scholarly journals Do Family History Questions Improve the Predictive Value of a Standardized Pediatric Bleeding Assessment Tool?

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 2111-2111
Author(s):  
Kelly Bajorek ◽  
Matthew Martin ◽  
Joseph S. Palumbo ◽  
Cristina Tarango ◽  
Eric S. Mullins ◽  
...  
Keyword(s):  
Family History ◽  
Board Of Directors ◽  
Predictive Value ◽  
Predictive Power ◽  
Assessment Tool ◽  
Assessment Tools ◽  
Entire Group ◽  
Advisory Committees ◽  
Predictive Values ◽  
Bleeding History

Abstract Bleeding assessment tools to standardize and interpret bleeding history have variable reported sensitivity and specificity to identify patients with mild bleeding disorders (MBD), particularly in subspecialty referral cohorts or younger patients with fewer hemostatic challenges. Here we review the predictive value of the International Society of Thrombosis and Haemostasis (ISTH) bleeding assessment tool, BAT, with or without the addition of 2 family history questions (FHQ), the BAT+, in our clinical cohort. Our hypothesis was that the addition of FHQ would improve the predictive value of the BAT for presence of a MBD in newly referred pediatric hematology clinic patients, particularly those < 8 yr. After 4 quality improvement cycles, a BAT flowsheet in the electronic medical record has been administered to new clinic patients referred to rule out MBD. The exploratory FHQ are added (BAT+), asking about the presence of a first degree relative with a bleeding disorder (yes = 1 point) or first- or second-degree relatives with any of a list of bleeding symptoms (yes = 1 point for each symptom). After IRB approval, electronic records from new clinic visits for "possible MBD" from 1/29/19 to 2/28/20 were retrospectively reviewed for clinical and demographic data, including scoring of the BAT/BAT+. Data are reported descriptively. Positive predictive values (PPV) and negative predictive values (NPV) were compared to assess the predictive power of dichotomized scores. The predictive power of continuous scores were assessed by comparing area under the curves (AUC) of receiver operating characteristics (ROC) curves for each questionnaire. To assess whether higher scores were predictive of multiple diagnoses, we estimated nested hurdle and Poisson regressions with robust standard errors, with the count of bleeding diagnoses as dependent variable and BAT/BAT+ scores as predictors. Over 13 months, in 313 new visits in patients ages 0-21 yr., 309 (98.7%) had BAT+ assessment and were evaluable. Common referral indications were abnormal lab results (48%), epistaxis (20%) and easy bruising (15%). Clinician-initiated documentation of screening for joint hypermobility by examination or history-taking occurred in 85 visits (28%), with 15 (5%) assigned a hypermobility diagnosis. At least 1 MBD was identified in 86 (28%) and 171 ( 55%) had MBD ruled out by the clinician. The average scores for BAT/BAT+ were 1.7/2.6 respectively for those judged by clinician not to have MBD, vs. 2.5/3.9 for 1 MBD diagnosis and 4/6.2 for 2 or more MBD. Using a threshold score of 3 for BAT as predictor of MBD in pediatrics, a threshold of 6 for the BAT+ was selected because its NPV for the whole group was close to that of the BAT for threshold of 3. For all patients and children <8 yr. the PPV of the BAT+ was higher than for the BAT, indicating better ability to predict MBD, for a comparable NPV. This was statistically significant (p=0.033) in the full sample and marginally so (p=0.064) among <8 yr. (Table 2). The AUC for the entire group were 0.597 (0.523-0.670) for the BAT, improving to 0.627 (0.555- 0.6) for the BAT+; however, for < 8 yr. the BAT AUC of 0.528 (0.396-0.660) vs. 0.559 (0.426-0.692) for BAT+ did not significantly differ. By Poisson regression analyses, higher scores on either the BAT or BAT+ predicted more diagnoses, with FHQ improving the goodness of fit (p=0.012) for the whole group (and similar but not statistically significant for < 8 yr.). Scores trended higher for platelet disorders and hypermobility than for low von Willebrand factor/disease or other factor deficiencies. We conclude that the BAT is helpful for standardizing bleeding history among clinicians and trainees and, with flowsheet format, can streamline documentation and sustain high utilization rates. While estimates suggest that FHQ improve predictive power of the BAT, a larger sample size is needed for confirmation. Threshold scores cutoffs based upon pubertal status and gender in < 21 year-olds may need to be lower than for older adults with additional hemostatic challenges. In the entire group and for <8 yr., the BAT under-performed compared to highest published estimates for PPV, NPV and AUC, as has been reported in recent, more rigorous literature, highlighting the complexity of evaluating young specialty referral populations for MBD. Figure 1 Figure 1. Disclosures Tarango: Sanofi: Honoraria, Membership on an entity's Board of Directors or advisory committees; Bayer: Membership on an entity's Board of Directors or advisory committees.

scholarly journals High Correlation Clinical Responses to 1st Line Acute Myeloid Leukemia Treatment with an Ex Vivo Native Environment Precision Medicine Test

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 4837-4837
Author(s):  
Pau Montesinos ◽  
Joan Ballesteros ◽  
David Martínez-Cuadrón ◽  
Joaquín Martínez-López ◽  
Josefina Serrano ◽  
...  
Keyword(s):  
Flow Cytometry ◽  
Board Of Directors ◽  
Roc Curve ◽  
Predictive Value ◽  
Research Funding ◽  
Ex Vivo ◽  
Clinical Correlation ◽  
Advisory Committees ◽  
Patient Response ◽  
Predictive Values

Abstract Background: We have overcome the limitations of 40 years of ex vivo testing. The aim of this study is to determine the ability of Vivia's novel test to predict the complete remission (CR) rates after induction chemotherapy with cytarabine (Ara-C) and idarubicin (Ida) in 1st line AML. Material and Methods: Bone marrow samples from adult patients diagnosed with de novo AML in Spanish centers from the PETHEMA group were included. Whole marrow samples maintaining their Native Environment were incubated for 48h in well plates containing Ara-C, Ida, or their combination. Pharmacological responses are calculated using population models. Induction response was assessed according to the Cheson criteria (2003). Patients attaining a CR/CRi were classified as responders and the remaining as resistant. Results: 390 patient samples were used to calculate the dose response (DR) curves for Ara-C alone, Ida alone, and their synergism. For clinical correlation we used 142 patients with median 56 years. The strongest clinical predictor was the Area Under the Curve (AUC) of the DR of Ara-C, and the AUC of IDA. The GAM models revealed a significant relationship between the AUC of the concentration-effect curves of both, idarubicin and, particularly, Ara-C, with greater values associated to higher probabilities of post-induction resistance. The fitted Generalized Additive Method predictions of expected values for each patient were in turn related to overall survival when a discrimination value to define positive and negative test results that prioritized specificity over sensitivity was chosen based on equaling positive and negative predictive values (Fig 1A). Prioritizing specificity over sensitivity reflects the higher cost of false positive over false negative decisions: only in very rare instances, an effective treatment would be erroneously negated to a sensitive patient at the expense of overlooking a number of resistant patients. However, the later patients could take their chances on re-induction therapy. While for diagnostics sensitivity and specificity should both be optimized, for Personalized Medicine the positive and negative predictive values should be optimized preferentially because they define the patient response correlation. Fig 1B shows a table illustrating the correlation between clinical outcome (columns) and the test predictions (lines). From a diagnostic criteria (columns), clinically resistant patients (1st column) are not well predicted with a Sensitivity of 51%, while clinically sensitive patients (2nd column) are very well predicted with a Specificity of 94%. From a Precision Medicine criteria (Lines), patients predicted resistant (1st line) and well predicted with 80% positive predictive value, similar to patients predicted sensitive (2nd line) well predicted with 79% Negative Predictive Value. The test does not properly identify 23/142 that are clinically resistant and the test predicts as sensitive (bottom left quadrant right panel). This mismatched subgroup mimics the problems from molecular markers where a resistant clone present in a minority of leukemic cells cannot be detected yet drives the patient response. However, this group mismatch does not prevent a good correlation with the test predicted outcomes. Flow cytometry identified 2 clones in 75% of these 23 samples, and we revised all samples analyzing each of 2 clones separately whenever they were present. Results did not change by this clonal analysis, suggesting flow cytometry may not identify resistant clones. Future improvements of the test adding 16 concentrations to the dose response curves may be able to detect the presence and parameters of these resistant clones driving patient response. Conclusions: This novel test is able to predict the clinical response to Ida + Ara-C induction with overall correlation and predictive values of 80%, higher than ever achieved. It is significantly higher than the current clinical response rate of 66.7%. Thus this novel test may be valuable information to guide 1st line patient therapy. Figure 1. ROC curve and clinical correlation Figure 1. ROC curve and clinical correlation Disclosures Ballesteros: Vivia Biotech: Employment. Cordoba:Celgene: Research Funding. Ramos:GlaxoSmithKline: Honoraria; Janssen-Cilag: Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Honoraria; Celgene Corporation: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Consultancy, Honoraria. Gaspar:Vivia Biotech: Employment. Gorrochategui:Vivia Biotech: Employment. Rojas:Vivia Biotech: Employment. Gomez:Vivia Biotech: Employment. Hernández:Vivia Biotech: Employment. Robles:Vivia Biotech: Employment.

scholarly journals Combining PET Radiomic Features with MYC Gene Rearrangement Results in High Prediction of Outcome in Diffuse Large B-Cell Lymphoma

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 451-451
Author(s):  
Jakoba J Eertink ◽  
Gerben J.C Zwezerijnen ◽  
Sanne E Wiegers ◽  
Martine E.D Chamuleau ◽  
Pieternella Lugtenburg ◽  
...  
Keyword(s):  
Board Of Directors ◽  
Predictive Value ◽  
Research Funding ◽  
Performance Status ◽  
Model Performance ◽  
B Cell Lymphoma ◽  
Advisory Committees ◽  
Predictive Values ◽  
Clinical Model ◽  
Pet Ct

Abstract Introduction Genetic abnormalities, such as MYC oncogene rearrangements, contribute to the outcome heterogeneity in diffuse large B-cell lymphoma (DLBCL) patients. These rearrangements occur in 10-15% of DLBCL patients and have been associated with a poor prognosis. Recently, radiomics features extracted from PET/CT scans have shown to be predictive of outcome. The aim of this study was to investigate if the ability to predict outcome in DLBCL can be improved by combining different clinical, radiomics and genetic features. Methods 323 DLBCL patients from the HOVON-84, HOVON-130, and PETAL trials with a baseline PET/CT scan and a minimum follow-up of two years were included. MYC status was assessed using Fluorescence in situ hybridization (FISH). 245 patients were MYC negative, whereas 25 patients had a MYC rearrangement and 57 patients had MYC and BCL2 and/or BCL6 rearrangements. Lesions were delineated using a semi-automated preselection of 18F-FDG avid structures defined by a SUV4.0 threshold using the ACCURATE tool. Next, 5 conventional PET features (maximum standardized uptake value (SUV max), SUV peak, SUV mean, metabolic tumor volume (MTV) and total lesion glycolysis and 18 dissemination features were extracted. Dissemination features were pertaining to distance between lesions, differences in uptake between lesions and differences in volume between lesions. Logistic regression with backward feature selection was used to predict 2-year time to progression, defined as time from baseline PET/CT to progression. We tested the predictive value of 4 models. 1) a clinical model using individual components of the international prognostic index (IPI): Ann Arbor stage (categorical), WHO performance status (categorical), lactate dehydrogenase (LDH) levels (dichotomous) and age (continuous), 2) a model that included clinical and genetic predictors: MYC status (categorical) and IPI components, 3) a model that included radiomics features: 5 conventional PET and 18 dissemination features and 4) a model that combined clinical and genetic predictors with radiomics features. Model performance was assessed using repeated cross-validation (5-fold, 1000 repeats) yielding the cross-validated area under the curve of the receiver-operator-characteristics curve (CV-AUC). To match prevalence of MYC-positive patients with real-world prevalence (Rosenwald et al, JCO 2019) all 245 MYC-negative patients were used for each repeat, and 10 MYC-FISH_positive DLBCL patients and 20 patients with MYC and BCL2 and/or BCL6 rearrangements were selected using random stratified sampling. Regression coefficients were averaged over all folds to calculate the probability of progression for all patients. High- and low-risk groups were defined based on prevalence of events and the diagnostic performance was assessed using positive- and negative predictive values. Results The highest model performance for the clinical model was observed when combining Ann Arbor stage, LDH and extranodal involvement and yielded in a CV-AUC of 0.69 (95% confidence interval (CI): 0.52-0.83). MYC status combined with WHO performance status, LDH and extranodal involvement yielded an improved CV-AUC of 0.71 (95% CI: 0.52-0.86). The highest model performance for the radiomics model was observed for MTV combined with the maximum distance between the largest lesion and any other lesions (Dmax bulk), the maximum difference in SUV peak between two lesions (DSUVpeak patient) and the maximum difference in volume between two lesions (DVol patient) yielding a CV-AUC of 0.77 (95% CI: 0.62-0.90). The optimal combined model included MYC status, WHO performance status, LDH, MTV, Dmax patient, DSUVpeak patient and DVol patient after backward feature selection and yielded a CV-AUC of 0.77 (95% CI: 0.60 - 0.90). The positive predictive value was highest for the combined model (53.0%) and increased by 20% compared to the optimal clinical model (33.1%). Negative predictive values were comparable between models and ranged between 85.8-88.1%. Conclusions Prediction models using 18F-FDG PET/CT radiomics features at baseline aids in identifying DLBCL patients at high risk for relapse. The positive predictive value increased when radiomics features were added to the clinical and genetic parameters. Therefore, radiomics features can increase the efficiency of clinical trials by only selecting poor prognosis patients. Figure 1 Figure 1. Disclosures Chamuleau: Gilead: Research Funding; Genmab: Research Funding; Celgene: Research Funding. Lugtenburg: Incyte: Honoraria; Regeneron: Honoraria; Genmab: Honoraria; Servier: Honoraria, Research Funding; Takeda: Honoraria, Research Funding; Celgene: Honoraria, Other: Non-financial support; Travel support; Roche: Honoraria, Research Funding. Dührsen: CPT Cellex Patient Treatment: Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees. Hüttmann: Celgene: Honoraria; Gilead: Honoraria; Lead Discovery Center GmbH: Consultancy; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees. Richter: HTG Molecular Diagnostics, Inc.: Current Employment, Research Funding. Klapper: Regeneron: Consultancy, Research Funding; Amgen: Research Funding; Roche: Consultancy, Research Funding; Takeda: Consultancy, Research Funding. Zijlstra: Takeda: Research Funding.

Bleeding after surgery and application bleeding assessment tool to surgical patients in Hanoi Medicine University Hospital

2021 ◽  
Vol 25 (2) ◽  
pp. 94-101
Author(s):  
Thi Minh Khue Nguyen ◽  
Quang Tung Nguyen
Keyword(s):  
Predictive Value ◽  
Assessment Tool ◽  
Bleeding Risk ◽  
University Hospital ◽  
Surgical Patients ◽  
Risk Of Bleeding ◽  
Patients At Risk ◽  
Abnormal Bleeding ◽  
Medical University ◽  
Bleeding History

Objectives: Describe bleeding characteristics and evaluate the correlation between surgical-related bleeding and bleeding risk according by ISTH – BATs. Methods: Research was conducted on 340 surgical patients at Hanoi Medical University Hospital. Results: The percentage of patients with bleeding during and after surgery is 13.5%. The proportion of patients at risk of bleeding according to BATs is 1.8%. There was a correlation between bleeding risk according to ISTH - BAT with bleeding status during and after surgery with p = 0.004. The positive predictive value of ISTH - BATs is 66.7%, negative predictive value is 87.4%, the sensitivity is 8.7%, the specificity is 99.3%. Conclusions: Surgery has a high risk of abnormal bleeding. Bleeding history has important implications in assessing bleeding risk during and after surgery. The ISTH - BATs is a bleeding history assessment tool that can be used to assess the risk of bleeding before surgery.

scholarly journals Impact of DNMT3a Status on Post Induction NPM1 MRD Predictive Value on Survival in Elderly AML Patients Treated Intensively

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 7-8
Author(s):  
Maël Heiblig ◽  
Hélène Labussière ◽  
Marie Virginie Larcher ◽  
Gaelle Fossard ◽  
Marie Balsat ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Board Of Directors ◽  
Predictive Value ◽  
Scoring System ◽  
Research Funding ◽  
Risk Group ◽  
Advisory Committees ◽  
Post Induction ◽  
Mutational Status ◽  
Elderly Aml

Minimal residual disease is now a powerfull surrogate marker to assess response to chemotherapy in acute myeloid leukemia (AML). In younger adults, NPM1 MRD has recently demonstrated to be a favorable predictive marker for EFS and OS independently of fms-like tyrosine kinase-3 internal tandem duplications (FLT3-ITD) status. However, there is very few datas regarding predictive value of NPM1 MRD in elderly patients treated with intensive chemotherapy. Moreover, numerous studies have suggested the negative impact of DNMT3a mutation in NPM1 AML patients, especially in those with concurrent FLT3-ITD mutation. In this study, we aimed to investigate the impact of DNMT3a status on post induction NPM1 MRD1 predictive value for survival in a retrospective cohort of AML patients aged over 60 years old treated intensively. A total of 138 patients treated for NPM1 mutated AML in two French institutions (Lyon, Lille) were analyzed retrospectively. Median age of the entire cohort was 66.1 years old (range 60-78.2). An FLT3-ITD mutation was evidenced in 52 of 138 patients (37.6%) with a median FLT3-ITD AR of 0.53 (range, 0.05-3). With a median follow-up of 19.61 months (0.07-128.4), the overall CR rate was 89.9% with no influence of DNMT3a or FLT3 mutational status on the probability of CR. In this elderly cohort of NPM1mut patients, a 4log reduction of NPM1 bone marrow (BM) MRD1 was associated with better outcome (median OS: NR vs 13.4 months, HR=0.35, p<0.01)(Figure A). Overall, DNMT3 status did not influence the probability of having a ≥ 4log MRD1 reduction after induction. However, only 9/44 (20.4%) FLT3-ITD patients reached ≥ 4log MRD1 reduction whereas 38/80 FLT3wt (47.5%) were good molecular responders (p<0.001). FLT3-ITD mutated patients who achieved a 4log reduction had a superior outcome compared to those who did not (HR=0.34; 95% CI, 0.16 to 0.70; P <0.001). Similarly, NPM1mut FLT3wt patients with a 4log reduction in NPM1 BM-MRD1 had a longer OS (3-year OS, 68.1%; 95% CI, 48.8 to 82.9) than those without good molecular response (3-year OS, 46.5%; 95% CI, 30.2 to 61.7)(Figure B). DNMT3a negative patients who achieved a 4log reduction had a superior outcome to those who did not reached at least a 4log reduction (HR=0.23; 95% CI, 0.07 to 0.72; P <0.001). However, postinduction NPM1 MRD1 reduction was not predictive of OS and leukemia free survival (LFS) in DNMT3amut patients. DNMT3amut patients has a very poor LFS which was even worst in poor NPM1 MRD1 responders compared to those who reached at least 4log reduction (median LFS: 8.3 months vs 17.4 months, HR = 0.48, 95% CI, 0.25-0.91, p=0.023)(Figure C). In multivariate analysis, only DNMT3a mutational status and a 4-log reduction in NPM1 BM-MRD were significantly associated with survival. Based on these results, we identified among NPM1 positive patients 3 groups with distinct prognosis, based on FLT3-ITD, DNMT3a status and NPM1 BM-MRD post induction response (NPM1 scoring system)(Figure D). When compared to ELN 2017 intermediate risk group (AUC=0.695), NPM1 scoring system (NPM1 SS) was more accurate for OS prediction in patients within intermediate (AUC=0.833) and unfavorable (AUC=0.863) NPM1 SS risk group. However, there was no significant difference in AUC between NPM1 SS favorable and ELN 2017 favorable risk group. These results confirm that post-induction NPM1 MRD1 is a reliable tool to assess disease outcome in elderly AML patients. However, the presence of DNMT3a also identify a subgroup of patients at very high risk of relapase, despite good molecular responses. As hematopoietic stem cell transplantation (HSCT) might improve OS in elderly patients, DNMT3a positive AML elderly patients should be considered for HSCT or post induction maintenance strategies, even within the favorable ELN risk group. Figure Disclosures Sujobert: Gilead/Kyte: Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Sunesis: Research Funding.

scholarly journals Mental Health Assessment of Youth with Sickle Cell Disease and Their Primary Caretakers: Baseline Depression and COVID-19 Pandemic-Associated Psychosocial Stress in a Multi-Site Study

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 41-42
Author(s):  
Nancy S. Green ◽  
Deepa Manwani ◽  
Kim Smith-Whitley ◽  
Banu Aygun ◽  
Abena Appiah-Kubi ◽  
...  
Keyword(s):  
Mental Health ◽  
Depressive Symptoms ◽  
Food Insecurity ◽  
Board Of Directors ◽  
Research Funding ◽  
Assessment Tools ◽  
Mental Health Symptoms ◽  
Advisory Committees ◽  
Health Symptoms ◽  
Work Arrangements

Introduction: Youth with sickle cell disease (SCD) and their families are susceptible to stress and depression associated with chronic illness and social factors disproportionately affecting under-resourced U.S. communities. The COVID-19 pandemic has adversely impacted psychosocial and economic well-being, especially in some of these same communities. Our concurrent HABIT multi-site randomized trial aims to improve hydroxyurea adherence in youth with SCD ages 10-18 years through an intervention led by community health workers(NCT03462511). Subjects enrolled as youth-primary caretaker dyads; adults were mostly parents. We hypothesized that some HABIT subjects had depressive symptoms at baseline, and many had additional stressors during the pandemic. Methods: Two self-reported assessment tools were used, with options of English or Spanish: 1) PROMIS® pediatric (8a, v1.0) or adult (4a, v1.0) depression measures, completed at HABIT enrollment, nearly all between May 2018 - March 2020 ("baseline"); 2) A pandemic-related open-access survey originated by Johns Hopkins University on established core adult mental health assessed risks and behaviors.[1] Questions were closely adapted for use by youth. The pandemic survey assessed recent mental health symptoms and substance or domestic abuse. Two validated food insecurity screening questions were added.[2] Of 92 HABIT subjects, 84 were offered survey participation between May - July, 2020. Participants completed both assessment tools via electronic linkage to REDCap data capture. Analyses used chi square or Fisher exact test. Results: In all, 75% (63 of 84) responded to the pandemic survey; 31 were youth-parent dyads and one unpaired parent. Baseline demographics were: Youth (N=31): mean age 12.9±1.9 years, 48.4% female, 80.6% grade 6-12, 45.3% hospitalized within the prior 12 months; Caretakers (N=32): mean age 44.0±9.6 years, 87.5% Black, 18.8% Latinx, 37.50% married or living with a partner, 59.4% with at least some college education. At baseline, youth mean PROMIS® Depression T-Score was 49.9±10.1 (normal <50), with 64.5% reporting mild, moderate or severe depressive symptoms, compared to Caretaker' mean score 46.6±9.4 (normal <55) with 15.5% symptomatic (p=0.0002) (Table). In contrast, the pandemic survey revealed that 3 (9.7%) youth and 8 (25.0%) caretakers had recently felt depressed and/or anxious (NS). Loneliness (1 in 5) and especially not feeling hope for the future (1 in 2) were common in both groups. More youth than caretakers (89.1% vs.46.9%) had changes made to their school or work arrangements (p=0.008). Four (12.5%) caretakers and 1 (3.2%) youth had histories of mental illness. Substance use/abuse or verbal abuse were reported in <10% of each group. Food insecurity was reported in 6 (18.8%) families. "Red flag" replies to the pandemic survey necessitated referral of 6 dyads (18.8%) to their SCD social workers for support. Conclusions: In this sample of subjects from the HABIT Trial, at baseline a higher proportion of youth had depressive symptoms compare to their primary caretakers. During the initial pandemic peak in the Northeast, disrupted work arrangements and especially school cancellation were widespread. Fewer youth but similar proportions of caretakers reported feeling depressed and/or anxious. Both groups commonly reported loneliness or not feeling hopeful for the future. History of mental health conditions, current substance use/abuse or verbal abuse were uncommon. Concordant with concerns for under-resourced communities, a sizeable minority of families reported food insecurity. Under the limitations of using 2 different assessment tools, in this modest sample the majority of youth with SCD but not caretakers were mildly-moderately depressed at baseline and that, during the pandemic, the 2 groups reported similar proportions of mental health symptoms. These findings suggest that screening for mental health symptoms, social disruption and food insecurity may be warranted in this high-risk group overall and during the pandemic. References: 1) COVID-19 and mental health measurement working group, Johns Hopkins Bloomberg School of Public Health, March 18, 2020 2) Barnidge E., et al., Screening for Food Insecurity in Pediatric Clinical Settings. J. Community Health 42(1):51-57, 2017 The HABIT Trial is supported by 5R01NR017206-04 (Green, Smaldone). The authors have no conflicts to disclose. Disclosures Smith-Whitley: Novartis: Membership on an entity's Board of Directors or advisory committees; Global Blood Therapeutics: Membership on an entity's Board of Directors or advisory committees; Prime: Other: Education material; Celgene: Membership on an entity's Board of Directors or advisory committees. Aygun:bluebird bio: Membership on an entity's Board of Directors or advisory committees, Research Funding; National Institute of Nursing Research: Research Funding; Patient-Centered Outsomes Research Institute: Research Funding; National Heart, Lung, and Blood Institute: Research Funding.

Retrospective Chart Review of Gastrointestinal Bleeding in Patients with Von Willebrand Disease

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 20-21
Author(s):  
Jonathan C. Roberts ◽  
Miguel A. Escobar ◽  
Suchitra Acharya Acharya ◽  
Nina Hwang ◽  
Michael Wang ◽  
...  
Keyword(s):  
Board Of Directors ◽  
Chart Review ◽  
Von Willebrand Disease ◽  
Gi Bleeding ◽  
Prophylactic Regimen ◽  
Advisory Committees ◽  
History Of ◽  
Gi Bleed ◽  
Bleeding History ◽  
Von Willebrand

Background: Recurrent overt or occult gastrointestinal (GI) bleeding is a serious complication of von Willebrand Disease (VWD) and is the most common cause of hospitalization for patients with VWD. Data from the VWD Prophylaxis Network (VPN) emphasized the importance of prophylaxis in minimizing bleeding episodes in VWD; however, the management of GI bleeding in these patients remains challenging. Despite the availability of von Willebrand factor (VWF) replacement therapy, GI bleeding may be refractory and require the use of multiple treatment approaches. Currently, there are limited published data and no consensus regarding the most effective treatment for GI bleeding in patients with VWD. Aims: To describe the natural history of treatment and management of GI bleeds in patients with VWD, stratified by those patients who have a history of GI bleeding that precedes this chart review versus patients who experienced their first GI bleed within the 5 years of this chart review. Outcomes following the use of VWF replacement products and adjuvant therapy, including recombinant VWF were collected. Methods: This ongoing retrospective, multicenter, observational chart review (abstraction initiated 2019) will include up to 20 patients from 6 US centers with confirmed congenital VWD with ≥1 GI bleed within the last 5 years. Demographics and clinical information, including potential etiology, treatment regimens, will be gathered from patient records on all recorded GI bleeds within the last 5 years. Clinical effectiveness will be defined by treatment response, change in duration of treatment, or time to bleed resolution across treatment cohorts (e.g., prophylaxis vs on-demand; recombinant VWF [rVWF] vs plasma-derived VWF [pdVWF]), at the time of a GI bleed and for any subsequent period of prophylactic treatment to prevent GI bleed recurrence. Data will be analyzed descriptively. Results: To date, data on 37 bleeds in 13 patients with Type 1 (23%), Type 2 (46%) or Type 3 (31%) VWD have been abstracted; 54% were female, mean (±SD) age was 53.9 (22.0) years, 85% had ≥1 recorded GI-specific morbidity, 6 patients (46%) had no history of prior GI bleeding. Three patients (23%) were on regular prophylaxis using pdVWF-factor VIII (FVIII) concentrates at initial GI bleed presentation. All were receiving Humate-P; dose was not recorded for 2 patients and 1 patient received 50 IU/kg. Out of 37 bleeding episodes, 9 (24%) occurred in patients during VWF prophylaxis, of which 7 occurred in 1 patient. Among the 7 patients with a previous history of GI bleeding, 1 was on a prophylactic regimen prior to the initial GI bleeding episode. None of the patients without a history of GI bleeding were on a prophylactic regimen at the initiation of the chart review; 1 patient was receiving prophylaxis at the time the fourth bleed was documented. On-demand treatment for GI bleeding included aminocaproic acid, tranexamic acid, pdVWF-FVIII concentrates, rFVIII, rVWF, corticosteroids, polypectomy, and thalidomide. After resolution of the GI bleeding episode, in 17/37 bleeding events, prophylactic treatment continued (either as part of the final treatment regimen to resolve the bleed and sustained prophylaxis, or after the final treatment regimen purely as prophylaxis). At the conclusion of data collection for the current patients, 4 out of 6 without a GI bleeding history, and 1 out of 7 with a GI bleeding history, were receiving prophylaxis. Conclusions: Data from this retrospective chart review are the first to describe prophylactic regimens prior to and after GI bleeding, in VWD patients with and without a GI bleeding history. More patients with congenital VWD and a history of GI bleeding were treated with prophylaxis following GI bleeds, compared to patients without a history of GI bleeds. These data describe the role of prophylaxis in management of GI bleeding and add to existing data from the VPN describing a modest reduction of GI bleeding in some patients on prophylaxis. These data underscore the continuing unmet need of the successful management of GI bleeding in VWD. Further data will be collected, and additional analyses performed to determine if this trend persists in a larger sample of patients with VWD. Disclosures Roberts: uniQure:Consultancy;Takeda:Consultancy, Research Funding, Speakers Bureau;Pfizer:Consultancy;Novo Nordisk:Consultancy, Speakers Bureau;Sanofi:Consultancy, Speakers Bureau;Octapharma:Consultancy, Speakers Bureau.Escobar:National Hemophilia Foundation:Consultancy, Membership on an entity's Board of Directors or advisory committees;Takeda:Consultancy, Membership on an entity's Board of Directors or advisory committees;Sanofi:Consultancy, Membership on an entity's Board of Directors or advisory committees;Pfizer:Consultancy, Membership on an entity's Board of Directors or advisory committees;Genentech, Inc.:Consultancy, Membership on an entity's Board of Directors or advisory committees;Novo Nordisk:Consultancy, Membership on an entity's Board of Directors or advisory committees.Acharya:Novonordisk, BPL:Membership on an entity's Board of Directors or advisory committees.Hwang:Takeda:Honoraria;Shire:Honoraria.Wang:Bioverativ Inc:Honoraria;CSL Behring:Honoraria;Biomarin:Honoraria;Genentech:Honoraria;Takeda:Honoraria;Bayer:Honoraria.Hale:Takeda Pharmaceutical Company Limited:Current Employment.Oladapo:Takeda:Current Employment, Current equity holder in publicly-traded company.Asghar:HCD Economics:Current Employment.

Influence of Cytogenetics in Patients with Relapsed and Refractory Multiple Myeloma (MM) Treated with Carfilzomib (CFZ).

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 1827-1827 ◽  
Author(s):  
Andrzej Jakubowiak ◽  
Luhua Wang ◽  
Robert Z Orlowski ◽  
Sundar Jagannath ◽  
David Siegel ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Partial Response ◽  
Board Of Directors ◽  
Research Funding ◽  
Chromosomal Abnormalities ◽  
Single Agent ◽  
Entire Group ◽  
Fish Analysis ◽  
Advisory Committees ◽  
Minor Response

Abstract Abstract 1827 Poster Board I-853 Background It is now well established that cytogenetic abnormalities can affect the responses to therapies in multiple myeloma (MM) patients. Bortezomib, used alone or in combination with other agents, has been shown to overcome the adverse impact of several common unfavorable cytogenetic features. More recently, responses with lenalidomide and dexamethasone have been reported in patients with some types of unfavorable cytogenetics. Carfilzomib (CFZ) is a novel proteasome inhibitor that has demonstrated single agent activity in relapsed and/or refractory MM patients. The objective of this analysis was to provide the first preliminary information on the influence of cytogenetics in patients (pts) with relapsed and/or refractory MM treated with CFZ. Methods We evaluated 79 pts treated on two single agent CFZ studies (PX-171-003 and PX-171-004) in relapsed and/or refractory myeloma in which metaphase cytogenetics and/or FISH analysis for del 13q, t(4:14), and t(14;16) chromosomal abnormalities were available. Metaphase cytogenetics was conducted for all pts in the analysis; fluorescence in situ hybridization (FISH) results were available for 28 of the 79 pts. Twenty-one pts with relapsed and refratory MM (PX-171-003) and 58 pts with relapsed or refractory MM (PX-171-004) received CFZ at 20 mg/m2 IV on days 1, 2, 8, 9, 15, and 16 in a 28-day cycle for up to 12 cycles. For this analysis, responders were defined as pts who achieved at least a Minor Response (MR) [MR + Partial Response (PR) + Very Good Partial Response (VGPR) + Complete Response (CR)] by IMWG and EBMT criteria. Results The median age of analysed pts was 63 yrs and 100% of pts were relapsed, with 70% refractory to their last therapy. Analysis of their histories demonstrated prior thalidomide treatment in 75% of pts, prior lenalidomide treatment in 57%, prior bortezomib treatment in 55%, and prior stem cell transplantation in 84%. The response rate (≥MR) for the entire group of patients was 40.5%. Twenty three of 79 pts had at least one of the abnormalities. The presence of del 13q, t(4;14), or t(14;16) did not significantly change the response rates, with 43.5% of pts with one or more abnormalities responding compared to 39.3% with none. The median time to progression (TTP) for all patients in this analysis was 203 days. The TTP for pts with one or more of the abnormalities was 195 days and was not significantly different from the TTP of 208 days for pts with none of the abnormalities (Figure; P > 0.05). Conclusion In this preliminary analysis, CFZ showed comparable activity in relapsed and relapsed/refractory MM with del 13q and/or t(4:14), and/or t(14;16) versus none of these abnormalities, with ≥MR in 43.5% vs. 39.3% of patients, and a TTP of 195 vs. 208 days, respectively. Updated efficacy data and TTP data will be presented at the meeting. Disclosures Jakubowiak: Millennium: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Centocor Ortho Biotech: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Exelixis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Bristol-Myers-Squibb: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. Wang:Proteolix, Inc.: Research Funding. Jagannath:Millennium: Honoraria, Membership on an entity's Board of Directors or advisory committees; Merck: Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees. Siegel:Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Millennium: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Stewart:Takeda-Millenium, Celgene, Novartis, Amgen: Consultancy; Takeda, Millenium: Research Funding; Genzyme, Celgene, Millenium, Proteolix: Honoraria. Kukreti:Celgene: Honoraria. Lonial:Celgene: Consultancy; Millennium: Consultancy, Research Funding; BMS: Consultancy; Novartis: Consultancy; Gloucester: Research Funding. McDonagh:Proteolix: Research Funding. Vallone:Proteolix, Inc.: Employment. Kauffman:Proteolix, Inc.: Employment. Vij:Proteolix: Research Funding.

Measurement of PTCH1 Expression at Diagnosis Is an Appropriate Tool for Tyrosine Kinase Inhibitors Selection in Chronic Myeloid Leukemia Patients in Chronic Phase

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 2791-2791
Author(s):  
Juan Manuel Alonso-Dominguez ◽  
Felipe Casado ◽  
MariaTeresa Gómez Casares ◽  
Ismael Buno ◽  
Francisca Ferrer-Marin ◽  
...  
Keyword(s):  
Board Of Directors ◽  
Research Funding ◽  
First Line ◽  
Advisory Committees ◽  
Expression Ratio ◽  
Predictive Values ◽  
Free Survival ◽  
Exact Test ◽  
Sensitivity Specificity ◽  
Prognostic Power

Abstract Imatinib treatment has radically changed the prognosis of patients with CML. However, around 23-32% of patients discontinue this therapy due to lack of efficacy. Second generation TKI are available, which exhibit greater potency, so there is scope to further improve the strategy of selection of the appropriate TKI in the first line setting. Measurement of PTCH1 expression at diagnosis has been proposed as a useful strategy to tailor first line therapy as patients with low PTCH1 expression showed a worse outcome. Signalling via SMO is inhibited by non-Hedgehog ligated PTCH1 in Hedgehog pathway. SMO and PTCH1/SMO expression ratio has also been related to response to imatinib. Our aim was to corroborate imatinib outcome prediction in a different cohort and compare the prognostic power of PTCH1, SMO and PTCH1/SMO. We have retrospectively studied 101 pre-treatment samples of patients who received first-line imatinib from 14 Spanish centres. Clinical data were recorded in the Spanish CML Registry (RELMC). Informed consent was signed by every patient. Predesigned assays for PTCH1, SMO and GUSB (control gene) were used in single qPCR reactions in duplicates and run in an ABI 7900. Receiver operating characteristic (ROC) curves were plotted for PTCH1, SMO and PTCH1/SMO expression ratio and the area under curve (AUC) was used to compare its capacity to predict imatinib failure free survival (IFFS). For the measurement with higher AUC a threshold was set to divide patients with high and low expression. TKI failure was defined as loss of CCyR, progression to advanced phase disease, death or change in treatment from imatinib due to lack of efficacy. Secondary endpoints were: probability of achieving <10% BCRABL/ABL at 3 months, probability of achieving CCyR; probability of achieving MMR, progression free survival (PFS) and overall survival related to CML (CML OS). TFFS, CCyR, MMR and CML OS were analyzed by Kaplan-Meier analysis and log-rank test. Fishers exact test was employed to analyze the relationship with <10% BCRABL/ABL at 3 months and PFS. All analysis were carried out in an intention-to-treat basis. Age, Sokal, and EUTOS scores were introduced with categorised PTCH1 expression in a forward stepping Cox regression analysis for prediction of IFFS. Sensitivity, specificity and negative predictive values for prediction of IFFS were calculated. Patient median follow-up was 33 months (2-151). 13 patients (12.9%) showed imatinib failure. The AUC of PTCH1, SMO and PTCH1/SMO expression ratio were 0.72, 0.55 and 0.71. A PTCH1 expression of 0.026 was used as cut-off. Low and high PTCH1 expression groups had a 10 year rates of IFFS of 64% vs 95% (p=0.01), CCyR at 1 year of 91% vs 93% (p=0.261) and MMR at 12 months of 53% vs 81% (p=0.022). Median time of the entire cohort of achievement of CCyR was 6 months. Fishers exact test for achievement of <10% BCRABL/ABL at 3 months was significant (p=0.021). Three patients who progressed to accelerated or blastic phase and two of them who died from CML were included in the low expression group but no significant results were obtained due to the low number of events. PTCH1 expression was the unique independent predictor of IFFS in the multivariate analysis (p=0.023, HR=5.8(1.3-26)). Sensitivity, specificity and negative predictive values were 84.6%, 55.7 and 96.1%. We have confirmed PTCH1 expression prognostic power and found a greater predictive capacity than SMO and PTCH1/SMO expression ratio. Compared to previous PTCH1 studies this is a more real-to-life cohort, extracted from tertiary and secondary hospitals and the results confirm PTCH1 expression can be applied to very different clinical settings (previous studies had been performed in a cohort from a national CML reference hospital). Maybe the greater prognostic power of PTCH1 expression reflects its biological role in CML expands further than controlling SMO activity. Therefore PTCH1 could be used as a therapeutic target instead of SMO inhibitors which have shown poor results and high toxicity in early phase clinical trials. A reference standard, similarly as made for BCRABL/ABL1 measurement, could be developed with a level of PTCH1 expression equivalent to the cut-off established in this study. In this way PTCH1 expression could be implemented in the clinical setting. Figure 1. Figure 1. Disclosures García-Gutierrez: Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; BMS: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Ariad: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding. Martinez-Lopez:Janssen: Honoraria; Bristol-Meyer Squibb: Honoraria; Novartis: Honoraria, Research Funding; Celgene: Honoraria.

Appropriateness of Thrombophilia Testing in Tertiary Care Centers in Edmonton

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 4470-4470
Author(s):  
Alabdurubalnabi Zainab ◽  
Salma Shivji ◽  
Cynthia Wu
Keyword(s):  
Family History ◽  
Board Of Directors ◽  
Protein C ◽  
Protein S ◽  
Test Results ◽  
Advisory Committees ◽  
Increased Risk ◽  
History Of ◽  
Thrombophilia Testing

Abstract INTRODUCTION Thrombophilia is associated with an increased risk of venous thromboembolism (VTE). Despite this link, determining the presence or absence of such conditions has no role in VTE management including determining the choice or duration of anticoagulant therapy. Testing can be potentially harmful when results are misinterpreted or impact patient anxiety and insurance eligibility. METHODS We performed a retrospective chart review of adult patients presenting to the emergency department (ED) or were admitted to the University of Alberta Hospital (UAH), Royal Alexandra Hospital (RAH) and Grey Nuns Hospital (GNH) and underwent any number of thrombophilia tests (including factor V Leiden [FVL], prothrombin gene mutation [PT20210], protein C [PC], protein S [PS], antithrombin [AT] and antiphospholipid antibody testing). To assess for appropriateness of testing, categories of data were collected including presence of other strong risk factors obviating the need to look for other causes, indicators for higher yield (age of patient, presence of family history of VTE, idiopathic nature of VTE), presence of factors that confound testing (such as therapeutic anticoagulation) and relevant follow up (appropriate repeat testing when necessary). We also collected basic patient demographics, VTE details and ordering physician/service details to evaluate under what circumstances testing may be ordered more frequently. RESULTS 134 charts of patients tested for thrombophilia were reviewed between 2007-2013 at UAH and RAH Hospitals. A total of 965 thrombophilia tests were done (see analysis table). 13.4% of the testing was ordered by hematologists, 23.1% by neurologists, 52.2% by other internists. Overall, all patients had tests performed inappropriately, lacked appropriate follow up or had uninterpretable results and none had documented counseling prior to thrombophilia testing. CONCLUSIONS Thrombophilia testing is frequently ordered inappropriately and not adequately followed up. Strategies to educate physicians on indications and limitations of testing are warranted. These strategies can help decrease over/under/misinterpretation of thrombophilia testing as well as result in significant savings to the health care system if testing can be reduced. Table 1. Demographics Sample Size Males Females Total 74 (55.22%) 60 (44.78%) 134 (100%) Age at time of testing (Yrs) Range 19-88 Average 48.7 Patients' Test Results Test Times Performed Abnormal Results APCR 134 (100%) 32 (23.8%) FVL genetic test 58 (43%) 21 (39%) PT20210 105 (77%) 4 (3.8%) Protein C 100 (74.1%) 8 (8%) Protein S 99 (73.3%) 16 (16.2%) AT levels 99 (73.3%) 19 (19.2%) Anticardiolipin Ab 117 (86.7%) 4 (3.4%) Lupus Anticoagulant 109 (81.3%) 10 (10.2%) Provoking Factors Patients with One or More Provoking Factors Major 10 7.4% Moderate 74 56% Minor 29 21.8% No Provoking Factors 49 36.8% Family History of VTE 12 8.9% Protein C and Protein S Testing Done During Acute VTE 64 64% Patient was on Warfarin 25 25% Number of Abnormal Test Results 24 16% Number of Repeated Abnormal Tests 0 0% AT Testing Total Tests Performed 99 73.3% Done During Acute VTE 62 63% Patient was on Therap. Heparin or LMWH 62 62.6% Number of Abnormal Test Results 19 19.2% Abnormal Tests Repeated? 7 37% Repeat Tests Showing Normal Results 3 57% APA Testing Tests were Repeated After 12 Weeks for Confirmation 11% Disclosures Wu: Leo Pharma: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Pfizer: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees.

scholarly journals Potential Impact of Consolidation Radiation Therapy for Advanced Hodgkin Lymphoma: A Secondary Modeling of SWOG S0816 with Receiver Operating Characteristic Analysis

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 2927-2927 ◽  
Author(s):  
Chul S. Ha ◽  
Hongli Li ◽  
Heiko Schoder ◽  
Chelsea C Pinnix ◽  
Elizabeth Brem ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Board Of Directors ◽  
Hodgkin Lymphoma ◽  
Research Funding ◽  
Residual Disease ◽  
Entire Group ◽  
Advisory Committees ◽  
Potential Impact ◽  
Receiver Operating

Abstract Background:The role of radiation therapy (XRT) for advanced stage Hodgkin lymphoma (HL) is controversial. In the HD15 trial, the German Hodgkin Study Group (GHSG) administered XRT for PET-positive residual disease ≥2.5 cm at least 2 weeks after completion of chemotherapy and showed 91.5 % in-field control rate with a median follow-up of 102 months (Engert, A; personal communication). However, there is no comparison arm where patients with PET-positive residual disease ≥2.5 cm did not receive XRT. SWOG S0816 was a US intergroup trial utilizing ABVD-based therapy with response adaptation based on interim PET imaging; XRT was not allowed per protocol, and counted as an event. In this analysis, we identified patients in S0816 who would have met HD15 criteria for XRT, but did not receive XRT per design. We then modeled the potential impact of XRT on disease control. Patients and Methods:Of 336 eligible and evaluable HIV-negative patients enrolled in S0816, 49 had an end-of-treatment PET (termed "PET3," to be done 6-8 weeks after completion of chemotherapy) that was positive (i.e. Deauville 4-5) upon central review. We simulated the progression free survival (PFS) if XRT had been delivered per HD15 criteria (PET positive disease and ≥2.5 cm), evaluating by assumptions of 50, 80 and 90% control of the disease within the XRT fields. Receiver operating characteristics (ROC) analyses were performed with additional size cut-off points of 2.0 and 1.5 cm. Results:The median follow-up for the 49 PET3 positive patients was 71 months (range 9.7-92.6). For these 49 patients, the observed landmark PFS at 2 years after the date of PET3 was 30.6%. Twenty-four (49%), 33(67%), and 40 (82%) of the 49 patients had at least one site of disease that met the HD15 criteria for XRT with ≥2.5 cm, ≥2.0 cm, and ≥1.5 cm size cut-offs respectively. Sixteen, 19, and 25 patients had disease progression respectively from each group at median of 1.4-1.5 months. Twelve, 12, and 15 patients had relapses limited to the sites that would have been radiated following HD15 criteria with ≥2.5 cm, ≥2.0 cm, and ≥1.5 cm respectively. Estimated landmark PFS at 2 years for the 49 PET3 positive patients assuming 50, 80, and 90 % control of the disease within the radiated sites following HD15 guideline with ≥2.5 cm, ≥2.0 cm, and ≥1.5 cm cut-off are summarized in columns A, B, and C of the table respectively. For the entire group of 336 patients, the observed PFS at 2 years was 79%. Estimated 2-year PFS for the entire group of 336 patients assuming 50, 80, and 90 % control of the disease within the radiated sites following HD15 guideline with ≥2.5 cm, ≥2.0 cm, and ≥1.5 cm cut-off are in columns D, E, and F of the table respectively. Conclusion: Among the PET3 positive patients, consolidation XRT per HD15 criteria with cut-off points of 2.5, 2.0, and 1.5 cm could have raised the 2-year PFS by 12-28 % assuming 50-90% local control within radiated sites. However, the improvement in PFS is more moderate at 1.6-3.9 % if we consider the entire cohort of 336 patients. Although there may be some gain in PFS as the cut-off point is lowered by our ROC analysis, one needs to consider the trade-off against potentially increasing normal tissue toxicity as more sites are irradiated. Table. Table. Disclosures Brem: Pharamcyclics: Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees; Genetech: Membership on an entity's Board of Directors or advisory committees; Celgene: Speakers Bureau; Bayer: Membership on an entity's Board of Directors or advisory committees. Bartlett:Merck & Co: Research Funding; Forty Seven: Research Funding; Celgene: Research Funding; Immune Design: Research Funding; Seattle Genetics: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; ImaginAB: Research Funding; Janssen: Research Funding; KITE: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Acerta: Membership on an entity's Board of Directors or advisory committees; Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Research Funding; Millennium: Research Funding; Genentech: Research Funding; Astra Zeneca: Research Funding; Pharmacyclics: Research Funding; Gilead: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Bristol-Meyers Squibb: Research Funding; Affimed: Research Funding; Novartis: Research Funding; Pharmacyclics: Research Funding. Evens:Seattle Genetics, Inc.: Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Consultancy; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees; Affimed: Consultancy; Janssen: Consultancy; Tesaro: Research Funding; Bayer: Consultancy; Acerta: Consultancy; Pharmacyclics International DMC: Membership on an entity's Board of Directors or advisory committees; Abbvie: Consultancy. Rimsza:NanoString: Other: Inventor on the patent for the Lymph2Cx assay. Leonard:Novartis: Consultancy; Celgene: Consultancy; MEI Pharma: Consultancy; AstraZeneca: Consultancy; ADC Therapeutics: Consultancy; United Therapeutics: Consultancy; BMS: Consultancy; Biotest: Consultancy; Sutro: Consultancy; Karyopharm: Consultancy; Juno: Consultancy; Gilead: Consultancy; Genentech/Roche: Consultancy; Pfizer: Consultancy; Bayer: Consultancy. Kahl:Seattle Genetics: Consultancy; Genentech: Consultancy; Acerta: Consultancy; AstraZeneca: Consultancy; Abbvie: Consultancy; ADC Therapeutics: Consultancy; CTI: Consultancy; Gilead: Consultancy; Juno: Consultancy; Celgene: Consultancy. Smith:BMS: Consultancy; Portola: Honoraria. Friedberg:Bayer: Honoraria.

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