodgkin Lymphoma ◽  
Risk Group ◽  
False Positives ◽  
Low Risk ◽  
Cell Transplant ◽  
Aspergillus Infection ◽  
High Risk Patients ◽  
Risk Patients

Abstract Background and aims: Serum galactomannan (GM) is used as a screening test for the early diagnosis of Aspergillus infection in high risk patients for fungal invasive infection. Serial GM levels analysis have proven to be useful in the high risk clinical setting patients, specially when neutropenic and not receiving anti-mold agents prophylaxis. There is a lack of information regarding the benefit of GM in patients undergoing allogeneic hematopoietic cell transplant (HCT). The aim of this work is to measure the real clinical benefit of the serial periodic determination of GM in the post allo-HCT period. Material and methods: 139 consecutive patients who receivedan allo-HCT (59% related family member donorsand 41% unrelated donors) in our centre for five years (since January 2010 to February 2015) were included in the study. Median age was 46 years. Baseline characteristics of these patients are shown in figure 1. Patients were monitored with GM weekly and received primary prophylaxis with fluconazole since the admission until the immunosuppression was tapered. In order to find a population that could benefit the most for AGA monitoring, we classified our population in low risk patients for invasive fungal infection (IFI) versus high risk patients (those with previous proven or probable IFI or those suffering from GVHD; high risk patients received anti-mold prophyllaxis, mainly with voriconazole or posaconazole). Patients considered as low risk who suffered from Graft versus Host Disease (GVHD) in the ulterior outcome, were censored for low risk and considered as high risk since the development of GVHD, and therefore anti-mold agent prophylaxis was started. GM positivity was determined according standard criteria. When GM positivity was detected, radiological and clinical studies (chest/sinus CT scans, cultures, etc.) to discard Aspegillosis were done as soon as possible. Every patient was followed up prospectively until the last medical consultation or decease. Results: Global overall survival (OS) for the entire cohort was 55.39% and cumulative incidence for severe GVHD grade III/IV was 49.5%. During the follow up, GM became positive in 31/139 (22%) cases. With this approach, the global false positive and false negative rate was 31% and 6% respectively.110/139 (79.14%) patients were identificated as low risk cases. We observed GM positivization in 1.81% (2/110) and 37.18% (29/78) for low and high group respectively. All 2 positive GM in the low risk group were false positives. Regarding the high risk group, 34.48% (10/29) were false positives while in the rest 19 patients (65.52%), subsequent radiological and clinical findings allowed us to diagnose Aspergillus infection (besides they received anti-mold agent prophylaxis). Conclusions: In our experience there is not enough evidence for supporting making serial monitoring with GM in low risk patients for IFI in the post allo-HCT period. However it may be an useful tool in high risk patients. Table 1. N (%) Age (years) Mean 46.18 Median 48.01 Sex (man vs woman) 91 vs 48 (65 vs 35%) Hematology disease Acute Mieloid Leukemia Acute Limphoblastic Leukemia Multiple Myeloma Chronic Mieloid Leukemia Non Hodgkin Lymphoma Hodgkin Lymphoma Others diseases 79 (56.8%) 18 (12.9%) 9 (6.5%) 3 (2.2%) 13 (9.4%) 9 (6.5%) 8 (5.6%) Pre allo-HSCT IFI 17 (12.2%) Aconditioning Myeloablative Reduced Intensity 95 (68.3%) 44 (31.7%) Source of progenitors Peripherical blood Bone marrow 132 (95.0%) 7 (5.0%) Type of donor Related Non-related 82 (59.0%) 57 (41.0%) Graft time (days) Neutrophils (>500 in two consecutive determinations) Platelets (>30.000 in two consecutive determinations) 15.52 17.75 Post-transplant CMV viremia (number of patients with >600 copies in the post-HSCT period) 48 (34.5%) Disclosures No relevant conflicts of interest to declare.

Assessing a prognostic model for predicting VTE occurrence in cancer patients.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 1577-1577
Author(s):  
Deesha Sarma ◽  
So Yeon Kim ◽  
David H. Henry
Keyword(s):  
High Risk ◽  
Cancer Patients ◽  
Risk Group ◽  
Low Risk ◽  
Risk Category ◽  
Valuable Insight ◽  
Intermediate Risk ◽  
High Risk Patients ◽  
Prophylactic Measures ◽  
Risk Patients

1577 Background: Venous thromboembolism (VTE) poses a significant health risk to cancer patients and is one of the leading causes of death among this population. The most effective way to prevent VTE and reduce its prominence as a public health burden is by identifying high-risk patients and administering prophylactic measures. In 2008, Khorana et al. developed a model that classified patients by risk based on clinical factors. Methods: We conducted a retrospective study to test this model’s efficacy, on 150 patients with cancer receiving chemotherapy at an outpatient oncology clinic between January 1 and August 1, 2011. We aggregated data and assigned points based on the five factors in the Khorana model: site of cancer with 2 points for very high-risk site and 1 point for high-risk site, 1 point each for leukocyte counts more than 11 x 109/L, platelet counts greater than 350 X 109/L, hemoglobin levels less than 100 g/L and/or the use of erythropoiesis-stimulating agents, and BMI greater than 35 kg/m2 (Khorana et al., Blood 2008). Based on this scoring system, patients with 0 points were grouped into the low-risk category, those with 1-2 points were considered intermediate-risk, and those with 3-4 points were classified as high-risk. Results: As shown in the table, VTE incidence for the low-risk group was 1.9%, intermediate-risk group was 3.9%, and high-risk group was 9.1%. Conclusions: High-risk patients were about 4.5 times more likely to develop a VTE than low risk patients. These results provide valuable insight in determining which patients might benefit from prophylaxis and in motivating the design of prospective clinical trials that assess the VTE predictive model in various ambulatory cancer settings. [Table: see text]

The Effect Of Low Dose Intravenous Heparin On Anti-Factor Xa And Antithrombin III

1981 ◽  
Author(s):  
S A Jennings ◽  
B P Heather ◽  
R M Greenhalgh
Keyword(s):  
High Risk ◽  
Low Dose ◽  
Antithrombin Iii ◽  
Risk Group ◽  
Factor Xa ◽  
Low Risk ◽  
Heparin Infusion ◽  
High Risk Patients ◽  
Intravenous Heparin ◽  
Risk Patients

Preoperative blood samples from 17 patients undergoing major abdominal surgery were examined by the thrombelasto-graph saline dilution test, which has previously been shown to be a predictor of the risk of early postoperative deep vein thrombosis (DVT)(Heather et al 1980). By this test 8 patients were predicted to be at low risk of developing a DVT and received no special prophylaxis. 9 patients were considered to be at risk and were treated with a subcutaneous dose of 1000 units of heparin with the premedication together with a low dose of intravenous heparin infusion from the induction of anaesthesia until 2 hours after operation. Plasma antithrombin III (ATIII) concentration and anti-factor Xa activity were measured preoperatively, on day 1 and on day 3. No early DVT occurred, as assessed by I125 fibrinogen scanning, in either the untreated low risk patients or in the high risk patients receiving heparin infusion. The high risk patients had lower levels of ATIII before operation than the low risk patients (75±9%; 98±39%) and significantly lower levels on day 3 (64±25%; 106±34% p<0.02). However, these lowered levels of ATIII appeared in the high risk group to be augmented by the significant increase in anti-factor Xa activity 127±64%. before operation, 217±89%, on day 1 (p<0.02). Furthermore, on day 3 the high risk patients had significantly greater activity than those patients in the low risk group (212±76%; 106±34% p<0.02).These results show that those patients at risk of developing a postoperative DVT had a significantly enhanced activation of anti-factor Xa, as a result of intravenous low dose heparin with the subsequent abolition of early venous thrombosis.

Should adult medulloblastoma patients at low risk receive adjuvant chemotherapy? Long-term results of a prospective study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 2018-2018
Author(s):  
E. Franceschi ◽  
A. Tosoni ◽  
M. Ermani ◽  
V. Blatt ◽  
P. Amistà ◽  
...  
Keyword(s):  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Survival Rates ◽  
Low Risk ◽  
Long Term Results ◽  
High Risk Patients ◽  
Significant Difference ◽  
Risk Patients

2018 Background: Due to the rarity of medulloblastoma (MB) in adults, the few studies available on this condition are retrospective, and the follow-up tends to be short. Furthermore, the different therapeutic strategies used in these patients makes it difficult to assess survival rates and prognostic factors. Methods: Between January 1989 and February 2001, a prospective phase II trial was performed to evaluate the efficacy of treatment for adults with medulloblastoma. Patients were completely staged with a neuroradiological examination of the brain and neuraxis and by CSF cytology, according to Chang’s staging system. Low risk patients received radiotherapy alone, while high risk patients were given 2 cycles of upfront chemotherapy followed by radiotherapy and adjuvant chemotherapy. The results of the preliminary analysis of this study at a median follow-up of 3.7 years are reported elsewhere. The present papers reports on the long- term results of the same trial. Results: After a median follow up of 7.6 years, among a total of 36 enrolled adults with medulloblastoma, overall progression free survival (PFS) and overall survival (OS) at 5 years were 72% (range 59% to 84%) and 75% (62% to 91%), respectively. No difference was found between low and high risk patients in terms of PFS and OS at 5 years: in low-risk patients the 5-year PFS was 80% (range, 59–100%) and the 5-year OS, 80% (range, 58 - 100%); in high-risk patients the 5-year PFS was 69% (range, 54 -89%) and the 5-year OS, 73% (range, 58 - 92%). Conclusions: A long-term follow-up is essential to evaluate the real impact of treatments in adult patients with MB. Since there is no significant difference between low-risk and high-risk patients for PFS and OS, the use of chemotherapy is also questionable in low-risk patients. No significant financial relationships to disclose.

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