Empirical Vs. Prophylactic Antifungal Strategies: Comparison of Effectiveness In High Risk AML Patients at a Tertiary Cancer Center

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 1729-1729
Author(s):  
Dennis Gutmann ◽  
Jan Felix Kersten ◽  
Philippe Schafhausen ◽  
Tim H. Brummendorf ◽  
Martin Trepel ◽  
...  
Keyword(s):  
High Risk ◽  
Fungal Infections ◽  
Empirical Therapy ◽  
Primary Prophylaxis ◽  
Cancer Center ◽  
Group 3 ◽  
Group 2 ◽  
Tract Infections ◽  
Tertiary Cancer Center ◽  
Group 1

Abstract Abstract 1729 Objectives: Invasive fungal infections (IFI) remain a major threat for patients with acute myelogenious leukemia (AML). Since the publication of two landmark studies, which demonstrated a reduction in morbidity and mortality from IFI in high risk patients through prophylaxis with posaconazole, guidelines have recommend routine prophylaxis with posaconazole during induction chemotherapy. However, prompt empirical or pre-emptive therapy strategies are still commonly used alternatives. Real life data about posaconazole prophylaxis are scarce and potential overtreatment, increasing costs and development of resistant fungi are of concern. We therefore compared effectiveness of empirical and prophylactic antifungal strategies at a tertiary cancer center during a phase of intensive building (re-) construction Methods: 104 patients (pts.) with AML treated between January 2005 and February 2009 were retrospectively evaluated. Each induction chemotherapy or consolidation therapy with neutropenia >=10 days was counted as an episode (n=222). Patients were stratified according to their antifungal approach: primary prophylaxis (n=35, 51 episodes; group 1), empirical therapy (n=63, 111 indices; group 2), secondary prophylaxis (n=41, 60 episodes; group 3, which comprised of patients from groups 1 and 2). Group 1 received posaconazole 3 × 200 mg p.o.; group 2 received topical polyene prophylaxis and empirical treatment with voriconazole or fluconazole. Patients in group 3 received either voriconazole, posaconazole, fluconazole or intraconazole. Results: Demographics, AML subtypes, co-morbidities and neutropenic days (median = 13) were comparable in all three groups; no patient received G-CSF support. Logistic regression analysis revealed days of neutropenia, performance status, use of antibiotics and secondary AML as risk factors for development of IFI, while primary prophylaxis reduced the risk for possible/probable/proven IFI by 86,7% compared to empirical therapy (p=0.001). Incidences of probable/proven IFI were 3% in group 1, 29% in group 2 and 7% in group 3 (p=0.001) and 17%, 69% and 37% (p<0.001) when possible IFIs were included. Mortality during observation period was similar (4%, 6,4%, 7%, NS). Also similar were isolated pathogens, additional antifungals, change of antibiotics, days at intensive care unit (ICU). Bacterial infections were similiar in all groups except for pneumonia and GI-tract infections being significantly higher in pts with empirical antifungal therapy. Side effects were also slightly higher in this group (8% vs 2% and 5%, NS). Days of hospitalization, antifungal, antibiotic, and antiviral costs were comparable, while imaging costs were significantly higher in group 2 (p=0.006). Conclusion: Posaconazole prophylaxis significantly reduces incidences of IFI in high risk AML patients and leads to a reduction of costs for imaging studies, with a minimal overall reduction of costs for inpatients. Additionally, infectious complications such as pneumonia and GI-tract infections are also reduced, while mortality rates, days of hospitalization, anti-infective use or duration are not reduced. Accordingly, in areas/surroundings with high rates of fungal infections (e.g. due to intensive building (re-)construction), primary prophylaxis with posaconazole is recommended. Disclosures: Brummendorf: Pfizer: Membership on an entity's Board of Directors or advisory committees. Panse:Gilead: Honoraria; Schering-Plough: Honoraria; MSD: Travel Grant.

Abstract P711: Factors Affecting Intracranial Aneurysm Incidence and Phenotypes at Risk of Rupture in Autosomal Dominant Polycystic Kidney Disease

Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Chan-Hyuk Lee ◽  
Hyunjin Ryu ◽  
Curie Ahn ◽  
Hyun-Seung Kang ◽  
Seul-Ki Jeong ◽  
...  
Keyword(s):  
High Risk ◽  
Intracranial Aneurysm ◽  
Autosomal Dominant ◽  
Polycystic Kidney ◽  
Mitral Inflow ◽  
Group 3 ◽  
Autosomal Dominant Polycystic Kidney ◽  
Group 2 ◽  
Group 1 ◽  
Deceleration Time

Background: Autosomal dominant polycystic kidney disease (ADPKD) is an autosomal dominant genetic disorder in which cysts of various sizes invade the renal parenchyma. Intracranial aneurysms occur in 8-12% of ADPKD patients, which is approximately 3-4 times the rate of the healthy population. However, research on factors related to aneurysm incidence and rupture in patients with ADPKD is insufficient. Objective: We analyzed the factors associated with risk of aneurysm incidence and phenotype in ADPKD patients. Methods: From the ADPKD registry in the tertiary hospital, we screened patients with cerebral angiography enrolled between January 2007 and May 2017. Then, 926 enrolled patients were classified into three groups according to the intracranial aneurysm incidence and phenotype (multiplicity, size, location): no intracranial aneurysm (Group 1); low-risk intracranial aneurysm (Group 2); high-risk intracranial aneurysm (Group 3). We analyzed the difference of patients’ demographic factors, cardiovascular risk factors, laboratory data, echocardiographic data, and imaging data between groups. Results: The prevalence [C1] of intracranial aneurysm in ADPKD patients was 16.0%. Aneury[C2] sm-positive group (Group 2 and 3, n=148) was significantly older (p<0.001) and had a greater proportion of females (p<0.001) than patients in the aneurysm-negative group (Group 1, n=778). Compared to Group 1, Group 3 was significantly associated with age (odds ratio (OR) 1.027, p=0.007), female sex (OR 3.184, p<0.001), dyslipidemia (OR 0.460, P=0.001), basilar artery dolichoectasia (OR 8.443, p=0.016), and mitral inflow deceleration time (OR 1.005, p=0.039). Conclusion: Factors associated with a high-risk aneurysms were age, sex, dolichoectasia, dyslipidemia, and mitral inflow deceleration time in ADPKD patients. Identification of these factors would help detect high risk aneurysms and manage the aneurysms in ADPKD patients.

scholarly journals Appropriate secondary prevention and clinical outcomes after acute myocardial infarction according to atherothrombotic risk stratification: The FAST-MI 2010 registry

2018 ◽  
Vol 26 (4) ◽  
pp. 411-419 ◽  
Author(s):  
Victoria Tea ◽  
Marc Bonaca ◽  
Chekrallah Chamandi ◽  
Marie-Christine Iliou ◽  
Thibaut Lhermusier ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
High Risk ◽  
Secondary Prevention ◽  
High Risk Patients ◽  
Risk Patients ◽  
St Elevation ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Background Full secondary prevention medication regimen is often under-prescribed after acute myocardial infarction. Design The purpose of this study was to analyse the relationship between prescription of appropriate secondary prevention treatment at discharge and long-term clinical outcomes according to risk level defined by the Thrombolysis In Myocardial Infarction (TIMI) Risk Score for Secondary Prevention (TRS-2P) after acute myocardial infarction. Methods We used data from the 2010 French Registry of Acute ST-Elevation or non-ST-elevation Myocardial Infarction (FAST-MI) registry, including 4169 consecutive acute myocardial infarction patients admitted to cardiac intensive care units in France. Level of risk was stratified in three groups using the TRS-2P score: group 1 (low-risk; TRS-2P=0/1); group 2 (intermediate-risk; TRS-2P=2); and group 3 (high-risk; TRS-2P≥3). Appropriate secondary prevention treatment was defined according to the latest guidelines (dual antiplatelet therapy and moderate/high dose statins for all; new-P2Y12 inhibitors, angiotensin-converting-enzyme inhibitor/angiotensin-receptor-blockers and beta-blockers as indicated). Results Prevalence of groups 1, 2 and 3 was 46%, 25% and 29% respectively. Appropriate secondary prevention treatment at discharge was used in 39.5%, 37% and 28% of each group, respectively. After multivariate adjustment, evidence-based treatments at discharge were associated with lower rates of major adverse cardiovascular events (death, re-myocardial infarction or stroke) at five years especially in high-risk patients: hazard ratio = 0.82 (95% confidence interval: 0.59–1.12, p = 0.21) in group 1, 0.74 (0.54–1.01; p = 0.06) in group 2, and 0.64 (0.52–0.79, p < 0.001) in group 3. Conclusions Use of appropriate secondary prevention treatment at discharge was inversely correlated with patient risk. The increased hazard related to lack of prescription of recommended medications was much larger in high-risk patients. Specific efforts should be directed at better prescription of recommended treatment, particularly in high-risk patients.

Survival of Patients with High-Risk Pulmonary Arterial Hypertension Associated with Congenital Heart Disease

2021 ◽  
Vol 104 (6) ◽  
pp. 895-901
Keyword(s):  
Congenital Heart Disease ◽  
Heart Disease ◽  
High Risk ◽  
Congenital Heart ◽  
First Year ◽  
Pulmonary Arterial ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Background: Pulmonary arterial hypertension (PAH) is a common complication of congenital heart disease (CHD) with uncorrected left-to-right shunts. Currently, no consensus guideline exists on the management of PAH-CHD in children, especially those who do not meet operability criteria. Objective: To compare survival between three groups of high-risk PAH-CHD, group 1: total correction including both surgical and percutaneous intervention, group 2: palliative treatment, and group 3: conservative with medical treatment group. Materials and Methods: All pediatric patients with PAH-CHD that underwent cardiac catheterization between January 1, 2008 and December 31, 2017 were retrospectively reviewed. Inclusion criteria were high risk PAH-CHD patients who had pulmonary vascular resistance (PVR) greater than 6 Wood unit·m² and PVR-to-SVR ratio greater than 0.3 evaluated in room air. Exclusion criteria were younger than three months of age, severe left side heart disease with pulmonary capillary wedge pressure greater than 15 mmHg, obstructive total pulmonary venous return, and single ventricle physiology. The Kaplan-Meier analysis was performed from the date of PAH diagnosis to the date of all-cause mortality or to censored date at last follow-up. Results: Seventy-six patients with a median age at diagnosis of 27.5 months (IQR 14.5 to 69.0 months) were included in this study. The patients were divided into three subgroups and included 38 patients (50.0%) in group 1, six patients (7.9%) in group 2, and 32 patients (42.1%) in group 3. The median follow-up time was 554 days (IQR 103 to 2,133 days). The overall mortality was 21.7%. One-year survival in patients with simple lesion in group 1 and 3 were 79.5% and 87.5% and patients with complex lesions in group 1, 2, and 3 were 93.8%, 83.3%, and 73.1%, respectively. The results showed that most mortalities occurred in the first year. There were no statistically significant differences in survival among difference types of treatment (log rank test, p=0.522). Conclusion: The mortality of high-risk PAH-CHD patients were not different among those who underwent corrective surgery, palliative, or conservative treatment. The mortality was high in the first year after PAH diagnosis and remain stable afterward. Management decision for an individual with high-risk PAH-CHD patients requires comprehensive clinical assessment to balance the risks and benefits before making individualized clinical judgment. Keywords: Pulmonary hypertension; Congenital heart disease; High-risk patients

scholarly journals Prevention of Delayed Nausea: A University of Rochester Cancer Center Community Clinical Oncology Program Study of Patients Receiving Chemotherapy

2012 ◽  
Vol 30 (27) ◽  
pp. 3389-3395 ◽  
Author(s):  
Joseph A. Roscoe ◽  
Charles E. Heckler ◽  
Gary R. Morrow ◽  
Supriya G. Mohile ◽  
Shaker R. Dakhil ◽  
...  
Keyword(s):  
Statistical Significance ◽  
Cancer Center ◽  
Double Blind ◽  
Group 4 ◽  
Community Clinical Oncology Program ◽  
Delayed Nausea ◽  
Group 3 ◽  
Group 2 ◽  
Mean Differences ◽  
Group 1

Purpose We conducted a double-blind randomized clinical trial of the following four regimens for controlling delayed nausea (DN): group 1: palonosetron + dexamethasone on day 1 with prochlorperazine on days 2 and 3; group 2: granisetron + dexamethasone on day 1 with prochlorperazine on days 2 and 3; group 3: aprepitant + palonosetron + dexamethasone on day 1 with aprepitant + dexamethasone on days 2 and 3; and group 4: palonosetron + dexamethasone on day 1 with prochlorperazine + dexamethasone on days 2 and 3. Patients and Methods Chemotherapy-naive patients received doxorubicin, epirubicin, cisplatin, carboplatin, or oxaliplatin. The primary end point was average nausea assessed four times daily on days 2 and 3. Primary analyses were whether nausea control would be improved by using palonosetron versus granisetron on day 1 (group 1 v group 2); by adding dexamethasone on days 2 and 3 (group 1 v group 4); and by using aprepitant versus prochlorperazine (group 3 v group 4). Statistical significance was set at P = .017. Results Two hundred thirty-four, 234, 241, and 235 evaluable patients were accrued to groups 1, 2, 3, and 4, respectively. Adjusted mean differences for the three planned analyses were as follows: palonosetron versus granisetron: −0.01 (95% CI, −0.23 to 0.20; P = .72); adding dexamethasone on days 2 and 3: 0.20 (95% CI, −0.02 to 0.41; P = .01); and using aprepitant versus prochlorperazine: −0.03 (95% CI, −0.24 to 0.19; P = .56). Conclusion The addition of dexamethasone on days 2 and 3 reduced DN. Palonosetron and granisetron have similar effects on DN. The beneficial effect of adding aprepitant for control of DN was the same as adding prochlorperazine.

Clinical Outcomes According to Genomic Abnormalities in 566 Newly Diagnosed Multiple Myeloma Patients Treated with Bortezomib-Based Regimens.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 1868-1868 ◽  
Author(s):  
Michele Cavo ◽  
Sara Bringhen ◽  
Nicoletta Testoni ◽  
Paola Omedè ◽  
Giulia Marzocchi ◽  
...  
Keyword(s):  
High Risk ◽  
First Line ◽  
Cytogenetic Abnormalities ◽  
Post Hoc Analysis ◽  
Significant Difference ◽  
Genomic Aberrations ◽  
Group 3 ◽  
Group 2 ◽  
Post Hoc ◽  
Group 1

Abstract Abstract 1868 Poster Board I-893 Introduction Bortezomib was initially reported to overcome the poor prognosis related to the presence of del(13q) in patients with advanced refractory/relapsed multiple myeloma (MM). However, more recent evaluations of genomic aberrations in MM provided demonstration that only t(4;14) and del(17p) retained prognostic value for both EFS and OS, thus identifying a subgroup of patients at high risk of progression or death. The combination of bortezomib with melphalan and prednisone, actually licensed as first-line therapy for MM patients who are not eligible for autologous stem-cell transplantation (ASCT), showed comparable activities in terms of time to progression and OS among patients with or without high-risk cytogenetic profiles. However, the number of high-risk patients analyzed was very limited, due to the low frequency of these genomic abnormalities. To more carefully assess the role of bortezomib in patients with high-risk cytogenetics [(e.g. carrying t(4;14) and/or del(17p)], we performed a post-hoc analysis of two phase 3 studies of first-line bortezomib-based regimens for the treatment of a large series of MM patients. Both studies are actually conducted by the Italian Myeloma Network GIMEMA. Patients and methods The activity of three different bortezomib-based regimens in terms of achievement of best high-quality response (immunofixation negative CR) and PFS was analyzed. Regimens evaluated were bortezomib-thalidomide-dexamethasone (VTD), bortezomib-melphalan-prednisone (VMP) and bortezomib-melphalan-prednisone-thalidomide (VMPT). VTD was followed by ASCT. Treatment details are as follows: VTD (Bortezomib, 1.3 mg/m2 twice-weekly, every 21/d cycle; Thalidomide, 200 mg/d; Dexamethasone, 320 mg/cycle); VMP (Bortezomib 1.3 mg/m2 on d 1, 8, 15 and 22, every 35/d cycle; Melphalan, 9 mg/m2 on d 1 through 4, every cycle; Prednisone, 60 mg/m2 on d 1–4 of each cycle); VMPT (VMP, as previously described; Thalidomide, 50 mg/d). A total of 566 patients for whom results of interphase FISH analysis at diagnosis were available for the presence or absence of del(13q) and/or t(4;14) and/or del(17p), were included in the present study. Three cytogenetic subgroups of patients were identified, including those without genomic abnormalities (group 1; n=257), those with del(13q) alone (group 2; n=162) and those who carried t(4;14) and/or del(17p) with or without del(13q) (group 3; n=147). For the purpose of the present analysis, clinical outcomes (e.g. CR rate and PFS) of patients treated with the 3 bortezomib-based regimens were compared according to the presence or absence of different genomic aberrations (e.g. group 1 vs 3 and group 2 vs 3). Results Overall, the frequency of patients belonging to group 1 (no abnormalities), group 2 [del(13q) alone] and group 3 [t(4;14)±del(17p)] was 45%, 29% and 26%, respectively. Comparable rates of genomic aberrations were detected in patients treated with the 3 bortezomib-based regimens [no genetic abnormalities: 46% in VTD vs 48% in VMP vs 42% in VMPT; del(13q) alone: 30% in VTD vs 28% in VMP vs 28% in VMPT; t(4;14)±del(17p): 24% in VTD vs 24% in VMP vs 30% in VMPT]. No statistically significant difference in terms of CR rate was detected by comparing patients in group 3 with those in group 1 (38% vs 31.5%, respectively; P=0.1) and in group 2 (48%, P=0.07). The 2-year projected PFS was 63% for patients with high-risk cytogenetics vs 71% for those with del(13q) alone (P=0.1) vs 75% for patients without cytogenetic abnormalities (P=0.01). The finding that in the high-risk cytogenetic subgroup the VMP regimen comprising once-weekly standard-dose bortezomib effected the lowest rate of CR and PFS may explain, at least in part, the longer PFS for the subgroup without cytogenetic abnormalities. Indeed, after exclusion from the analysis of the VMP regimen, no statistically significant difference in terms of PFS was seen among VTD- and VMPT-treated patients according to the presence of high-risk cytogenetics or the absence of genomic abnormalities (P=0.09). Conclusions These results, based on a post-hoc analysis of patients with different age and treatment exposure, should be cautiously interpreted, although consistencies exist between them and previous reports on the activity of bortezomib in MM with high-risk cytogenetic abnormalities. Further analyses of large series of homogeneously treated patients are needed before firm conclusions can be drawn about the ability of bortezomib-based regimens to overcome the adverse prognosis related to t(4;14) and/or del(17p). Disclosures: Cavo: Ortho Biotech, Janssen-Cilag: Honoraria, Research Funding, Speakers Bureau; Millennium Pharmaceuticals: Honoraria; Novartis: Honoraria; Celgene: Honoraria. Boccadoro:Ortho Biotech, Janssen-Cilag: Honoraria, Speakers Bureau. Palumbo:Ortho Biotech, Janssen-Cilag: Honoraria; Celgene: Honoraria, Speakers Bureau.

Therapy Related Acute Lymphoblastic Leukemia: Pethema Experience

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 4994-4994
Author(s):  
Nicholas John Kelleher ◽  
David Gallardo ◽  
Salut Brunet ◽  
Pau Montesinos ◽  
Josep-Maria Ribera ◽  
...  
Keyword(s):  
Acute Lymphoblastic Leukemia ◽  
High Risk ◽  
De Novo ◽  
Lymphoblastic Leukemia ◽  
Cytotoxic Therapy ◽  
Survival Group ◽  
Significant Difference ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Abstract Background Therapy related acute lymphoblastic leukemia, a subset of secondary acute lymphoblastic leukemia has been estimated as accounting for between 1.2 and 6.9% of all adult acute lymphoblastic leukemia cases. It has been associated with an increased frequency of high risk cytogenetic alterations and with worse clinical outcomes. It has been suggested these patients should be included in high risk treatment protocols. Method In order to evaluate these characteristics in a group of similar patients we contacted centres working within the PETHEMA group to request data on patients diagnosed with ALL asking for clinical information including the presence or absence of previous neoplasia and of previous cytotoxic therapy along with treatment responses and survival data. Results We received information on 429 patients of whom 22 had received cytotoxic therapy for a prior neoplasm.Patients were divided into group 1 with prior cytotoxic therapy, group 2 with prior neoplasia without cytotoxic therapy and group 3 de novo ALL. We found patients in group 3 to be younger than the other two groups Group 1( 55 years) Group 2 (65 years) Group 3 (34 years) (p=0.001). No statistically significant difference was shown for white cell count, cytopenias, CNS involvement, LDH or for B versus T immunophenotype. Nor did our series show a significant difference in the frequencies of high risk cytogenetics between the groups. Figures for complete remission [Group 1- 13 (93%); Group 2- 6 (75%); Group 3-346 (85%) p=0.477] were higher in group 1 therapy related ALL compared with de novo patients without reaching clinical significance. Nor was a statistically significant difference shown for 3 year overall survival [Group 1 (80%); Group 2 (38%); Group 3 (47%) p=0.151] , 3 year event free survival [Group 1 (67%); Group 2 (38%); Group 3 (42%) p=0.24] or for complete remission duration [Group 1 (75%);Group 2 (50%); Group 3 (60%) p=0.462] Conclusion Apart from age, our series did not show an increase in poor risk clinical or cytogenetic features in therapy related ALL patients compared with de novo disease cases and nor was clinical outcome demonstrated to be worse. This would suggest that risk stratification should be carried out using currently recognized parameters without specifically taking into account the status of therapy related disease. Disclosures: No relevant conflicts of interest to declare.

The Majority of Myeloma Patients Are Hypogonadal but This Is Not Associated with High Risk Cytogenetics

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 5329-5329
Author(s):  
Beau Snoad ◽  
Samantha Hudzik ◽  
Douglas W Sborov ◽  
Nita Williams ◽  
Desiree Jones ◽  
...  
Keyword(s):  
Overall Survival ◽  
High Risk ◽  
Conflicts Of Interest ◽  
Serum Testosterone ◽  
Clinic Visit ◽  
Total Testosterone ◽  
Testosterone Levels ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Abstract Introduction: Hypogonadism, i.e. low total testosterone, is present in approximately a quarter of men older than 70 years (Harman SM et al, J. Clin Endo & Met, 2001, PMID 11158037 and Wu FCW et al, J Clin Endo & M et, 2008, PMID 18270261). Myeloma patients are known to suffer from fatigue and decreased functional performance, mood disturbances, and anemia; similar trends have been found in people with hypogonadism. Cytogenetically high risk myeloma characterized by the amplification of 1q21 is associated with increased serum levels of soluble IL-6 receptor (sIL-6r) (Stephens OW, Blood, 2012, PMID 22072558). We hypothesized that total testosterone levels will be associated with overall survival from the time of diagnosis, presence of 1q21 amplification by CD138-selected FISH, anemia, and anti-depressant use. Methods: The Buckeye Myeloma Registry (OSU 10115) opened in 2011 to enroll any patient with a plasma cell dyscrasia. Serum total testosterone was measured at the time of the initial clinic visit to the myeloma group at Ohio State. Less than 325 ng/dL was defined as the hypogonadal range, and testosterone was divided into <100 (group 1), 100-240 (group 2), 240-325 (group 3), and greater than 325 ng/dL (group 4), although normal testosterone decreases with age. Female patient testosterone levels were also analyzed and divided into <10 (group 1), 10-60 ng/dL (group 2), and >60 ng/dL (group 3). A retrospective chart review was initiated to review all myeloma patients with a serum testosterone drawn at the time of their initial clinic visit to OSU. Results: Among 418 male MM patients, median age was 65 y.o. (range 24-95), 86% were Caucasian and 14% African-American, and the distribution of ISS stage was 32% stage 1, 22% stage 2, and 19% stage 3 with 28% missing staging data. Cytogenetic data was missing from 28% of patients. Out of 418 male MM patients, 29 (7%) had serum testosterone <100, 202 (48%) with testosterone 100-240, 79 (19%) with testosterone 241-325, and 108 (26%) > 325 ng/dL. Out of 172 female MM patients, 44 (26%) had an undetectable serum testosterone, 120 (70%) with testosterone 10-60, and 8 (5%) with testosterone > 60. Among male MM patients, log-rank [Mantel-Cox] analysis of overall survival with serum testosterone including all 4 groups demonstrated no significant differences (p=0.917) with only 80 events. Among 275 male MM patients with cytogenetic information available, there was no correlation between presence of 1q21 trisomies or tetrasomies and overall survival (r=0.0714, p=0.238). There was a strong and expected correlation between testosterone and BMI (r=0.14, p=0.00468). Among 161 total female MM patients, log-rank analysis with serum testosterone including all 3 groups also demonstrated no differences (p=0.416) with only 29 events in total. Among 101 females with cytogenetic information, there was also no correlation with 1q21 amplification (r=0.0895, p=0.373). Conclusion: The majority of male MM patients (74%) have secondary hypogonadism and approximately half have total testosterone levels <240 ng/dL. Cox proportional hazards analyses of survival adjusted for significant univariate covariates will be presented at the meeting. Correlations with anemia and medication use (specifically opiates and anti-depressants) will also be presented at the meeting. Disclosures No relevant conflicts of interest to declare.

scholarly journals UPDATES IN ANTIBIOTIC THERAPY OF BILIARY TRACT INFECTIONS

2015 ◽  
Vol 18 (1) ◽  
pp. 34-38
Author(s):  
Cristian Balahura ◽  
◽  
Petre Iacob Calistru ◽  
Gabriel Constantinescu ◽  
◽  
...  
Keyword(s):  
Biliary Tract ◽  
Antimicrobial Agents ◽  
Empirical Therapy ◽  
Biliary Stent ◽  
Gram Negative Bacteria ◽  
Gram Negative ◽  
Group 2 ◽  
Tract Infections ◽  
A Prospective Study ◽  
Group 1

Introduction. The management of biliary tract infections involves systemic antibiotherapy and a biliary drainage procedure. Current guidelines provide recommendations for empirical antimicrobial therapy in cholangitis but development of multi-drug resistant organisms can make many of these antibiotics ineffective. This study aimed to analyze the microbiology of bile and the susceptibility profiles of organisms identified in patients with extrahepatic cholestatis, with or without a previously placed biliary stent. Materials and methods. We conducted a prospective study including 136 patients with biliary obstruction who were endoscopically drained between June 2014 and March 2015 in Emergency Hospital “Floreasca”, Bucharest. One hundred and four of these patients had no biliary stent in situ (group 1). Thirty-two procedures were performed in patients with at least one biliary stent in place (group 2). Microbiological examination of bile aspirates was performed and antibiotic susceptibilities were determined for the isolated bacteria. Results. One hundred eighteen of 136 analyzed cultures were positive (81% in group 1 vs. 100% in group 2; p<0.05). In both groups, the most frequent pathogens were Escherichia coli, Klebsiella spp. and Proteus spp. The most effective antimicrobial agents against Gram-negative bacteria in group 1 and group 2 were imipenem, cefoperazone/sulbactam and piperacillin/tazobactam. Susceptibilities to ceftazidime, cefotaxime, cefepime and fluoroquinolones were significantly lower in group 2. Conclusion. This survey shows that Gram-negative bacteria are the predominant bile pathogens found in patients with cholestatis. Cefoperazone/sulbactam, piperacillin/tazobactam or imipenem can be recommended in biliary infections. Cephalosporins and fluroquinolones should not be used as empirical therapy if a biliary stent is in place.

scholarly journals Improvement in Survival of Multiple Myeloma Patients: A Long-Term Institutional Experience

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 4573-4573
Author(s):  
Jordan Nunnelee ◽  
Qiuhong Zhao ◽  
Don M. Benson ◽  
Ashley E. Rosko ◽  
Maria Chaudhry ◽  
...  
Keyword(s):  
High Risk ◽  
Maintenance Therapy ◽  
Therapy Group ◽  
Standard Of Care ◽  
Group 4 ◽  
Dexamethasone Group ◽  
Group 3 ◽  
Group 5 ◽  
Group 2 ◽  
Group 1

Introduction-Multiple myeloma (MM) represents 1.8% of all new cancer cases in the U.S., with an estimated 32,110 new cases in 2019. While not curable, advances in treatment, including autologous stem cell transplant (ASCT) and maintenance therapy, have dramatically improved progression free survival (PFS) and overall survival (OS). The Ohio State University bone marrow transplant program began utilizing ASCT for newly diagnosed MM (NDMM) patients in 1992. With the introduction of new and more effective drugs used before and after ASCT, we performed survival analysis in NDMM patients from 1992-2016 receiving ASCT to examine our institutional progress. Method-We performed a retrospective analysis of 1002 consecutive transplant eligible NDMM patients. Patients were split into five groups based on historic changes in novel agents for treatment of MM: 1992-1998 (vincristine/doxorubicin/dexamethasone-group 1), 1999-2002 (thalidomide/dexamethasone-group 2), 2003-2008 (bortezomib/lenalidomide/dexamethasone-group 3), 2009-2013 (carfilzomib/pomalidomide/dexamethasone, and maintenance therapy-group 4), and 2014-2016 (agents used for relapsed MM, including daratumumab/elotuzumab/ixazomib/dexamethasone, and maintenance therapy-group 5). Pre-ASCT conditioning regimen was melphalan 140-200 mg/m2 in 94.4% of patients. Data were consistently obtained since 2003 for both standard and high-risk patients at diagnosis. High-risk patients had del17, t(4:14), t(14:16), hypodiploidy and/or 1q abnormality. Primary endpoints were PFS and OS. PFS was defined as time to progressive disease or death from any cause from the date of transplantation. OS was defined as time from transplantation to death from any cause, censoring those who were still alive at the last follow up. Kaplan Meier curves were used to calculate PFS and OS. Results-The median age of all patients at transplant was 58 years (range: 18-81 years) and 58.5% were male. The median patient age increased significantly, from 54 to 60 years, over 1992-2016 (p<0.001). The majority of patients (53.6%) had IgG myeloma and 19.3% had light chain disease. 30% of patients with known cytogenetic data were high-risk. Melphalan 200 mg/m2 was used in 80.5% of patients. It was noted that across the years (1992-2016), there was a statistically significant improvement in both PFS (p<0.01) and OS (p<0.01). Median PFS and OS of all patients was 1.3 and 2.0 years in group 1 (1992-1998); 1.0 and 3.2 years in group 2 (1999-2002); and 2.0 and 5.8 years in group 3 (2003-2008), respectively. This response was further improved to PFS and OS of 4.1 years and not reached (NR) in group 4 (2009-2013), and 3.8 years and NR in group 5 (2014-2016), respectively (Figure 1). The 3 year PFS of groups 1 through 5 was 26%, 25%, 35%, 57% and 58%, respectively. The 3 year OS of groups 1 through 5 was 45%, 54%, 74%, 82% and 80%, respectively. On subset analysis, across years, significant increases in PFS (p<0.01) and OS (p<0.01) were seen in patients ≤65 years of age. For patients >65 years old, there was a statistically significant improvement in PFS (p<0.01) but not in OS (p=0.054). For both standard and high-risk disease, there was significant improvement in PFS (p<0.01 and p<0.01), and OS (p=0.02 and p=0.02), respectively. The rate of response both pre- and post-transplant showed statistically significant improvement across the years (p<0.01). The pre-transplant rate of very good partial response (VGPR), or better, increased from 5.3% in early 1990's (group 1), 15.3% (group 2), 39.8% (group 3) to 51.2% (group 4) and 54% (group 5). The post-transplant rate of response (VGPR or better) also increased from 31.5% (group 1), 28.8% (group 2), 65.6% (group 3), to 79.6% (group 4) and 76.3 % (group 5). Conclusion-Our data show that NDMM patients' survival and response to standard of care treatment have improved dramatically since 1992, primarily due to inclusion of novel therapies and maintenance. For NDMM patients receiving ASCT, the 3 year overall survival rate has significantly improved from 45% in 1992-1998 to 80% in 2014-2016, which is similar to the post-ASCT OS shown in the 2012 study by McCarthy et al. The significantly increasing age of NDMM patients receiving ASCT over time suggests improving supportive care and expansion of standard of care therapies to more of the population, improving survival and quality of life. Disclosures Rosko: Vyxeos: Other: Travel support. Efebera:Takeda: Honoraria; Akcea: Other: Advisory board, Speakers Bureau; Janssen: Speakers Bureau.

scholarly journals Results of neuroblastoma treatment in Lithuania: a single centre experience

2017 ◽  
Vol 24 (2) ◽  
pp. 128-137 ◽  
Author(s):  
Austėja Juškaitė ◽  
Indrė Tamulienė ◽  
Jelena Rascon
Keyword(s):  
Survival Rate ◽  
High Risk ◽  
Age At Diagnosis ◽  
Mycn Amplification ◽  
Disease Group ◽  
High Risk Patients ◽  
Risk Patients ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Background. Neuroblastoma (NB) is the most common extracranial solid tumour in children. This is a very rare disease with heterogeneous biology varying from complete spontaneous regression to a highly aggressive tumour responsible for 15% of malignancy-related death in early childhood. Analyses of survival rates in Europe have shown a considerable difference between Northern/Western and Eastern European countries. Treatment results of NB in Lithuania have never been analyzed. Aim. To assess the survival rate of children with NB according to initial spread of the disease, age at diagnosis, the MYCN amplification, risk group, and treatment period. Patients and methods. A retrospective single-centre analysis of patients’ records was performed. Children diagnosed and treated for NB between 2000 and 2015 at the Centre of Paediatric Oncology and Haematology of the Children’s Hospital, Affiliate of Vilnius University Hospital Santaros Klinikos were included. The patients were divided into three groups according to the spread of the disease: group 1 – patients with local NB older than 12 years of age; group 2 – stage IV patients, also called the M stage; group 3 – infants with stages 4S and MS. The patients were stratified into three risk groups – low, intermediate and high risk. Estimates of five-year overall survival (OS5y) were calculated using the Kaplan-Meier method comparing survival probability according to spread of the disease, age at diagnosis, the MYCN amplification, risk group and treatment period (2000–2007 vs 2008–2015). Results. Overall 60 children (31 girls and 29 boys) with NB were included. The median age at diagnosis was 1.87 years (ranged from 4 days to 15 years). Seventy-eight percent of cases were found to be differentiated or undifferentiated NB, 22% – ganglioneuroblastoma. The local form of the disease was predominant: 57% (34/60) of patients were allocated to the group 1, 37% (22/60) with initial metastatic disease were assigned to group 2, and infants with 4S or MS stage comprising 7% (4/60) allocated to group 3, respectively. The probability of OS5y for the entire cohort was 71% with the median follow-up of 8.8 ± 4.8 years. The probability of OS5y for local disease (group 1) was significantly higher compared to metastatic disease (group 2) (94% vs. 34%, p = 0.001, respectively) as well as for infants compared to children older than 12 months at the time of diagnosis (90% vs 60%, p = 0.009, respectively). The MYCN gene amplification had a negative influence on OS5y, with 78% of MYCN-negative patients surviving in comparison to 40% of MYCN-positive patients who did not survive (p = 0.153). The high-risk patients had significantly worse OS5y than children with intermediated or low risk (35% vs. 82% vs. 100%, respectively, p = 0.001). Comparison of OS5y between two treatment periods in the entire patient population revealed a non-significant increase in survival from 66% in the 2000–2007 period to 82% in the 2008–2015 period (p = 0.291), mostly due to a dramatic improvement achieved for high-risk patients whose survival rate increased from 9% in the 2000–2007 period to 70% in the 2008–2015 period (p = 0.009). Conclusions. There was a slight predominance of low-risk patients, probably due to a higher number of infants. A better probability of OS5y was confirmed in infants with local disease and in MYCN-negative patients. The OS5y for children treated for NB at our institution over 16 years increased from 66% in the 2000–2007 period to 82% in the 2008–2015 period with the most significant improvement achieved for high risk patients. The current survival rate of children treated for NB at our institution is in line with the reported numbers in Northern and Western European countries.

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