Clinical and neurophysiologic prospective study with time-event and long-term analysis of the chronic neurotoxicity associated with oxaliplatin in patients with colorectal cancer (CRC).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15150-e15150
Author(s):  
Javier Cassinello ◽  
Carolina Serrano ◽  
Melchor Alvarez De Mon
Keyword(s):  
Predictive Factor ◽  
Protective Factor ◽  
Female Gender ◽  
First Year ◽  
Clinical Scales ◽  
Fine Fiber ◽  
End Of Treatment ◽  
Maximum Improvement

e15150 Background: The sensitive, symmetric, chronic neurotoxicity is a frequent dose-dependent and dose-limiting secondary effect of oxaliplatin (COXALIN). Time-event and long-term studies about COXALIN and its progression after the end of treatment ( coasting) are lacking. Methods: A prospective, translational, clinical and neurophysiologic study was performed in patients (p) with CRC treated with oxaliplatin. We analyzed COXALIN during and after treatment (at the time of initial, maximum coasting, improvement and maximum improvement). We followed p every 3 months the first year and every 6 months thereafter. The NCI-CTC V3.0 sensitive and modified TNSc (without motor and autonomic skills) clinical scales and Quantitave Sensitive Test and ENG were used. Results: 41 chemo naive p with CRC were included, 22 men, median age 60 y (IA:55-73).Oxaliplatin was administrated as adjuvant treatment in 36p. FOLFOX combination was used in 40p. The median cumulative doses was 825,25 mg/m2 (IA: 697-963). The median follow-up was 21,5m (11-27). 38 p developed COXALIN at median 5,5 m (IA: 4,4-6,6) and maximum coasting at median 8,5 m (IA: 7,6-9,5); in multivariant analysis, cumulative dose at 3 months (p = 0,039; OR 2,5; p = 0,027; HR 0,5) was predictive factor and female gender (p = 0,017; OR 0,11) was protective factor. Fine fiber neuropathy was detected in 47,4% p. All p improved at median 8,7m (IA: 7,1-10,2) since COXALIN, reaching the maximum improvement at 13,4 m (IA:16,0-20,4); on multivariate analysis, the COXALIN intensity was the predictive factor (p = 0,03; HR 0,42). 76,6%p showed residual COXALIN (73,9% p subclinical/mild, 17,4% p moderated and 8,7% p severe). A high correlation was found between clinical scales and neurophysiologic studies along the study (p < 0,0001). Sensitive NCI-CTC scale was more sensible than modified TNSc to evaluate COXALIN intensity in our study. Conclusions: We confirm coasting in COXALIN which prolongs 6 months after treatment. About 80% p showed residual COXALIN in the long-term but it was subclinical or mild in most cases. Sensitive NCI-CTC 3.0 scale is a simple and reliable method for the follow-up of COXALIN.

scholarly journals Long-Term Follow-Up of 106 Multiple Sclerosis Patients Undergoing Interferon-β 1a or 1b Therapy: Predictive Factors of Thyroid Disease Development and Duration

2005 ◽  
Vol 90 (7) ◽  
pp. 4133-4137 ◽  
Author(s):  
N. Caraccio ◽  
A. Dardano ◽  
F. Manfredonia ◽  
L. Manca ◽  
L. Pasquali ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Predictive Factors ◽  
Predictive Factor ◽  
Thyroid Disease ◽  
Thyroid Dysfunction ◽  
Thyroid Autoimmunity ◽  
First Year ◽  
Disease Development

Abstract Background: Conflicting data have been reported on the association between interferon (IFN)-β therapy of multiple sclerosis (MS) patients and thyroid disease development. Aims: The goals of this study are as follows: to assess the actual occurrence of thyroid dysfunction and autoimmunity during long-term IFN-β therapy; to establish the possible presence of predictive factors for thyroid dysfunction development and duration; and to suggest an effective follow-up protocol for patients receiving long-term IFN-β therapy. Study Protocol: A total of 106 MS patients (76 women) underwent IFN-β 1a or 1b therapy for up to 84 months (median, 42 months). Thyroid function and autoimmunity were assessed at baseline and every 3–6 months throughout the treatment course. Results: Baseline thyroid autoimmunity was detected in 8.5% of patients and hypothyroidism in 2.8%. Thyroid dysfunction (80% hypothyroidism, 92% subclinical, 56% transient) developed in 24% (68% with autoimmunity) of patients and autoimmunity in 22.7% (45.5% with dysfunction), without significant differences between the two cytokines; 68% of dysfunctions occurred within the first year. Autoimmunity emerged as the only predictive factor for dysfunction development (relative risk, 8.9), whereas sustained disease was significantly associated with male gender (P &lt; 0.003). Conclusions: Both incident thyroid autoimmunity and dysfunction frequently occur in MS patients during IFN-β therapy, particularly within the first year of treatment. Thyroid dysfunction is generally subclinical and transient in over than half of cases; preexisting or incident autoimmunity emerged as the only significant predictive factor for thyroid dysfunction development. Thyroid function and autoimmunity assessment is mandatory within the first year of IFN-β therapy; thereafter, serum TSH measurement only in patients with thyroid disease could be sufficient.

Muenke syndrome: long-term outcome of a syndrome-specific treatment protocol

2019 ◽  
Vol 24 (4) ◽  
pp. 415-422 ◽  
Author(s):  
Bianca K. den Ottelander ◽  
Robbin de Goederen ◽  
Marie-Lise C. van Veelen ◽  
Stephanie D. C. van de Beeten ◽  
Maarten H. Lequin ◽  
...  
Keyword(s):  
Treatment Protocol ◽  
First Year ◽  
Ventricular Size ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Skull Growth ◽  
Muenke Syndrome ◽  
First Year Of Life

OBJECTIVEThe authors evaluated the long-term outcome of their treatment protocol for Muenke syndrome, which includes a single craniofacial procedure.METHODSThis was a prospective observational cohort study of Muenke syndrome patients who underwent surgery for craniosynostosis within the first year of life. Symptoms and determinants of intracranial hypertension were evaluated by longitudinal monitoring of the presence of papilledema (fundoscopy), obstructive sleep apnea (OSA; with polysomnography), cerebellar tonsillar herniation (MRI studies), ventricular size (MRI and CT studies), and skull growth (occipital frontal head circumference [OFC]). Other evaluated factors included hearing, speech, and ophthalmological outcomes.RESULTSThe study included 38 patients; 36 patients underwent fronto-supraorbital advancement. The median age at last follow-up was 13.2 years (range 1.3–24.4 years). Three patients had papilledema, which was related to ophthalmological disorders in 2 patients. Three patients had mild OSA. Three patients had a Chiari I malformation, and tonsillar descent < 5 mm was present in 6 patients. Tonsillar position was unrelated to papilledema, ventricular size, or restricted skull growth. Ten patients had ventriculomegaly, and the OFC growth curve deflected in 3 patients. Twenty-two patients had hearing loss. Refraction anomalies were diagnosed in 14/15 patients measured at ≥ 8 years of age.CONCLUSIONSPatients with Muenke syndrome treated with a single fronto-supraorbital advancement in their first year of life rarely develop signs of intracranial hypertension, in accordance with the very low prevalence of its causative factors (OSA, hydrocephalus, and restricted skull growth). This illustrates that there is no need for a routine second craniofacial procedure. Patient follow-up should focus on visual assessment and speech and hearing outcomes.

Long-Term Follow-Up of Early Cochlear Implant Device Activation

2021 ◽  
pp. 1-11
Author(s):  
Stefanie Bruschke ◽  
Uwe Baumann ◽  
Timo Stöver
Keyword(s):  
Speech Recognition ◽  
Side Effects ◽  
Cochlear Implant ◽  
Surgical Techniques ◽  
Control Group ◽  
First Year ◽  
Safe Procedure ◽  
Sound Processor

Background: The cochlear implant (CI) is a standard procedure for the treatment of patients with severe to profound hearing loss. In the past, a standard healing period of 3–6 weeks occurred after CI surgery before the sound processor was initially activated. Advancements of surgical techniques and instruments allow an earlier initial activation of the processor within 14 days after surgery. Objective: Evaluation of the early CI device activation after CI surgery within 14 days, comparison to the first activation after 4–6 weeks, and assessment of the feasibility and safety of the early fitting over a 12 month observation period were the objectives of this study. Method: In a prospective study, 127 patients scheduled for CI surgery were divided into early fitting group (EF, n = 67) and control group (CG, n = 60). Individual questionnaires were used to evaluate medical and technical outcomes of the EF. Medical side effects, speech recognition, and follow-up effort were compared with the CG within the first year after CI surgery. Results: The early fitting was feasible in 97% of the EF patients. In the EF, the processor was activated 25 days earlier than in the CG. No major complications were observed in either group. At the follow-up appointments, side effects such as pain and balance problems occurred with comparable frequency in both groups. At initial fitting, the EF showed a significantly higher incidence of medical minor complications (p < 0.05). When developing speech recognition within the first year of CI use, no difference was observed. Furthermore, the follow-up effort within the first year after CI surgery was comparable in both groups. Conclusions: Early fitting of the sound processor is a feasible and safe procedure with comparable follow-up effort. Although more early minor complications were observed in the EF, there were no long-term wound healing problems caused by the early fitting. Regular inspection of the magnet strength is recommended as part of the CI follow-up since postoperative wound swelling must be expected. The early fitting procedure enabled a clear reduction in the waiting time between CI surgery and initial sound processor activation.

scholarly journals Inter-relationships between Gender, Frailty and 10-Year Survival in Older Italian Adults: an observational longitudinal study

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Graziamaria Corbi ◽  
Francesco Cacciatore ◽  
Klara Komici ◽  
Giuseppe Rengo ◽  
Dino Franco Vitale ◽  
...  
Keyword(s):  
Longitudinal Study ◽  
Cox Model ◽  
Survival Rates ◽  
Staging System ◽  
Female Gender ◽  
Term Survival ◽  
Fractional Polynomial ◽  
The Impact

AbstractAim of the present study was to assess the impact of gender on the relationship between long-term mortality and clinical frailty. In an observational, longitudinal study on 10-year mortality, we examined 1284 subjects. The Frailty Staging System was used to assess frailty. The Cox model was employed to assess variables independently associated with survival using a backward stepwise algorithm. To investigate the possible interactions between gender and the selected variables, an extension of the multivariable fractional polynomial algorithm was adopted. Women were more likely to be older, have a higher disability, present with more comorbidities, consume more drugs, be frail and have a higher rate of survival at the follow-up than were men. At the Cox multivariate analysis only age (HR 2.26), female gender (HR 0.43), and number of drugs (HR 1.57) were significant and independent factors associated with all-cause mortality. In the survival analyses, only frailty (vs no frailty) showed significant interaction with gender (p < 0.001, HR = 1.92). While the presence of frailty reduced the survival rate in women, no effect was observed in men. Importantly, frail women showed higher survival rates than did both frail and no frail men. The main finding of the present study is that gender shapes up the association between frailty and long-term survival rates.

scholarly journals Bioabsorbable vascular scaffolds in routine practice: long-term results

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
R M Mori ◽  
I N G Nunez
Keyword(s):  
Protective Factor ◽  
Randomized Clinical Trials ◽  
Real Life ◽  
Long Term Results ◽  
Routine Practice ◽  
Target Vessel ◽  
Intracoronary Imaging ◽  
Vascular Scaffolds

Abstract Background Recent publications suggest that bioabsorbable vascular scaffolds (BVS) carry an excess of thrombotic complications. Our goal was to describe the results in real life and in the long term, in a series of patients who received a BVS which is currently off the market. Methods Two hundred and thirteen consecutive patients who received at least 1 BVS between May 2012 and December 2016 were analyzed. The primary objective was the incidence of the compound event “target vessel failure” that included infarction or target vessel revascularization and cardiac death. Results Seventy-five percent of patients were men with a mean age of 61.4 years. They had a high prevalence of dyslipidemia (62.44%) and smoking (65.26%). The most common cause of admission was myocardial infarction without ST elevation (53.52%). A total of 233 coronary lesions were treated, with an average of 1.3±0.3 lesions per patient. The implant was successful in 99.5% of cases. Predilatation was performed in 89.3% and post dilation in 33.5% of cases. The use of intracoronary imaging (Optical Coherence Tomography OCT and/or Intravascular ultrasonography IVUS) to optimize the BVS implant was performed in 86 patients (40.38%). With a mean follow-up of 42.5 months, the incidence of target vessel failure was 6.57% during the first 24 months and 7.98% at the end of the follow-up. Regarding the device, this included 6 cases (2.81%) of thrombosis (definitive, probable or possible) and 10 cases (4.69%) of restenosis. Patients with a history of diabetes mellitus (HR 1.72 95% CI 1.01–2.95 P=0,05) and/or chronic oral anticoagulation (HR 5.71 95% CI 1.12–28.94 P=0.04) had a higher risk of target vessel failure. The use of intracoronary imaging (OCT and/or IVUS) during the BVS implantation had a considerable trend toward significance as a protective factor (HR 0.32 95% CI 0.11–1.03 P=0.06). Conclusions In this series of patients; in real life conditions, the incidence of target vessel failure was comparable to that previously described in randomized clinical trials. The events were more frequent during the first 2 years of follow-up, in the presence of greater cardiovascular comorbidity and in the absence of intracoronary imaging during the implantation. FUNDunding Acknowledgement Type of funding sources: Other. Main funding source(s): European Society of Cardiology KM curve for target vessel failure (TVF) Predictor analysis for TVF

Abstract TMP83: Long-term Risk of Venous Thromboembolism After Stroke

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Santosh B Murthy ◽  
Alexander E Merkler ◽  
Gino Gialdini ◽  
Abhinaba Chatterjee ◽  
Costantino Iadecola ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Venous Thromboembolism ◽  
Proportional Hazards ◽  
Cox Regression ◽  
Multivariable Analysis ◽  
First Year ◽  
Cumulative Rate ◽  
Incident Cases

Background: There are few data on the long-term risk of venous thromboembolism (VTE) among stroke survivors. We aimed to compare the incidence of VTE amongst patients with ischemic stroke versus those with intracerebral hemorrhage (ICH). Methods: We identified all adults discharged from nonfederal acute care hospitals in CA, NY, and FL between 2005 and 2012 with previously validated ICD-9-CM codes for ischemic stroke and ICH. Our primary outcome of VTE was defined as pulmonary embolism or deep vein thrombosis. To capture incident cases of VTE, we excluded patients with a VTE prior to or during the index stroke. Kaplan-Meier survival statistics were used to calculate the cumulative rate of incident VTE. Cox regression was used to compare the risk of VTE after stroke while adjusting for demographics, vascular risk factors, and Elixhauser comorbidity index. As there was a violation of the proportional-hazards assumption, we calculated separate hazard ratios (HR) for each year of follow-up. Results: We identified 834,660 patients with stroke, of whom 712,440 (85.3%) had ischemic stroke and 112,220 (14.7%) had ICH. Over a mean follow-up of 2.8 (+/-2.4) years, 19,937 (2.4%) developed VTE. After 7 years, the cumulative rate of VTE was 4.7% (95% confidence interval [CI], 4.5-4.9%) in patients with ICH and 4.4% (95% CI, 4.3-4.5%) in patients with ischemic stroke. In multivariable analysis, VTE risk was higher in the first year after ICH compared to ischemic stroke (HR 1.51; 95% CI, 1.43-1.58). However, following the first year, the hazard of VTE was higher among patients with ischemic stroke versus those with ICH (Figure). Conclusions: The risk of VTE after stroke varies by stroke type and time. Patients with ICH have a higher risk of VTE in the first year after stroke as compared to those with ischemic stroke while patients with ischemic stroke have a higher risk beyond 1 year.

Abstract 11503: Mindfulness is Inversely Associated with Psychological Symptoms in Long-Term Cardiac Arrest Survivors

Circulation ◽  
2021 ◽  
Vol 144 (Suppl_2) ◽  
Author(s):  
Alex Presciutti ◽  
Jonathan Greenberg ◽  
Ethan Lester ◽  
Mary M Newman ◽  
Jonathan Elmer ◽  
...  
Keyword(s):  
Cardiac Arrest ◽  
Protective Factor ◽  
Psychological Symptoms ◽  
Sudden Cardiac Arrest ◽  
Survey Study ◽  
Present Moment ◽  
Cross Sectional ◽  
Patient Health

Introduction: We sought to identify correlates with psychological symptoms in long-term cardiac arrest (CA) survivors. Mindfulness, or nonjudgmental awareness of the present moment, is a modifiable protective factor against psychological symptoms in various clinical populations and could be a potential treatment target for CA survivors. Methods: We conducted a longitudinal survey study between 10-11/2019 (baseline) and 10-11/2020 (1-year follow-up) with long-term CA survivor members of the Sudden Cardiac Arrest Foundation. We collected demographic and CA characteristics at baseline. At both timepoints, we assessed posttraumatic stress symptoms (PTS) through the PTSD Checklist-5 (PCL-5) and depression and anxiety symptoms through the Patient Health Questionnaire-4 (PHQ-4). At follow-up, we assessed mindfulness through the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). We used adjusted linear regression to predict 1-year PCL-5 and PHQ-4 scores, with particular consideration of the CAMS-R as a cross-sectional correlate of outcome. Results: We included 129 CA survivors (mean age: 52 years, 52% male, 98% white). At 1-year follow-up, in adjusted models, CAMS-R (β: -0.35, p <0.001) and baseline PCL-5 scores (β: 0.56, p <0.001) were associated with 1-year PCL-5 scores. CAMS-R (β: -0.34, p <0.001) and baseline PHQ-4 scores were associated with 1-year PHQ-4 scores (β: 0.37, p<0.001). Conclusion: Mindfulness was inversely associated with psychological symptoms in long-term CA survivors. Future studies should examine the longitudinal relationship of mindfulness and psychological symptoms after CA.

Safety and tolerability of prescribed usage of Derise® (Darbepoetin Alfa, Hetero) in symptomatic anemia: A Post Marketing Surveillance Study

2020 ◽  
Author(s):  
Shubhadeep Sinha ◽  
Vamsi Krishna Bandi ◽  
Bala Reddy Bheemareddy ◽  
Pankaj Thakur ◽  
Sreenivasa Chary ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Adverse Events ◽  
Darbepoetin Alfa ◽  
P Value ◽  
End Of Treatment ◽  
Post Marketing Surveillance ◽  
Post Marketing

Abstract Background This post marketing surveillance, observational, prospective, safety study evaluated the safety, tolerability and long term immunogenicity of prescribed usage of Darbepoetin alfa, (DA-α, manufactured by Hetero Biopharma) in Indian patients with chronic kidney disease with anemia.Methods All patients with anemia of chronic kidney disease prescribed Hetero-Darbepoetin were the target patient population. The present study gathered the data from 503 Hetero-Darbepoetin alfa prescribed patients. This study collected information of patient demography, patient's medical history, concomitant medications, action taken with respect to Hetero-Darbepoetin-alfa, AE details (AE term, start date, stop date, severity, action taken, outcome and causality), periodic Hemoglobin (Hb) levels and abnormal laboratory tests results until treatment is discontinued or the patient is lost to follow-up. Immunogenicity data was collected in 121 patients at the end of treatment and after 1 year. Statistical analyses were performed to explore and analyze details of individual case safety reports of adverse events such as incidence, severity, seriousness, outcome, duration, action taken, and causality relationship of individual adverse event (AE) to the prescribed study drug. Results 87 AEs were reported in this study and most of them were mild to moderate in intensity. No deaths or serious adverse events (SAEs) were reported in this study. Anti-drug antibodies were not detected in any subject at the end of treatment phase and after 12 months long term follow up period. Baseline mean Hemoglobin value was 8.34 (SD 1.24) g/dL and last visit mean Hemoglobin value was 10.42 (SD 1.28) g/dL. The mean difference between baseline and last visit was 2.10 [2.00, 2.20], statistically significant (p-value <.0001). Conclusions The safety and tolerability of the usage of DA-α (manufactured by Hetero Biopharma) is similar to that reported in the published literature of the innovator. No patients showed anti-drug antibodies after treatment. Additionally, the patients also showed significant improvement in hemoglobin levels, compared to baseline.Clinical Trial Registry Number: CTRI/2017/04/008338 [Registered on CTRI http://ctri.nic.in/Clinicaltrials/login.php : 12/04/2017]; Trial Registered Retrospectively

scholarly journals Stability of Drinking Reductions and Long-term Functioning Among Patients with Alcohol Use Disorder

2020 ◽  
Author(s):  
Katie Witkiewitz ◽  
Henry R. Kranzler ◽  
Kevin A. Hallgren ◽  
Deborah S. Hasin ◽  
Arnie P. Aldridge ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Alcohol Use ◽  
Alcohol Use Disorder ◽  
Well Being ◽  
Total Sample ◽  
World Health ◽  
End Of Treatment

Abstract Background The World Health Organization (WHO) categorizes alcohol consumption according to grams consumed into low-, medium-, high-, and very-high-risk drinking levels (RDLs). Although abstinence has been considered the ideal outcome of alcohol treatment, reductions in WHO RDLs have been proposed as primary outcomes for alcohol use disorder (AUD) trials. Objective The current study examines the stability of WHO RDL reductions and the association between RDL reductions and long-term functioning for up to 3 years following treatment. Design and Participants Secondary data analysis of patients with AUD enrolled in the COMBINE Study and Project MATCH, two multi-site, randomized AUD clinical trials, who were followed for up to 3 years post-treatment (COMBINE: n = 694; MATCH: n = 806). Measures Alcohol use was measured via calendar-based methods. We estimated all models in the total sample and among participants who did not achieve abstinence during treatment. Key Results One-level RDL reductions were achieved by 84% of patients at the end of treatment, with 84.9% of those individuals maintaining that reduction at a 3-year follow-up. Two-level RDL reductions were achieved by 68% of patients at the end of treatment, with 77.7% of those individuals maintaining that reduction at a 3-year follow-up. One- and two-level RDL reductions at the end of treatment were associated with significantly better mental health, quality of life (including physical quality of life), and fewer drinking consequences 3 years after treatment (p < 0.05), as compared to no change or increased drinking. Conclusion AUD patients can maintain WHO RDL reductions for up to 3 years after treatment. Patients who had WHO RDL reductions functioned significantly better than those who did not reduce their drinking. These findings are consistent with prior reports suggesting that drinking reductions, short of abstinence, yield meaningful improvements in patient health, well-being, and functioning.

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