(Press-News.org) Contact information: Dr. Anna-Sabine Ernst
presse@iqwig.de
49-022-135-6850
Institute for Quality and Efficiency in Health Care
Regorafenib: hint of minor added benefit
Advantage in overall survival, but disadvantage in severe side effects
Regorafenib (trade name: Stivarga) has been approved in Germany since August 2013 for adults with metastatic colorectal cancer in whom previous treatments are no longer effective or for whom these alternatives are not an option. 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).
According to the findings, there is a hint of a minor added benefit of regorafenib. Patients have a survival advantage, but certain severe side effects occur more frequently.
"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 and improve quality of life.
The manufacturer presented data from the approval study (CORRECT) in its dossier. One study group was treated with regorafenib plus BSC, and the control group received a placebo plus BSC. However, it was not allowed to use other systemic anticancer treatments as part of the BSC.
Reduced reliability of the conclusions: not more than a hint can be derived
There are several reasons why the reliability of the conclusions of the results from CORRECT is limited: On the one hand, it remained unclear whether the excluded anticancer treatments would have been able to relieve the symptoms and thus should have been part of the – palliative – BSC. In the follow-up phase, i.e. after the end of the study treatment, 25 to 30 per cent of the patients received this kind of further systemic anticancer treatment.
On the other hand, only patients with a certain status of the disease (ECOG-PS 0 or 1) could participate in the study, although regorafenib is also approved for patients with poorer general condition (ECOG-PS > 1).
For these reasons, not more than a hint of an added benefit can be derived from the data presented in the dossier.
Advantage in overall survival
The analysis of the data showed a statistically significant difference between the two study arms in favour of regorafenib for the outcome "overall survival". Half of the patients who received regorafenib had died after 6.5 months. In the control group, this was already the case after about 5 months. IQWiG therefore considers there to be a hint of a considerable added benefit.
Data on morbidity and quality of life were not evaluable
Data on symptoms and complaints (morbidity) and on health-related quality of life were recorded with questionnaires, but were not evaluable for the benefit assessment. The main reason was that this information was only actually available for some of the participants at the end of the treatment (< 70%). The low response rate of the questionnaires cannot be sufficiently explained by the death of these patients.
Severe side effects more frequent under regorafenib
There were no statistically significant differences between the two treatment arms with regards to serious adverse events and treatment discontinuation due to adverse events. The situation was different with regards to severe side effects (CTCAE Grade 3): They were more frequent in the regorafenib group than in the placebo group. The biggest differences (? 5%) occurred in fatigue, diarrhoea, hand-foot syndrome and certain types of skin rash (exanthemas).
Regarding side effects, IQWiG therefore derives a hint of greater harm with the extent "major". However, this greater harm does not completely outweigh the survival advantage, so that, overall, IQWiG considers there to be a hint of a minor added benefit.
G-BA decides on the extent of added benefit
The dossier assessment is part of the overall procedure for early benefit assessments supervised 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 then 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 regorafenib.
The G-BA website contains both general English-language information on benefit assessment pursuant to §35a Social Code Book (SGB) V and specific German-language information on the assessment of regorafenib.
### END
Regorafenib: hint of minor added benefit
Advantage in overall survival, but disadvantage in severe side effects
2014-01-10
ELSE PRESS RELEASES FROM THIS DATE:
KIT researchers develop artificial bone marrow
2014-01-10
KIT researchers develop artificial bone marrow
This news release is available in German. Artificial bone marrow may be used to reproduce hematopoietic stem cells. A prototype has now been developed by scientists of KIT, the Max Planck Institute for Intelligent ...
Study quantifies costs when failed banks shun financial transparency
2014-01-10
Study quantifies costs when failed banks shun financial transparency
New study shows that more transparent accounting helps bidders, lowers costs when financial institutions fail
Good accounting isn't just a hallmark of a well-run company: As a new study ...
Fresh faced: Looking younger for longer
2014-01-10
Fresh faced: Looking younger for longer
Newcastle University researchers have identified an antioxidant Tiron, which offers total protection against some types of sun damage and may ultimately help our skin stay looking younger for longer.
Publishing in ...
The cyborgs era has started
2014-01-10
The cyborgs era has started
This news release is available in German. Medical implants, complex interfaces between brain and machine or remotely controlled insects: Recent developments combining machines and organisms have great potentials, but also give rise ...
Cilia use different motors for different tasks
2014-01-10
Cilia use different motors for different tasks
PROVIDENCE, R.I. [Brown University] — Cilia are one of nature's great multipurpose tools. The tiny, hair-like fibers protrude from cell membranes and perform all kinds of tasks in all kinds of creatures, from helping clear ...
1 species, 2 outcomes: Team seeks source of body louse pathology
2014-01-10
1 species, 2 outcomes: Team seeks source of body louse pathology
CHAMPAIGN, Ill. — A new study seeks to determine how one parasitic species can give rise to two drastically different outcomes in its host: The ...
Primary care practitioners hesitate to prescribe antidepressants for depressed teens
2014-01-10
Primary care practitioners hesitate to prescribe antidepressants for depressed teens
Even in severe cases, most wouldn't use medications, says study in Journal of Developmental & Behavioral Pediatrics
Philadelphia, Pa. (January 10, 2014) – Pediatric ...
Researchers at Rensselaer Polytechnic Institute uncover mechanism of genetic mutations known to cause familial Alzheimer's disease
2014-01-10
Researchers at Rensselaer Polytechnic Institute uncover mechanism of genetic mutations known to cause familial Alzheimer's disease
New study pinpoints structural effects of V44M and V44A mutations
Troy, N.Y. - New research, led by Rensselaer Polytechnic Institute ...
Bacteria-invading virus yields new discoveries
2014-01-10
Bacteria-invading virus yields new discoveries
TALLAHASSEE, Fla. — Innovative work by two Florida State University scientists that shows the structural and DNA breakdown of a bacteria-invading virus is being featured on the cover of the February issue of ...
'Hip-hop' students unfairly targeted, study finds
2014-01-10
'Hip-hop' students unfairly targeted, study finds
EAST LANSING, Mich. - Black and Latino "hip-hop" students are disproportionately punished in urban schools, finds a two-year study that sheds light on some of the unfair disciplinary practices newly targeted by the Obama ...
LAST 30 PRESS RELEASES:
Corpse flowers are threatened by spotty recordkeeping
Riding the AI wave toward rapid, precise ocean simulations
Are lifetimes of big appliances really shrinking?
Pink skies
Monkeys are world’s best yodellers - new research
Key differences between visual- and memory-led Alzheimer’s discovered
% weight loss targets in obesity management – is this the wrong objective?
An app can change how you see yourself at work
NYC speed cameras take six months to change driver behavior, effects vary by neighborhood, new study reveals
New research shows that propaganda is on the rise in China
Even the richest Americans face shorter lifespans than their European counterparts, study finds
Novel genes linked to rare childhood diarrhea
New computer model reveals how Bronze Age Scandinavians could have crossed the sea
Novel point-of-care technology delivers accurate HIV results in minutes
Researchers reveal key brain differences to explain why Ritalin helps improve focus in some more than others
Study finds nearly five-fold increase in hospitalizations for common cause of stroke
Study reveals how alcohol abuse damages cognition
Medicinal cannabis is linked to long-term benefits in health-related quality of life
Microplastics detected in cat placentas and fetuses during early pregnancy
Ancient amphibians as big as alligators died in mass mortality event in Triassic Wyoming
Scientists uncover the first clear evidence of air sacs in the fossilized bones of alvarezsaurian dinosaurs: the "hollow bones" which help modern day birds to fly
Alcohol makes male flies sexy
TB patients globally often incur "catastrophic costs" of up to $11,329 USD, despite many countries offering free treatment, with predominant drivers of cost being hospitalization and loss of income
Study links teen girls’ screen time to sleep disruptions and depression
Scientists unveil starfish-inspired wearable tech for heart monitoring
Footprints reveal prehistoric Scottish lagoons were stomping grounds for giant Jurassic dinosaurs
AI effectively predicts dementia risk in American Indian/Alaska Native elders
First guideline on newborn screening for cystic fibrosis calls for changes in practice to improve outcomes
Existing international law can help secure peace and security in outer space, study shows
Pinning down the process of West Nile virus transmission
[Press-News.org] Regorafenib: hint of minor added benefitAdvantage in overall survival, but disadvantage in severe side effects