Breaking News
July 21, 2018 - Intervention program that includes a personalized app could benefit teens with suicidal thoughts
July 21, 2018 - Researchers identify new compound that protects against neurodegeneration
July 21, 2018 - Gene therapy may hold potential to treat people with spinal cord injuries
July 21, 2018 - FDA Approves Nivestym (filgrastim-aafi), a Biosimilar to Neupogen
July 21, 2018 - Surgeons have substantial impact on genetic testing in breast cancer patients who need it
July 21, 2018 - Species diversity can have positive and negative impacts on disease transmission
July 21, 2018 - Genome research suggests presence of enteric fever in medieval Europe
July 21, 2018 - Risk of Sensory Deficits Drops With Rising Gestational Age
July 21, 2018 - Mum’s sleep matters—the effect of sleep on an unborn baby
July 21, 2018 - UC San Diego researchers awarded two grants for investigating stem cell-based therapies
July 21, 2018 - Cellular ‘garbage disposal’ may actually work on some of the proteins to neuronal development
July 21, 2018 - More Pregnant Women Having Heart Attacks
July 21, 2018 - Acne Breakouts | NIH News in Health
July 21, 2018 - Change health messaging to focus on potential impact to help stop the next pandemic
July 21, 2018 - Frailty associated with poor survival rates in young heart patients
July 21, 2018 - New discovery could save millions of lives from fatal fungal infections
July 21, 2018 - OBD presents latest data on the use of EpiSwitch™ in predicting patient response to immunotherapy and identifying lymphoma subtypes
July 21, 2018 - Childhood adversity increases susceptibility to addiction via immune response
July 21, 2018 - Scientists identify potential target for the treatment of binge eating
July 21, 2018 - Whole-brain LIPUS therapy improves cognitive dysfunction in mice simulating dementia, Alzheimer’s
July 21, 2018 - Digital media use raising risk of ADHD symptoms among the young
July 21, 2018 - Phase 3 study of tanezumab in patients with osteoarthritis pain meets all three co-primary endpoints
July 21, 2018 - Restoring mitochondrial function to reverse aging-related skin wrinkles, hair loss in mice
July 21, 2018 - SP PennTech introduces RW-500 rotary vial washer for biotech, pharmaceutical applications
July 21, 2018 - Researchers to study molecular mechanisms behind susceptibility of males to autism
July 21, 2018 - Researchers study efficacy and safety of new treatment for OUD
July 21, 2018 - Fourth Published Clinical Trial Confirms Long-Term Safety of Niagen Supplementation at High Doses and Shows Potential for Improvement in Liver Health
July 21, 2018 - Study examines effects of a two-day intermittent calorie restriction diet for patients with type 2 diabetes
July 21, 2018 - Greening vacant urban land reduces feelings of depression for surrounding residents
July 21, 2018 - Parents say intense gun violence in PG-13 movies appropriate for teens 15 and older
July 21, 2018 - Collaborative study to assess effects of exercise training for cognitive deficits in MS
July 21, 2018 - FAU researchers find possible cause of Parkinson’s disease in the patients’ immune system
July 21, 2018 - Protective qualities of ‘good cholesterol’ reduce after menopause
July 21, 2018 - Researchers develop new way to uncover hidden breast cancer tumors
July 21, 2018 - FDA approves first drug for treatment of adult AML patients with specific genetic mutation
July 21, 2018 - Top AI companies join hands to discover novel drugs for DMD
July 21, 2018 - Ferring announces FDA approval of ZOMACTON for injection in four new pediatric indications
July 20, 2018 - Researchers design proteins that can self-assemble into complex structures
July 20, 2018 - AVITA Medical expands management team to support launch of RECELL device to treat burns
July 20, 2018 - FDA Approves Tibsovo (ivosidenib) for Relapsed or Refractory Acute Myeloid Leukemia with an IDH1 Mutation
July 20, 2018 - Developmental screening and surveillance rates remain low, new study suggests
July 20, 2018 - TGen opens tissue donation portal to advance DIPG research
July 20, 2018 - Health impact of highly processed summertime staples
July 20, 2018 - Exergaming can improve health in overweight and obese children, study shows
July 20, 2018 - Postmenopausal factors may impact heart-protective qualities of ‘good cholesterol’
July 20, 2018 - MRI and blood test combination results in improved prostate cancer diagnosis
July 20, 2018 - Update Health Professional and Consumer on Recent Recalled Products
July 20, 2018 - Researchers trace Parkinson’s damage in the heart
July 20, 2018 - Wearable device designed to measure cortisol in sweat
July 20, 2018 - Scientists demonstrate a new regulation mechanism for skeletal muscles
July 20, 2018 - Exposure to mobile phone radiation may negatively impact memory performance in adolescents
July 20, 2018 - SUSU scientists find alternative method to treat post-traumatic stress disorder syndrome
July 20, 2018 - Gestational diabetes may increase offspring’s heart disease risk
July 20, 2018 - New vaccine could protect unborn babies from Zika virus
July 20, 2018 - Researchers find high mercury and methylmercury concentrations in traditional Tibetan medicine
July 20, 2018 - Brief Safety Plan Intervention in ER Can Cut Suicidal Behavior
July 20, 2018 - The Mount Sinai Hospital receives accreditation as geriatric emergency department
July 20, 2018 - Toward a better understanding of Parkinson’s disease
July 20, 2018 - Med school communications office wins four national awards | News Center
July 20, 2018 - Professional baseball players with faster hand-eye coordination may have better batting performance
July 20, 2018 - Study looks into mechanisms that control sleep and wakefulness
July 20, 2018 - Scientists identify melanoma biomarkers that could help tailor immunotherapy treatments
July 20, 2018 - Research reveals long-term efficacy of drug used to treat common cause of kidney failure
July 20, 2018 - Timing of dinner associated with breast and prostate cancer risks
July 20, 2018 - Health Tip: Performing the Heimlich Maneuver
July 20, 2018 - Nearly all adolescents have eating, activity or weight-related issues
July 20, 2018 - Sage launches new web-based tool that helps explore curated genomic analyses of Alzheimer’s
July 20, 2018 - High-performance porous polymeric material for chromatography applications
July 20, 2018 - New molecule shows great promise for future treatment of many cancers
July 20, 2018 - New research project investigates alternative treatments for eye infections
July 20, 2018 - Immune T cells are built to react as fast as possible, shows study
July 20, 2018 - ZHX2 protein could offer a new treatment strategy for kidney cancer
July 20, 2018 - EKF’s Quo-Lab POC HbA1c analyzer meets international quality targets for diabetes testing
July 20, 2018 - Health burdens of very high risk drinking are potentially large, study reveals
July 20, 2018 - Using miniature drug-filled nanocarriers to target headaches and tumors
July 20, 2018 - Researchers uncover cause for progression of prostate cancer to incurable stage
July 20, 2018 - Studies highlight issues regarding black lung, opioid overdose, police violence and more
July 20, 2018 - AbbVie submits supplemental NDA to FDA for venetoclax to treat acute myeloid leukemia
July 20, 2018 - Researchers are one step closer to developing eye drops to treat age-related macular degeneration (AMD)
July 20, 2018 - Patients maintain muscle mass five years after surgically induced weight loss
IQWiG experts contradict MINDACT study data on biomarker tests for breast cancer

IQWiG experts contradict MINDACT study data on biomarker tests for breast cancer

image_pdfDownload PDFimage_print

The American Society of Clinical Oncology (ASCO) recently updated its guideline on biomarkers with regard to the MammaPrint test and published this update in the Journal of Clinical Oncology (JCO). On the basis of data from the MINDACT study, they concluded that in certain patient groups, MammaPrint can better identify those patients who do not require chemotherapy and that therefore this test could support decision-making on the type of treatment.

A group of authors from the German Institute for Quality and Efficiency in Health Care (IQWiG) has contradicted this conclusion in a letter to the editor: As the first prospective randomized controlled trial, MINDACT provides valuable findings on biomarker tests. However, the IQWiG authors believe that the conclusion drawn by the ASCO authors is incorrect.

Per protocol analysis insufficiently considered

The MINDACT study primarily aimed to answer a non-inferiority question, namely, whether patients with a high recurrence risk according to conventional clinical criteria, but a low recurrence risk according to the biomarker test, could omit chemotherapy. However, in these patients a per-protocol analysis showed a statistically significant disadvantage of the test for the outcome “disease-free survival”. Moreover, with an absolute risk difference of 3 percent after only 5 years, this difference reached a magnitude that had been defined as clinically relevant for other questions of MINDACT.

In addition, the IQWiG authors presented their own analysis of the published MINDACT data, which indicates that the MammaPrint test does not provide an information gain in comparison with conventional clinical criteria. However, original data from MINDACT would be required to verify this finding. In their response to IQWiG’s letter to the editor, the ASCO authors noted that IQWiG’s additional analysis was interesting and agreed that a more complete analysis of the MINDACT data would be useful if the original data could be obtained.

German S3 guideline also recently revised

An update of the German S3 guideline has also recently been published. The guideline authors incorporated the comments IQWiG made in the consultation phase. IQWiG’s doubts about MammaPrint, which the Institute had already raised in its benefit assessment of the biomarker test in December 2016, were considered in verbatim form. However, the recommendation on the use of biomarker tests in certain situations remained unchanged.

Source:

https://www.iqwig.de/en/press/press-releases/biomarker-tests-in-early-breast-cancer-iqwig-criticizes-interpretation-of-mindact-data-in-an-updated-us-guideline.8145.html

Tagged with:

About author

Related Articles