High Expression of the Very Late Antigen (VLA)-4 (CD49d) Integrin Predicts for Reduced Risk of Relapse and Better Outcome in Pediatric Acute Myeloid Leukemia (AML): A Report From the Children's Oncology Group.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 1592-1592
Author(s):  
Walter B. Walter ◽  
Todd A. Alonzo ◽  
Robert B. Gerbing ◽  
Franklin O. Smith ◽  
Susana C. Raimondi ◽  
...  
Keyword(s):  
High Risk ◽  
Clinical Outcome ◽  
Risk Classification ◽  
Low Risk ◽  
Significant Heterogeneity ◽  
Oncology Group ◽  
Monosomy 7 ◽  
Entire Cohort ◽  
The Impact ◽  
Standard Risk

Abstract Abstract 1592 Poster Board I-618 Background Previous studies highlighted the importance of the cell adhesion molecule, VLA-4, for chemoresistance and minimal residual disease (MRD) in AML, suggesting promise as therapeutic target. By comparison, the prognostic role of VLA-4 in AML remains controversial with retrospective studies implying either adverse or favorable prognosis. Therefore, we prospectively evaluated VLA-4 expression in participants of a recent Children's Oncology Group (COG) AML pilot protocol. Methods COG-AAML03P1 enrolled 340 newly diagnosed children (aged 1 month - 21 years) with de novo non-acute promyelocytic AML, excluding those with Down syndrome, and tested the feasibility of combining gemtuzumab ozogamicin (GO) with intensive induction chemotherapy followed by GO-containing intensification therapy or matched related donor stem cell transplantation; 216 patients submitted diagnostic marrow specimens for flow cytometric determination of VLA-4 expression that was then correlated with patient demographics, laboratory characteristics, and clinical outcome. Cytogenetics and molecular prognostic markers were used for risk classification as follows: low risk (mutation in core-binding factor, NPM1, or CEBPa; n=73), high risk (-5/5q-, monosomy 7, or FLT3/ITD with high allelic ratio; n=25), or standard risk (all other patients with cytogenetic/molecular data; n=101); 17 patients had insufficient data for risk classification. Results Among the 216 diagnostic specimens, the mean fluorescence intensity (MFI) of VLA-4 expression varied over 35-fold from a baseline of 30 to 1110 (median, 219.5). Patients with high VLA-expression (>median MFI) were younger (p<0.001), had a lower prevalence of FLT3/ITD (p=0.002). Presence of extramedullary disease (EMD, chloroma or CNS involvement) was significantly higher in patients with high VLA-4 expression (16% vs. 5%, p=0.013), where 17/22 (77%) of patients with EMD had high VLA-4 expression. We initially inquired whether VLA-4 expression as a continuous variable correlated with disease outcome. We demonstrated that over the range of VLA-4 expression levels, every 10-unit increase in VLA-4 MFI corresponded to a 2% decrease in relapse risk (RR; p=0.023) and 2% increase in disease-free survival (DFS) from end of induction I (p=0.015). We subsequently divided the study patients into two cohorts based on median MFI and determined the clinical outcome per median VLA-4 MFI for the entire cohort as well as in specific risk groups (i.e., high risk, low risk, and standard risk). In the evaluation of the entire cohort, patients with high VLA-4 expression had a significantly superior DFS (67% vs 48%, p=0.023) and lower RR (24% vs 44%, p=0.011) compared to those with lower VLA-4 expression. In subgroup analyses, high VLA-4 expression was associated with significantly superior DFS (69% vs 34%, p=0.011) and lower RR (26% vs 61%, p=0.009) in patients with standard-risk AML but not in patients with high or low risk disease. In multivariate Cox regression analyses that included age, cytogenetics, and molecular prognostic factors, low VLA-4 expression remained significantly associated with elevated RR (hazard ratio for low VLA-4: 2.25, p=0.011). Finally, we determined the impact of MRD in the context of VLA-4 expression. The prevalence of MRD was similar for patients with low or high VLA-4 expression (29% vs. 25%, p=0.70). In patients with low VLA-4 expression, those with MRD had a RR of 75% compared to that of 35% for the MRD negative cohort (p=0.005). Corresponding DFS was 19% and 54% for those with and without MRD (p=0.018), a difference mainly attributable to increased RR. In patients with high VLA-4 expression, those with MRD had a RR of 31% vs. 23% for the MRD-negative patients (p=0.28) with a corresponding DFS of 46% and 75% for the MRD positive and negative patients (p=0.014), a difference mainly explained by higher treatment-related mortality in MRD positive patients. Conclusion This study demonstrates significant heterogeneity of VLA-4 expression in pediatric AML and its association with EMD and clinical outcome. This study further demonstrates that VLA-4 expression is an independent prognostic factor for clinical outcome and can identify the risk status in patients with no identifiable cytogenetic or molecular risk factors. Disclosures No relevant conflicts of interest to declare.

The Clinical Usefulness of Novel Prognostic Factors in CLL: A Study of 477 Patients with Low-Risk (Non-11q, Non-17p) FISH and Known IGVH Mutation Status.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 3079-3079 ◽  
Author(s):  
Constantine S. Tam ◽  
Michael J. Keating ◽  
Apostolia M. Tsimberidou ◽  
Susan O’Brien ◽  
Alessandra Tsimberidou ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
High Risk ◽  
Hazard Ratio ◽  
Low Risk ◽  
P Value ◽  
Mutation Status ◽  
Trisomy 12 ◽  
The Impact ◽  
Standard Risk ◽  
Active Disease

Abstract In order to develop integrated models utilizing commonly available prognostic factors, we studied the clinical signficance of IGVH mutation, CD38 and ZAP-70 in 477 CLL patients (pts) with low-risk (non-11q, non-17p) FISH findings. All pts were untreated at the time of FISH assessment, and were collected prospectively in the MD Anderson CLL database. Two hundred & fifteen pts (45%) had mono- (n=160) or bi-alleleic (n=55) deletion of 13q {DEL13Q}, 162 pts (34%) had a negative FISH panel {NEG}, and 100 pts (21%) had trisomy 12 as sole FISH abnormality (n=78) or in association with deletion 13q (n=22) {T12}. Compared to other FISH groups, DEL13Q pts had lower B2m (median 2.2 v 2.6mg/L, p=0.01) and were less likely to be IGVH unmutated (33% v 48%, p=0.001). In contrast, T12 pts were more likely to present with advanced stage disease (Rai≥2 36% v 23%, p=0.01), be CD38 positive (44% v 13%, p<0.001), and have karyotypic abnormalities (48% v 7%, p<0.001). One hundred and twenty-three pts had active disease requiring immediate therapy and 354 pts had stable disease, of whom 291 were evaluable for disease progression. At a median follow-up of 20 months, 73 pts had developed active disease with NCI-WG indication(s) for treatment. Actuarial 2 year time to treatment (TTT) was 26%, with no significant difference between 13q, NEG and T12 pts (p=0.27). TTT was associated with elevated B2m (≥1.5ULN), IGVH mutation status and ZAP-70 in DEL13Q and NEG pts, but not in T12 patients (Table). For DEL13Q/NEG pts, a simple model using IGVH mutation and B2m separated high risk pts (unmutated or high B2m, 2yr TTT 43%) from standard risk pts (mutated and low B2m, 2yr TTT 11%, p<0.0001). For T12 pts, a model based on CD38 positivity and karyotypic abnormalities separated high risk pts (2 factors, 2yr TTT 75%) from standard risk pts (0 or 1 factor, 2yr TTT 15%, p=0.008). These results show that the impact of prognostic factors on TTT is dependent on the underlying FISH karyotype, and underscores the need for future studies in CLL prognostic factors to take into account the complete risk profile of the pt. NEGATIVE FISH DELETION 13Q TRISOMY 12 p-value hazard ratio p-value hazard ratio p-value hazard ratio IGVH Mutation <0.001 8.0 0.003 2.9 0.97 0.98 B2m ≥1.5ULN <0.001 4.5 0.07 2.2 0.54 0.68 CD38 Positivity 0.05 2.5 0.05 2.4 0.06 7.4 Abn Cytogenetics <0.001 11.0 0.27 2.2 0.09 2.8 ZAP-70 0.02 2.9 0.007 3.1 0.70 1.3 Figure Figure Figure Figure

Correlation of Mir-155 Expression with Clinical Outcome in Childhood AML: A Report from Children’s Oncology Group

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 3545-3545
Author(s):  
Ranjani Ramamurthy ◽  
Maya D Hughes ◽  
Hamid Bolouri ◽  
Robert B. Gerbing ◽  
Yi-Cheng Wang ◽  
...  
Keyword(s):  
High Risk ◽  
Prognostic Factor ◽  
Clinical Outcome ◽  
Mirna Expression ◽  
Target Genes ◽  
Low Risk ◽  
Molecular Features ◽  
Disease Characteristics ◽  
Induction Failure ◽  
Standard Risk

Abstract Acute myeloid leukemia (AML) is characterized by genomic abnormalities that impair differentiation and promote proliferation. Karyotypic alterations and somatic mutations are associated with relapse risk but are rarely predictive of response to induction chemotherapy. Aberrant miRNA expression has been implicated in AML pathogenesis. We present association of altered miR-155 expression with specific molecular characteristics and show its association with high risk of induction failure and worse clinical outcome in children with normal karyotype (NK) AML treated on COG AML trial, AAML0531. Of 1022 patients enrolled, 233 were NK. 198 diagnostic specimens were available for testing. miR-155 expression was evaluated by quantitative TaqMan miRNA assays normalized against normal marrow. Expression varied by 4 log fold. Patients were divided into 4 quartiles (Q1-Q4) based on expression levels. Q1 had patients with the lowest and Q4, with the highest expression. We correlated disease characteristics and clinical outcome across quartiles. All comparisons and data presented is between high (Q4) vs. low (Q1-Q3) expressors. Males (66% vs. 48%, p=0.027), Asians (15% vs. 5%, p=0.048) and high median diagnostic WBC (59.4 vs. 22.6, p=0.002) were over-represented in high expressors. Molecular abnormalities were used to stratify risk. Low-risk patients were those with mutations in CEBPA/NPM and high-risk, in FLT3-ITD. Others were designated as standard-risk. High miR-155 expression was associated with a high prevalence of FLT3-ITD mutations (69% vs. 31%, p < 0.001) and high-risk disease (52% vs. 15%, p<0.001), and had an inverse association with low-risk (22% vs. 38%, p=0.041) and standard-risk disease (26% vs. 47%, p=0.008). There was no association with mutations in CEBPA (p=0.710) or NPM (p=0.826). We evaluated expression levels and response to induction chemotherapy, morphologic complete remission (CR). CR rates for high vs. low expressors was 46% vs. 83% (p<0.001). As high expressors were more likely FLT3-ITD+, we computed CR for those without FLT3-ITD mutations. High vs. low expressors who were FLT3-ITD-, had CR rates of 47% vs. 86% (p=0.002), suggesting that miR-155 expression may independently provide data on response to chemotherapy We evaluated overall survival (OS) and event-free survival (EFS) at 3 years. OS for high vs. low expressors was 51% vs. 75% (p=0.002) and EFS was 32% vs. 59% (p<0.001). Association of high miR-155 and worse survival was also verified against RNASeq data, in an independent cohort of children with NK-AML (p=0.005). We performed Cox regression analyses to evaluate the impact of miR-155 expression level as a predictor of clinical outcome in the context of prognostic factors (FLT3-ITD, NPM, CEBPA mutations, treatment arm, risk group, age, WBC) and molecular risk groups using them as covariates in both univariate and multivariate models. In the univariate model, high expression was a prognostic factor for inferior OS (HR of 2.19, p= 0.002) and EFS (HR 2.24, p<0.001). Patients with low-risk molecular features also had improved OS (HR 0.29, p<0.001) and EFS (HR 0.22, p<0.001). In a multivariate model that included the aforementioned prognostic features, high miR-155 expression retained prognostic significance for OS (HR 1.92, p=0.022) and EFS (HR 1.75, p= 0.019). High risk molecular features were no longer an independent predictor of outcome. Low-risk molecular features remained an independent prognostic factor for improved OS (HR 0.34, p=0.005) and EFS (HR 0.22, p < 0.0001). We extended our study to identify target genes whose expression was impacted or regulated by miR-155 expression. Comparison of the mRNA expression profile for the 23 highest vs. 23 lowest expressors identified anti-correlation of miR-155 and 15 target genes. High miR-155 levels were associated with down-regulation of 9 genes, including E2F2 and ETS1. Low miR-155 levels were associated with up-regulation of 6 genes, including DET1, GATM and SMAD1. We demonstrate association of miR-155 with specific disease characteristics and clinically significant mutations in pediatric AML. We also show that high expression is highly predictive of induction failure and outcome providing potential biomarkers for identifying patients at high risk of poor response prior to therapy. miRNA expression could provide clinically important information for use in therapeutic allocation. Disclosures No relevant conflicts of interest to declare.

scholarly journals High Expression of Neutrophil Elastase Predicts Improved Survival In Pediatric Acute Myeloid Leukemia: A Report From the Children's Oncology Group

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 2762-2762
Author(s):  
Roland B. Walter ◽  
Chelsea J. Gudgeon ◽  
Rhonda E. Ries ◽  
Todd A. Alonzo ◽  
Robert B. Gerbing ◽  
...  
Keyword(s):  
High Risk ◽  
Neutrophil Elastase ◽  
Myeloid Leukemia ◽  
Small Sample Size ◽  
Small Sample ◽  
Low Risk ◽  
Core Binding Factor ◽  
Entire Cohort ◽  
Binding Factor ◽  
Standard Risk

Abstract Abstract 2762 Background: Recent studies indicated that high expression of neutrophil elastase, a primary granule serine protease encoded by ELANE (ELA2), predicts longer survival of patients with chronic-phase chronic myeloid leukemia (CML) and improved outcome following allogeneic hematopoietic stem cell transplantation for advanced-phase CML. In contrast, the prognostic role of neutrophil elastase in acute myeloid leukemia (AML) is unknown. Therefore, we evaluated its expression in participants in a recent Children's Oncology Group (COG) AML pilot protocol. Methods: COG-AAML03P1 enrolled 340 newly diagnosed children (aged 1 month to 21 years) with de novo AML, excluding those with acute promyelocytic leukemia and Down syndrome, and tested the feasibility of combining gemtuzumab ozogamicin (GO) with intensive induction chemotherapy followed by GO-containing intensification therapy or matched related donor stem cell transplantation. Diagnostic marrow specimens from 113 randomly selected patients were used for ELANE mRNA quantification using a sandwich nucleic acid hybridization method employing branched DNA molecules to amplify the signal from captured target RNA. Expression levels were normalized using beta glucuronidase (GUSB) and then correlated with patient demographics, laboratory characteristics, and clinical outcome. Cytogenetics and molecular prognostic markers were used for risk classification as follows: low risk (mutation in core-binding factor, NPM1, or CEBPa; n=43), high risk (−5/5q−, monosomy 7, or FLT3-ITD with high allelic ratio; n=16), or standard risk (all other patients with cytogenetic/molecular data; n=54). Results: Among the 113 diagnostic specimens, ELANE mRNA expression levels were undetectable in 3 samples and varied more than 70,000-fold relative to GUSB in the rest, from 0.0005 to 36.32 (median, 0.89). Patients with high ELANE expression (>median expression) were more likely to have myelomonocytic cell characteristics (FAB M4, p<0.001) and more likely to have core-binding factor translocations, t(8;21) (p=0.05) or inv(16) (p<0.003). They had a lower prevalence of megakaryocytic leukemia (p<0.02). There was no difference in the prevalence of FLT3-ITD or NPM1 mutations. As a result of these characteristics, patients with high ELANE expression were more likely to have low-risk disease (p<0.001) at the expense of standard-risk disease, while the prevalence of high-risk disease was similar. We subsequently determined the clinical outcome per median ELANE expression for the entire cohort as well as the specific risk groups. In the entire cohort, patients with high ELANE expression had a significantly superior 3-year overall survival (OS; 80±11% vs 61±13%, p=0.045) and tended to have better disease-free survival (66±14% vs 51±16%, p=0.118). Subgroup analyses were limited by the small sample size. Nevertheless, in both high- and low-risk disease, patients with high ELANE expression tended to have a better 3-year OS than patients with low ELANE expression (67±38% vs 30±29%, p=0.308 for high risk; 90±11% vs 75±25%, p=0.361 for low risk). By comparison, OS in standard-risk patients appeared similar for patients with high and low ELANE expression (70±21% vs 66±17%, p=0.849). In multivariate Cox regression analyses that included age, cytogenetics, and molecular prognostic factors, high ELANE expression was associated with reduced overall mortality (hazard ratio: 0.66); however, this result did not reach statistical significance (95% confidence interval: 0.33–1.35, p=0.260), possibly because of the small sample size. Conclusion: This study revealed significant heterogeneity of ELANE expression in pediatric AML and its association with improved OS. This association is at least partly due to the high proportion of AMLs with core-binding factor aberrations in patients with high ELANE expression. Nevertheless, high ELANE expression may predict improved OS even within specific risk groups, in particular high-risk disease, although further studies with a larger patient cohort will be necessary to confirm this finding. Disclosures: No relevant conflicts of interest to declare.

Biology-Driven Classification of Childhood Acute Lymphoblastic Leukemia: A Combined Analysis of Prognostic Markers from the Pediatric Oncology Group (POG) and Children’s Cancer Group (CCG).

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 519-519
Author(s):  
Kirk R. Schultz ◽  
Jeanette Pullen ◽  
Harland Sather ◽  
Jonathan Shuster ◽  
Michael J. Borowitz ◽  
...  
Keyword(s):  
High Risk ◽  
Classification System ◽  
Risk Classification ◽  
Low Risk ◽  
Significant Advance ◽  
Cell Phenotype ◽  
Childhood All ◽  
Risk Patients ◽  
Standard Risk ◽  
Very High

Abstract Risk adapted therapy, tailoring treatment to the likelihood of relapse, has constituted a significant advance in the treatment of childhood ALL. The recent merger of the POG and CCG provided an opportunity to reassess previous approaches and to develop a new biology driven classification system based on data from both legacy groups. All children (age 12 months to 21.99 years) with newly diagnosed B-precursor (ALL), consecutively enrolled on CCG (December 1988 to August 1995, N = 3056) and POG (January 1986 to November 1999, N = 6800) protocols, were evaluated for the impact of numerous clinical and laboratory variables on event free survival at 5 and 8 years in each group separately, thereby superseding differences in treatment approaches. Infants and patients with a T- cell phenotype were excluded from the analyses. Very high risk was defined as the group for which myeloablative therapy might be indicated with an anticipated 5 year EFS &lt;45%, while a reduction in therapy could be justified for the lowest risk patients with a &gt;85% 5 year EFS. Patients identified as being at very high risk for relapse had hypodiploidy (&lt;45 chromosomes) (CCG 34.8%, POG 46.5% - 5 year EFS), induction failure (CCG 11.3% 5 year EFS) or t(9;22) or BCR/ABL (POG 27.5%, CCG 29.6% 5 year EFS). Patients identified as low risk for relapse were NCI standard risk patients with either t(12;21) (TEL-AML1) (CCG 86%, POG 85% 5 year EFS) or all three trisomies of 4, 10, and 17 (CCG 91.5%, POG 89.3% 5 year EFS). Certain NCI high risk patients were identified as having a higher risk for relapse but did not fall into the VHR category: t(4;11)(POG 49.9%, CCG 50.0% 5 year EFS),CNS3 (CCG 59.3%, POG 67.8% 5 year EFS) and slow early response (SER) defined by M2/3 at day 14 (Standard risk 66% SER versus 84% and for high risk ALL 63% SER versus 75%). Other potential VHR factors that require confirmation included, slow early responder t(4;11) (CCG 11.1% 5 year EFS) and monosomy 7 (CCG 44%, POG 66.6% 5 year EFS). A balanced t(1;19) had only a minor unfavorable effect on EFS. The COG has identified a risk classification system that builds on the previous NCI risk classification system for childhood ALL, incorporating the cytogenetic and molecular genetic features of the blasts, as well as rapidity of clinical response. The division of B-precursor ALL patients into low risk (18%), standard risk (49%), high risk (30%) and very high risk (3%) groups will : 1) identify those patients for whom therapy might be reduced without sacrificing overall cure rates, 2) determine those patients who will require intensified therapy and 3) suggest underlying biological pathways that mediate cure or treatment failure.

Prospective study to measure the impact of MMprofiler on treatment intention in newly diagnosed multiple myeloma patients (PROMMIS).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 8030-8030
Author(s):  
Parameswaran Hari ◽  
Suzanne Lentzsch ◽  
David Samuel DiCapua Siegel ◽  
Saad Zafar Usmani ◽  
Binod Dhakal ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
High Risk ◽  
Treatment Strategies ◽  
Progression Free Survival ◽  
Risk Classification ◽  
Newly Diagnosed ◽  
Treatment Paradigm ◽  
Risk Patients ◽  
The Impact ◽  
Standard Risk

8030 Background: Multiple Myeloma (MM) is recognized as a heterogeneous group of patients with varying response and outcome of their disease, associated with various risk factors including genetic aberrations. Risk adapted treatment strategies are beginning to emerge (e.g. mSMART), which include gene expression signatures. SKY92, a 92-gene prognostic signature, classifies MM patients as “high” or “standard” risk. It has been reported to be a robust predictor for Overall and Progression Free Survival (Kuiper 2012, 2015). Here we report the preliminary impact of SKY92 on risk classification and treatment intention decisions in newly diagnosed MM patients enrolled in the PRospective Observational Multiple Myeloma Impact Study (PROMMIS). Methods: Patients with MM had their BM aspirate analyzed using the MMprofiler with SKY92. The physician completed questionnaires with his/her treatment intention, before and after knowing SKY92 results. Results: 39 MM patients were enrolled from 5 US centers. The SKY92 signature classified 15 patients (38%) as high risk. Prior to knowing SKY92 results, physicians regarded 20 (51%) patients as clinically high risk, for whom SKY92 indicated 12 patients to be standard risk. Upon revealing SKY92, 8 patients were then considered standard risk by the physician. For 2 patients with concordant high risk classification results, the confirmation of the risk classification was considered helpful. The impact of treatment intention decisions in clinical high risk patients was 40% (8 out of 20). In the 19 patients (49%) that were regarded clinically standard risk prior to knowing SKY92, SKY92 indicated 7 patients to be high risk. Physicians agreed to this classification. For 4 patients with concordant risk classification, the confirmation was found helpful. The impact of treatment intention decisions in clinical standard risk patients was 37% (7 out of 19). Conclusions: Preliminary results from the PROMMIS trial indicate that SKY92 impacts the physician’s treatment intention for 38% of patients with newly diagnosed MM. Moreover, the physicians found the SKY92 result useful for 54% of the patients. This underlines the relevance and need for assessment of SKY92 in MM patients, and associated risk stratified treatment paradigm. Clinical trial information: NCT02911571.

scholarly journals TissueCypher Barrett’s esophagus assay impacts clinical decisions in the management of patients with Barrett’s esophagus

2021 ◽  
Vol 09 (03) ◽  
pp. E348-E355
Author(s):  
David L. Diehl ◽  
Harshit S. Khara ◽  
Nasir Akhtar ◽  
Rebecca J. Critchley-Thorne
Keyword(s):  
High Risk ◽  
Barrett’S Esophagus ◽  
Barrett's Esophagus ◽  
Clinical Decision Making ◽  
Eradication Therapy ◽  
Low Risk ◽  
Management Approach ◽  
Low Grade ◽  
Management Decisions ◽  
The Impact

Abstract Background and study aims The TissueCypher Barrett’s Esophagus Assay is a novel tissue biomarker test, and has been validated to predict progression to high-grade dysplasia (HGD) and esophageal adenocarcinoma (EAC) in patients with Barrett’s esophagus (BE). The aim of this study was to evaluate the impact of TissueCypher on clinical decision-making in the management of BE. Patients and methods TissueCypher was ordered for 60 patients with non-dysplastic (ND, n = 18) BE, indefinite for dysplasia (IND, n = 25), and low-grade dysplasia (LGD, n = 17). TissueCypher reports a risk class (low, intermediate or high) for progression to HGD or EAC within 5 years. The impact of the test results on BE management decisions was assessed. Results Fifty-two of 60 patients were male, mean age 65.2 ± 11.8, and 43 of 60 had long segment BE. TissueCypher results impacted 55.0 % of management decisions. In 21.7 % of patients, the test upstaged the management approach, resulting in endoscopic eradication therapy (EET) or shorter surveillance interval. The test downstaged the management approach in 33.4 % of patients, leading to surveillance rather than EET. In the subset of patients whose management plan was changed, upstaging was associated with a high-risk TissueCypher result, and downstaging was associated with a low-risk result (P < 0.0001). Conclusions TissueCypher was used as an adjunct to support a surveillance-only approach in 33.4 % of patients. Upstaging occurred in 21.7 % of patients, leading to therapeutic intervention or increased surveillance. These results indicate that the TissueCypher test may enable physicians to target EET for TissueCypher high-risk BE patients, while reducing unnecessary procedures in TissueCypher low-risk patients.

scholarly journals CanAssist Breast Impacting Clinical Treatment Decisions in Early-Stage HR+ Breast Cancer Patients: Indian Scenario

2019 ◽  
Author(s):  
Satish Sankaran ◽  
Jyoti Bajpai Dikshit ◽  
Chandra Prakash SV ◽  
SE Mallikarjuna ◽  
SP Somashekhar ◽  
...  
Keyword(s):  
High Risk ◽  
Early Stage ◽  
Risk Groups ◽  
Treatment Decisions ◽  
Low Risk ◽  
Not Given ◽  
Breast Cancer Patients ◽  
Number Of Patients ◽  
Risk Of Cancer ◽  
The Impact

AbstractCanAssist Breast (CAB) has thus far been validated on a retrospective cohort of 1123 patients who are mostly Indians. Distant metastasis–free survival (DMFS) of more than 95% was observed with significant separation (P < 0.0001) between low-risk and high-risk groups. In this study, we demonstrate the usefulness of CAB in guiding physicians to assess risk of cancer recurrence and to make informed treatment decisions for patients. Of more than 500 patients who have undergone CAB test, detailed analysis of 455 patients who were treated based on CAB-based risk predictions by more than 140 doctors across India is presented here. Majority of patients tested had node negative, T2, and grade 2 disease. Age and luminal subtypes did not affect the performance of CAB. On comparison with Adjuvant! Online (AOL), CAB categorized twice the number of patients into low risk indicating potential of overtreatment by AOL-based risk categorization. We assessed the impact of CAB testing on treatment decisions for 254 patients and observed that 92% low-risk patients were not given chemotherapy. Overall, we observed that 88% patients were either given or not given chemotherapy based on whether they were stratified as high risk or low risk for distant recurrence respectively. Based on these results, we conclude that CAB has been accepted by physicians to make treatment planning and provides a cost-effective alternative to other similar multigene prognostic tests currently available.

The national impact of the COVID-19 pandemic on U.S. prostate cancer community care.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 5061-5061
Author(s):  
Matthew R. Cooperberg ◽  
Paul Brendel ◽  
Daniel J. Lee ◽  
Rahul Doraiswami ◽  
Hariesh Rajasekar ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Language Processing ◽  
Care Delivery ◽  
Specific Antigen ◽  
Risk Groups ◽  
Low Risk ◽  
T Stage ◽  
Risk Stratum ◽  
The Impact

5061 Background: We used data from a specialty-wide, community-based urology registry to determine trends in outpatient prostate cancer (PCa) care during the COVID-19 pandemic. Methods: 3,165 (̃ 25%) of US urology providers, representing 48 states and territories, participate in the American Urological Association Quality (AQUA) Registry, which collects data via automated extraction from electronic health record systems. We analyzed trends in PCa care delivery from 156 practices contributing data in 2019 and 2020. Risk stratification was based on prostate-specific antigen (PSA) at diagnosis, biopsy Gleason, and clinical T-stage, and we used a natural language processing algorithm to determine Gleason and T-stage from unstructured clinical notes. The primary outcome was mean weekly visit volume by PCa patients per practice (visits defined as all MD and mid-level visits, telehealth and face-to-face), and we compared each week in 2020 through week 44 (November 1) to the corresponding week in 2019. Results: There were 267,691 PCa patients in AQUA who received care between 2019 and 2020. From mid-March to early November, 2020 (week 10 – week 44) the magnitude of the decline and recovery varied by risk stratum, with the steepest drops for low-risk PCa (Table). For 2020, overall mean visits per day (averaged weekly) were similar to 2019 for the first 9 weeks (̃25). Visits declined to week 14 (18.19; a 31% drop from 2019), recovered to 2019 levels by week 23, and declined steadily to 11.89 (a 58% drop from 2019) as of week 44, the cut off of this analysis. Conclusions: Access to care for men with PCa was sharply curtailed by the COVID-19 pandemic, and while the impact was less for men with high-risk disease compared to those with low-risk disease, visits even for high-risk individuals were down nearly one-third and continued to fall through November. This study provides real-world evidence on the magnitude of decline in PCa care across risk groups. The impact of this decline on cancer outcomes should be followed closely.[Table: see text]

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