Featured Research

from universities, journals, and other organizations

Enzalutamide in prostate cancer: Hints of added benefit

Date:
December 6, 2013
Source:
Institute for Quality and Efficiency in Health Care
Summary:
Enzalutamide can prolong survival in certain patients with prostate cancer, and delay occurrence of bone lesions. The new drug also offers advantages with regards to pain.

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).

Related Articles


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 tumor. 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 tumors 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.


Story Source:

The above story is based on materials provided by Institute for Quality and Efficiency in Health Care. Note: Materials may be edited for content and length.


Cite This Page:

Institute for Quality and Efficiency in Health Care. "Enzalutamide in prostate cancer: Hints of added benefit." ScienceDaily. ScienceDaily, 6 December 2013. <www.sciencedaily.com/releases/2013/12/131206111705.htm>.
Institute for Quality and Efficiency in Health Care. (2013, December 6). Enzalutamide in prostate cancer: Hints of added benefit. ScienceDaily. Retrieved November 22, 2014 from www.sciencedaily.com/releases/2013/12/131206111705.htm
Institute for Quality and Efficiency in Health Care. "Enzalutamide in prostate cancer: Hints of added benefit." ScienceDaily. www.sciencedaily.com/releases/2013/12/131206111705.htm (accessed November 22, 2014).

Share This


More From ScienceDaily



More Health & Medicine News

Saturday, November 22, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

WFP: Ebola Risks Heightened Among Women Throughout Africa

WFP: Ebola Risks Heightened Among Women Throughout Africa

AFP (Nov. 21, 2014) Having children has always been a frightening prospect in Sierra Leone, the world's most dangerous place to give birth, but Ebola has presented an alarming new threat for expectant mothers. Duration: 00:37 Video provided by AFP
Powered by NewsLook.com
Could Your Genes Be The Reason You're Single?

Could Your Genes Be The Reason You're Single?

Newsy (Nov. 21, 2014) Researchers in Beijing discovered a gene called 5-HTA1, and carriers are reportedly 20 percent more likely to be single. Video provided by Newsy
Powered by NewsLook.com
Raw: Paralyzed Marine Walks With Robotic Braces

Raw: Paralyzed Marine Walks With Robotic Braces

AP (Nov. 21, 2014) Marine Corps officials say a special operations officer left paralyzed by a sniper's bullet in Afghanistan walked using robotic leg braces in a ceremony to award him a Bronze Star. (Nov. 21) Video provided by AP
Powered by NewsLook.com
Milestone Birthdays Can Bring Existential Crisis, Study Says

Milestone Birthdays Can Bring Existential Crisis, Study Says

Newsy (Nov. 21, 2014) Researchers find that as people approach new decades in their lives they make bigger life decisions. Video provided by Newsy
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:

Strange & Offbeat Stories


Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins