scholarly journals Efficacy and Safety of Rivaroxaban: An Observationalmulticenter Cohort Study Reporting the Routine Use in Adolescents & Adults with DVT

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 5083-5083
Author(s):  
Manuela Krause ◽  
Alexander Bauer ◽  
Hartmut Clausnizer ◽  
Gili Kenet ◽  
Dorothee Kowalski ◽  
...  
Keyword(s):  
Cohort Study ◽  
Conflicts Of Interest ◽  
Coagulation Factors ◽  
Efficacy And Safety ◽  
Blood Samples ◽  
Routine Administration ◽  
Von Willebrand ◽  
The Impact ◽  
D Dimer

Abstract Background: Antithrombotic therapy with Rivaroxaban [RIVA] is increasingly being administered for secondary TE prophylaxis in adults. The objective of the present study was to evaluate efficacy and safety of standard RIVA administered as routine medication in an outpatient cohort of pts with TE. Furthermore, on an explorative basis we investigated the influence of RIVA on coagulation factors and biomarkers, and the impact of RIVA monitoring during routine administration. Methods: In 140 consecutively admitted whiteoutpts (15-82 yrs; male 56%) with TE and standard RIVA medication (2x 15 mg followed by 20 mg absolute) recruited between January 2013 and January 2014, a comprehensive monitoring of RIVA through (24h) and peak levels (2h, 4h; Xa-based chromogenic substrate S-2732; Haemochrom Diagnostica) alongwith anti-factor-Xa-activities [Xa; Xa-based assay, Haemochrom Diagnostica], selected coagulation factors and biomarkers (factors II, V, VIII, von-Willebrand-Ristocetin-cofactor [RICO], antithrombin [AT], protein C [PC], D-Dimer, prothrombin fragment F1+2 [F1+2], dRVVT-ratio) was performed during routine follow-up. Efficacy endpoints were defined as any TE or thrombus progression during treatment, safety endpoints were defined as significant bleeding requiring any medical intervention, such as dose reduction, withdrawal of RIVA or death related to therapy. Blood samples were taken during routine follow-up visits in the study centers on a monthly (RIVA start) to 3-months (maintenance) interval. Apart from descriptive analysis non-parametric statistics was performed. In addition, chi-square or Fisher’s exact test was applied. Results: During the study period of 15 months in 140 pts 210 follow-up visits including analyses of 420 individual blood samples were performed. Median pt age was 49yrs, with no difference between males and females. Median (min-max) body weight [bw] per kg was 85 (50-151). Median (min-max) daily RIVA dose per kgbw was 0.2 mg (0.09-0.51).Due to a significant lower bw the median daily RIVA dose of 0.24 mg (0.1-0.51) in females was significantly higher compared to males with 0.20 mg (0.09-0.4; p<0.000). The RIVA dose was clearly correlated to Xa (p<0.0001; rho=0.945). Median (min-max) 24h RIVA levels were 19 ng/ml (0-182) corresponding to Xa activities of 0.1 IU/ml (0.1-1.5), 2h RIVA levels were 175 ng/ml (13-390) and 2h Xa levels 1.19 IU/ml (0.1-2.86). Finally, 4h levels revealed 169 ng/ml (26.8-427) for RIVA and 1.47 IU/ml (0.15-3.27) for Xa activities. During the study period in one out of 140 patients thrombosis progression was observed [0.71%]: Shortly after reduction to once daily 20 mg RIVA a 21-year-old woman developed severe TE progression with the need to switch from RIVA to Enoxaparin, since during RIVA induction (2x15 mg) gastrointestinal hemorrhage had occurred. A total of 11 clinical relevant bleeding episodes [7.86%] were diagnosed during the follow-up in 9 of 140 patients, 8 females, 1 male (gastrointestinal n=2, both-sided recurrent nose bruising n=2, large hematomas n=3, uterine hemorrhage n=4), with a median (min-max) age of 23 years (15-80). Median (min-max) RIVA dose per kgbw was significantly higher in bleeders compared to non-bleeders (0.28 mg [0.18-0.51] vs. 0.20 mg [0.09-0.40]; p=0.04) corresponding to a significantly enhanced RIVA through level (43.5 ng/ml [23-153] vs. 18.7ng/ml [0-182]; p< 0.000). In addition, in two females mild von-Willebrand-disease could not be ruled out, and in the 80-year-old male with recurrent bruising ASA co-medication was documented.When coagulation factors at RIVA through levels were compared with peak levels, significantly reductions were measured for FII, FV, FVIII, D-Dimer and F1+2 and, vice versa, elevated activities for AT, PC and RICO were found. dRVVT ratios were normal at baseline only. Of note, elevated AT levels measured via Xa-based assays during RIVA treatment mask inherited AT deficiency previously confirmed by sequencing (n=3). Conclusion: In conclusion, data of this cohort study demonstrated that efficacy of RIVA in outpts with TE is good, however, the bleeding rate of 7.86% is too high. With respect to this safety endpoint we have demonstrated a dose - and a drug-level-dependency of RIVA standard therapy. We suggest that drug monitoring is mandatory in selected pts, especially in cases of bleeding-related co-mediations or concomitant bleeding disorders. Disclosures No relevant conflicts of interest to declare.

scholarly journals Evaluation of Triton X-100 Effect on Coagulation Tests

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 4674-4674
Author(s):  
Sarah Nadeau Marchand ◽  
Daniel Khalaf ◽  
Chantal Nadeau ◽  
Normand Blais
Keyword(s):  
Conflicts Of Interest ◽  
Coagulation Factors ◽  
P Value ◽  
Ionic Surfactant ◽  
Enzymatic Reactions ◽  
Thrombin Time ◽  
Coagulation Tests ◽  
Triton X ◽  
The Impact ◽  
D Dimer

Abstract CONTEXT: Triton X-100 is a non-ionic surfactant that has been proposed as a virus inactivator in a laboratory setting for it causes cell lysis through lipid membrane disruption without denaturing proteins. Very few studies have tried to evaluate its effect on laboratory tests, especially on coagulation tests that require a phospholipid subtract. METHOD: Plasma samples were collected. Triton X-100 was spiked at a concentration of 0,25% and specimens were incubated for an hour. We performed international normalized ratio (INR), activated partial thromboplastin time (aPTT), thrombin time (TT), fibrinogen dosing and D-Dimer dosing, comparing the standard plasma with the triton X-100 exposed plasma. We also dosed coagulation factors, and performed dilution and lupus anticoagulant studies. Finally, we compared prothrombin time and aPTT using reagents from various manufacturers. RESULTS: We observed an important difference for the INR and the aPTT with addition of triton x-100. A slight decrease of an average of 6.6 to 16.4% was also found in factor assays. Differences in the INR and the aPTT were dependent respectively on the ISI and the phospholipids content of the reagent. CONCLUSION: The addition of triton x-100 significantly modifies INR and aPTT results with every reagent tested. The impact on TT and fibrinogen is not clinically relevant, and the D- Dimer dosage is not affected. The slight decrease in all coagulation factors does not explain those results. The interference could result from an interaction with phospholipids, calcium or some enzymatic reactions caused by the presence of triton x-100 in the analyzed specimen. Table. Test Mean Mean Mean of difference p-value (paired t-test) without Triton with Triton INR 1,59 2,87 68,80% p<0,001 aPTT 31,59 sec 61,80 sec 86,10% p<0,001 TT 16,82 sec 17,42 sec 3,50% p<0,001 Fibrinogen 3,27 g/L 3,21 g/L -0,70% p=0,001 D-Dimer 2897 mcg/L 2905 mcg/L 4,30% p=0,697 Disclosures No relevant conflicts of interest to declare.

Cognitive Impairment and Physical Activity in Old Age: The Impact on All-Cause Mortality in a 15-Year Follow-Up of the Bambuí Cohort Study of Aging

2020 ◽  
Author(s):  
Erico Castro-Costa ◽  
Jerson Laks ◽  
Cecilia Godoi Campos ◽  
Josélia OA Firmo ◽  
Maria Fernanda Lima-Costa ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cohort Study ◽  
Cognitive Impairment ◽  
Old Age ◽  
All Cause Mortality ◽  
The Impact

scholarly journals Cohort study of ageing from Bagé (SIGa-Bagé), Brazil: profile and methodology

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Elaine Thumé ◽  
Marciane Kessler ◽  
Karla P. Machado ◽  
Bruno P. Nunes ◽  
Pamela M. Volz ◽  
...  
Keyword(s):  
Older Adults ◽  
Health Care ◽  
Cohort Study ◽  
Primary Health Care ◽  
Rio Grande ◽  
Cognitive Testing ◽  
Rio Grande Do Sul ◽  
Primary Health ◽  
The Impact

Abstract Background The Bagé Cohort Study of Ageing is a population-based cohort study that has recently completed the first follow-up of a representative sample of older adults from Bagé, a city with more than 100,000 inhabitants located in the state of Rio Grande do Sul, Brazil. This is one of the first longitudinal studies to assess the impact of primary health care coverage on health conditions and inequalities. Our aim is to investigate the prevalence, incidence and trends of risk factors, health behaviours, social relationships, non-communicable diseases, geriatric diseases and disorders, hospitalisation, self-perceived health, and all-cause and specific-cause mortality. In addition, we aim to evaluate socioeconomic and health inequalities and the impact of primary health care on the outcomes under study. Methods/design The study covers participants aged 60 or over, selected by probabilistic (representative) sampling of the urban area of the city of Bagé, which is covered by Primary Health Care Services. The baseline examination included 1593 older adults and was conducted from July 2008 to November 2008. After eight to nine years (2016/2017), the first follow-up was conducted from September 2016 to August 2017. All participants underwent an extensive core assessment programme including structured interviews, questionnaires, cognitive testing (baseline and follow-up), physical examinations and anthropometric measurements (follow-up). Results Of the original participants, 1395 (87.6%) were located for follow-up: 757 elderly individuals (47.5%) were re-interviewed, but losses in data transfer occurred for 22. The remaining 638 (40.1%) had died. In addition, we had 81 (5.1%) refusals and 117 (7.3%) losses. Among the 1373 older adults who were followed down, there was a higher proportion of female interviewees (p=0.042) and a higher proportion of male deaths (p=0.001) in 2016/2017. There were no differences in losses and refusals according to gender (p=0.102). There was a difference in average age between the interviewees (68.8 years; SD ±6.5) and non-interviewees (73.2 years; SD ±9.0) (p<0.001). Data are available at the Department of Social Medicine in Federal University of Pelotas, Rio Grande do Sul, Brazil, for any collaboration.

scholarly journals The U-Shaped Association between Bilirubin and Diabetic Retinopathy Risk: A Five-Year Cohort Based on 5323 Male Diabetic Patients

2018 ◽  
Vol 2018 ◽  
pp. 1-7 ◽  
Author(s):  
Miao Liu ◽  
Jianhua Wang ◽  
Yao He
Keyword(s):  
Diabetic Retinopathy ◽  
Cohort Study ◽  
Risk Model ◽  
Continuous Variable ◽  
Hazard Ratio ◽  
Diabetic Patients ◽  
Lower Baseline ◽  
The Impact ◽  
Chinese Male

Aims. This study aimed at assessing the impact of baseline bilirubin (TBiL) on the incidence of diabetic retinopathy (DR) based on a five-year cohort study which consisted of 5323 Chinese male diabetic patients.Methods. A cohort study based on 5323 male diabetic patients was conducted in Beijing, from 2009 to 2013. Both baseline TBiL and follow-up changes were measured. Cox proportional risk model was used to calculate the hazard ratio (HR) of TBiL for DR risk.Results. During the follow-up period, there were 269 new DR cases. The incidence of five-year follow-up was 5.1% (95% CI: 4.5%~5.6%). The TBiL level of those who had diabetic retinopathy was lower than that of those without (12.51+ 1.20 mol/L and 13.11+ 1.32μmol/L,P=0.033). And more interestingly, along with the quintiles of baseline TBiL, there showed a U-shaped curve with DR incidence. And the RRs were 0.928 (95% CI: 0.646–1.331), 0.544 (95% CI: 0.365–0.811), 0.913 (95% CI: 0.629–1.324), and 1.035 (95% CI: 0.725–1.479) for the second, third, fourth, and fifth quintiles of baseline TBiL levels, respectively, compared with the first quintile. For follow-up TBiL changes, after being adjusted for related covariables and baseline TBiL levels (as continuous variable) in the model, the RRs for DR were 1.411 (95% CI: 1.081–1.842) for those who had decreased TBiL level and 0.858 (95% CI: 0.770–0.947) for those who had increased TBiL level during follow-up. And this association was more prominent among those with lower baseline TBiL level.Conclusions. Serum TBiL had a U-shaped relationship with DR incidence, which was independent of control status of diabetes and other related covariates.

scholarly journals The impact of the Safer Anaesthesia from Education (SAFE) Obstetric Anaesthesia training course in Ethiopia: A mixed methods longitudinal cohort study

2020 ◽  
Vol 48 (4) ◽  
pp. 297-305
Author(s):  
Jolene N Moore ◽  
Wayne W Morriss ◽  
Gebrehiwot Asfaw ◽  
Gosa Tesfaye ◽  
Aaliya R Ahmed ◽  
...  
Keyword(s):  
Cohort Study ◽  
Mixed Methods ◽  
Maternal Mortality ◽  
Longitudinal Cohort Study ◽  
Structured Interviews ◽  
Middle Income ◽  
Longitudinal Cohort ◽  
Obstetric Anaesthesia ◽  
The Impact

Summary Reducing maternal mortality remains a global priority, particularly in low- and middle-income countries (LMICs). The Safer Anaesthesia from Education (SAFE) Obstetric Anaesthesia (OB) course is a three-day refresher course for trained anaesthesia providers addressing common causes of maternal mortality in LMICs. This aim of this study was to investigate the impact of SAFE training for a cohort of anaesthesia providers in Ethiopia. We conducted a mixed methods longitudinal cohort study incorporating a behavioural questionnaire, multiple-choice questionnaires (MCQs), structured observational skills tests and structured interviews for anaesthesia providers who attended one of four SAFE-OB courses conducted in two regions of Ethiopia from October 2017 to May 2018. Some 149 participants from 60 facilities attended training. Behavioural questionnaires were completed at baseline ( n = 101, 69% response rate). Pre- and post-course MCQs ( n = 121, n = 123 respectively) and pre- and post-course skills tests ( n = 123, n = 105 respectively) were completed, with repeat MCQ and skills tests, and semi-structured interviews completed at follow-up ( n = 88, n = 76, n = 49 respectively). The mean MCQ scores for all participants improved from 80.3% prior to training to 85.4% following training ( P < 0.0001) and skills test scores improved from 56.5% to 83.2% ( P < 0.0001). Improvements in MCQs and skills were maintained at follow-up 3–11 months post-training compared to baseline ( P = 0.0006, < 0.0001 respectively). Participants reported improved confidence, teamwork and communication at follow-up. This study suggests that the SAFE-OB course can have a sustained impact on knowledge and skills and can improve the confidence of anaesthesia providers and communication within surgical teams.

Prothrombotic State Induced by Middle-Distance Endurance Exercise in Middle-Aged Athletes

2018 ◽  
Vol 44 (08) ◽  
pp. 747-755 ◽  
Author(s):  
Gian Salvagno ◽  
Cantor Tarperi ◽  
Matteo Gelati ◽  
Martina Montagnana ◽  
Elisa Danese ◽  
...  
Keyword(s):  
Blood Coagulation ◽  
Blood Group ◽  
Thrombin Generation ◽  
Area Under The Curve ◽  
Abo Blood Group ◽  
Middle Aged ◽  
Endurance Running ◽  
Von Willebrand ◽  
The Impact ◽  
D Dimer

AbstractSince the impact of possible prothrombotic factors on blood coagulation resulting from exercise remains elusive, this study investigated the acute effects of middle-distance endurance running on blood coagulation parameters in middle-aged athletes. The study population consisted of 33 male endurance runners who were engaged in a 21.1 km run under competitive conditions. Blood samples were collected before the run, immediately after the run, and 3 hours after run completion. Samples were assessed for activated partial thromboplastin time (APTT), prothrombin time (PT), fibrinogen, D-dimer, factor VIII (FVIII), von Willebrand factor antigen (VWF:Ag), endogenous thrombin potential (area under the curve of thrombin generation [TGA-AUC]), and peak thrombin generation (TGA-PK). Post-run variations were expressed as delta (Δ). At baseline, APTT was found to be significantly associated with ABO blood group, VWF:Ag, and FVIII; fibrinogen with age; VWF:Ag with BMI, training regimen, and ABO blood group; APTT with FVIII; FVIII with VWF:Ag and ABO blood group; APTT with VWF:Ag; and TGA-PK with ABO blood group, PT, and TGA-AUC. Immediately after the run, statistically significant increases were observed for PT, D-dimer, VWF:Ag, and FVIII, while statistically significant reductions could be observed for APTT, TGA-AUC, and TGA-PK. Fibrinogen values remained unchanged. Significant correlations were observed between Δ VWF:Ag and Δ FVIII, Δ APTT and Δ VWF:Ag, Δ APTT and Δ FVIII, Δ TGA-AUC and Δ TGA-PK, and between Δ D-dimer and Δ TGA-AUC and Δ TGA-PK. No Δ variation was associated with running time. The results of this study seemingly suggest that middle-distance competitive running may evoke several prothrombotic changes in blood coagulation.

Diabetes does not influence activation of coagulation, fibrinolysis or anticoagulant pathways in Gram-negative sepsis (melioidosis)

2011 ◽  
Vol 106 (12) ◽  
pp. 1139-1148 ◽  
Author(s):  
Joost Meijers ◽  
Rapeephan Maude ◽  
Direk Limmathurotsakul ◽  
Nicholas Day ◽  
Sharon Peacock ◽  
...  
Keyword(s):  
Protein C ◽  
Burkholderia Pseudomallei ◽  
Blood Donors ◽  
Protein S ◽  
Admission Diagnosis ◽  
Procoagulant Effect ◽  
Multiple Abnormalities ◽  
The Impact ◽  
D Dimer

SummaryDiabetes is associated with a disturbance of the haemostatic balance and is an important risk factor for sepsis, but the influence of diabetes on the pathogenesis of sepsis remains unclear. Melioidosis (Burkholderia pseudomallei infection) is a common cause of community-acquired sepsis in Southeast Asia and northern Australia. We sought to investigate the impact of pre-existing diabetes on the coagulation and fibrinolytic systems during sepsis caused by B. pseudomallei. We recruited a cohort of 44 patients (34 with diabetes and 10 without diabetes) with culture-proven melioidosis. Diabetes was defined as a pre-admission diagnosis of diabetes or an HbA1c>7.8% at enrolment. Thirty healthy blood donors and 52 otherwise healthy diabetes patients served as controls. Citrated plasma was collected from all subjects; additionally in melioidosis patients follow-up specimens were collected seven and ≥28 days after enrolment where possible. Relative to uninfected healthy controls, diabetes per se (i.e. in the absence of infection) was Characterised by a procoagulant effect. Melioidosis was associated with activation of coagulation (thrombin-antithrombin complexes (TAT), prothrombin fragment F1+2 and fibrinogen concentrations were elevated; PT and PTT prolonged), suppression of anti-coagulation (antithrombin, protein C, total and free protein S levels were depressed) and abnormalities of fibrinolysis (D-dimer and plasmin-antiplasmin complex [PAP] were elevated). Remarkably, none of these haemostatic alterations were influenced by pre-existing diabetes. In conclusion, although diabetes is associated with multiple abnormalities of coagulation, anticoagulation and fibrinolysis, these changes are not detectable when superimposed on the background of larger abnormalities attributable to B. pseudomallei sepsis.

The Addition of Thalidomide to the Induction Treatment of Newly Presenting Myeloma Patients Increases the CR Rate Which Is Likely to Translate Into Improved PFS and OS.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 352-352 ◽  
Author(s):  
Gareth J Morgan ◽  
Faith E Davies ◽  
Walter M Gregory ◽  
Susan E Bell ◽  
Alex J Szubert ◽  
...  
Keyword(s):  
Flow Cytometry ◽  
Conflicts Of Interest ◽  
Residual Disease ◽  
Response Rates ◽  
Multiparameter Flow Cytometry ◽  
Induction Treatment ◽  
Overall Response ◽  
Patient Pathways ◽  
The Impact

Abstract Abstract 352 We present updated results from MRC Myeloma IX study evaluating the role of the addition of thalidomide to the induction and maintenance of patients with myeloma. The study ran from May 2003 – November 2007 and randomised 1,970 patients and now has a median follow up of more than 3.5 years giving it improved power to detect changes in outcome developing later after treatment. Projected median OS younger fitter patients 66 months, median OS older less fit patients 32 months. The trial comprised of 2 patient pathways, one for younger fitter patients comparing CTD (cyclophosphamide, thalidomide, dexamethasone) with CVAD (cyclophosphamide, vincristine, adriamycin, dexamethasone), all patients going on to receive an ASCT – median age 59 years. In older less fit patients, melphalan and prednisolone (MP) was compared to CTD attenuated – median age 73 years. In both pathways following initial treatment, eligible patients were randomised to low-dose thalidomide or no maintenance. Patient's response was monitored using electrophoresis, serum free light chain and multiparameter flow cytometry. Cytogenetics was availabel on up to 60% of cases and gene expression on a subset of these. CTD is a well tolerated regimen with a good safety profile giving excellent survivals in both groups of patients despite a small increase in risk of VTE. Using modified EBMT criteria, the addition of thalidomide to induction treatment increases both response rates and depth of response for all age groups. Preliminary results as follows: overall response: CTD vs CVAD: 91% v 82%; CR 21% v 14% and 100 days post-HDM, better responses were seen in CTD with CR rates 65% v 48%. Remission depth was also greater in CTD with more patients achieving minimal residual disease negativity by flow cytometry. The addition of thalidomide increases response rates overall, and particularly complete response (CR) rates (a 17% increase in CR rates post HDM, p=.006). In older/less fit patients CTDa vs MP: overall response 83% v 46%; CR 21% v 4%. Definitive results of these analyses will be presented as well as how they translate into PFS and OS and by cytogenetic subgroup. There is a substantial increase in response with the inclusion of thalidomide but at a median follow-up of three years we are not as yet seeing a substantial increase in survival in either of the two broad patient groups. We have collected data on treatment at relapse to explore how this confounds OS data. Importantly modelling analyses indicate when and to what extent, with further follow-up, the survival differences that should accrue from this increase in CR rate are likely to translate into a survival benefit. These results have a number of important implications. We show the benefit of the addition of thalidomide to myeloma treatment but also highlight the importance of later analysis of such trials because of the emergence of significant changes at these later time points. We will present full updated results from the study including the impact of thalidomide on cytogenetic subgroups and in the maintenance setting. Disclosures: No relevant conflicts of interest to declare.

Autologous Hematopoietic Stem Cell Transplantation (autoHSCT) in CLL: First Results of An EBMT Randomized Trial Comparing Autotransplant Versus Wait and Watch.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 877-877
Author(s):  
Mauricette Michallet ◽  
Peter Dreger ◽  
Laurent Sutton ◽  
Ronald Brand ◽  
Sue Richards ◽  
...  
Keyword(s):  
Conflicts Of Interest ◽  
Progression Free Survival ◽  
Disease Status ◽  
Primary Objective ◽  
Phase Iii ◽  
Induction Treatment ◽  
Hematopoietic Stem ◽  
Binet Stage ◽  
The Impact

Abstract Abstract 877 This phase-III randomized EBMT-intergroup trial studied the impact of a consolidating autoHSCT vs no consolidation for patients with CLL in Binet stage A progressive, B or C , in CR, nodular PR or VGPR after first or second line therapy. The primary objective was to show that autoHSCT increased the 5-year progression-free survival (PFS) by 30%. Although it had been calculated that 270 patients were to be randomized, the study was terminated by the steering committee in July 2007 due to poor accrual. Here we present a first analysis based on 69% of expected follow-up forms. Results: Between November 2001 and July 2007, 223 patients were enrolled (SFGM-TC/FCLLG n=98, MRC n=62, GCLLSG n=32, SAKK n=10, other EBMT centers n=17). There were 74% males and 26% females. Binet stages were progressive A 13%, B 67%, C 20%; 59% were in CR, and 41% in very good or nodular PR. Of note, SFGM-TC/FCLLG included only patients in CR. 82% of the patients were enrolled in 1st, and 18% in 2nd remission. Patients were randomized between group 1 (autoHSCT n=112) and group 2 (observation n=111) after an induction treatment which was left at the discretion of the investigators. Median PFS was 43 months in the observation group but not reached in the autoHSCT group; 5-year PFS was 48% and 65%, respectively (p=0.005). Accordingly, autoHSCT halved the relapse risk (5-year relapse incidence 25% vs. 51%; HR 0.4 [0.23-0.71], p=0.002). Cox modeling for randomization arm, Binet stage, disease status, line of treatment, contributing group (country), and the interaction between randomization arm and contributing group confirmed that autoHSCT significantly improved PFS (HR 0.41 [0.23-0.75] p=0.004). The beneficial effect of autoHSCT was stable over all contributing groups although patients accrued by SFGM-TC/FCLLG overall had a significantly better PFS than patients from other countries (HR 0.2 [0.08-0.55], p=0.001). At 5 years, the probability of OS was 92% and 91% for autoHSCT and observation, respectively. Significant differences in terms of non-relapse death were not observed. At the last follow up, among 205 evaluable patients, 186 are alive (147CR, 39 relapse), 19 died (14 from relapse and 5 from non-relapse causes) . In conclusion, in patients with CLL in first or second remission, consolidating autoHSCT reduces the risk of progression (PFS) by more than 50%, but has no effect on overall survival. Disclosures: No relevant conflicts of interest to declare.

Day 100 PET Scan Positivity Predicts for Worse Survival in Lymphoma Patients Given Allogeneic Peripheral Blood Stem Cells After Non-Myeloablative Conditioning,

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 4155-4155
Author(s):  
Aurélie Jaspers ◽  
Pacome Fosse ◽  
Nadia Withofs ◽  
Marie Lejeune ◽  
Evelyne Willems ◽  
...  
Keyword(s):  
Ct Scan ◽  
Hodgkin’S Lymphoma ◽  
Conflicts Of Interest ◽  
Autologous Transplantation ◽  
Pet Scan ◽  
Hodgkin's Lymphoma ◽  
Myeloablative Conditioning ◽  
The Impact ◽  
Pet Scans

Abstract Abstract 4155 Background PET scan is increasingly used in the follow-up of lymphoma patients given allogeneic hematopoietic cell transplantation (Allo-HCT). However, whereas several studies addressed the question of the impact of PET positivity after autologous transplantation on transplantation outcomes, very few have been performed after allo-HCT. This is the aim of the current retrospective study. Methods We retrospectively analyzed data from 50 lymphoma patients who underwent an allo-HSCT after non-myeloablative conditioning between March 2000 and March 2009. The diagnoses were Hodgkin's lymphoma (n=8) and non-Hodgkin's lymphoma (n=42; 14 follicular, 11 mantle cell, 9 diffuse large B cell, 2 MALT, 1 Burkitt, 1 lymphocytic and 4 T-cell lymphomas). Patients were scheduled to benefit from a follow-up by PET scan on days 100, 180 and 365 and then yearly for a total of five years. Results Day 100 PET scans were not performed in 5/50 patients (4 patients died before day 100, while another onewas in intensive care unit at that time).Among the remaining 45 patients, 20 (44.4%) presented hypermetabolic lesions, including 9 patients(20%) who had hypermetabolic lesions evocative of lymphoma.One-year OS (Figure 1) was higher in patients whose PET scan was negative or positivefor infectious/inflammatory reasons than for those with typical lymphoma lesions (85% vs 44%, p=0.0013). Among patients with day-100 PET positivity evocative of lymphoma, 7 patients died, 5 of them of their lymphoma, while 2 patients remained alive. During further follow-up, twenty patients (44.4%) never presented hypermetabolic lesions after transplantation and 25 (55.6%) had at least one abnormal PET scan. Among the 25 patients, only 11 (24.5%) had probable/proven neoplasia: 1 died with residual disease, 2 had residual lymphoma that went into remission after GVHR, 5 had biopsy-proven relapse, 1 had non-biopsy proven progression, 1 had lung cancer and 1 lung PTLD. The other 14 patients (31.1%) had suspicious lesions at one of the follow-up PET scans, but after further work-up, none of these lesions proved to be a relapse, and all disappeared afterwards. Biopsies were performed in 6 of these cases, including 2 lymph node (1 normal and 1 lymphoid hyperplasia), 2 lung (1 normal and 1 aspergillosis) and 2 GI (1 normal and 1GVHD) biopsies. For 6 patients, imaging studies (CT scan, MRI or echography) were normal or demonstrated infectious or inflammatory (including gut GVHD) disorders. The last 2 patients were thought to relapse based on both PET and CT scans, but refused biopsies, but their lesions regressed spontaneously. Conclusion In our study, a positive PET scan at day 100 after transplant is predictive of poorer OS. However, there is a noteworthyincidence of false-positive PET scans after non-myeloablativeallo-HCT. We therefore recommend that every suspicious lesion,and particularly in areas not previously involved by lymphoma, should be explored at least by CT scan and/or biopsy, before initiating any new treatment. Disclosures: No relevant conflicts of interest to declare.

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