Clinical Significance of Indeterminate Lupus Anticoagulant (LAC) Results.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 3988-3988
Author(s):  
Khaldoun J. Alkayed ◽  
Kandice Kottke-Marchant
Keyword(s):  
Autoimmune Disease ◽  
Clinical Significance ◽  
Lupus Anticoagulant ◽  
Statistical Significance ◽  
The United States ◽  
Test Results ◽  
Clinical Variables ◽  
Significant Difference ◽  
Initial Cohort

Abstract 3988 Poster Board III-924 Abstract: Introduction The International Society of Thrombosis and Hemostasis (ISTH) criteria for the diagnosis of the lupus anticoagulant (LAC) include: Screening test that demonstrates the prolongation of a phospholipid-dependent (PL-D) clotting time; mixing test that confirms the presence of an inhibitor; the confirmation that the inhibitor is PL-D and exclusion of other coagulopathies. Test results that do not fulfill all the criteria are considered indeterminate. These indeterminate results are common (Kottke-Marchant et al. J Thromb Haemost. 2007; 5 Supplement 2: P-M-455), still there is no published data regarding clinical significance. Patients/methods This study investigated the prevalence of thrombotic events in an initial cohort of unselected patients (n=256) from one tertiary hospital in the United States, who were tested for LAC and other antiphospholipid (aPL) antibodies from a 2 month period in 2006. The laboratory results (PT/INR, aPTT, dilute Russell's viper venom time (DRVVT), STACLOT and platelet neutralization (PNP)) were evaluated. The profile included 3 separate PL -D assays (DRVVT confirm, STACLOT, PNP). Samples containing heparin (>0.1U/ml) were pre-treated with Hepadsorb. The LAC profile was considered indeterminate if PL test results were positive, but without a positive aPTT or DRVVT mixing study. The initial cohort included 83 patients with indeterminate results. From this group, 18 patients were excluded: Four due to incomplete data, 2 due to high heparin level (anti Xa>1.0 U/ml), 5 due to other prothrombotic etiologies and 7 with other positive aPL antibodies. For an assessment of thrombotic history, we performed retrospective chart reviews and tabulated all Sapporo clinical features, malignancy and auto-immune disorders within 5 years before and 2 years after the index laboratory testing. Events that did not fulfill diagnostic criteria for thrombosis, ischemic events or obstetrical complications were excluded. The final analysis sample included 65 patients with indeterminate LAC, 106 with negative and 27 with positive LAC. Results The final indeterminate LAC cohort included 65 patients, with mean follow-up of 18 months. Malignancy was present in 29% and autoimmune disease in 25% of patients. The most common thrombotic events were deep vein thrombosis (DVT) (28%), cerebral ischemic stroke (14%) and pulmonary embolism (14%). When compared to those with negative tests, indeterminate group patients were more likely males, relatively older, and more likely to have DVT, superficial thrombosis (ST) or myocardial infarction (MI) (P= 0.049, 0.021, 0.044, 0.005 and 0.045 respectively). Concurrent coumadin (warfarin) therapy was more prevalent in the indeterminate group, but it did not reach statistical significance (p=0.15). There was no statistical significant difference in the prevalence of cancer or autoimmune disease (P=0.19 and 0.48 respectively). In the multivariate analysis model none of the previous variables reached any statistical significance between the two groups. When compared the above clinical variables between indeterminate results and positive LAC results groups from the same cohort, we failed to show any major statistically significant differences. We noticed very poor retesting rate in the indeterminate group during the follow up period of 2 years (15% only). Conclusions Indeterminate results are common among patients referred for LAC testing. When compared to those with negative results, patients with indeterminate results are more likely to have a history of DVT, superficial thrombosis or MI, but none of the clinical variables reached statistical significance in a multivariate model. On the other hand, patients in the indeterminate group shared demographic and clinical profiles with those in the positive results group. This further highlights the need to study the clinical significance of indeterminate LAC results in a prospective study. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Differences in Clinical Presentation and Outcomes between Metropolitan and Rural Myeloma Patients

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 44-45
Author(s):  
Stephanie Clugston ◽  
Portia Smallbone ◽  
Duncan Purtill ◽  
Dustin Hall ◽  
Rebecca De Kraa ◽  
...  
Keyword(s):  
Overall Survival ◽  
Western Australia ◽  
Clinical Presentation ◽  
Statistical Significance ◽  
The United States ◽  
Early Mortality ◽  
First Line ◽  
Remote Areas ◽  
Significant Difference

Introduction: Australia's largest state, Western Australia (WA), comprises a land area of more than 2.5 million square kilometres, an area than larger than that of Texas and Alaska in the United States combined, with a population of more than 2.6 million. Whilst a large proportion of Western Australians live in the capital city Perth, approximately 20% are dispersed across the state in regional and remote areas. The diagnosis and treatment of myeloma require specialist Haematologist management and frequent follow-up. Access to Haematology specialist services and treatment in WA is centred in metropolitan Perth, with outreach services visiting regional and remote areas limited in location and frequency. Some patients are required to travel long distances or relocate to access treatment. The aim of our study was to assess difference in clinical presentation, treatment and outcomes of myeloma patients living in regional or remote Western Australia compared to metropolitan Perth. Methods: A retrospective chart review of new cases of symptomatic multiple myeloma diagnosed between January 2008 and December 2019 and referred to Royal Perth Hospital and Fiona Stanley Hospital, two tertiary metropolitan hospitals was conducted. Data was obtained regarding patient demographics, disease characteristics, treatment, response and survival outcomes, through review of patient paper and electronic medical records. Patients were grouped into those living inside or outside the Perth metropolitan area (metro or non-metro) according to area codes obtained from the WA government data suite. Results: Two hundred and seventy-five cases were identified, 218 (79%) metro and 57 (21%) non-metro. Baseline characteristics for the two groups are listed in Table 1. The median age at diagnosis was 68.4 years (range 30-91.5 years) and 47% were female, with no significant difference between the groups. There were a higher number of patients with lytic bone disease at diagnosis in the non-metro cohort (75.4% non-metro vs 60.2% metro, p=0.03) as well as a higher proportion of patients with international staging system (ISS) stage II or III disease (77.8% non-metro vs 55.8% metro, p=0.005). Sixty three percent of patients overall received first line bortezomib based therapy and 27% first line imid based therapy, with no significant difference by location. Overall 41% of patients underwent autologous stem cell transplantation, 70% of those ≤70 years of age, with no significant difference between the groups (33.3% non-metro vs 42.5% metro, p=0.21). The median overall survival (OS) was 47 months for the entire cohort. Survival was lower in the non-metro cohort, although this did not reach statistical significance (median OS 52 months for metro vs 40 months for non-metro, p=0.05) Figure 1. Progression free survival (PFS) was similar between the two groups (median PFS 23 months metro vs 12 months non-metro, p=0.12) Figure 2. Early mortality at 6 and 12 months was higher in the non-metro cohort (Six-month mortality was 21.1% non-metro vs 8.3% metro, p=0.01. Twelve-month mortality was 28.1% non-metro vs 13.4% metro, p=0.01) Figure 3. There was a trend in cause of early mortality due to infection being higher in the metro cohort, and cause of early mortality due to renal failure being higher in the non-metro cohort, Table 1. Conclusions: In our cohort, patients living in non-metropolitan locations were more likely to present with higher ISS stage and lytic lesions at diagnosis. Rates of early mortality were significantly higher in the non-metropolitan cohort. There was a trend towards shorter overall survival although this did not meet statistical significance. These differences may represent delays in clinical presentation and diagnostic workup and highlight the need for optimisation of follow up of patients in non-metropolitan areas particularly during the early time period post diagnosis. Periods of resource constraint and travel restrictions as is faced currently may accentuate these disparities. In addition, the nature of myeloma therapy is evolving with addition of treatments requiring expertise to deliver, such as monoclonal antibodies and chimeric antigen receptor T cells. As these therapies become commercial further studies are needed to assess adequacy of access for patients from non-metropolitan centres. Disclosures Leahy: Pfizer: Membership on an entity's Board of Directors or advisory committees. Sidiqi:Celgene: Honoraria, Other: Travel grant; Amgen: Honoraria; Janssen: Honoraria.

scholarly journals Testing telediagnostic thyroid ultrasound in Peru: a new horizon in expanding access to imaging in rural and underserved areas

2021 ◽  
Author(s):  
T. J. Marini ◽  
S. L. Weiss ◽  
A. Gupta ◽  
Y. T. Zhao ◽  
T. M. Baran ◽  
...  
Keyword(s):  
Thyroid Nodule ◽  
Standard Of Care ◽  
The United States ◽  
Epidemiological Studies ◽  
Thyroid Ultrasound ◽  
Target Region ◽  
Experienced Radiologist ◽  
Significant Difference ◽  
Size Evaluation

Abstract Purpose Thyroid ultrasound is a key tool in the evaluation of the thyroid, but billions of people around the world lack access to ultrasound imaging. In this study, we tested an asynchronous telediagnostic ultrasound system operated by individuals without prior ultrasound training which may be used to effectively evaluate the thyroid and improve access to imaging worldwide. Methods The telediagnostic system in this study utilizes volume sweep imaging (VSI), an imaging technique in which the operator scans the target region with simple sweeps of the ultrasound probe based on external body landmarks. Sweeps are recorded and saved as video clips for later interpretation by an expert. Two operators without prior ultrasound experience underwent 8 h of training on the thyroid VSI protocol and the operation of the telemedicine platform. After training, the operators scanned patients at a health center in Lima. Telediagnostic examinations were sent to the United States for remote interpretation. Standard of care thyroid ultrasound was performed by an experienced radiologist at the time of VSI examination to serve as a reference standard. Results Novice operators scanned 121 subjects with the thyroid VSI protocol. Of these exams, 88% were rated of excellent image quality showing complete or near complete thyroid visualization. There was 98.3% agreement on thyroid nodule presence between VSI teleultrasound and standard of care ultrasound (Cohen’s kappa 0.91, P < 0.0001). VSI measured the thyroid size, on average, within 5 mm compared to standard of care. Readers of VSI were also able to effectively characterize thyroid nodules, and there was no significant difference in measurement of thyroid nodule size (P = 0.74) between VSI and standard of care. Conclusion Thyroid VSI telediagnostic ultrasound demonstrated both excellent visualization of the thyroid gland and agreement with standard of care thyroid ultrasound for nodules and thyroid size evaluation. This system could be deployed for evaluation of palpable thyroid abnormalities, nodule follow-up, and epidemiological studies to promote global health and improve the availability of diagnostic imaging in underserved communities.

scholarly journals Impact of percutaneous embolization versus subinguinal microsurgical ligation on semen parameters in primary varicocele patients: comparative study

2020 ◽  
Vol 51 (1) ◽  
Author(s):  
Haytham M. Nasser ◽  
Ahmed Hussein ◽  
Gad M. Behairy ◽  
Mostafa Abdo
Keyword(s):  
Sperm Count ◽  
Semen Analysis ◽  
Statistical Significance ◽  
Semen Parameters ◽  
Male Factor ◽  
Percutaneous Embolization ◽  
Significant Difference ◽  
Group 2 ◽  
Group 1

Abstract Background Varicocele is an abnormally dilated pampiniform plexus of the veins within the spermatic cord and is considered the most common correctable cause of male factor infertility. Many approaches are described for treatment either surgical (tradition inguinal, subinguinal, and laparoscopic) or non-surgical percutaneous embolization. During the period from August 2017 to December 2018, we prospectively analyzed the preoperative and post-operative alteration of semen parameters (at 3 and 9 months) of the data collected from 63 patients with clinically evident varicocele referred to our tertiary hospital. Patients were divided into two groups: group 1, thirty-three patients who underwent subinguinal microsurgical ligation, and group 2, thirty patients who underwent percutaneous embolization. Results Sixty-three patients enrolled in this study were divided in two groups: group 1, patients who underwent surgery, and group 2, patients who underwent embolization; the mean age is 24.6 ± 1.27 years in group 1 and 23.7 ± 2 years in group 2; there was no statistically significant difference between the two groups as regards BMI, diabetes, hypertension, and smoking. Bilaterality was present in 15.2% of group 1 patients and 10% in group 2 patients (P value 0.06). Most of the patients were classified as grades 2 and 3 with no statistical significance regarding severity of the disease. Preoperative semen parameters for patients including sperm count, motility, and abnormal forms showed no statistically significant difference between the two groups. Post-intervention semen analysis was done twice during follow-up after 3 months and 9 months from the date of intervention. After 3 months, the semen parameters were improved in both groups in spite of the higher sperm count in group 2 but with no statistical significance. After 9 months follow-up, semen analysis showed persistent increase in sperm mobility in group 1 patients in comparison to group 2 patients. Both groups had better improvement in count of normal form with no statistical significant change. Conclusion Improvement of semen parameters while treating primary varicocele by either subinguinal microsurgery approach or percutaneous embolization shows equivalent outcomes.

Effects of Orthokeratology Lens On Axial Length Elongation in Myopia With Anisometropia Children

2021 ◽  
Author(s):  
Ziyang Chen ◽  
Kai-Ming Chen ◽  
Ying Shi ◽  
Zhao-Da Ye ◽  
Sheng Chen ◽  
...  
Keyword(s):  
Retrospective Study ◽  
Axial Length ◽  
Statistical Significance ◽  
Spherical Equivalent ◽  
Significant Difference ◽  
The Mean ◽  
The Difference ◽  
Better Than ◽  
Group 1

Abstract AimTo investigate the effect of orthokeratology (OK) lens on axial length (AL) elongation in myopia with anisometropia children.MethodsThirty-seven unilateral myopia (group 1) and fifty-nine bilateral myopia with anisometropia children were involved in this 1-year retrospective study. And bilateral myopia with anisometropia children were divided into group 2A (diopter of the lower SER eye under − 2.00D) and group 2B(diopter of the lower SER eye is equal or greater than − 2.00D). The change in AL were observed.The datas were analysed using SPSS 21.0.Results(1) In group 1, the mean baseline AL of the H eyes and L eye were 24.70 ± 0.89 mm and 23.55 ± 0.69 mm, respectively. In group 2A, the mean baseline AL of the H eyes and L eyes were 24.61 ± 0.84 mm and 24.00 ± 0.70 mm respectively. In group 2B, the mean baseline AL of the H eyes and L eyes were 25.28 ± 0.72 mm and 24.70 ± 0.74 mm. After 1 year, the change in AL of the L eyes was faster than the H eyes in group 1 and group 2A (all P<0.001).While the AL of the H eyes and L eyes had the same increased rate in group 2B. (2) The effect of controlling AL elongation of H eyes is consistent in three groups (P = 0.559).The effect of controlling AL elongation of L eyes in group 2B was better than that in group 1 and group 2A (P < 0.001). And the difference between group 1 and group 2A has no statistical significance. (3) The AL difference in H eyes and L eyes decreased from baseline 1.16 ± 0.55mm to 0.88 ± 0.68mm after 1 year in group 1.And in group 2A, the AL difference in H eyes and L eyes decreased from baseline 0.61 ± 0.34mm to 0.48 ± 0.28mm. There was statistically significant difference (all P<0.001). In group 2B, the baseline AL difference in H eyes and L eyes has no significant difference from that after 1 year (P = 0.069).ConclusionsMonocular OK lens is effective on suppression AL growth of the myopic eyes and reduce anisometropia value in unilateral myopic children. Binocular OK lenses only reduce anisometropia with the diopter of the low eye under − 2.00D. Binocular OK lenses cannot reduce anisometropia with the diopter of the low eye equal or greater than − 2.00D. Whether OK lens can reduce refractive anisometropia value is related to the spherical equivalent refractive of low refractive eye in bilateral myopia with anisometropia children after 1-year follow-up.

Abstract 14600: Pre-existing Autoimmune Disease and the Risk for Cardiovascular and Non-cardiovascular Immune Mediated Adverse Events With Immune Checkpoint Inhibitors

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Charlotte Lee ◽  
Zsofia D Drobni ◽  
Amna Zafar ◽  
Raza M Alvi ◽  
Sean P Murphy ◽  
...  
Keyword(s):  
Coronary Artery ◽  
Autoimmune Disease ◽  
Adverse Events ◽  
Immune Checkpoint ◽  
Cardiovascular Events ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Skin Toxicity ◽  
Significant Difference

Introduction: The use of immune checkpoint inhibitors (ICIs) is associated with an increase in cardiovascular events. The mechanism is likely related to immune activation and inflammation. Patients with pre-existing autoimmune disease have a baseline increased risk for cardiovascular disease and have been traditionally excluded from clinical trials of ICIs. There is limited data on the cardiovascular and non-cardiovascular safety of ICIs in these patients. Methods: This was a retrospective study of 2845 patients treated with an ICI at the Massachusetts General Hospital. This cohort was screened by individual chart review for patients with a diagnosis of an autoimmune disease prior to ICI therapy. These autoimmune patients were compared to controls at a 1:2 ratio. Baseline characteristics and risk of cardiovascular and non-cardiovascular immune related adverse events (iRAEs) were compared. Cardiovascular events were a composite of myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), stroke, transient ischemic attack (TIA), deep venous thrombosis (DVT), pulmonary embolism (PE), or myocarditis. Results: 93 patients had a diagnosis of an autoimmune disease prior to ICI. These patients were more likely to be older and to have a history of coronary artery disease, heart failure, chronic kidney disease, hypertension and diabetes mellitus. There were 12 events over a median follow-up period of 300 days. There was no significant difference in composite of cardiovascular events in follow-up (13 vs. 9.1%, autoimmune vs. none, P =0.41). The individual cardiovascular event rates were as follows: MI (4.3 vs. 0.5%, P =0.04), PCI (0 vs. 0.5%, P =1), CABG (0. vs. 0.5%, P =1), stroke (0 vs. 0%), TIA (0 vs. 0.5%, P =1), DVT (5.4 vs. 2.2%, P =0.17), PE (1.1 vs. 4.8%, P =0.17), and myocarditis (2.2 vs. 1.1%, P =0.60). There was an increased rate of pneumonitis (14 vs. 4%, P <0.001) and skin toxicity (16 vs. 0%, P <0.001). Conclusions: Patients with pre-existing autoimmune disease treated with an ICI had a higher baseline cardiovascular risk but did not have a significant increase in cardiovascular events in an unadjusted analysis. These patients did, however, have an increased rate of pneumonitis and skin toxicity after ICI.

scholarly journals Association between follow-up in health services and antihypertensive medication adherence

2018 ◽  
Vol 71 (6) ◽  
pp. 3006-3012 ◽  
Author(s):  
Nila Larisse Silva de Albuquerque ◽  
Andressa Suelly Saturnino de Oliveira ◽  
Jacqueline Mota da Silva ◽  
Thelma Leite de Araújo
Keyword(s):  
Medication Adherence ◽  
Data Collection ◽  
Health Services ◽  
Antihypertensive Medication ◽  
Statistical Significance ◽  
Cardiovascular Complications ◽  
Test Results ◽  
Collection Period ◽  
Use Of Health Services

ABSTRACT Objective: To analyze the association between the characteristics of follow-up in health services and adherence to antihypertensive medication in patients with cardiovascular disease. Method: Analytical study carried out with 270 patients suffering from hypertension and hospitalized due to cardiovascular complications. Data collection occurred between November 2015 and April 2016, involving sociodemographic variables, presence of self-reported diabetes, accessibility and use of health services, blood pressure levels and medication adherence (analyzed through the Morisky–Green Test). Results: The rate of adherence to antihypertensive therapy was 63.0%. Enrollment in the Hiperdia program had no statistical significance to medication adherence. People who attended at least between 4 and 6 nursing consultations throughout the data collection period (p = 0.02) had better adherence. Conclusion: The study’s findings provide support for the reorientation of health services and their public policies towards improving adherence to antihypertensive therapeutics.

Effect of Different Obturation Techniques on the Prognosis of Endodontic Therapy: A Retrospective Comparative Analysis

2016 ◽  
Vol 17 (7) ◽  
pp. 582-586 ◽  
Author(s):  
Jyoti Sachdeva ◽  
Anurag Sarin ◽  
Ajai Gupta ◽  
Shobhit Sachdeva
Keyword(s):  
Comparative Analysis ◽  
Clinical Significance ◽  
Analysis Of Variance ◽  
Root Canal ◽  
Root Canal Therapy ◽  
Quality Of Treatment ◽  
Significant Difference ◽  
Level Of Significance

ABSTRACT Introduction Success of root canal therapy (RCT) is largely dependent upon the quality of biomechanical preparation and obturation of the pulp canal. Improperly cleaned or shaped root canal, regardless of the type of obturation method and obturating material, cannot lead to the success of endodontic therapy. Hence, we conducted a clinical comparative analysis of two obturating techniques. Materials and methods A total of 140 patients receiving RCT at the department of Endodontic were included in the present study. The average follow-up time for the patients was 29 months (18–38 months). Patients were grouped into two depending on the type of obturating technique used. Evaluation of the clinical and radiographic follow-up records of the patients was done and analysis was made. One-way analysis of variance (ANOVA) was used for assessing the level of significance. Results The average age of the patients undergoing obturation with carrier-based obturation (CO) technique and lateral compaction (LC) technique was 43 and 48 years respectively. While comparing failure and success of the teeth at the time of follow-up, nonsignificant results were obtained. Significant difference was seen, while comparing the presence of voids and type of teeth in which endodontic therapy was performed using different obturating techniques. Conclusion Endodontic therapy done with LC obturating technique or with CO technique shows prognostic difference on the outcome or quality of treatment therapy. Clinical significance Quality of obturation is more important rather than type while performing endodontic therapy for better prognosis. How to cite this article Sarin A, Gupta P, Sachdeva J, Gupta A, Sachdeva S, Nagpal R. Effect of Different Obturation Techniques on the Prognosis of Endodontic Therapy: A Retrospective Comparative Analysis. J Contemp Dent Pract 2016;17(7):582-586.

Pentostatin and Cladribine in Hairy Cell Leukemia- a Retrospective Comparison of a Large Series with Long Follow up.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 3472-3472 ◽  
Author(s):  
Monica Else ◽  
Nnenna Osuji ◽  
Ilaria Del ◽  
Estella Matutes ◽  
Rosa Ruchlemer ◽  
...  
Keyword(s):  
Hairy Cell Leukemia ◽  
Statistical Significance ◽  
Disease Free Survival ◽  
Disease Diagnosis ◽  
Hairy Cell ◽  
Cell Leukemia ◽  
Retrospective Comparison ◽  
Significant Difference ◽  
Alternative Agent

Abstract Complete responses (CR) of up to 95% have been reported with both pentostatin and cladribine in patients with hairy cell leukemia (HCL). Although responses are durable, relapses occur even 10 years after treatment. No trial has compared pentostatin to cladribine for HCL. Furthermore, few series achieve sufficient maturity to answer the question: can these agents induce a cure in HCL? We reviewed retrospectively 219 patients with HCL (median follow up (FU) from diagnosis: 12.6 years) to compare pentostatin with cladribine in the treatment of HCL, and to assess the potential for cure in this disease. Diagnosis of HCL and exclusion of HCL-variant were confirmed by central review. Overall response to 1st line pentostatin (n=185) was 96% with CR of 81% and median FU of 10.8 (range 0.3–17.9) years. Response to cladribine was 100% with CR of 82%. No significant difference in response was seen with cladribine (n=34) at median FU of 7.2 (range 0.5–11.5) years. Median disease free survival (DFS) for both agents was 10 years. 38% of patients relapsed 4.9 (range 1–16) years and 4.4 (range 1–10) years after treatment with pentostatin and cladribine, respectively. Although responses were maintained for pentostatin and cladribine when used at 2nd (94% and 100% respectively) and 3rd line (100% and 100% respectively) treatment, CR decreased significantly with each sequential relapse through 70% to 45% (p≤0.01). Attainment of CR at 1st line treatment was significantly associated with increased DFS (p=0.000) as compared to those achieving only partial response (PR). Figure Figure A similar result was seen at 2nd line therapy (p=0.000). DFS also showed a significant decline with sequential treatment (p=0.001) mirroring the reduced likelihood of achieving CR with increasing number of courses. There was some crossover of patients. At 1st relapse, 20 patients received pentostatin of whom 17 had previously received this agent, and 53 patients received cladribine of whom 44 were previously treated with pentostatin. Patients relapsing after an initial CR showed no significant difference in ability to re-attain CR as opposed to PR or no response, whether retreated with the same agent, or switched to the other. However, for patients who initially failed to achieve CR, switching to the alternative agent was associated with an increased rate of CR although this difference did not achieve statistical significance. Known 2nd malignancies (excluding basal cell carcinoma) occurred in 20 patients (9 %). In a separate group of 7 patients who were never treated with either agent, 2 patients developed 2nd malignancies. We demonstrated equivalent efficacies of pentostatin and cladribine in the treatment of HCL. Median survival has not been reached for either agent. At 10 years FU, the survival is 83% (pentostatin) and 90% (cladribine). DFS curves show no plateau for either agent with relapses occurring up to 16 years after pentostatin treatment. True cure in this disease thus remains elusive, however, our results suggest that first line CR with purine analogue therapy should be the prime aim of HCL treatment.

A Randomised Controlled Trail of Plasma Exchange in Rapidly Progressive Renal Failure of Myeloma.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 4899-4899
Author(s):  
William F. Clark ◽  
A. Keith Stewart ◽  
Gail A. Rock ◽  
Marion Sternbach ◽  
David M. Sutton ◽  
...  
Keyword(s):  
Serum Creatinine ◽  
Sample Size ◽  
Plasma Exchange ◽  
Kidney Failure ◽  
Statistical Significance ◽  
Control Group ◽  
Significant Difference ◽  
The Mean ◽  
Baseline Characteristics

Abstract In myeloma, plasma exchange (PE) has been suggested to prevent rapidly progressive kidney failure by reducing exposure to nephrotoxic light chains. We carried out a randomized controlled multi-centre trial comparing PE or no PE in 104 patients of whom 101 met the inclusion, exclusion criteria and 4 were lost to follow-up. We compared baseline characteristics as well as renal outcomes and performed a futility analysis to determine the sample size necessary for potential statistical significance for the changes noted. Thirty-nine patients were randomized to the control group and 58 to the PE group with a 6-month follow-up. The baseline characteristics of these 2 groups were similar including serum creatinine, dialysis dependence, age, gender, serum calcium, serum albumin, 24 -hour urine for protein levels and Durie-Salmon myeloma staging. Thirteen (33.3%) of the control group and 19 (33.3%) of the PE group died within 6 months of follow up. Ten patients (31%) in the control and 10 patients (21%) in the PE arm were dialysis dependent at 6 months. Seven patients (47%) came off dialysis in the control and 13 patients (59%) in the PE arm with the mean number of dialysis days from 0–6 months being 45.7±67.6 in the control versus 29.2±56.1 in the PE arm at 6 months. The mean serum creatinine in the control group was 314.6±256.1 μmol/L versus 215.4±215.3 μmol/L in the PE group and the composite end point of death, dialysis or serum creatinine >254 μmol/L occurred in 12 (30.8%) in the control and 11 (19.3%) in the PE arm. The futility analysis to indicate the per group sample size necessary to achieve statistical significance at 6 months for the difference we observed was infinite for cumulative mortality, 805 for dialysis dependence, 2418 for coming off dialysis, 321 for number of dialysis days, 132 for creatinine difference of 100 μmol/L and for the composite outcome of death, dialysis or creatinine>354 μmol/L, 737. We did not observe a statistically significant difference in mortality or renal morbidity for PE versus no PE in patients with myeloma and rapidly progressive kidney failure.

Efficacy of Yttrium-90 Zevalin Outside of Clinical Trials: Preliminary Results of a Retrospective Bi-Center Study

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 5015-5015
Author(s):  
Francesco Cicone ◽  
Francesco Scopinaro ◽  
Sebastien Baechler ◽  
Nicolas Ketterer ◽  
Franz Buchegger ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Setting ◽  
Patient Population ◽  
Statistical Significance ◽  
University Hospital ◽  
Low Grade ◽  
Number Of Patients ◽  
Significant Difference ◽  
Routine Clinical Setting

Abstract Background and Aim: Due to limited data regarding the efficacy of Radioimmunotherapy with 90Y-Zevalin (RIT-Z) outside of controlled clinical trials, we carried out a biinstitutional, international retrospective study to assess the efficacy of RIT-Z in a routine clinical setting. The relationship between the number of previous therapies and outcomes as well as the response to the last therapy was assessed. Possible differences in outcomes for patients treated in the two different centers were also analyzed. Materials and Methods: Forty-three consecutive patients treated at the University Hospital of Lausanne (CHUV, Switzerland) and at S. Andrea University Hospital of Rome (Italy) were evaluated, none of which had been previously included in clinical trials. Only 31 patients entered the final analysis: patients lost at follow up, undergoing autologous transplantation (ASCT), or treated within the last 3 months were excluded. Efficacy of therapy was evaluated in terms of Overall Survival (OS), Progression Free Survival (PFS), and Time to Next Treatment (TTNT). Survival curves were obtained with the Kaplan- Meier method (statistical significance = p&lt;0.05). Results: Characteristics of the patient population are listed in Table 1. Although 50% of the patients had aggressive histologies, patients treated at S. Andrea had slightly more favorable features than those treated at CHUV. Fourteen patients (45%) had received at least 4 previous treatments, and all had received Rituximab. Fourteen patients (45%) had not responded to the last therapy, while 6 (19%), all treated at S.Andrea, were considered disease-free at the time of RIT-Z, which was administered for consolidation. Median follow up time was 20 months (11.5 vs. 25 months for S.Andrea and CHUV, respectively). Median PFS and TTNT were similar. After achieving a partial response, 2 patients were referred to Rituximab maintenance after RIT-Z and remain progression-free. Median OS was still not attained. Although not statistically significant, a trend towards better outcomes for S. Andrea patients was found. In comparing patients with indolent and aggressive lymphoma, only PFS was found to be significantly different (median PFS: 10 vs. 5 months, p&lt;0.05). In patients with &lt;4 and ≥ 4 previous therapies, twenty month OS was 88% vs. 53.6% (p=0.02), respectively; median TTNT was 22 vs. 5 months (p=0.013), while differences in PFS did not attain statistical significance. The duration of response in non-responders to their last therapy was shorter than in responders: 20-month OS- 44% vs. 94% (p=0.0015), median PFS and TTNT- 3.5 vs. 15 months (p=0.0002) and 4 vs. 15 months (p=0.0001), respectively. Median PFS and TTNT after RIT-Z did not differ from those found after the last therapy. A significant difference in outcomes for heavily pretreated or refractory patients was found in those with low grade follicular lymphoma. Conclusions: Poorer outcomes were found in our patient population treated in a routine clinical setting compared to those enrolled in clinical trials. This may be related to greater heterogeneity of our study cohort which included more patients with unfavorable conditions (e.g. aggressive NHL, ≥4 treatment courses including rituximab in all, and ASCT in 25%). Our results suggest that the best benefit may be expected with RIT-Z either for consolidation or relatively earlier in the course of NHL treatment. Table 1. Total CHUV S. Andrea Population Analyzed (72%) Number of patients 43 23 20 31 Median Age 61 63 58,5 62 Aggressive Histology (FL grade 3 or DLBCL) 18 (41,8%) 8 (34,7%) 10 (50%) 11 (35,5%) Indolent Histology (FL grade 1 or 2) (%) 25 (58,2%) 15 (65,3%) 10 (50%) 20 (64,5%) Patients with ≥4 previous treatments 19 (44,2%) 12 (52,1%) 7 (35%) 14 (45,2%) Patients with previous ASCT 11 (25,6%) 6 (26%) 5 (25%) 8 (25%)

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