Excellent Outcome In Infants below One Year of Age with AML – Results of Studies AML-BFM -98 and -2004

Abstract Abstract 17 Infants <1 year of age with AML are very vulnerable patients who may not tolerate intensive treatment, which is however required to achieve complete remission (CR) and long-term survival. In several pediatric AML studies, outcome of this age group is described as unfavorable. Here we report the improved outcome of 108 infants with AML (Down syndromes excluded) who were treated within the studies AML-BFM 98 and -2004 until end of 2008. Treatment regimens of study AML-BFM 98 (see Creutzig, J Clin Oncol 24, 2006) and AML-BFM 2004 were largely similar. AML-BFM 2004: Induction with AIE (cytarabine, idarubicin and etoposide) or ADxE (Dx=liposomal daunorubicin) - exclusively in high-risk (HR) patients supplemented by HAM (high-dose cytarabine [HD-Ara-C] and mitoxantrone) - continued by two short therapy cycles with medium and HD-Ara-C and anthracyclines, followed by intensification with HAE (HD-Ara-C and etoposide) and maintenance. Allogeneic stem cell-transplantation (SCT) in 1st CR from a family donor was restricted to HR patients. Drug dosage was generally calculated according to bodyweight instead of bodysurface in this age cohort; HD-Ara-C was dose adjusted for age (from 20% in the <3-month- to 60% in >11-month-olds). Patients' age was 0.6 years in median (interquartile range 0.3 –0.7 years) and white blood cell count 26,000μ /L (interquartile range 8,500 – 106,250μ /L). Most infants (103/108) were HR patients according to morphology, cytogenetics, molecular genetics, and therapy response. Four of the 5 standard risk patients had favorable cytogenetics with inv(16) and t(15;17); 47/90 (52%) patients with data showed a MLL rearrangement. Results in this cohort of infants were similar compared to older HR patients. Early death rate was higher by trend compared to 1–3 year old patients: 6/108 (5.6%) vs. 3/156 (1.9%), px2 0.12; non-response rates were similar: 11/108 (10.2%) vs. 14/154 (9.1%), px2 0.77. Overall survival (OS) in the total group (n=108) was 68%+5%. OS improved from study -98 to -2004 from 60%+6% (n=59) to 78%+6% (n=49), plogrank 0.07. Event-free survival (EFS) in the total group was 45%+5%; EFS results in study -98 vs. -2004 were similar: 43%+7% vs. 47%+8%, plogrank 0.98. There was no difference in OS, EFS and cumulative incidence for relapse in infants aged 1–3, 4–6, 7–9 or 10–12 months, regardless of whether presenting with or without initial CNS involvement, MLL rearrangement or other molecular-/cytogenetic features (the number of patients with favorable cytogenetic was too low). Results for HR infants (95% of the patients) were similar to those in older age groups (1-2 or 2–10 year olds, plogrank 0.75). All 8 patients receiving allogeneic (SCT) in 1st remission survived although 2 children relapsed. Five of 10 patients transplanted after initial non-/partial response and 19/30 patients transplanted after relapse are still alive. Survival after relapse (n=37) was 50±8%. The rate of grade III/IV toxicities after induction was highest in infants <1 year of age and decreased in the age groups of 1–2 and 2–3 years (general condition 52% vs. 44% vs. 30%, (px2 <1 vs. 2–3 years 0.07); infection 47% vs.49% vs. 23% (px2 <1 vs. 2–3 year olds 0.06); lung problems, e.g. artificial respirator needed 31% vs. 18% vs. 0% (px2 <1 vs. 2–3 years 0.01); whereas the treatment related death rate was in the same range as in older patients (4%). Conclusion: Our data show that intensive AML treatment is feasible in infants. Toxicities can be managed, and outcome is excellent, which is partly due to salvage therapy after relapse, with a present 5-year OS rate of 78%. *Supported by the Deutsche Krebshilfe e.V. Disclosures: Off Label Use: liposomal daunorubicin is used, which is off label for pediatric AML. It was used because it offers a possibility to increase cumulative dosages of anthracyclines with lower cardiotoxicity.

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Old Patients and Uremia: Rates of Acceptance to and Withdrawal from Dialysis

The International Journal of Artificial Organs ◽

10.1177/039139888701000307 ◽

1987 ◽

Vol 10 (3) ◽

pp. 166-172 ◽

Cited By ~ 37

Author(s):

D.G. Husebye ◽

C.M. Kjellstrand

Keyword(s):

Risk Factors ◽

Medical Center ◽

Age Groups ◽

The United States ◽

Living Situation ◽

Term Survival ◽

Old Patients ◽

Hennepin County ◽

Number Of Patients ◽

Patients At Risk

We studied the entry of elderly uremic patients to chronic dialysis in the U.S. in 1979. We also reviewed long-term survival, causes of death, and risk factors for death in old patients on dialysis at one center for the period 1966 to 1983. A comparison of the number of patients at risk with the number entering dialysis in the United States in 1979 indicates that 80% of the patients aged 25-45 years, 30% of patients over the age of 65 years, and 6% of those over the age of 75 years entered dialysis during that period. Of 239 patients over the age of 70 years followed at the Regional Kidney Disease Program at Hennepin County Medical Center in Minneapolis, the seven-year cumulative survival was 17%. In this program withdrawal from dialysis was the commonest cause of death, accounting for 40% of all deaths. Age groups over 75 years, sex, time period, duration of dialysis, eight pre-existing degenerative diseases, living situation, family support, and site and type of dialysis were not risk factors for termination of dialysis, but living in a nursing home was. When compared to the young, total deaths and deaths from discontinuation were much higher, and this decision was made earlier. Half of the patients who died because dialysis was discontinued were competent and decided for themselves; the other half were incompetent and families and physicians made the decision. Thus, old patients do not live as long, and they withdraw from dialysis more frequently than the young. Qualitatively, though, the decisions to stop dialysis are no different from those decisions made by or for younger patients.

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Long-Term Relative Survival after Stroke: The Dijon Stroke Registry

Neuroepidemiology ◽

10.1159/000505160 ◽

2019 ◽

Vol 54 (6) ◽

pp. 498-505

Author(s):

Gaëlle Romain ◽

Anne-Sophie Mariet ◽

Valérie Jooste ◽

Gauthier Duloquin ◽

Quentin Thomas ◽

...

Keyword(s):

Sex Differences ◽

Age Groups ◽

Relative Survival ◽

Older Age ◽

Term Survival ◽

Old Patients ◽

Stroke Registry ◽

Stroke Subtypes ◽

Age And Sex

Objective: The aim of this study was to assess long-term survival after stroke and to compare survival profiles of patients according to stroke subtypes, age, and sex, using relative survival (RS) method. Methods: All patients with a first-ever stroke were prospectively recorded in the population-based Dijon Stroke Registry from 1987 to 2016. RS is the survival that would be observed if stroke was the only cause of death. Ten-year RS was estimated using a flexible parametric model of the cumulative excess mortality rate, which was obtained by matching the observed all-cause mortality in the stroke cohort to the expected mortality in the general population. A separate model was fitted for each stroke subtypes, first fitted for each age and sex separately, and then adjusted for age and sex. Results: In total, 5,259 patients (mean age 74.9 ± 14.3 years, 53% women) were recorded including 4,469 ischemic strokes (IS), 655 intracerebral hemorrhages (ICH), and 135 undetermined strokes. In IS patients, unadjusted RS was 82% at 1 year and decreased to 62% at 10 years. Adjusted RS showed a lower survival in older age groups (p < 0.001), but no difference between men and women (p = 0.119). In ICH patients, unadjusted RS was 56 and 42% at 1 and 10 years, respectively, with a lower adjusted survival in older age groups (p < 0.001), but no sex differences (p = 0.184). Conclusion: This study showed that RS after stroke is lower in older than in younger patients but without significant sex differences, and survival profiles differ according to stroke subtypes. Since RS allows a better estimation of stroke-related death than observed survival does, especially in old patients, such a method is adapted to provide reliable information when considering long-term outcome.

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Relapsed Acute Myeloid Leukemia in Children and Adolescents: Interim Results of the International Randomised Phase III Study “Relapsed AML 2001/01”.

Blood ◽

10.1182/blood.v106.11.897.897 ◽

2005 ◽

Vol 106 (11) ◽

pp. 897-897

Author(s):

Gertjan J. Kaspers ◽

M. Zimmermann ◽

G. Fleischhack ◽

R. Tamminga ◽

B. Gibson ◽

...

Keyword(s):

Central Nervous System Involvement ◽

Phase Iii ◽

Late Relapse ◽

Unrelated Donor ◽

Term Outcome ◽

Term Survival ◽

Long Term Outcome ◽

Liposomal Daunorubicin ◽

Total Group

Abstract Relapse occurs in 30–40% of newly diagnosed AML patients, with long-term survival in 20% of them. We initiated a study for relapsed AML excluding AML M3 and those >18 years of age. As backbone, FLAG is being used for 2 consecutive courses: fludarabine 30 mg/m2/day x 5, cytarabine 2 g/m2/day x 5, G-CSF 200 μg/m2/dose for 6 days, starting day −1. Liposomal daunorubicin (DaunoXome®, DNX) is a “new” anthracycline with potentially less cardiotoxicity, applicable in the total group of patients, and with the perspective to be useful at initial treatment as well. Therefore, DNX at 60 mg/m2/day on days 1, 3 and 5 was added or not in a 1:1 randomised fashion to the first course of FLAG. The ongoing prospective study must determine the efficacy and toxicity of DNX when added to FLAG, and the long-term outcome in a large group of relapsed AML patients. 13 groups worldwide are enrolling patients. 303 patients were registered as per April 2005. This planned interim analysis with blinded efficacy data concerns 226 eligible and evaluable patients with first relapsed AML, 140 (62%) being male. Median age at relapse was 9.7 (range, 0.7–18) years. 50% of patients relapsed within 1 year from initial diagnosis. The majority concerned isolated bone marrow relapse (85%), with 1% isolated and 5% combined central nervous system involvement. Median WBC at relapse was 4.0 (range, 0.4–293) x 109/l. Dominating FAB types are M2 with auer rods, M4 without eosinophils and M5. The randomisation was actually performed in 81% of patients. A total of 63% of patients was transplanted, the majority with a matched unrelated donor. Poor response to the 1st course of therapy (>20% of blasts in the BM shortly before the 2nd course), was seen in 23% of patients. Early death occurred in 6% of patients. Complete remission (CR) was achieved in 62% of patients, and they have a probability of survival at 2 years (2-yr pSurv.) of 47±6% (compared to 33±5% for the total group), 38±9% for early relapses and 54±7% for late relapses. Patients not achieving CR had a 2-yr pSurv. of 5±4%. Compared to early relapses, patients with late relapse had higher CR rates (74 vs 51%), and higher 2-yr pSurv.: 42±6% vs 21±5%. There was significant grade III/IV toxicity, but no unexpected toxicity, and no clinically relevant differences between the arms with and without DNX, especially not in cardiotoxicity. In conclusion, it is feasible to perform a large randomised study in a very international setting. DNX added to FLAG does not result in major additional toxicity, but follow-up of cardiotoxicity should be extended as planned in this protocol. Late relapses do better in terms of CR and overall survival, but early relapses achieving CR have a realistic chance of survival as well. The study is ongoing until 360 patients have been randomised, to answer the question whether liposomal daunorubicin improves outcome in pediatric relapsed AML. Meanwhile, overall outcome is encouraging, with CR achieved in 62% of patients of whom 47% are survivors at 2 years.

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Features of the complex treatment of ulcerative colitis in clinical practice

Terapevt (General Physician) ◽

10.33920/med-12-2005-01 ◽

2020 ◽

pp. 6-11

Author(s):

Svetlana Svetlana ◽

Mikhail Klimentov ◽

Olga Neganova ◽

Alina Nazmieva ◽

Anastasiya Kochurova

Keyword(s):

Ulcerative Colitis ◽

Clinical Practice ◽

Statistical Study ◽

Age Groups ◽

Length Of Hospital Stay ◽

Unknown Etiology ◽

Number Of Patients ◽

First Republic ◽

Bowel Diseases ◽

Inflammatory Bowel

Nowadays there are certain difficulties in the early diagnosis of ulcerative colitis, proceeding with minimal intestinal symptoms. The etiology of the disease remains unclear to this day; there is no exact information about the prevalence of the disease due to the large number of latent forms and the low number of patients seeking medical help. This article presents the results of a retrospective analysis of the incidence of ulcerative colitis in the coloproctology department of the First Republic Clinical Hospital of Izhevsk. The study was conducted to assess the frequency of occurrence and determine the internal picture of ulcerative colitis. To achieve this goal, we selected 34 patients with ulcerative colitis. A statistical study was conducted on the following criteria: gender composition, age groups, forms of the disease, localization, complications, and main complaints. The length of hospital stay often was not more than 20 days. The literature on this pathology was also studied and presented in the form of a theoretical basis, which consisted of the determination and etiology of inflammatory bowel diseases. Due to the unknown etiology, insufficiently studied pathogenesis, difficult differential diagnosis with other intestinal diseases and insufficiently perfect treatment methods, there are a large number of unresolved problems in the field of ulcerative colitis. That is why, in this article we tried to reveal the problem of the features of the course and complex therapy of that disease in clinical practice.

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Characteristics of Osteoporosis & Osteoporotic Fractures in Korea Based on Health Insurance Review and Assessment (HIRA) Database: 2009–2017

Healthcare ◽

10.3390/healthcare9030324 ◽

2021 ◽

Vol 9 (3) ◽

pp. 324

Author(s):

Ho-Seok Oh ◽

Sung-Kyu Kim ◽

Hyoung-Yeon Seo

Keyword(s):

Health Insurance ◽

Age Groups ◽

Osteoporotic Fractures ◽

Prescription Data ◽

Diagnostic Codes ◽

Number Of Patients ◽

Upper And Lower Extremities ◽

Fractures Of The Spine ◽

And Gender ◽

Age Range

To investigate the incidence and characteristics of osteoporosis and osteoporotic fractures in Korea, we used the Health Insurance Review and Assessment Service (HIRA) database. Patients over 50 years old, who were diagnosed or treated for osteoporosis and osteoporotic fractures in all hospitals and clinics, were analyzed between 1 January 2009 and 31 December 2017 by using the HIRA database that contains prescription data and diagnostic codes. These data were retrospectively analyzed by decade and age-specific and gender-specific incidents in each year. We also evaluated other characteristics of patients including medication state of osteoporosis, primary used medical institution, regional-specific incidence of osteoporosis, and incidence of site-specific osteoporotic fractures. The number of osteoporosis patients over 50 years old, as diagnosed by a doctor, steadily increased from 2009 to 2017. The number of osteoporosis patients was notably greatest in the 60′s and 70′s age groups in every study period. Patients undergoing treatment for osteoporosis increased significantly (96%) from 2009 to 2017. Among the patients diagnosed with osteoporosis, the proportion who experienced osteoporotic fracture increased gradually (60%) from 2009 to 2017. The number of patients with osteoporotic fractures of the spine and hip was highest in the 70 to 90 age range, and the number of patients with osteoporotic fractures in the upper and lower extremities was highest in the 50 to 70 age range. Understanding the trends of osteoporosis in Korea will contribute to manage the increased number of patients with osteoporosis and osteoporotic fractures.

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Durable Continuous-Flow Mechanical Circulatory Support: State of the Art

Hearts ◽

10.3390/hearts2010010 ◽

2021 ◽

Vol 2 (1) ◽

pp. 127-138

Author(s):

Antonio Loforte ◽

Luca Botta ◽

Silvia Boschi ◽

Gregorio Gliozzi ◽

Giulio Giovanni Cavalli ◽

...

Keyword(s):

Heart Transplantation ◽

Continuous Flow ◽

Mechanical Circulatory Support ◽

State Of The Art ◽

Ease Of Use ◽

Circulatory Support ◽

Pulse Modulation ◽

Ventricular Assist ◽

Old Patients ◽

Number Of Patients

Implantable mechanical circulatory support (MCS) systems for ventricular assist device (VAD) therapy have emerged as an important strategy due to a shortage of donor organs for heart transplantation. A growing number of patients are receiving permanent assist devices, while fewer are undergoing heart transplantation (Htx). Continuous-flow (CF) pumps, as devices that can be permanently implanted, show promise for the treatment of both young and old patients with heart failure (HF). Further improvement of these devices will decrease adverse events, enable pulse modulation of continuous blood flow, and improve automatic remote monitoring. Ease of use for patients could also be improved. We herein report on the current state of the art regarding implantable CF pumps for use as MCS systems in the treatment of advanced refractory HF.

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Letter to the Editor: Microbiota in the Respiratory System—A Possible Explanation to Age and Sex Variability in Susceptibility to SARS-CoV-2

Microbiology Insights ◽

10.1177/1178636120988604 ◽

2021 ◽

Vol 14 ◽

pp. 117863612098860

Author(s):

Vishal Shah

Keyword(s):

Respiratory System ◽

Elderly Population ◽

Age Groups ◽

The Elderly ◽

Elderly Adult ◽

Human Respiratory Tract ◽

System A ◽

Number Of Patients ◽

Children And Young Adults ◽

Age And Sex

The Human respiratory tract is colonized by a variety of microbes and the microbiota change as we age. In this perspective, literature support is presented for the hypothesis that the respiratory system microbiota could explain the differential age and sex breakdown amongst COVID-19 patients. The number of patients in the older and elderly adult group is higher than the other age groups. The perspective presents the possibility that certain genera of bacteria present in the respiratory system microbiota in children and young adults could be directly or through eliciting an immune response from the host, prevent full-fledged infection of SARS-CoV-2. The possibility also exists that the microbiota in older adults and the elderly population have bacteria that make it easier for the virus to cause infection. I call upon the scientific community to investigate the link between human microbiota and SARS-CoV-2 susceptibility to further understand the viral pathogenesis.

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Endovascular aortic repair with EndoAnchors demonstrate good mid-term outcomes in physician-initiated multicenter analysis—The PERU registry

Vascular ◽

10.1177/1708538121992596 ◽

2021 ◽

pp. 170853812199259

Author(s):

Andrés Reyes Valdivia ◽

Arindam Chaudhuri ◽

Ross Milner ◽

Giovanni Pratesi ◽

Michel MPJ Reijnen ◽

...

Keyword(s):

Real World ◽

Endovascular Aneurysm Repair ◽

Abdominal Ultrasound ◽

Interquartile Range ◽

Technical Success ◽

Number Of Patients ◽

Hostile Neck ◽

Aneurysm Repair ◽

Related Mortality

Objectives We aim to describe real-world outcomes from multicenter data about the efficacy of adjunct Heli-FX EndoAnchor usage in preventing or repairing failures during infrarenal endovascular aneurysm repair (EVAR), so-called EndoSutured-aneurysm-repair (ESAR). Methods The current study has been assigned an identifier (NCT04100499) at the US National Library of Medicine ( https://ClinicalTrials.gov ). It is an observational retrospective study of prospectively collected data from seven vascular surgery departments between June 2010 and December 2019. Patients included in the ANCHOR registry were excluded from this analysis. The decision for the use of EndoAnchors was made by the treating surgeon or multidisciplinary aortic committee according to each center’s practice. Follow-up imaging was scheduled according to each center’s protocol, which necessarily included either abdominal ultrasound or radiography or computed tomographic scan imaging. The main outcomes analyzed were technical success, freedom from type Ia endoleaks (IaEL), all-cause and aneurysm-related mortality, and sac variation and trends evaluated for those with at least six months imaging follow-up. Results Two hundred and seventy-five patients underwent ESAR in participating centers during the study period. After exclusions, 221 patients (184 males, 37 females, mean age 75 ± 8.3 years) were finally included for analysis. Median follow-up for the cohort was 27 (interquartile range 12–48) months. A median 6 (interquartile range 3) EndoAnchors were deployed at ESAR, 175 (79%) procedures were primary and 46 (21%) revision cases, 40 associated with type IaEL. Technical success at operation (initial), 30-day, and overall success were 89, 95.5, and 96.8%, respectively; the 30-day success was higher due to those with subsequent spontaneous proximal endoleak seal. At two years, freedom from type IaEL was 94% for the whole series; 96% and 86% for the primary and revision groups, respectively; whereas freedom from all-cause mortality, aneurysm-related mortality, and reintervention was 89%, 98%, and 87%, respectively. Sac evolution pre-ESAR was 66 ± 15.1 vs. post ESAR 61 ± 17.5 (p < 0.001) and for 180 patients with at least six-month follow-up, 92.2% of them being in a stable (51%) or regression (41%) situation. Conclusions This real-world registry demonstrates that adjunct EndoAnchor usage at EVAR achieves high rates of freedom from type IaEL at mid-term including in a high number of patients with hostile neck anatomy, with positive trends in sac-size evolution. Further data with longer follow-up may help to establish EndoAnchor usage as a routine adjunct to EVAR, especially in hostile necks.

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Comparison of Human Thymus Gland between Young and Old Age

10.53350/pjmhs211561907 ◽

2021 ◽

Vol 15 (6) ◽

pp. 1907-1909

Author(s):

Faiza Mehboob ◽

Ponum Mirani ◽

M. Kamran Ameer ◽

Khurram Shabeer ◽

Muhammad Ali Qamar ◽

...

Keyword(s):

Connective Tissue ◽

Old Age ◽

Age Groups ◽

Young Age ◽

University Hospital ◽

P Value ◽

Old Patients ◽

Human Thymus ◽

Group I ◽

Significant Difference

Aim: Study was conducted to examine the different parameters of human thymus glands of young and old patients and compare the findings between both age groups. Study Design: Comparative/observational study Place and Study: Study was conducted at Anatomy department of Nishtar Medical University Hospital, Multan for duration of six months from 15th January 2020 to 15th July 2020. Methods: Total 54 specimens of human thymus of 54 patients were enrolled in this study. All specimens were divided in to two groups I and II, Group I contains 27 patients with ages <30 years and group II with 27 patients having ages 45 to 60 years. All specimens were fixed in 10% formalin solution and then processed for paraffin embedding. Compare the different parameters such as thickness of interlobular connective tissue and thymic capsule, length and number of Hassal’s corpuscles between both groups. Data was analyzed by SPSS 24.0. Results: In group I 12 (44.44%) patients were ages <15 years and 15 (55.56%) patients were ages >15 years. In group 13 (48.15%) and 14 (51.85%) patients were ages <50 years and >50 years. There was a significant difference observed between both groups regarding thickness of interlobular connective tissue and thymic capsule, quantity and length of Hassal’s corpuscles with p-value <0.05. Conclusion: It is to be concluded that patients with young age had significantly less thickness of thymic capsule and interlobular connective tissue with more in number and decreasing size of Hassal’s corpuscles as compared to old age patients. Keywords: Human Thymus Glands, Young Age, Old Age

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Patients Satisfaction Undergoing Endometrial Thermal Balloon Ablation for the Treatment of Intractable Menorrhagia

10.53350/pjmhs2115102537 ◽

2021 ◽

Vol 15 (10) ◽

pp. 2537-2539

Author(s):

Saman Ejaz ◽

Maryam Raana ◽

Ambar Riaz ◽

Netasha Nazar ◽

Amara Mumtaz ◽

...

Keyword(s):

Age Groups ◽

Balloon Catheter ◽

Uterine Cavity ◽

Premenopausal Women ◽

Patients Satisfaction ◽

Number Of Patients ◽

Significant Difference ◽

Insignificant Difference ◽

Balloon Ablation ◽

Thermal Balloon

Background: Heavy amounts of menstrual blood loss regularly in three or more consecutive cycles are characterized as menorrhagia which has been shown to be present among in many peri-menopausal and premenopausal women. Aim: To determine the frequency of patients’ satisfaction with TBA for the treatment of intractable menorrhagia. Methods: This descriptive study was undertaken in Department of Obstetrics and Gynecology, Lady Wallington Hospital Lahore from January to July 2017. A sample size of 200 patients was calculated and informed consent was taken to fill predesigned Performa. Prophylactic dose of 1g Ceftriaxon antibiotic was administered and Foly’s catheters were placed simultaneously in uterine cavity of patients after curettage and dilations. The uterine balloon catheter was then entered into the uterus and balloon was filled with sterile fluid. Results: A high number of 157(78.5%) women were found to be satisfied with thermal balloon ablation while different age groups presented an insignificant difference on level of satisfaction. Level of education and BMI had insignificant difference (p >0.05) while a significant difference (p<0.05) was observed among patients suffering from long duration of >6 months as compared to short duration of 3-6 months. Conclusion: Thermal balloon ablation is the method of choice for treatment of women suffering from menorrhagia and high number of patients revealed their trust on this method. Keywords: Menorrhagia, Dysmenorrhea, Blooding, Satisfaction, Endometrium.

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