Neoadjuvant radiotherapy vs. surgery alone for stage II/III mid-low rectal cancer with or without high risk factors: A multicenter randomized trial.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 3537-3537
Author(s):  
Ziqiang Wang ◽  
Xiangbing Deng ◽  
Ping Liu ◽  
Xin Wang ◽  
Dan Jiang ◽  
...  
Keyword(s):  
Risk Factors ◽  
Rectal Cancer ◽  
Lymph Node ◽  
High Risk ◽  
Primary Endpoint ◽  
Low Risk ◽  
Short Term ◽  
High Risk Factors ◽  
Risk Patients ◽  
Secondary Endpoints

3537 Background: Neoadjuvant (chemo)radiotherapy (NRT) is the standard treatment for locally advanced rectal cancer (RC),which reducing local recurrence (LR) without survival benefit. There are also reports claiming similar local control achieved by surgery alone in selected patients, that raising the issue of omitting NRT in low risk patients. The aim of this study was to clarify the benefit of NRT in stage II/III RC with or without high risk factors. Methods: Eligible participants with mid-low cT3-4aN± RC were included and classified as high risk patients and low risk patients according to the clinical staging. High risk was defined as T3 tumor with extramural spread > 5mm, T4a or lymph node > 8mm. High and low risk patients were both randomized into two groups: high risk radiotherapy (HRR) or high risk surgery (HRS), low risk radiotherapy (LRR) or low risk surgery (LRS) separately. Patients in HRR and LRR received short term NRT (5*5Gy) + TME, while patients in HRS and LRS underwent surgery alone. The primary endpoint was 3-y LR. The secondary endpoints were OS, DFS, quality of surgery and safety. Results: From Jun. 2011 to Dec. 2015,401 consecutive patients were analyzed (LRS 99, LRR 97, HRS 102, HRR 103). As for primary endpoint, 3-y LR was obviously lower in low risk patients (3% vs. 9%, p = 0.026), but comparable in LRR vs. LRS (3% vs. 2%, p = 0.32) and HRR vs. HRS (11% vs. 7%, p = 0.42). Concerning secondary endpoints, low risk patients were favorable in 3-y OS (p < 0.001), DFS (p < 0.001), and distant metastasis (p = 0.001), compared to the high risk. And 3-y OS in HRR was higher than that in HRS (82% vs. 70%, p = 0.032). NRT caused 1.5% grade 3/4°radiation-related complications with a higher rate of late leakage (4.5% vs 0.0%, p = 0.004). Besides, positive CRM was higher in HRS (HRS 14.7% vs. HRR 4.9%, p = 0.017). Conclusions: Depth of extramural spread and lymph node status are favorable predictors for LR and survival. NRT may improve OS for high-risk RC. Low-risk RC has very low LR, suggesting against routine use of NRT. Relatively high LR and better OS in high risk patients justify use of NRT or NCR. Short-term radiation is safe for Asian patients, given caution be paid to more late leakage. Clinical trial information: NCT01437514.

The prominent value of apparent diffusion coefficient in assessing high-risk factors and prognosis for patients with endometrial carcinoma before treatment

2020 ◽  
pp. 028418512094027
Author(s):  
Quan Quan ◽  
Yunfeng Lu ◽  
Beibei Xuan ◽  
Jingxian Wu ◽  
Wanchun Yin ◽  
...  
Keyword(s):  
Risk Factors ◽  
Diffusion Coefficient ◽  
Lymph Node ◽  
High Risk ◽  
Lymph Node Metastasis ◽  
Apparent Diffusion Coefficient ◽  
Treatment Schedule ◽  
Node Metastasis ◽  
High Risk Factors ◽  
Apparent Diffusion

Background To date, there are no consensus methods to evaluate the high-risk factors and prognosis for managing the personalized treatment schedule of patients with endometrial carcinoma (EC) before treatment. Apparent diffusion coefficient (ADC) is regarded as a kind of technique to assess heterogeneity of malignant tumor. Purpose To explore the role of ADC value in assessing the high-risk factors and prognosis of EC. Material and Methods A retrospective analysis was made on 185 patients with EC who underwent 1.5-T magnetic resonance imaging (MRI). Mean ADC (mADC), minimum ADC (minADC), and maximum ADC (maxADC) were measured and compared in different groups. Results Among the 185 patients with EC, the mADC and maxADC values in those with high-risk factors (type 2, deep myometrial invasion, and lymph node metastasis) were significantly lower than in those without. According to receiver operating characteristic (ROC) curve analysis, the areas under the curve (AUC) were significant for mADC, minADC, and maxADC predicting high-risk factors. Furthermore, the AUCs were significant for mADC and maxADC predicting lymph node metastasis but were not significant for minADC. Patients with lower mADC were associated with worse overall survival and disease-free survival; the opposite was true for patients with higher mADC. Conclusion Our study showed that ADC values could be applied to assess the high-risk factors of EC before treatment and might significantly relate to the prognosis of EC. It might contribute to managing initial individualized treatment schedule and improve outcome in patients with EC.

Neoadjuvant Radiotherapy Versus Surgery Alone for Stage II/III Mid-low Rectal Cancer With or Without High-risk Factors

2019 ◽  
Vol 272 (6) ◽  
pp. 1060-1069 ◽  
Author(s):  
Xiangbing Deng ◽  
Ping Liu ◽  
Dan Jiang ◽  
Mingtian Wei ◽  
Xin Wang ◽  
...  
Keyword(s):  
Risk Factors ◽  
Rectal Cancer ◽  
High Risk ◽  
Low Rectal Cancer ◽  
Stage Ii ◽  
Neoadjuvant Radiotherapy ◽  
High Risk Factors

Abstract 78: Risk Factors Associated with Failure of Aggressive Medical Therapy in the SAMMPRIS Trial

Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Michael F Waters ◽  
Brian L Hoh ◽  
Michael J Lynn ◽  
Tanya N Turan ◽  
Colin P Derdeyn ◽  
...  
Keyword(s):  
Risk Factors ◽  
High Risk ◽  
Medical Therapy ◽  
Primary Endpoint ◽  
Univariate Analysis ◽  
Baseline Risk ◽  
Medical Group ◽  
High Risk Patients ◽  
Increased Risk ◽  
Risk Patients

Background: The SAMMPRIS trial showed that aggressive medical therapy was more effective than stenting for preventing stroke in high-risk patients with symptomatic intracranial stenosis. However, 15% of patients in the medical group still had a primary endpoint (any stroke or death within 30 days of enrollment or stroke in the territory beyond 30 days) during a median follow-up of 32.7 months. We sought to determine baseline risk factors that were associated with a primary endpoint in the medical arm of SAMMPRIS. Methods: Data on 227 patients randomized to the medical group in SAMMPRIS were analyzed. Baseline demographic features, vascular risk factors, qualifying event, brain imaging and angiographic features were analyzed. The hazard ratio and p-value from a Cox proportional hazard regression model relating time until a primary endpoint to each factor were calculated. Results: Female gender, diabetes, stroke as the qualifying event (especially non-penetrator stroke), old infarct in the territory of the stenotic artery, and > 80% stenosis were associated (p < 0.10) with a higher risk of the primary endpoint on univariate analysis (see accompanying table) (multivariate analysis will be available by the time of ISC). Variables not associated with a higher risk of a primary endpoint in the medical arm included: age, race, antithrombotic therapy at the time of a qualifying event, time from qualifying event to enrollment (< 7 days vs. > 7 days), and location of stenosis. Conclusions: Several features were associated with an increased risk of the primary endpoint in the medical group in SAMMPRIS. On univariate analysis, the most important risk factors were an old infarct in the territory of the stenotic artery and stroke (especially non-penetrator stroke) as the qualifying event. These features will be useful for identifying particularly high-risk patients who should be targeted for future clinical trials testing alternative therapies to aggressive medical management.

scholarly journals Measurable Residual Disease at Induction Redefines Partial Response in Acute Myeloid Leukemia and Stratifies Outcomes in Patients at Standard Risk Without NPM1 Mutations

2018 ◽  
Vol 36 (15) ◽  
pp. 1486-1497 ◽  
Author(s):  
Sylvie D. Freeman ◽  
Robert K. Hills ◽  
Paul Virgo ◽  
Naeem Khan ◽  
Steve Couzens ◽  
...  
Keyword(s):  
Risk Factors ◽  
Acute Myeloid Leukemia ◽  
High Risk ◽  
Complete Remission ◽  
Myeloid Leukemia ◽  
Residual Disease ◽  
High Risk Factors ◽  
Risk Patients ◽  
Standard Risk ◽  
Acute Myeloid

Purpose We investigated the effect on outcome of measurable or minimal residual disease (MRD) status after each induction course to evaluate the extent of its predictive value for acute myeloid leukemia (AML) risk groups, including NPM1 wild-type (wt) standard risk, when incorporated with other induction response criteria. Methods As part of the NCRI AML17 trial, 2,450 younger adult patients with AML or high-risk myelodysplastic syndrome had prospective multiparameter flow cytometric MRD (MFC-MRD) assessment. After course 1 (C1), responses were categorized as resistant disease (RD), partial remission (PR), and complete remission (CR) or complete remission with absolute neutrophil count < 1,000/µL or thrombocytopenia < 100,000/μL (CRi) by clinicians, with CR/CRi subdivided by MFC-MRD assay into MRD+ and MRD−. Patients without high-risk factors, including Flt3 internal tandem duplication wt/− NPM1-wt subgroup, received a second daunorubicin/cytosine arabinoside induction; course 2 (C2) was intensified for patients with high-risk factors. Results Survival outcomes from PR and MRD+ responses after C1 were similar, particularly for good- to standard-risk subgroups (5-year overall survival [OS], 27% RD v 46% PR v 51% MRD+ v 70% MRD−; P < .001). Adjusted analyses confirmed significant OS differences between C1 RD versus PR/MRD+ but not PR versus MRD+. CRi after C1 reduced OS in MRD+ (19% CRi v 45% CR; P = .001) patients, with a smaller effect after C2. The prognostic effect of C2 MFC-MRD status (relapse: hazard ratio [HR], 1.88 [95% CI, 1.50 to 2.36], P < .001; survival: HR, 1.77 [95% CI, 1.41 to 2.22], P < .001) remained significant when adjusting for C1 response. MRD positivity appeared less discriminatory in poor-risk patients by stratified analyses. For the NPM1-wt standard-risk subgroup, C2 MRD+ was significantly associated with poorer outcomes (OS, 33% v 63% MRD−, P = .003; relapse incidence, 89% when MRD+ ≥ 0.1%); transplant benefit was more apparent in patients with MRD+ (HR, 0.72; 95% CI, 0.31 to 1.69) than those with MRD− (HR, 1.68 [95% CI, 0.75 to 3.85]; P = .16 for interaction). Conclusion MFC-MRD can improve outcome stratification by extending the definition of partial response after first induction and may help predict NPM1-wt standard-risk patients with poor outcome who benefit from transplant in the first CR.

Cardiac Complications Following Allogeneic Bone Marrow Transplantation: Evaluation of Risk Factors, Outcomes and Enhanced Screening for At Risk Populations.

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 3070-3070
Author(s):  
Michael Henry ◽  
Rong Guo ◽  
Mala Parthasarathy ◽  
John Lopez ◽  
Patrick Stiff
Keyword(s):  
Risk Factors ◽  
Atrial Fibrillation ◽  
High Risk ◽  
Organ Transplant ◽  
Solid Organ Transplant ◽  
Low Risk ◽  
Solid Organ ◽  
Cardiac Events ◽  
Post Transplant ◽  
Risk Patients

Abstract Abstract 3070 Life-threatening cardiac events following allogeneic bone marrow transplants (BMT) are not uncommon at 5–12.5% of patients. While BMT programs perform screening EKGs and ejection fraction measurements, solid organ transplant centers follow a risk stratification screening algorithm to assess for coronary artery disease (CAD) which includes stress tests and as indicated, angiography in those with 2 or more risk factors. It is currently unknown whether this algorithm should be applied in the BMT setting. Methods: We performed a retrospective review of 296 patients who underwent allogeneic BMT at Loyola University Medical Center 2007–2011, to assess cardiac events using the solid organ transplant advanced screening criteria: age over 60 or over 40 with peripheral vascular disease or diabetes and then divided patients into low risk (one CV risk factor) and high risk groups (greater than one CV risk factor). Risk factors included age, hypertension, diabetes, smoking, family history of CAD, and obesity according to the Framingham risk assessment score for CAD. Cardiac events during the first year post-transplant were recorded including CHF, myocardial infarction (MI), and symptomatic arrhythmias. One hundred day and 1-year Kaplan-Meier survival for high and low risk patients were determined and curves compared by log-rank tests. A multivariate analysis of the various prognostic factors was performed using the Cox regression model. Results: Of the 296 total allografts, 116 patients (39%) fit the solid organ transplant criteria for advanced screening; 62% were male (n = 72) and the mean age was 60.6 (range 40–72). Graft source was evenly distributed between siblings (42%), unrelated (39%) and cord blood (28%). Acute myeloid leukemia was the most common indication for BMT at 40%, followed by MDS (21%), non-Hodgkin lymphoma (16%), and CLL (10%). Of the 116, 21 were considered low risk (1 risk factor), while 95 were high risk (2+ risk factors). Low risk and high risk groups did not differ in disease type (p = 0.43), graft source (p = 0.81), or graft type (p = 0.54). Surprisingly, both high and low risk patients had a similar incidence of cardiac events of 36% and 48%, respectively. This correlated to comparable 100-day and 1 year survival rates. To determine the importance of cardiac complications on outcome and whether there were other risk factors for complications we analyzed those with a complication. Forty-four cardiac events occurred in the first year after transplant in 38 (33%) patients. Cardiac events included arrhythmias (n = 33), new onset CHF (n = 6), and MI (n = 5). Median time to event was 16 days post-transplant. Symptomatic arrhythmias included atrial fibrillation (n = 27, 82%), supraventricular tachycardia (n = 5, 15%) and sustained ventricular tachycardia (n =1, 3%). Median age for patients with cardiac events was 62.7 years, compared to 59.6 for patients who experienced no cardiac events (hazard ratio estimate: 1.076; p = 0.02). As compared to patients with no post-transplant cardiac events, both the 100 day and 1 year survival rates of patients with cardiac events were lower with one year survival of 21% vs. 63% (p < 0.0001). Evaluating risk factors, 3 were significant: donor source with MUD donors the highest hazard (p = 0.04); age, with cardiac events occurring at a rate twice as high in patients greater than age 60 (n = 27, 36.5% vs. n = 6, 19.4%), and with all five cases of myocardial infarction and 5/6 new CHF diagnoses occurring in patients aged 60 or greater; and patients with a history of atrial fibrillation demonstrated a higher probability of developing a cardiac event post-transplant (p = 0.02). Conclusions: In this analysis, we saw a much higher incidence of post-BMT cardiac events (33%) than previously reported, although we focused only on at risk patients using the solid organ screening algorithm (pts > 40 with significant risk factors or all pts > 60). As mortality rates at 100 day and 1 year are higher for patients who suffer a post-BMT cardiac event, and only graft source, age and prior atrial fibrillation marked patients at a very high risk, this data indicates that it is appropriate to investigate prospectively the solid organ transplant algorithm in all allogeneic BMT patients > age 40, with low cardiac risk or any patient > 60 with stress tests and as indicated, cardiac catheterization. Whether this will decrease events and thereby improve survival remains to be determined by prospective studies. Disclosures: No relevant conflicts of interest to declare.

Multicentre validation of the Geneva Risk Score for hospitalised medical patients at risk of venous thromboembolism

2014 ◽  
Vol 111 (03) ◽  
pp. 531-538 ◽  
Author(s):  
Drahomir Aujesky ◽  
Daniel Hayoz ◽  
Jürg Beer ◽  
Marc Husmann ◽  
Beat Frauchiger ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
High Risk ◽  
Risk Score ◽  
Primary Endpoint ◽  
Low Risk ◽  
Prediction Score ◽  
Medical Patients ◽  
Cumulative Rate ◽  
Patients At Risk ◽  
Risk Patients

SummaryThere is a need to validate risk assessment tools for hospitalised medical patients at risk of venous thromboembolism (VTE). We investigated whether a predefined cut-off of the Geneva Risk Score, as compared to the Padua Prediction Score, accurately distinguishes low-risk from high-risk patients regardless of the use of thromboprophylaxis. In the multicentre, prospective Explicit ASsessment of Thromboembolic RIsk and Prophylaxis for Medical PATients in SwitzErland (ESTIMATE) cohort study, 1,478 hospitalised medical patients were enrolled of whom 637 (43%) did not receive thromboprophylaxis. The primary endpoint was symptomatic VTE or VTE-related death at 90 days. The study is registered at ClinicalTrials.gov, number NCT01277536. According to the Geneva Risk Score, the cumulative rate of the primary endpoint was 3.2% (95% confidence interval [CI] 2.2–4.6%) in 962 high-risk vs 0.6% (95% CI 0.2–1.9%) in 516 low-risk patients (p=0.002); among patients without prophylaxis, this rate was 3.5% vs 0.8% (p=0.029), respectively. In comparison, the Padua Prediction Score yielded a cumulative rate of the primary endpoint of 3.5% (95% CI 2.3–5.3%) in 714 high-risk vs 1.1% (95% CI 0.6–2.3%) in 764 lowrisk patients (p=0.002); among patients without prophylaxis, this rate was 3.2% vs 1.5% (p=0.130), respectively. Negative likelihood ratio was 0.28 (95% CI 0.10–0.83) for the Geneva Risk Score and 0.51 (95% CI 0.28–0.93) for the Padua Prediction Score. In conclusion, among hospitalised medical patients, the Geneva Risk Score predicted VTE and VTE-related mortality and compared favourably with the Padua Prediction Score, particularly for its accuracy to identify low-risk patients who do not require thromboprophylaxis.

scholarly journals The Risk of Stroke Using CHA2 DS2 -VASc Score in Hemodialysis Patients at a Tertiary Hospital in Riyadh, Saudi Arabia

2019 ◽  
Vol 4 (7) ◽  
Keyword(s):  
Risk Factors ◽  
High Risk ◽  
Stroke Risk ◽  
Hemodialysis Patients ◽  
Low Risk ◽  
High Risk Patients ◽  
Stroke Risk Factors ◽  
Increased Risk ◽  
Risk Patients ◽  
History Of

Introduction: Patients undergoing hemodialysis are at increased risk of stroke. However, less known about the impact of some of the stroke risk factors, and the value of stroke risk scores in determining the risk in those patients. Our main goal. To assess the risk factors for stroke in hemodialysis patients and the use of the new CHA2DS2-VASc score for stroke assessment. Methods: Single center, retrospective cohort study of 336 patients undergoing hemodialysis from June 24, 2018, to September 6, 2018, was recruited. Baseline demographics, clinical, and laboratory data were collected. We calculated the CHA2 DS2 -VASc score for stroke assessment in all patients and categorized them into high, moderate and low risk patients according to CHA2 DS2 - VASc score and subcategorized them to two groups atrial fibrillation (AFib) and Non- Atrial fibrillation (Non AFib) patients. Results: 336 patients were included in our study; the majority of patients were at high risk with a CHA2 DS2 -VASc Score mean of 2.9± 1.5, although history of stroke was observed only in 15 patients (4.46%). According to CHA2 DS2 - VASc score, 280 patients were at high risk, 172 (51.19%) were high-risk patients on treatment (anticoagulant or antiplatelet) and 108(32.14%) patients were high risk patients not on treatment 48 were at moderate risk (14.28%) and 8 were at low risk (2.38 %). Patients were divided into subgroups as non-AFib and AFib. In non-AFib patients 320 (95.23%), high-risk patients 103 (32.18%) were not treated; high-risk patients with treatment are 162 (50.62%), moderate patients were 47 (14.68%), 8(2.5%) was in low risk. AFib patients were 16 with a mean CHA2 DS2 -VASc score of 4.4±1.1. Patients with AFib were all at high risk except 1 was at moderate risk (6.25%). There were 11 (68.75%) patients on treatment and 5 (31.25%) patients not on treatment. The risk factors for stroke that were statistically significant in increasing score risk for all patients were: age > 65 (95% CI, -2.04– -1.29; p = 0.000), being female (95% CI, -1.36– -0.68; p = 0.000) hypertension (95% CI, -2.59– -1.37; p = 0.000), diabetes (95% CI, -2.10– -1.50; p = 0.000), CVD (95% CI, -2.07– -1.24; p=0.000), history of stroke or TIA (95% CI, -3.70– -2.03; p = 0.000), CHF or LVEF (95% CI, -2.28– - 0.91; p = 0.000). Conclusions: The risk of stroke in hemodialysis patients is significant according to the use of CHA2 DS2 -VASc score in Non-AFib hemodialysis patients shows supportive evidence of increased risk of stroke in those patients, which suggest the importance of close monitoring of patients with stroke risk factors by the nephrologist and the stroke team which will lead to the initiation of early prophylaxis in those patients.

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