Short‐term monitoring of single or a few atypical melanocytic lesions in low‐risk patients should not be confused with long‐term monitoring of multiple melanocytic lesions in high‐risk patients

2020 ◽  
Vol 34 (8) ◽  
Author(s):  
J. Paoli ◽  
S. Berglund
Keyword(s):  
High Risk ◽  
Low Risk ◽  
Short Term ◽  
High Risk Patients ◽  
Melanocytic Lesions ◽  
Risk Patients ◽  
Long Term Monitoring ◽  
Term Monitoring

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

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

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

scholarly journals Long-term monitoring of arrhythmias in cardiac sarcoidosis

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Bakker ◽  
H Mathijssen ◽  
J Balt ◽  
V.F Van Dijk ◽  
M Veltkamp ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Risk Stratification ◽  
Cardiac Death ◽  
Cardiac Sarcoidosis ◽  
Low Risk ◽  
Risk Patients ◽  
Long Term Monitoring ◽  
Term Monitoring

Abstract Introduction Screening for cardiac sarcoidosis (CS) is recommended since it can manifest with ventricular arrhythmias (VA), atrioventricular conduction block (AVB) and sudden cardiac death (SCD). However, risk stratification for SCD is challenging, in particular in patients without overt cardiac symptoms. Purpose This study reports the practice-based risk stratification for SCD and the incidence of arrhythmias and mortality in CS patients by long-term monitoring of arrhythmias. Methods A retrospective, single center cohort study was performed in 537 patients with sarcoidosis screened for cardiac involvement with cardiac MRI and fluorodeoxyglucose PET in an hospital, a Dutch tertiary referral center. CS was diagnosed in 115 of 537 patients (21%), complete follow up was available in 108 patients (94%). After risk assessment for SCD (figure 1) an ICD was implanted in 16 high-risk patients. Within the92 low-risk patients, 80 had an internal loop recorder (ILR) implanted and 12 patients received no device. Chart review was performed to assess the occurrence of VA, AVB, death, ICD therapy and device related complications. Results During a mean follow-up of 31±15 months, 9 out of 80 ILR patients (11.3%) received an ICD of whom 7 (8.8%) based on recorded arrhythmias (VA in 5 and AVB in 2 patients). Five out of the total 25 ICD patients (20%) experienced sustained VA successfully treated with anti-tachycardia pacing in 2 (8%) and terminated spontaneously in all other patients. Two ICD patients experienced a mild pocket infection, treated with antibiotics. Two deaths occurred in the low-risk patients: 1 non-cardiac death and 1 SCD due to asystole. Conclusion The practice-based risk stratification supported an ICD implantation in up to 5% of sarcoidosis patients screened for CS. Sustained VA occurred in 20% of ICD patients.Early detection of important arrhythmias with an ILR can optimize risk assessment for SCD in CS. Practise-based risk stratification Funding Acknowledgement Type of funding source: None

scholarly journals Effectiveness of Short Term Home-Based Care for Long Term Prevention of Heart Failure Hospitalizations of High Risk Patients

2019 ◽  
Vol 25 (8) ◽  
pp. S109
Author(s):  
Victoria Thomas ◽  
Andrew Nagel ◽  
Rebecca Kafer ◽  
Cathy Schubert ◽  
Roopa Rao
Keyword(s):  
Heart Failure ◽  
High Risk ◽  
Short Term ◽  
High Risk Patients ◽  
Home Based ◽  
Risk Patients ◽  
Home Based Care

Long Term Outcome of Patients with Acute Promyelocytic Leukemia Treated with All-Trans Retinoic Acid, Arsenic Trioxide with or without Gemtuzumab Ozogamicin

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 3776-3776
Author(s):  
Farhad Ravandi ◽  
Jorge E. Cortes ◽  
Guillermo Garcia-Manero ◽  
Elihu Estey ◽  
Gautam Borthakur ◽  
...  
Keyword(s):  
High Risk ◽  
Research Funding ◽  
Gemtuzumab Ozogamicin ◽  
Low Risk ◽  
Newly Diagnosed ◽  
Term Outcome ◽  
Long Term Outcome ◽  
High Risk Patients ◽  
Risk Patients

Abstract Background - Combination of all-trans retinoic acid (ATRA) and arsenic trioxide (ATO) for the initial treatment of patients with low and intermediate risk acute promyelocytic leukemia (APL) has been shown to be superior to ATRA plus chemotherapy but there is limited available long-term follow up on the "chemotherapy-free" combinations. Methods - We examined the long-term outcome of patients with newly diagnosed APL treated at our institution on three consecutive prospective clinical trials of the combination of ATRA and ATO with or without gemtuzumab ozogamicin (GO) (ID01-014; NCT01409161; NCT00413166). Initially patients received ATRA 45 mg/m2 in two divided doses daily and beginning 10 days later, ATO 0.15 mg/kg daily. With subsequent studies, the schedule was modified for all patients to receive concomitant therapy with ATRA and ATO from day 1. Patients with WBC > 10 x 109/L and patients whose WBC rose to greater than 10 x 109/L during therapy also received a dose of GO 9 mg/m2. Standard supportive care as well as steroids for prophylaxis for differentiation syndrome were administered to all patients. A bone marrow exam to assess response was performed between days 21 and 28 and, if necessary, repeated weekly. Once in CR, patients received consolidation with ATO 0.15 mg/kg daily 5 days/week for 4 weeks every 8 weeks for a total of 4 cycles and ATRA 45 mg/m2 daily for 2 weeks every 4 weeks for a total of 8 months. Bone marrow assessment was performed every 3 months for 1 year and if PCR for PML-RARA was confirmed positive, a dose of GO would be administered. Results - From July 2002 to May 2015, 183 patients have been enrolled into the three trials. During the same period a total of 235 patients with newly diagnosed APL were seen at our institution. Reasons for not being enrolled in the studies were: insurance/socio-economic in 39 (75%) and died within 48 hours of presentation in 13 (25%). Median age of the study patients was 50 years (range, 14-84). 52 (28%) were older than 60 years. Median WBC at presentation was 2.2 x 109/L (range, 0.3-187.9). 52 (28%) had high risk disease with WBC > 10 x 109/L and 131 (72%) had low risk disease with a WBC ≤ 10 x 109/L. Cytogenetics were t(15;17) alone in 117 (64%), t(15;17) plus other in 48 (26%), other, not done, or insufficient in 18 (10%). PCR was positive for PML-RARA in all patients (100%) with the long isoform in 104 (57%), short in 78 (43%), and both in 1 (<1%). Overall 176 (96%) achieved CR with CR rate of 96% for low risk patients and 96% for high risk patients. Early death (occurring within 1 month of study entry) occurred in 7 (4%) and was due to 1 infection/multi-organ failure (MOF), 3 hemorrhage, 3 MOF/hemorrhage/infection. Differentiation syndrome was diagnosed in 21 (11.5%) Other toxicities included QT prolongation in 14 (7.7%), infections in 44 (24.0%), and hemorrhagic events in 10 (5.5%). The median duration of follow-up is 39.6 months (range, 0.8 - 138.8). Six patients (3%) have relapsed including 2 (1%) with extramedullary (both CNS) relapse. The median event-free (EFS), disease-free (DFS) and overall survival (OS) have not yet been reached. The 5-year EFS is 85%, DFS is 96%, and OS is 87% (Figures 1). The 5-year DFS and OS for low risk patients is 99% and 88%, respectively and for the high risk patients 87% and 85%, respectively (figure 2). Conclusion - The combination of ATRA and ATO, with and without GO is effective and associated with excellent long-term DFS and OS in both low and high risk patients with newly diagnosed APL. Figure 1. Figure 1. Figure 2. Figure 2. Disclosures Cortes: Teva: Research Funding; BerGenBio AS: Research Funding; Pfizer: Consultancy, Research Funding; BMS: Consultancy, Research Funding; Novartis: Consultancy, Research Funding; Ariad: Consultancy, Research Funding; Astellas: Consultancy, Research Funding; Ambit: Consultancy, Research Funding; Arog: Research Funding; Celator: Research Funding; Jenssen: Consultancy. Jabbour:Pfizer: Consultancy, Research Funding. Faderl:Celator: Research Funding; Astellas: Research Funding; Seattle Genetics, Inc.: Research Funding; Karyopharm: Consultancy, Research Funding; Onyx: Speakers Bureau; Ambit: Research Funding; BMS: Research Funding; JW Pharma: Consultancy; Celgene: Consultancy, Research Funding, Speakers Bureau; Pfizer: Research Funding. Wierda:Glaxo-Smith-Kline Inc.: Research Funding; Celgene Corp.: Consultancy. DiNardo:Novartis: Research Funding. Konopleva:Novartis: Research Funding; AbbVie: Research Funding; Stemline: Research Funding; Calithera: Research Funding; Threshold: Research Funding.

Transcatheter Aortic Valve Implantation

2009 ◽  
Vol 4 (4) ◽  
pp. 197-205
Author(s):  
Jian Ye ◽  
Samuel V. Lichtenstein
Keyword(s):  
High Risk ◽  
Aortic Valve ◽  
Operative Mortality ◽  
Low Risk ◽  
Term Outcome ◽  
Long Term Outcome ◽  
High Risk Patients ◽  
Risk Patients

There has been significant improvement in device designs, operative techniques, and early clinical outcomes in <5 years. Presently, there are two catheter-based bioprostheses (balloon expandable or self-expandable), which have been widely used in humans and are undergoing clinical investigations. Three approaches, including transvenous, transarterial, and transapical have been used for delivery of the catheter-based bioprostheses, and transarterial and transapical approaches have been adopted by cardiologists and cardiac surgeons worldwide. The most recent clinical results have been very encouraging and promising. With experience, 30-day operative mortality with either balloon-expandable or self-expandable bioprosthesis was reduced significantly to approximately 10% in high-risk patients. In vivo long-term durability of catheter-based bioprostheses remains unknown, and presently transcatheter procedure is limited to the cohort of high-risk patients. Expanding this new technology to low-risk patients should be done with extreme caution because conventional aortic valve replacement still provides the best long-term outcome with minimal operative mortality and morbidity in low-risk patients. Ongoing clinical trials will address many unanswered questions, such as patient selection, long-term in vivo durability, preoperative assessment, and the role of the procedures in management of valvular diseases.

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

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

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

LONG-TERM Outcome of a Fondazione Italiana Linfomi Study Comparing Short Rituximab Maintenance Vs Observation after Brief First-LINE R-FND Chemoimmunotherapy Followed By Rituximab Consolidation in Elderly Patients with Advanced Follicular Lymphoma (FL)

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 3985-3985
Author(s):  
Carola Boccomini ◽  
Marco Ladetto ◽  
Francesca Dutto ◽  
Simone Ferrero ◽  
Luca Baldini ◽  
...  
Keyword(s):  
High Risk ◽  
Low Risk ◽  
First Line ◽  
Term Outcome ◽  
Long Term Outcome ◽  
High Risk Patients ◽  
Rituximab Maintenance ◽  
Risk Patients

Abstract Introduction: we previously reported (Vitolo U, JCO 2013) the results of a randomized study with brief first-line chemoimmunotherapy followed by rituximab maintenance vs observation. With a median follow-up of 42 months, 3-year Progression Free Survival (PFS) and Overall Survival (OS) were 66% and 89%, respectively. The addition of Rituximab maintenance gave a benefit to the patients: 2-year PFS was 81% for rituximab maintenance versus 69% for observation with a HR of 0.63 (95% CI: 0.38-1.05, p=0.079), although not statistically significant. Moreover we also found that achievement of Minimal Residual Disease (MRD) negativity predicted a better PFS: 3-year PFS 72% vs 39%, HR 3.1 (Ladetto M, Blood 2013). Overall these data showed the good efficacy of this brief chemoimmunotherapy regimen in elderly FL patients. Aim of this analysis was to report long-term outcome and long-term toxicities of this regimen. Methods: From January 2004 to December 2007, 242 treatment-naive patients aged 60-75 years with FL Grade I, II and IIIa were enrolled by 33 FIL centres. Patients had to have advanced (high tumor burden stage II or stage III-IV) disease requiring treatment: 4 monthly courses of R-FND (standard doses of Rituximab, Fludarabine, Mitoxantrone, Dexamethasone) every 28 days followed by 4 weekly Rituximab infusions as consolidation. Responders patients [complete remission (CR) + unconfirmed CR + partial remission (PR)] were randomized to brief rituximab maintenance (Arm A), once every 2 months for a total of 4 doses, or observation (Arm B). MRD for the bcl-2/IgH translocation was determined on bone marrow cells in a centralized laboratory belonging to Euro-MRD consortium, using qualitative and quantitative PCR. Results: a total of 234 patients began chemoimmunotherapy: after induction and consolidation treatment overall response rate was 86%, with 69% CR. Of these, 210 completed the planned treatment and 202 responders were randomized. Up to date, median follow-up were 96 months from enrollment and 87 months from randomization; additional follow-up data were available for 127/146 (87%) not relapsed/progressed patients. Five- and 7-year PFS for the whole population were 57% and 51%, respectively; 5- and 7-year OS for the whole population were 85% and 80%, respectively. From enrollment, an advantage in term of PFS and also OS was observed in FLIPI low risk patients: 7-year PFS was 67% for low risk versus 38% for intermediate-high risk patients (p<0.001) and 7-year OS was 86% versus 75%, respectively (p=0.03). After randomization, no differences between the two arms were detected for both PFS and for OS at 5 (data not showed) and 7 years: 7-year PFS was 55% for rituximab maintenance arm versus 52% for observation arm (p=0.331; HR 0.8); 7-year OS was 83% for both arms (p=0.208; HR 0.67). Moreover, after randomization no differences between the two arms were detected for both FLIPI low risk and intermediate-high risk patients: 7-year PFS was 67% for Rituximab maintenance arm versus 68% for observation arm (p=0.808) in low risk patients; in intermediate-high risk patients 7-year PFS was 46% vs 35% (p=0.301), respectively in Arm A vs B. Conversion to PCR negativity at the end of treatment maintains predictive value for better PFS: 7-year PFS were 58% and 36% (p=0.084), respectively for MRD negative vs positive patients. The same risk of late toxicity (infections or cardiac events) or secondary cancers was observed in both arms: in particular, 13 secondary neoplasms in maintenance arm vs 16 in observation arm were recorded. Conclusions: the present long-term results of this trial with a prolonged follow-up of 7 years confirm that a good outcome is achievable in elderly FL patients with a short-term chemoimmunotherapy (R-FND + Rituximab consolidation) with a 7-year PFS of 51% and low toxicity. In addition these results did not show clear evidence in favor of a shortened Rituximab maintenance after R-fludarabine containing chemotherapy. Conversely, the achievement of PCR negativity maintains predictive value for a better outcome. Figure 1. Figure 1. Disclosures Off Label Use: Rituximab maintenance was not licensed in first-line treatment for follicular lymphoma at that time in Italy; Rituximab was provided free by Roche.

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