Feasibility and Efficacy of BEAM as a Frontline High Dose Chemotherapy Supported by Autologous PBSCT in Elderly Patients (≥60 Years) with DLBCL

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 4449-4449
Author(s):  
Vadim Ivanov ◽  
Diane Coso ◽  
Jerome Rey ◽  
Therese Aurran ◽  
Anne-Marie Stoppa ◽  
...  
Keyword(s):  
High Risk ◽  
Elderly Patients ◽  
Older Patients ◽  
Disease Stage ◽  
High Dose ◽  
Line Treatment ◽  
First Line ◽  
High Risk Patients ◽  
Risk Patients ◽  
Autologous Pbsct

Abstract Limited data is available concerning feasibility and efficacy of high dose therapy (HDT) supported by autologous PBSCT in elderly patients with non-Hodgkin lymphoma (NHL). In young patients with poor prognostic features intensification supported by PBSCT as a part of first-line treatment suggests survival benefit. It is not clear if the same strategy is applicable to the older patients. The Institute Paoli-Calmettes database was reviewed for all DLBCL patients who received BEAM followed by PBSCT in patients >=60 years old between January 1998 and December 2006 (9 years). All patients were HIV-negative and received BEAM intensification as a part of front-line treatment. All of them were in a complete or partial response after CHOP or R-CHOP induction prior to autograft. Twenty seven auto-transplanted patients were identified (median age 63 y, range 60–68). This cohort was compared with closely matched group of 37 patients of same age range, who received first-line CHOP or R-CHOP regimen without intensification in the same 9-years interval. Only patients in a complete response after first line were included. As frontline autoPBSCT was performed in high-risk patients, the group without HDT was naturally privileged in the terms of Ann-Arbor stage and aaIPI index. There was significant difference in the localised vs disseminated disease (stage I–II: 54% in no-HDT vs 26% in HDT group, p=0.03)) and aaIPI (0–1: 66% in no-HDT vs 37% in HDT, p=0.046) between the two groups. Factors evaluated included treatment-related mortality (TRM), overall survival (OS) and event-free survival (EFS). TRM in the HDT group (1/27 pts (3,7%)) was comparable with previously published data. The estimated 5-year OS was 75,5% (95%CI 52–90 %) for HDT group compared to 79,9% (95%CI 58–92%) in the no-HDT group (p=0,75). There were 8 events (1 TRM and 7 relapses) in the HDT group and 11events (all relapses) in no-HDT (5-year EFS 49,4% vs 64,2%, p=0.45). We conclude that frontline autologous PBSCT with BEAM conditioning can be safely performed in patients aged 60 years or above with DLBCL after CHOP of R-CHOP induction. There was no difference in OS and EFS between cohorts with and without intensification even if the auto-transplantation procedure was reserved for the high risk patients. We conclude that first-line HDT with autologous PBSCT in older patients with high-risk IPI score might improve survival in this group and produce results similar to those in the low-risk group.

Frontline High Dose Chemotherapy Supported by Autologous PBSCT Might Improve Survival In Elderly Patients (≥60 Years) with High Risk Diffuse Large B-Cell Lymphoma (DLBCL)

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 5190-5190
Author(s):  
Vadim Ivanov ◽  
Diane Coso ◽  
Jerome Rey ◽  
Therese Aurran-Schleinitz ◽  
Anne-Marie Stoppa ◽  
...  
Keyword(s):  
High Risk ◽  
Older Patients ◽  
Complete Response ◽  
Secondary Malignancy ◽  
High Dose ◽  
Line Treatment ◽  
Front Line ◽  
First Line ◽  
Risk Patients ◽  
Autologous Pbsct

Abstract Abstract 5190 Limited data is available concerning feasibility and efficacy of high dose therapy (HDT) supported by autologous PBSCT in elderly patients with non-Hodgkin lymphoma (NHL). In young patients with poor prognostic features intensification supported by PBSCT as a part of first-line treatment suggests survival benefit. It is not clear if the same strategy is applicable to the older patients. The Institute Paoli-Calmettes database was reviewed for all DLBCL patients who received BEAM followed by PBSCT in patients >=60 years old between January 1998 and January 2010 (13 years). All patients were HIV-negative and received BEAM intensification as a part of front-line treatment. All of them were in a complete response after CHOP or R-CHOP induction prior to autograft. Thirty six auto-transplanted patients were identified (median age 63 y, range 60–68). This cohort was compared with closely matched group of 43 patients of same age range, who received first-line CHOP or R-CHOP regimen without intensification in the same 13-year interval. Only patients in a complete response after first line were included. As frontline autoPBSCT was performed in high-risk patients, the group without HDT was naturally privileged in the terms of Ann-Arbor stage and aaIPI index. There was significant difference in the localised vs disseminated disease (stage I-II: 53,4% in no-HDT vs 14% in HDT group, p=0,00025) and aaIPI (0-1: 72% in no-HDT vs 28% in HDT, p=0,000086) between the two groups. Factors evaluated included treatment-related mortality (TRM), overall survival (OS) and event-free survival (EFS). There were no transplant-related deaths in the HDT group. The estimated 5-year OS was 81,3% (95% CI 62,5-91,9 %) and 10-year OS was 65% (95%CI 34,2-86,9%) for HDT group compared to 91,5% (95% CI 77,5-97,1%) and 58,4% (95% CI 20–88,8%) in the no-HDT group (p=NS). There were 8 events (6 relapses and 2 secondary malignancy deaths) in the HDT group and 11 events (9 relapses and 2 secondary malignancy deaths) in no-HDT (5-year EFS 77,6% (95% CI 60,3-88,8%) vs 78,3% (95%CI 62,3-88,8%), p=NS)). We conclude that front-line autologous PBSCT with BEAM conditioning can be safely performed in patients aged 60 years or above with DLBCL after CHOP of R-CHOP induction. There was no difference in OS and EFS between cohorts with and without intensification even if the auto-transplantation procedure was reserved for the high risk patients only. The first-line HDT with autologous PBSCT in older patients with high-risk IPI score might improve survival in this group and produce results similar to those in the low-risk group. Disclosures: No relevant conflicts of interest to declare.

Relapsed Hodgkin Lymphoma in Older Patients: A Comprehensive Analysis From the German Hodgkin Study Group

2013 ◽  
Vol 31 (35) ◽  
pp. 4431-4437 ◽  
Author(s):  
Boris Böll ◽  
Helen Goergen ◽  
Nils Arndt ◽  
Julia Meissner ◽  
Stefan W. Krause ◽  
...  
Keyword(s):  
High Risk ◽  
Older Patients ◽  
Prognostic Score ◽  
Treatment Strategies ◽  
Study Group ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Early Relapse ◽  
Risk Patients

Purpose Progression or relapse of Hodgkin lymphoma (HL) is common among older patients. However, prognosis and effects of second-line treatment are thus far unknown. Patients and Methods We investigated second-line treatment and survival in older patients with progressive or relapsed HL. Patients treated within German Hodgkin Study Group first-line studies between 1993 and 2007 were screened for refractory disease or relapse (RR-HL). Patients with RR-HL age ≥ 60 years at first-line treatment were included in this analysis. Results We identified 105 patients (median age, 66 years); 28%, 31%, and 41% had progressive disease, early relapse, or late relapse, respectively. Second-line treatment strategies included intensified salvage regimens (22%), conventional polychemotherapy and/or salvage-radiotherapy with curative intent (42%), and palliative approaches (31%). Median overall survival (OS) for the entire cohort was 12 months; OS at 3 years was 31% (95% CI, 22% to 40%). A prognostic score with risk factors (RFs) of early relapse, clinical stage III/IV, and anemia identified patients with favorable and unfavorable prognosis (≤ one RF: 3-year OS, 59%; 95% CI, 44% to 74%; ≥ two RFs: 3-year OS, 9%; 95% CI, 1% to 18%). In low-risk patients, the impact of therapy on survival was significant in favor of the conventional polychemotherapy/salvage radiotherapy approach. In high-risk patients, OS was low overall and did not differ significantly among treatment strategies. Conclusion OS in older patients with RR-HL can be predicted using a simple prognostic score. Poor outcome in high-risk patients cannot be overcome by any of the applied treatment strategies. Our results might help to guide treatment decisions and evaluate new compounds in these patients.

Newly Diagnosed Myeloma Pateints Are at Risk of Venous Thrombotic Events - High Risk Patients Need To Be Identified and Recieve Thromboprophylaxis: The MRC Experience.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 2395-2395
Author(s):  
Faith E. Davies ◽  
J. Anthony Child ◽  
Kim Hawkins ◽  
Susan Bell ◽  
Julia Brown ◽  
...  
Keyword(s):  
High Risk ◽  
Older Patients ◽  
Autologous Transplantation ◽  
High Dose ◽  
Central Venous ◽  
Thrombotic Risk ◽  
Younger Patients ◽  
High Risk Patients ◽  
Increased Risk ◽  
Risk Patients

Abstract Standard treatment for younger patients with presenting myeloma is VAD followed by high-dose melphalan with stem cell support. However this regimen requires a central venous catheter with risks of recurrent line infections and central venous thrombus. A number of oral alternatives have been used including dexamethasone (Dex), thalidomide (Thal) or combinations (Thal/Dex), although to date no randomized control trial has compared an intravenous with oral induction therapy. In older patients melphalan/prednisolone (MP) remains the standard approach. Thal combinations (MPT, CTD, DVdT) improve response rates and providing side effects can be managed effectively may also be appropriate for an elderly population. Patients with myeloma have an increased risk of venous thrombotic events (VTEs), and presenting patients receiving Thal may be at increased risk due to bulk disease. Combination with anthracyclines may also exacerbate this risk. The MRC Myeloma IX trial has been designed to address some of these issues. Younger patients are randomized to receive intravenous CVAD or an oral Thal containing regimen, CTD prior to autologous transplantation; older patients are randomized to MP or the Thal containing regimen, CTDa. At trial initiation (May 2003) physicians were advised that patients should start low-dose Thal (100mg od in the intensive and 50mg od in the non-intensive arm) and slowly dose escalate to 200mg. Patients at high risk of VTE should be considered for full anticoagulation with either warfarin or LMWH. As of Aug 2004 420 patients (239 intensive, 181 non-intensive) have been randomized and a total of 30 VTEs in 28 patients have been reported (22 intensive, 6 non-intensive). In the intensive arm there were 8 DVT, 9 PE and 7 line-related thromboses. In the non-intensive arm there were 4 DVT and 2 PE. CVAD CTD CTDa MP DVT 4.2% 2.5% 4.4% 0% PE 1.7% 5.8% 2.2% 0% Line related 5.0% 0.8% NA NA Total 10.9% 9.1% 6.6% 0% The median time from randomization to DVT/PE was 54.5 days (range 15–113). 4 patients were identified who had additional risk factors (2 immobility, 1 recent operation, 1 renal failure). Only 1 patient was receiving prophylaxis having previously suffered a DVT. There was one PE-related death. Importantly 2 PE and 5 DVT occurred in patients not receiving Thal therapy. All central thrombosis occurred in relation to the central line. In the non-intensive arm the addition of Thal increased VTE risk compared to MP. In conclusion myeloma patients have an increased incidence of VTE (5.9%–8.3%) although in this study so far patients on MP appear to have no excess thrombotic risk. Patients receiving infusional regimes are also at increased risk of line-related events (additional 5.0%). Using the combination of a slowly increasing Thal dose and thromboprophylaxis based on identification of high risk patients the addition of Thal marginally increased DVT/PE risk over and above the risk seen in patients with infusional regimens, but even in a large study such as this the number of events are too small to make firm recommendations. Currently our advice remains unchanged and ALL high risk patients should receive thromboprophylaxis.

NOTCH1, SF3B1 and BIRC3 Mutations in Chronic Lymphocytic Leukemia (CLL) Patients Requiring First-LINE Treatment: Correlation with Biological Parameters and Response to Treatment

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 1784-1784 ◽  
Author(s):  
Sabina Chiaretti ◽  
Marilisa Marinelli ◽  
Ilaria Del Giudice ◽  
Silvia Bonina ◽  
Sara Gabrielli ◽  
...  
Keyword(s):  
High Risk ◽  
Elderly Patients ◽  
Clinical Impact ◽  
Biological Parameters ◽  
Line Treatment ◽  
First Line ◽  
Cytogenetic Abnormalities ◽  
Risk Patients ◽  
Notch1 Mutations ◽  
First Line Treatment

Abstract Abstract 1784 Introduction: The introduction of whole exome sequencing has allowed to unravel novel molecular lesions in CLL. NOTCH1, SF3B1 and BIRC3 mutations are detected, according to the phases of disease, in 4–12%, 5–17% and 4–24% of patients, respectively. In retrospective studies, their presence has been shown to correlate with overall survival (OS) and treatment-free interval shortening. Aims: To define the incidence, correlation with known prognostic factors and clinical impact of NOTCH1, SF3B1 and BIRC3 mutations in CLL patients undergoing first-line treatment. Methods: We evaluated 162 CLL patients enrolled in the GIMEMA LLC0405 protocol (n=80) for patients aged <60 yrs and in the ML21445 protocol (n=82) for elderly patients (aged >65 yrs or 60–65 if not eligible for fludarabine-based programs). In the GIMEMA LLC0405 protocol, patients were stratified into low and high-risk: patients with del17p or with del11q plus an unmutated IGHV status and/or CD38 positivity and/or ZAP70 positivity were considered as high-risk (HR) and underwent Fludarabine plus Campath, followed by stem cell transplantation procedures, whereas low-risk patients received Fludarabine and Cyclophosphamide. The MLL21445 protocol consisted of 8 cycles of Chlorambucil and 6 of Rituximab induction treatment. NOTCH1 (exon 34), SF3B1 (exons 14 and 15) and BIRC3 (exons 2–9, including splicing sites) were screened by Sanger sequencing on either genomic DNA (gDNA) or whole genome amplified DNA (WGA) collected at the time of treatment. These studies were not part of the clinical protocols. Results: NOTCH1 mutations were detected at the time of treatment in 18 cases (22%) enrolled in the LLC0405 study. There was a significant association with high-risk stratification (p=0.036), namely with an IGHV unmutated status (p=0.0035), CD38 (p=0.03), +12 (p=0.034) and, partly, ZAP-70 expression (p=0.059). While the overall response rate (ORR) did not differ between NOTCH1 mutated vs wild-type (WT) cases (82% vs 77%, respectively), the complete response (CR) rate was significantly lower in NOTCH1 mutated patients (43% for WT vs 17% for NOTCH1 mutated cases; p=0.05). So far, no significant difference between mutated and WT patients has emerged in terms of OS and progression-free survival (PFS); this may be contributed by the fact that most NOTCH1 mutated cases were HR and were therefore treated more aggressively. SF3B1 mutations were recorded in 9 cases (11%); no significant associations were found with known biological parameters and, so far, with the ORR and CR rate. A single case harbored a BIRC3 mutation; this patient had an IGHV unmutated status, no FISH abnormalities and a concomitant SF3B1 mutation. In the ML21445 cohort, NOTCH1 mutations were found in 12 cases (15%), were associated with an unmutated IGHV status (p=0.047) and ZAP-70 expression (p=0.007), and did not impact on the ORR and CR rate. SF3B1 mutations were found in 11 cases (13%); no significant associations were found with known biological parameters and the ORR rate. Of interest, only 1/11 SF3B1 mutated patients achieved a CR. BIRC3 mutations were recorded in 3 patients (3.6%); of these, 2 were IGHV mutated, 1 had no cytogenetic abnormalities and 1 carried a del11q, while the third patient was IGHV unmutated status and had no cytogenetic abnormalities. No NOTCH1 and/or SF3B1 mutations were detected. Overall, NOTCH1, SF3B1 and BIRC3 mutations were largely mutually exclusive among each other and with TP53 lesions in the whole cohort. Conclusions: This study confirms the association of NOTCH1 mutations with unfavorable biologic markers and +12, while the presence of SF3B1 mutations was not coupled to poor prognostic markers in CLL patients requiring first-line treatment. Furthermore, it suggests that NOTCH1 mutations impact on the CR rate of young patients receiving Fluda-based regimens, while SF3B1 appears to impact on the CR rate of elderly patients treated with Chlorambucil and Rituximab. Given the small numbers of patients harboring BIRC3, it is at present difficult to draw any conclusion on the clinical impact of this mutation in the cohort of patients hereby analyzed. Disclosures: No relevant conflicts of interest to declare.

Percutaneous cholecystotomy as first line treatment for high-risk patients with biliary sepsis: our experience so far

2013 ◽  
Vol 68 ◽  
pp. S16
Author(s):  
Philip Borg ◽  
John M. Trotter ◽  
Heather Harris ◽  
Nick Everett ◽  
Krish Ravi ◽  
...  
Keyword(s):  
High Risk ◽  
Line Treatment ◽  
First Line ◽  
High Risk Patients ◽  
Biliary Sepsis ◽  
Risk Patients ◽  
First Line Treatment

scholarly journals Implementation of the acutely presenting older patient (APOP) screening program in routine emergency department care

2021 ◽  
Author(s):  
Laura C. Blomaard ◽  
Bas de Groot ◽  
Jacinta A. Lucke ◽  
Jelle de Gelder ◽  
Anja M. Booijen ◽  
...  
Keyword(s):  
Emergency Department ◽  
High Risk ◽  
Older Patients ◽  
Screening Program ◽  
Admission Rate ◽  
Older Patient ◽  
Hospital Admission Rate ◽  
High Risk Patients ◽  
Risk Patients

Abstract Objective The aim of this study was to evaluate the effects of implementation of the acutely presenting older patient (APOP) screening program for older patients in routine emergency department (ED) care shortly after implementation. Methods We conducted an implementation study with before-after design, using the plan-do-study-act (PDSA) model for quality improvement, in the ED of a Dutch academic hospital. All consecutive patients ≥ 70 years during 2 months before and after implementation were included. The APOP program comprises screening for risk of functional decline, mortality and cognitive impairment, targeted interventions for high-risk patients and education of professionals. Outcome measures were compliance with interventions and impact on ED process, length of stay (LOS) and hospital admission rate. Results Two comparable groups of patients (median age 77 years) were included before (n = 920) and after (n = 953) implementation. After implementation 560 (59%) patients were screened of which 190 (34%) were high-risk patients. Some of the program interventions for high-risk patients in the ED were adhered to, some were not. More hospitalized patients received comprehensive geriatric assessment (CGA) after implementation (21% before vs. 31% after; p = 0.002). In 89% of high-risk patients who were discharged to home, telephone follow-up was initiated. Implementation did not influence median ED LOS (202 min before vs. 196 min after; p = 0.152) or hospital admission rate (40% before vs. 39% after; p = 0.410). Conclusion Implementation of the APOP screening program in routine ED care did not negatively impact the ED process and resulted in an increase of CGA and telephone follow-up in older patients. Future studies should investigate whether sustainable changes in management and patient outcomes occur after more PDSA cycles.

scholarly journals Prevention of Hypotension following Spinal Anaesthesia in Caesarean Section - then and now

2012 ◽  
Vol 8 (4) ◽  
pp. 415-419
Author(s):  
J K Mitra
Keyword(s):  
Risk Factors ◽  
Clinical Practice ◽  
High Risk ◽  
Caesarean Section ◽  
Spinal Anaesthesia ◽  
Limited Data ◽  
First Line ◽  
High Risk Patients ◽  
Risk Patients ◽  
Poor Efficacy

Hypotension during spinal anaesthesia for caesarean section remains a common scenario in our clinical practice. Certain risk factors play a role in altering the incidence of hypotension. Aortocaval compression counteraction does not help to prevent hypotension. Intravenous crystalloid prehydration has poor efficacy; thus, the focus has changed toward co-hydration and use of colloids. Phenylephrine is established as a first- line vasopressor, although there are limited data from high-risk patients. Ephedrine crosses the placenta more than phenylephrine and cause possible alterations in the foetal physiology.http://dx.doi.org/10.3126/kumj.v8i4.6242 Kathmandu Univ Med J 2010;8(4):415-19   

Is high-dose nafamostat mesilate effective for the prevention of post-ERCP pancreatitis, especially in high-risk patients?

Pancreatology ◽  
2013 ◽  
Vol 13 (2) ◽  
pp. e42
Author(s):  
D.H. Kang ◽  
C.W. Choi ◽  
S.B. Park ◽  
H.W. Kim ◽  
J.H. Park ◽  
...  
Keyword(s):  
High Risk ◽  
High Dose ◽  
Nafamostat Mesilate ◽  
High Risk Patients ◽  
Risk Patients

scholarly journals Preventing the rebound: improving care transition in hospital discharge processes

2010 ◽  
Vol 34 (4) ◽  
pp. 445 ◽  
Author(s):  
Ian A. Scott
Keyword(s):  
Heart Failure ◽  
High Risk ◽  
Older Patients ◽  
Single Component ◽  
Self Management ◽  
Controlled Trials ◽  
High Risk Patients ◽  
Patients With Heart Failure ◽  
Risk Patients ◽  
Multicomponent Interventions

Background.Unplanned readmissions of recently discharged patients impose a significant burden on hospitals with limited bed capacity. Deficiencies in discharge processes contribute to such readmissions, which have prompted experimentation with multiple types of peridischarge interventions. Objective.To determine the relative efficacy of peridischarge interventions categorised into two groups: (1) single component interventions (sole or predominant) implemented either before or after discharge; and (2) integrated multicomponent interventions which have pre- and postdischarge elements. Design.Systematic metareview of controlled trials. Data collection.Search of four electronic databases for controlled trials or systematic reviews of trials published between January 1990 and April 2009 that reported effects on readmissions. Data synthesis.Among single-component interventions, only four (intense self-management and transition coaching of high-risk patients and nurse home visits and telephone support of patients with heart failure) were effective in reducing readmissions. Multicomponent interventions that featured early assessment of discharge needs, enhanced patient (and caregiver) education and counselling, and early postdischarge follow-up of high-risk patients were associated with evidence of benefit, especially in populations of older patients and those with heart failure. Conclusion.Peridischarge interventions are highly heterogenous and reported outcomes show considerable variation. However, multicomponent interventions targeted at high-risk populations that include pre- and postdischarge elements seem to be more effective in reducing readmissions than most single-component interventions, which do not span the hospital–community interface. What is known about this topic?Unplanned readmissions within 30 days of hospital discharge are common and may reflect deficiencies in discharge processes. Various peridischarge interventions have been evaluated, mostly single-component interventions that occur either before or after discharge, but failing to yield consistent evidence of benefit in reducing readmissions. More recent trials have assessed multicomponent interventions which involve pre- and postdischarge periods, but no formal review of such studies has been undertaken. What does this paper add?With the exception of intense self-management and transition coaching of high-risk patients, and nurse home visits and telephonic support for patients with heart failure, single-component interventions were ineffective in reducing readmissions. Multicomponent interventions demonstrated evidence of benefit in reducing readmissions by as much as 28%, with best results achieved in populations of older patients and those with heart failure. What are the implications for practitioners and managers?Hospital clinicians and managers should critically review and, where appropriate, modify their current discharge processes in accordance with these findings and negotiate the extra funding and personnel required to allow successful implementation of multicomponent discharge processes that transcend organisational boundaries.

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