Erythropoietin Use In Patients with AML or Undergoing Allogeneic HSCT Significantly Improves Quality of Life and Reduces Red Blood Cells and Platelets Transfusions without Any Survival Effect.

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 3810-3810
Author(s):  
Mauricette Michallet ◽  
Karine Goldet ◽  
Stephane Morisset ◽  
Mohamad Sobh ◽  
Youcef Chelghoum ◽  
...  

Abstract Abstract 3810 Introduction: Despite frequent anemia and multiple transfusions during AML chemotherapy and allogeneic hematopoietic stem cell transplantation (allo-HSCT), recommendations and marketing authorization for erythropoietin (EPO) use are still missing. In the current prospective study, as primary objective, we evaluated the effect of EPO on patient's quality of life (QOL). Secondary objective was hemoglobin (Hb) recovery. In addition, a paired matched analysis using similar population was conducted to compare platelets (Pt) and red blood cells (RBC) transfusion number. Materials and methods: We included adult patients with Hb level ≤11g/dl induced by 1, 2 or 3 consolidation chemotherapy for AML in complete remission (CR) (group 1); or by allo-HSCT for any hematological disease (group 2). EPO was administered Sc. once per week during a maximum period of 6 months: for group 1, ARANESP® 150μg; for group 2, NEORECORMON® 30000IU; Hb level was monitored every week. Injections were stopped once the Hb level reached 12g/dl without any transfusion. If after 4 injections, no improvement was observed, doses were doubled, and if after 8 injections, no improvement was observed, patient was taken off-study for EPO inefficiency. The QOL was measured at baseline, at 1, 2, 3 and 6 months by the Functional Assessment of Cancer Therapy–Anemia (FACT–An). EPO responders patients were defined as having Hb level ≥12g/dl (EPO CR) or a ≥ 2g/dl increase [EPO partial response (EPO PR)] compared with baseline value without any transfusion requirement. The matching analysis took into account: sex, age, disease status, for the two groups, associated to cytogenetics, type of chemotherapy, sequential chemotherapy number for group 1, and diagnosis, conditioning, HSC source, number of previous transplants and GVHD for group 2. Results: Between April 2006 and December 2009, among 261 screened patients, 55 were included in group1 and 61 in group 2, patient characteristics for each group are summarized in Table1. Main exclusion criteria were EPO contra-indication and patient refusal. The median number of EPO injections/patient was 13 (3 – 24) in group1 and 8 (2 - 28) in group 2. For the global population (111 evaluable patients [52 group1 and 59 in group 2]), we have noticed a significant improvement of QOL during the 6 months follow-up according to FACT-An anemia (p=0.01). Despite a non-significant improvement for FACT-G, we observed a significant improvement in physical well-being (p<0.0001). There were 85 EPO CR (83% in group1 and 71% in group 2) and 3 (6%) EPO PR (only in group1). Among patients who reached the 6 months follow-up, 81% had a normal Hb level. Fourteen patients (13%) were withdrawn (6 in group1 and 8 in group 2) due to EPO inefficacy and 9 in group 2 for relapse or EPO related/unrelated serious adverse events (AEs). In group1: the median time to achieve an EPO CR was 34 days (17-67) after first consolidation and 41 days (12-67) after second consolidation (p=0.35). In group 2: the median time to achieve EPO CR was 39 days (14 - 180). After the pair-matched analysis, 44 patients in each group were matched with at least one case-control patient. When comparing RBC and Pt transfusions, there were 712 units and 751 units in the matched population versus 504 and 669 in the EPO population respectively [208 spared RBC (80 in group1, p=0.008 and 128 in group 2, p=0.004) and 100 spared Pt units (all in group1, p=0.001)]. The multivariate analysis studying different confounding factors on the cumulative incidence of EPO CR showed a significant positive impact of younger age (p=0.001) and intensive chemotherapy (p=0.03) in group1; and for group 2, the positive impact of Pt levels at baseline, the negative impact of female recipient and major ABO incompatibility. We did not find any significant difference in terms of overall (OS) and event free survival (EFS) between EPO and control groups. Conclusion: This prospective study showed a real benefit of EPO administration on QOL, an achievement of a normal Hb level and a significant spare of RBC and Pt transfusions. Young AML patients, male allo-HSCT recipient, ABO compatible pairs seem to be the best candidates to benefit from EPO administration, with low AEs and no impact on OS or EFS. A cost-effectiveness study is ongoing and results will be communicated. Disclosures: No relevant conflicts of interest to declare.

2015 ◽  
Vol 101 (2) ◽  
pp. 172-176 ◽  
Author(s):  
Elisa Benelli ◽  
Valentina Carrato ◽  
Stefano Martelossi ◽  
Luca Ronfani ◽  
Tarcisio Not ◽  
...  

ObjectiveTo evaluate the consequences of the last European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) and British Society of Paediatric Gastroenterology, Hepatology and Nutrition (BSPGHAN) guidelines for the diagnosis of coeliac disease (CD) by means of a prospective study.DesignProspective cohort study.SettingInstitute for Maternal and Child Health IRCCS Burlo Garofolo (Trieste, Italy).PatientsChildren diagnosed with CD without a duodenal biopsy (group 1), following the last ESPGHAN and BSPGHAN guidelines, and children diagnosed with a duodenal biopsy, matched for sex, age and year of diagnosis (group 2), were prospectively enrolled over a 3-year period. All patients were put on a gluten-free diet (GFD) and were followed up for clinical conditions and laboratory testing at 6 months every year since diagnosis (median follow up: 1.9 years).Outcome measuresResolution of symptoms, body mass index, laboratory testing (haemoglobin, anti-transglutaminase IgA), adherence to a GFD, quality of life, and supplementary post-diagnosis medical consultations.Results51 out of 468 (11%) patients were diagnosed without a duodenal biopsy (group 1; median age 2.1 years) and matched to 92 patients diagnosed with a biopsy (group 2; median age 2.4 years). At the end of follow-up the two groups were statistically comparable in terms of clinical and nutritional status, anti-transglutaminase IgA antibody titres, quality of life, adherence to a GFD, and number of supplementary medical consultations.ConclusionsOn the basis of this prospective study, diagnosis of CD can be reliably performed without a duodenal biopsy in approximately 11% of cases. At least during a medium-term follow-up, this approach has no negative consequences relating to clinical remission, adherence to diet, and quality of life of children with CD.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e16071-e16071
Author(s):  
Benjamin Guix ◽  
Teresa Maria Lacorte ◽  
Jose Maria Bartrina ◽  
Jose Ignacio Tello ◽  
Ines Guix ◽  
...  

e16071 Background: To report long term Health Related Quality of Life (HRQoL) in a prospective series of 629 patients with intermediate or high-risk clinically localized prostate cancer treated with either IMRT or IMRT + HDR. Methods: Between December 1999 and December 2010, 629 patients (pts) with PSA›10, Gleason score›6 and/or T2b-T3 N0 M0 prostate cancer entered the study. Pts were prospectively assigned to one of the two treatment groups: 76 Gy HD-3D-IMRT to the prostate in 38 fractions (group 1; 315 patients) or 46 Gy LD-3D-CRT+ 16 Gy HDR-B given in 2 fractions of 8 Gy (group 2, 316 patients), limiting the maximum rectal dose to 85% of the prescribed dose. Both groups were well balanced taking into account patient’s as well as tumors’ characteristics. Toxicities were scored by the EORTC /RTOG morbidity grading scales. Special attention to local, regional or distant recurrence, survival, late effects, PSA and testosterone levels as well as HRQOL was done. Results: All pts completed treatment. None pts included in group 1 or 2 had grade 3 or more rectal toxicity. With a mean follow-up of 96 m, the 8-year free-from-failure survival was 90.7% and 98.3% (p<0.02) in group 1 and 2 respectively; free-from-metastases survival 96.9% and 97.9% (p<0,08)for group 1 and 2; and cause-specific survival 97.4% and 98.3% (p<0.09). HRQoL was evaluated before treatment, at 3 months interval during the first year follow up and in a yearly basis until 10-year. I-PSS and EORTC’s QLQ-C30 with PR-25 were used. I-PSS scores at 1, 3 and 6 months and at 1, 2, 3, 5 and 8 years follow-up were 6.39, 5.00, 2.52, 2.21, 2.35, 3.65 and 1.43 for group 1 pts and 1.50, 1.10, 1.01, 1.05, 0.89, 0.66, 0.67 for group 2 pts. Global HRQoL scores at 1, 3 and 6 months and at 1, 2, 3 and 5 years follow up were 5.56, 5.75, 5.33, 6.00, 5.40, 5.58 and 5.11 for group 1 pts and 5.60, 6.40, 5.78, 5.89, 5.83, 6.37, 6.00 for group 2 pts, being found to be statistically significant at 3 and 5 years follow up (p<0,001 and p<0,024). Conclusions: High-dose 3D-IMRT + HDR brachytherapy was found to be a method of escalating the dose to the prostate that not only increased the chances of cure for patients if not increased their long-term Health Related Quality of Life.


PLoS ONE ◽  
2020 ◽  
Vol 15 (12) ◽  
pp. e0243592
Author(s):  
Pol Maria Rommens ◽  
Michiel Herteleer ◽  
Kristin Handrich ◽  
Mehdi Boudissa ◽  
Daniel Wagner ◽  
...  

Background In geriatric acetabular fractures, the quadrilateral plate is often involved in the fracture pattern and medially displaced. Open reduction and internal fixation (ORIF) includes reduction of the quadrilateral plate and securing its position. In this study, the concept of medial buttressing in acute and periprosthetic acetabular fractures is evaluated. Materials and methods Patients, who sustained an acetabular fracture between 2012 and 2018, in whom ORIF with a specific implant for medial buttressing was performed, were included in the study. Patients were divided in two groups; acute acetabular fractures (group 1) and periprosthetic acetabular fractures (group 2). Demographics, type of fracture, surgical approach, type of implant for medial buttressing, comorbidities, general and surgical in-hospital complications and length of hospital stay were recorded retrospectively. The following data were collected from the surviving patients by telephone interview: EQ-5D-5L, SF-8 physical and SF-8 mental before trauma and at follow-up, UCLA activity scale, Parker Mobility Score and Numeric Rating Scale. Results Forty-six patients were included in this study, 30 males (65.2%) and 16 females (34.8%). Forty patients were included group 1 and six patients in group 2. The median age of patients of group 1 was 78 years. Among them, 82.5% presented with comorbidities. Their median length of in-hospital stay was 20.5 days. 57.5% of patients suffered from in-hospital complications. The concept of medial buttressing was successful in all but one patient. ORIF together with primary total hip arthroplasty (THA) was carried out as a single stage procedure in 3 patients. Secondary THA was performed in 5 additional patients (5/37 = 13.5%) within the observation period. Among surviving patients, 79.2% were evaluated after 3 years of follow-up. Quality of life, activity level and mobility dropped importantly and were lower than the values of a German reference population. SF-8 mental did not change. The median age of patients of group 2 was 79.5 years, all of them presented with one or several comorbidities. The median length of in-hospital stay was 18.5 days. 50% of patients suffered from in-hospital complications. The concept of medial buttressing was successful in all patients. 5 of 6 patients (83.3%) could be evaluated after a median of 136 weeks. In none of these patients, secondary surgery was necessary. Quality of life, activity level and mobility importantly dropped as well in this group. SF-8 mental remained unchanged. Conclusion In geriatric acetabular fractures with involvement and medial displacement of the quadrilateral plate, medial buttressing as part of ORIF proved to be reliable. Only 13.5% of patients of group 1 needed a secondary THA within 3 years of follow-up, which is lower than in comparable studies. Despite successful surgery, quality of life, activity level and mobility dropped importantly in all patients. The loss of independence did however not influence SF-8 mental values.


2020 ◽  
Author(s):  
Ahmed H Hussein ◽  
Islam Khaled ◽  
Mohammed Faisal

Abstract Background: Laparoscopic sleeve gastrectomy (LSG) was recently described as an effective approach for the operative treatment of obesity, but the ideal procedure remains controversial. One of the most debated issues is the resection distance from the pylorus (DP). We conducted this study to elucidate any potential difference in the short-term outcome between 2 cm and 6 cm DP in LSG.Methods: This was an interventional, prospective, randomized study aimed at assessing the effect of the resection DP on the weight loss outcome as expressed by the excess weight loss percentage (%EWL) after LSG carried out from January 2018 to March 2020 in 96 patients with morbid obesity who had LSG performed at the Surgical Department, Suez Canal University. The patients were randomly separated into two equal groups; Group 1 (48 patients) underwent LSG with a 2 cm DP resection distance and Group 2 (48 patients) underwent LSG with a 6 cm DP resection distance. Body weight, body mass index, bariatric quality of life, lipid profile, and comorbidities were evaluated pre- and postoperatively for a duration of 12 months.Results: Statistically, there was no significant difference between the two study groups regarding the %EWL, comorbidity resolution throughout the postoperative follow-up, enhancement of the quality of life score throughout the postoperative follow-up, or incidence of complications (25% in Group 1 vs. 25% in Group 2, p > 0.05).Conclusion: LSG was an effective and safe management for morbid obesity and obesity-related comorbidities with significant short-term weight loss; it also improved weight-related quality of life and had an acceptable complication rate. The DP resection distance did not affect the short-term effects of LSG with regard to %EWL, resolution of comorbidities, change in quality of life, and occurrence of complications.


2021 ◽  
Author(s):  
Serhat Yildizhan ◽  
Mehmet Gazi Boyaci ◽  
Usame Rakip ◽  
Adem Aslan

Abstract Purpose The study aimed to investigate the effects and reliability in the prevention of tumour spread of radiofrequency ablation or ablation with vertebroplasty simultaneously applied for pain in patients with painful spinal vertebra metastasis and the effect of preventing tumor spread in long-term follow-up. Methods Patients with painful vertebrae metastasis in the XXX Health Sciences University, Medical Faculty, Hospital Neurosurgery Clinic between 01.01.2015 and 01.02.2019 were recruited. They were divided into groups according to the surgical procedures applied. Group 1 included 12 patients who underwent radiofrequency ablation only, and group 2 included 16 patients who underwent vertebroplasty with radiofrequency ablation. The metastatic lesion, pain, and quality of life were evaluated with imaging, Visual Analog Scale, and Oswestry Disability Survey before and after the procedure. Results A total of 28 patients diagnosed with painful spinal metastasis were included in our study. The degree of collapse increased in five patients in group 1, leading to vertebroplasty. Simple polymethyl methacrylate leakage was observed in four patients in group 2 without spinal cord compression. Pain and quality of life improved significantly in both groups, with more being in Group 2, and analgesic use was significantly reduced. No tumor spread in the vertebrae was observed in any patient during follow-up. Conclusion According to our results, patients with painful vertebral metastases should receive vertebroplasty simultaneously with radiofrequency ablation for palliative pain control and prevention of tumour spread.


EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
S Seliutskii ◽  
N Savina ◽  
A Chapurnykh

Abstract Background radiofrequency ablation (RFA) is considered to be one of the most preferred treatments for atrial fibrillation (AFib) in patients with heart failure (HF). Objective to study the effectiveness of AFib RFA in patients with HF, to compare the effectiveness of the procedure in patients with paroxysmal (PaAFib) and persistent (PeAFib) AFib. Materials and methods 65 patients with AF and HF with LVEF &lt; 50%, who underwent RFA were included in a prospective study. All patients underwent transthoracic echocardiography and quality of life assessment using the SF-36 questionnaire before RFA and after 12 months. AFib was recorded in 42 (65%) of patients, AFL in 23 (35%). Thirty (46%) patients had PaAfib (Group 1), and 35 (54%) PeAFib (Group 2). Results In 45 (69%) patients sinus rhythm (SR) was restored during RFA, in 15 (23%) SR was restored by electrical cardioversion. In 5 (8%) patients with PaAFib revealed SR at the time of RFA. Twelve month follow-up period revealed 49 (75%) patients who were free from AFib: 23 (77%) patients with PaAFib and 26 (74%) with PeAFib. After 12 month follow-up we revealed the improvement in LVEF (p &lt; 0.001 in both groups), decrease of anteroposterior size of left atrium (LA) (p &lt; 0.001 in both groups) and LA volume (p &lt; 0.001 in both groups), improvement in the mental (p = 0.008 in Group 1; p = 0.006 in Group 2) and physical component of health according to the SF-36 questionnaire (p = 0.036 in Group 1; p = 0.049 in Group 2). There were no significant differences between two groups of follow-up period. Conclusions AFib RFA significantly improves the course of heart failure and the quality of life of patients, leads to decrease of left atrium size and increase of LVEF. The effectiveness of RFA does not depend on the type of arrhythmia in  HF patients.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J Proff ◽  
B Merkely ◽  
R Papp ◽  
C Lenz ◽  
P.J Nordbeck ◽  
...  

Abstract Background The prevalence of chronotropic incompetence (CI) in heart failure (HF) population is high and negatively impacts prognosis. In HF patients with an implanted cardiac resynchronisation therapy (CRT) device and severe CI, the effect of rate adaptive pacing on patient outcomes is unclear. Closed loop stimulation (CLS) based on cardiac impedance measurement may be an optimal method of heart rate adaptation according to metabolic need in HF patients with severe CI. Purpose This is the first study evaluating the effect of CLS on the established prognostic parameters assessed by the cardio-pulmonary exercise (CPX) testing and on quality of life (QoL) of the patients. Methods A randomised, controlled, double-blind and crossover pilot study has been performed in CRT patients with severe CI defined as the inability to achieve 70% of the age-predicted maximum heart rate (APMHR). After baseline assessment, patients were randomised to either DDD-CLS pacing (group 1) or DDD pacing at 40 bpm (group 2) for a 1-month period, followed by crossover for another month. At baseline and at 1- and 2-month follow-ups, a CPX was performed and QoL was assessed using the EQ-5D-5L questionnaire. The main endpoints were the effect of CLS on ventilatory efficiency (VE) slope (evaluated by an independent CPX expert), the responder rate defined as an improvement (decrease) of the VE slope by at least 5%, percentage of maximal predicted heart rate reserve (HRR) achieved, and QoL. Results Of the 36 patients enrolled in the study, 20 fulfilled the criterion for severe CI and entered the study follow-up (mean age 68.9±7.4 years, 70% men, LVEF=41.8±9.3%, 40%/60% NYHA class II/III). Full baseline and follow-up datasets were obtained in 17 patients. The mean VE slope and HRR at baseline were 34.4±4.4 and 49.6±23.8%, respectively, in group 1 (n=7) and 34.5±12.2 and 54.2±16.1% in group 2 (n=10). After completing the 2-month CPX, the mean difference between DDD-CLS and DDD-40 modes was −2.4±8.3 (group 1) and −1.2±3.5 (group 2) for VE slope, and 17.1±15.5% (group 1) and 8.7±18.8% (group 2) for HRR. Altogether, VE slope improved by −1.8±2.95 (p=0.31) in DDD-CLS versus DDD-40, and HRR improved by 12.9±8.8% (p=0.01). The VE slope decreased by ≥5% in 47% of patients (“responders to CLS”). The mean difference in the QoL between DDD-CLS and DDD-40 was 0.16±0.25 in group 1 and −0.01±0.05 in group 2, resulting in an overall increase by 0.08±0.08 in the DDD-CLS mode (p=0.13). Conclusion First results of the evaluation of the effectiveness of CLS in CRT patients with severe CI revealed that CLS generated an overall positive effect on well-established surrogate parameters for prognosis. About one half of the patients showed CLS response in terms of improved VE slope. In addition, CLS improved quality of life. Further clinical research is needed to identify predictors that can increase the responder rate and to confirm improvement in clinical outcomes. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Biotronik SE & Co. KG


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
T Demenko ◽  
G.A Chumakova

Abstract Background Mental disorders in patients with cardiovascular disease have a significant impact on the course, the prognosis of the underlying disease and quality of life (QOL). Objective We aimed to examine the prevalence of anxiety and depressive disorders and their impact on the quality of life in patients with atrial fibrillation (AF). Materials and methods In 52 with permanent AF and 50 with paroxysmal AF patients, we administered the depression scale Tsung, the scale of situational anxiety (SA) and personal anxiety (PA) Spielberger-Hanin; QOL was assessed the SF-36 quality of life assessment scale. Correlation analysis using Spearman's rank correlation coefficient. Results The prevalence symptoms mild depression situational or neurotic genesis was 21.1% (12 patients) in Group 1 and 12.0% (6 patients) in Group 2 (p&gt;0.05). Subdepressive state was two percents of patients in Group 1 and Group 2. The incidence SA was 59.6% (31 patients) in Group 1 and 52.0% (26 patients) in Group 2. The incidence PA was 74.0% (37 patients) in Group 2 and 67.3% (35 patients) in Group 1. The average score the physical component of health (PCH) was 29,8±4,3 in Group 1, the mental component of health (MCH) – 49.5±7.4 points; p&lt;0.05. In Group 2: PCH – 44.8±6.6 points, MCH – 26.6±7.5 points; p&lt;0.05. Correlation analysis showed negative strong correlations between SA and MCH (r=−0.64, p=0.0005) and between PA and MCH (r=−0.69, p&lt;0.0001), between SA and PCH (r=−0.71, p=0.0001), between depression and PCH (r=−0.69, p=0.023). Negative statistically significant correlation between depression and MCH (r=−0.69, p=0.54) and negative medium correlation between depression and PCH (r=−0.64, p=0.23). Conclusion These findings suggest that we did not identify patients with symptoms of a true depressive (that can cause pseudodementia and influenced to complete tests). 16.5% patients with AF had mild depression of situational or neurotic genesis. Depression may be a pathogenetic factor of AF or develop because of paroxysms AF – psychological stress. More than 50% patients in Group 1 and Group 2 had an increased anxiety score. SA is more common in patients with permanent AF, probably because older people difficult to adapt to a new situation. PA is more common in patient with paroxysmal AF, probably because disease is sudden and causes anxiety. The PCH of QOL is more impairment in patients with permanent AF, because complications (for example heart failure) impairment physical activity. However, PCH also reduced in patient with paroxysmal AF, because disease is sudden may occur during physical activity. The MCH of QOL is more impairment in patients with paroxysmal AF, because waiting attack effect on mental health and social functioning. An increased level of anxiety and depression negatively affected the mental and physical health of patients with AF. Funding Acknowledgement Type of funding source: None


Pituitary ◽  
2021 ◽  
Author(s):  
Muhammad Fahad Arshad ◽  
Oluwafunto Ogunleye ◽  
Richard Ross ◽  
Miguel Debono

Abstract Purpose There is no consensus on quality of life (QOL) in patients with acromegaly requiring medical treatment after surgery compared with those achieving remission by surgery alone. Methods QuaLAT is a cross-sectional study comparing QOL in surgery-only treated acromegaly patients versus those requiring medical treatment post-surgery. Patients attending clinics were identified and divided into—Group 1: patients who had surgery only and were in biochemical remission, Group 2: all patients on medical treatment post-surgery, Group 3: patients from Group 2 with biochemical control. Participants were asked to fill three questionnaires; Acromegaly Quality of Life Questionnaire (ACROQOL), 36-Item Short Form Survey (SF36), and Fatigue Severity Scale (FSS). Results There were 32 patients in Group 1 and 25 in Group 2. There was no difference in QOL scores between groups 1 and 2, as measured by ACROQOL (mean difference [MD] = − 2.5, 95% CI − 16.6 to 11.6; p = 0.72), SF36v2 [Physical component score (PCS) MD = − 4.9, 95% CI − 10.9 to 1.2; p = 0.12; mental component score MD = − 3.0, 95% CI − 10.5 to 4.4; p = 0.44], or FSS (MD = − 0.004, 95% CI − 1.14 to 1.33; p = 0.1). Comparison between groups 1 and 3 however showed that PCS (and 3 subdomains) was significantly better in group 3 (MD = − 8.3, 95% CI − 14.8 to -1.8; p = 0.01). All three QOL scores were lower when compared with healthy controls. Conclusions Medical treatment not only achieves a QOL comparable to surgery, it may also be associated with better QOL in physical subdomains. When compared with healthy controls, QOL remains worse in treated acromegaly patients compared to controls.


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