(Press-News.org) Contact information: Dr. Anna-Sabine Ernst
presse@iqwig.de
49-022-135-6850
Institute for Quality and Efficiency in Health Care
Enzalutamide in prostate cancer: Hints of added benefit
Longer overall survival in patients without visceral metastases / bone complications and pain progression delayed
Enzalutamide (trade name: Xtandi) has been approved since June 2013 for men with metastatic prostate cancer in whom the commonly used hormone blockade is no longer effective and who have already been treated with the cytostatic drug docetaxel. In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether this new drug offers an added benefit over the appropriate comparator therapy specified by the Federal Joint Committee (G-BA).
In comparison with "best supportive care", there is a hint of a major added benefit in patients whose internal organs are free of metastases of the tumour. In patients with such visceral metastases, the extent of added benefit is "considerable".
"Best supportive care" was appropriate comparator therapy
The G-BA specified "best supportive care" (BSC) as appropriate comparator therapy. BSC means a therapy that provides the patient with the best possible individually optimized supportive treatment to alleviate symptoms (e.g. adequate pain therapy) and improve quality of life.
Adequate pain therapy questionable in approval study
Studies that tested a comparison of enzalutamide with or without BSC versus BSC alone could be considered for the benefit assessment. The approval study (AFFIRM) met these criteria. It was unclear, however, whether patients in the control group actually received adequate pain therapy throughout the entire study and whether therefore the criteria of BSC were fulfilled. Due to this increased uncertainty, at most "hints", but not "indications" could be derived from the AFFIRM results.
Survival advantage only in patients without tumours in internal organs
As the data showed, patients in the enzalutamide arm of the study survived longer than in the control group. However, there were also indications that the characteristic "presence or lack of metastases in internal organs" can influence the treatment result and is therefore a so-called "effect modifier". In separate analyses, overall survival was found to be longer only in patients without visceral metastases. Hence, there is an added benefit in mortality only for this subgroup.
Bone lesions occurred later, less pain
There were no effect modifiers regarding symptoms and late complications, i.e. the differences between the enzalutamide and the control arm apply to all patients. Bone complications like fractures occurred later in the study under enzalutamide than under BSC alone. Pain progression was also delayed, and, at the end of the study, pain intensity was lower in patients who had received enzalutamide.
Some data on side effects were not evaluable
Independent from the type of treatment, side effects occurred in almost all patients. However, most data on side effects submitted by the drug manufacturer were not evaluable.
This is due to the fact that the treatment and observation duration of the patients differed between the two treatment arms. The longer a treatment lasts, the more likely it becomes that side effects occur. However, the manufacturer did not consider this difference adequately in the analysis of the data. Hence no conclusions can be drawn with regards to serious adverse events (SAEs) or to treatment discontinuations due to side effects.
Data were uncertain, but interpretable
Despite this uncertainty, the data could be interpreted with the result that severe adverse events occurred less frequently in men who were treated with enzalutamide. This indicates lesser harm of the new drug. Because these results might be biased, the frequency – and thus the extent of this advantage – could not be accurately assessed.
The manufacturer's dossier did not contain any evaluable data on health-related quality of life.
Overall, the evaluable data only show positive effects
Hence the overall assessment only shows advantages of enzalutamide. No disadvantages could be determined in any aspect of the treatment for which evaluable data were available. IQWiG therefore considers there to be hints of an added benefit in all patients. However, it rates their extents differently: For patients with visceral metastases, the extent is "considerable"; for patients without visceral metastases, it is "major" because of the additional survival advantage.
G-BA decides on the extent of added benefit
The dossier assessment is part of the overall procedure for early benefit assessment conducted by the G-BA. After publication of the manufacturer's dossier and IQWiG's assessment, the G-BA conducts a commenting procedure, which may provide further information and result in a change to the benefit assessment. The G-BA decides on the extent of the added benefit, thus completing the early benefit assessment.
###
An overview of the results of IQWiG's benefit assessment is given by a German-language executive summary. In addition, the website gesundheitsinformation.de, published by IQWiG, provides easily understandable and brief German-language information on enzalutamide.
The G-BA website contains both general English-language information on benefit assessments pursuant to §35a Social Code Book V and specific German-language information on the assessment of enzalutamide.
If you would like to be informed when these documents are available, please send an e-mail to info@iqwig.de.
Enzalutamide in prostate cancer: Hints of added benefit
Longer overall survival in patients without visceral metastases / bone complications and pain progression delayed
2013-12-06
ELSE PRESS RELEASES FROM THIS DATE:
Study finds parental stress linked to obesity in children
2013-12-06
Study finds parental stress linked to obesity in children
Effects on Hispanic children more pronounced
TORONTO, Dec. 6, 2013—Parental stress is linked to weight gain in children, according to a new study from St. Michael's Hospital.
The study found that children ...
What is the link between erectile dysfunction and heart disease?
2013-12-06
What is the link between erectile dysfunction and heart disease?
New Rochelle, NY, December 6, 2013—Erectile dysfunction (ED) is caused by the inability of the artery that supplies blood to the penis to expand and contract properly. The ...
Coal yields plenty of graphene quantum dots
2013-12-06
Coal yields plenty of graphene quantum dots
Rice U. scientists find simple method for producing dots in bulk from coal, coke
HOUSTON – (Dec. 6, 2013) – The prospect of turning coal into fluorescent particles may sound too good to be true, but the possibility exists, thanks ...
Graphene: Growing giants
2013-12-06
Graphene: Growing giants
Huge grains of copper promote better graphene growth
WASHINGTON D.C. Dec. 6, 2013 -- To technology insiders, graphene is a certified big deal. The one-atom thick carbon-based material elicits rhapsodic descriptions as the strongest, ...
1 percent of the population is responsible for 63 percent of violent crime convictions
2013-12-06
1 percent of the population is responsible for 63 percent of violent crime convictions
The majority of all violent crime in Sweden is committed by a small number of people. They are almost all male (92%) who early in life develops violent criminality, substance abuse ...
Frequent cell phone use linked to anxiety, lower grades and reduced happiness in students
2013-12-06
Frequent cell phone use linked to anxiety, lower grades and reduced happiness in students
Today, smartphones are central to college students' lives, keeping them constantly connected with friends, family and the Internet. Students' cell phones are rarely out of reach ...
Taking probiotics in pregnancy or giving them to infants doesn't prevent asthma
2013-12-06
Taking probiotics in pregnancy or giving them to infants doesn't prevent asthma
Taking probiotics has health benefits but preventing childhood asthma isn't one of them, shows newly published research led by medical scientists at the ...
Counting the cost of infertility treatment
2013-12-06
Counting the cost of infertility treatment
From drug therapy to IVF, out-of pocket costs can range from $900 to $19,000 per treatment cycle, report researchers in The Journal of Urology®
New York, NY, December 6, 2013 – Although the demand for infertility treatment ...
Penn researcher traces the history of the American urban squirrel
2013-12-06
Penn researcher traces the history of the American urban squirrel
Until recently, Etienne Benson, an assistant professor in the University of Pennsylvania's Department of History and Sociology of Science, has trained his academic eye on the history of ...
At AGU: Shale sequestration, water for energy & soil microbes
2013-12-06
At AGU: Shale sequestration, water for energy & soil microbes
PNNL shares research at world's largest geophysical science meeting
SAN FRANCISCO – Scientists from the Department of Energy's Pacific Northwest National Laboratory will present a variety ...
LAST 30 PRESS RELEASES:
Hydroquinone-buffered covalent organic frameworks for long-term photocatalytic hydrogen peroxide production
From coal to chemicals: Breakthrough syngas catalysis powers green industrial future
AI detects the stiffness of cancer cell exosomes: DGIST develops deep learning-based lung cancer diagnostic technology
Positive ethnic identity fosters STEM career aspirations
Wildlife show wide range of responses to human presence in U.S. national parks
Great Tits show early signs of splitting up: Oxford researchers uncover social clues to bird 'divorce'
From the lab to the hand: nanodevice brings personalized genomics closer to reality
Women politicians receive more identity-based attacks on social media than men, study finds
Idaho National Laboratory accelerates nuclear energy projects with Amazon Web Services cloud and AI technologies
Kavraki elected to European Academy of Sciences
UK teens who currently vape as likely to start smoking as their peers in the 1970s
Higher ultra processed food intake linked to increased lung cancer risk
Exercise rehab lessens severity, frequency + recurrence of irregular heart rhythm (AF)
Deep heat beneath the United States traced to ancient rift with Greenland
Animals in national parks remained wary of human footprint during 2020 COVID shutdown
Stevens INI receives prestigious contract to advance women’s brain health
Fulbright funds OU professor’s biodiversity research
Antiviral treatment fails to slow early-stage Alzheimer’s
Can African countries meet 2030 childhood immunization goals?
Low pre-pregnancy blood sugar linked with higher risk of preterm birth, other risks
AI reveals language links between Reddit groups for hate speech, psychiatric disorders
A fast daily walk could extend your life: Study
Genome sequencing of butterflies resolves centuries-old conundrum
U-M study: E-cigarettes could unravel decades of tobacco control
Blending technologies may help coral offspring blossom
Research alert: Cannabis use disorder triples risk of oral cancer
Brown University to lead national institute focused on intuitive, trustworthy AI assistants
On track to produce better lab-grown burgers
Class divided: How Aussie highschoolers are separated on ability
Polygenic architecture of dental caries: single nucleotide polymorphisms in genetic epidemiology
[Press-News.org] Enzalutamide in prostate cancer: Hints of added benefitLonger overall survival in patients without visceral metastases / bone complications and pain progression delayed