Featured Research

from universities, journals, and other organizations

Investigating better endpoints for immunotherapy trials

Date:
September 8, 2010
Source:
Journal of the National Cancer Institute
Summary:
Cancer immunotherapy calls for revised clinical endpoints that differ from those used for chemotherapy, according to a new article.

Cancer immunotherapy calls for revised clinical endpoints that differ from those used for chemotherapy, according to an article published online September 8 in The Journal of the National Cancer Institute.

Unlike chemotherapy, which acts directly on tumors, cancer immunotherapies exert their effects on the immune system, which may delay or change response patterns, perhaps owing to the dynamics of the immune system itself. For example, initial tumor burden may increase due to lymphocytic infiltration, because of T-cell proliferation, which is followed by lymphocyte-induced tumor response. These delayed reactions and other novel patterns of anti-tumor response are not part of standard criteria from the World Health Organization (WHO), or the Response Evaluation Criteria in solid Tumors (RECIST).

To study and develop a new paradigm for immunotherapy clinical trials, Axel Hoos, M.D., of the Global Clinical Research division of Bristol-Myers Squibb, looked at design and outcomes of immunotherapy clinical trials, as part of several initiatives undertaken by the Cancer Immunotherapy Consortium of the Cancer Research Institute and partner organizations between 2004 and 2009. The resulting principles for redefining immunotherapy trial endpoints were subsequently tested by Bristol-Myers Squibb (a member of the Consortium) in its immunotherapy clinical trials. In these studies, four response patterns were detected: immediate response, durable stable disease, response after tumor burden increase, and development of new lesions. The latter two are specifically recognized with immunotherapeutic agents. The results were translated into new response criteria called the immune-related response criteria, or irRC.

Hoos writes, "The irRC are generally based on the WHO and RECIST criteria and do not require a substantial departure from standard oncology practice. The novelty of the irRC lies in the measurement of new lesions, which are included in the overall tumor burden, allowing for it to be described as a continuous variable."

Furthermore, "Considering the time of translation of immunologic responses into clinical activity, the survival of patients may not be affected until some months after treatment started compared with chemotherapy," writes Hoos, adding that the kinetics observed for survival may require new statistical approaches for planning randomized trials.

In an accompanying editorial, Donald A. Berry, M.D., of the University of Texas M.D. Anderson Center, addresses the conundrum of delayed responses often induced by immunotherapies: "Any delayed effect of therapy makes product development harder and more expensive than developing a drug that works by attacking the tumor directly."

Moreover, Berry worries about another potential problem in developing immunotherapies: "To fully investigate the potential of an immunotherapy, clinicians may have to stick with it beyond a patient's progression and thereby delay switching to potentially more effective therapy," he writes.


Story Source:

The above story is based on materials provided by Journal of the National Cancer Institute. Note: Materials may be edited for content and length.


Journal Reference:

  1. Axel Hoos, Alexander M. M. Eggermont, Sylvia Janetzki, F. Stephen Hodi, Ramy Ibrahim, Aparna Anderson, Rachel Humphrey, Brent Blumenstein, Lloyd Old, Jedd Wolchok. Improved Endpoints for Cancer Immunotherapy Trials. Journal of the National Cancer Institute, 2010; DOI: 10.1093/jnci/djq310

Cite This Page:

Journal of the National Cancer Institute. "Investigating better endpoints for immunotherapy trials." ScienceDaily. ScienceDaily, 8 September 2010. <www.sciencedaily.com/releases/2010/09/100908162940.htm>.
Journal of the National Cancer Institute. (2010, September 8). Investigating better endpoints for immunotherapy trials. ScienceDaily. Retrieved April 16, 2014 from www.sciencedaily.com/releases/2010/09/100908162940.htm
Journal of the National Cancer Institute. "Investigating better endpoints for immunotherapy trials." ScienceDaily. www.sciencedaily.com/releases/2010/09/100908162940.htm (accessed April 16, 2014).

Share This



More Health & Medicine News

Wednesday, April 16, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Could Even Casual Marijuana Use Alter Your Brain?

Could Even Casual Marijuana Use Alter Your Brain?

Newsy (Apr. 16, 2014) A new study conducted by researchers at Northwestern and Harvard suggests even casual marijuana use can alter your brain. Video provided by Newsy
Powered by NewsLook.com
Formerly Conjoined Twins Released From Dallas Hospital

Formerly Conjoined Twins Released From Dallas Hospital

Newsy (Apr. 16, 2014) Conjoined twins Emmett and Owen Ezell were separated by doctors in August. Now, nearly nine months later, they're being released from the hospital. Video provided by Newsy
Powered by NewsLook.com
Ebola Outbreak Now Linked To 121 Deaths

Ebola Outbreak Now Linked To 121 Deaths

Newsy (Apr. 15, 2014) The ebola virus outbreak in West Africa is now linked to 121 deaths. Health officials fear the virus will continue to spread in urban areas. Video provided by Newsy
Powered by NewsLook.com
Cognitive Function: Is It All Downhill From Age 24?

Cognitive Function: Is It All Downhill From Age 24?

Newsy (Apr. 15, 2014) A new study out of Canada says cognitive motor performance begins deteriorating around age 24. 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:
from the past week

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