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2017| April-June | Volume 2 | Issue 2
July 10, 2017
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Comparison of two care schedules for monitoring of cardiotoxicity in patients receiving trastuzumab-based therapy for early-stage breast cancer: study protocol for a randomized controlled non-inferiority trial
Olexiy Aseyev, Carol Stober, Jeffrey Sulpher, Mark Clemons, Christopher Johnson, Dean Fergusson, Lisa Vandermeer, Sasha Mazzarello, Susan Dent
April-June 2017, 2(2):40-45
Cardiotoxicity is a toxic side effect of trastuzumab-based therapy. Current guidelines for cardiac monitoring (every 3 months) in patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer receiving trastuzumab-based therapy have been dictated by the increased risk of cardiotoxicity observed in clinical trials. However, the majority of these patients are at a low risk of cardiac complications and may not require such frequent monitoring.
This randomized controlled clinical trial will be performed to demonstrate that cardiac monitoring (echocardiography (ECHO)/multiple gated acquisition scan (MUGA) every 4 months is not inferior to every 3 months in the detection of cardiac dysfunction (decrease in left ventricular ejection fraction (LVEF)) in patients receiving trastuzumab-based therapy for early-stage HER2-positive breast cancer.
From June 2016 to December 2018.
The Ottawa Hospital Cancer Centre.
Dr. Olexiy Aseyev and Dr. Susan Dent at Department of Medicine, Division of Medical Oncology, The Ottawa Hospital, University of Ottawa, Canada.
A prospective, single-center, randomized controlled non-inferiority clinical trial.
A total of 200 patients with early-stage HER2-positive breast cancer (
= 100 in each group) receiving trastuzumab-based therapy will be enrolled.
Patients with histologically confirmed early-stage HER2-positive breast cancer receiving trastuzumab-based therapy, who are over 18 years of age, have a normal baseline LVEF (> 53%) and are able to provide verbal consent will be included in this study.
Patients will be excluded if they have any contraindication to transthoracic echocardiography or MUGA.
Eligible and consented patients will be randomized using a permuted block design to receive cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months, or every 4 months while on treatment, 100 patients for each type of cardiac evaluation.
Primary outcome measure:
The rate of changes in LVEF diagnosed by ECHO or MUGA throughout trastuzumab-based therapy in both groups.
Secondary outcome measures:
Rates of trastuzumab delay/discontinuation, referral to cardiology, rate of cardiac events.
Human specimen collection:
This study was approved by the Ottawa Health Science Network Research Ethics Board.
ClinicalTrials.gov identifier: NCT02696707 on February 18, 2016.
This study is currently recruiting participants. Study enrolment is expected to be completed by July 2018 and analysis of primary outcome measure will be completed by October 2018 and the study will be completed by December 2018.
This study will present data on the cardiac safety of less frequent cardiac monitoring in patients with early-stage HER2-positive breast cancer. Future trials will explore cardiac monitoring strategies using composite data including baseline cardiac risk factors, baseline cardiac imaging and cardiac biomarkers. Health care economics will be explored.
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Tc-anti-TNF-α scintigraphy in the assessment of rheumatic disease activity
Bianca Gutfilen, Sergio Augusto Lopes de Souza, Gianluca Valentini
April-June 2017, 2(2):31-35
Tc-anti-TNF-α scintigraphy may recognize the molecule involved in the inflammatory process and provide crucial information to help physicians to make decisions about which drugs to be used based on biological evidence, and which are cost-effective and appropriate for the treatment of choice. This study protocol for phase I/II clinical trials was designed to investigate the efficacy and safety of
Tc-anti-TNF-α scintigraphy in the detection of disease activity.
This case analysis, single-center prospective phase I/II clinical trial has been performed at the Department of Radiology of the Federal University of Rio de Janeiro, Brazil.
Tc-anti-TNF-α scintigraphy and MRI were carried out in 12 rheumatoid arthritis (RA) patients, 2 axial spondyloarthritis (axSpA) patients, 8 ankylosing spondylitis (AS) patients, and 3 healthy volunteers. MRI was used as gold standard.
Tc-anti-TNF-α scintigraphy was well tolerated without any side effects in all patients. No radiopharmaceutical uptake was observed in the joints or skin of healthy volunteers.
Tc-anti-TNF-α scintigraphy results corresponded to MRI findings in 12 patients with RA, in two axSpA patients, in six AS patients (two positive for and four negative for active disease), but it did not correspond to MRI findings in two AS patients (one false negative for and one false positive for active disease). All three patients with mechanical lombalgia were negative for active disease in both scintigraphy and MRI.
We have developed a novel approach to label a fully human monoclonal anti-TNF-α antibody (Adalimumab) with
Tc, with high labeling efficiency (95%). This technique has shown great success in evaluating disease activity in patients with RA, axSpA and AS, avoiding unnecessary biological therapy. The findings from this trial will provide valuable evidence for the use of
Tc-anti-TNF-α scintigraphy in rheumatic diseases.
ClinicalTrials.gov identifier: NCT02134613; registered on April 28, 2014.
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Metastatic adenocarcinoma of the lung presenting as deep vein thrombosis: an evidence of anchoring bias
Walid Ibrahim, Hossam Abubakar, Lubna Osman, Muhammad Sheikh
April-June 2017, 2(2):36-39
Non-small cell lung cancer is the most common type of lung cancer and it is often diagnosed at the advanced stages of this disease. Although skeletal metastasis is a common manifestation of lung cancer, distal appendicular skeletal metastasis, especially distal to the knee and elbow joints, is relatively rare.
We described a 51-year-old female patient who had been admitted with a classical presentation and diagnosis of lower-extremity deep vein thrombosis that cannot be cured using conventional treatment. Further workup revealed a mass arising from the head of the fibula compressing the adjacent vasculature that was found to be metastatic pulmonary adenocarcinoma.
Identifying such uncommon presentations may be delayed or missed due to cognitive errors including anchoring bias. Knowledge and insight of such errors may possibly reduce their incidence and their consequent preventable patient injury.
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