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.

Related Articles


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 October 31, 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 October 31, 2014).

Share This



More Health & Medicine News

Friday, October 31, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Fauci Says Ebola Risk in US "essentially Zero"

Fauci Says Ebola Risk in US "essentially Zero"

AP (Oct. 30, 2014) NIAID Director Anthony Fauci said the risk of Ebola becoming an epidemic in the U.S. is essentially zero Thursday at the Washington Ideas Forum. He also said an Ebola vaccine will be tested in West Africa in the next few months. (Oct. 30) Video provided by AP
Powered by NewsLook.com
Nurse Defies Ebola Quarantine With Bike Ride

Nurse Defies Ebola Quarantine With Bike Ride

AP (Oct. 30, 2014) A nurse who vowed to defy Maine's voluntary quarantine for health care workers who treated Ebola patients followed through on her promise Thursday, leaving her home for an hour-long bike ride. (Oct. 30) Video provided by AP
Powered by NewsLook.com
Pot-Infused Edibles Raise Concerns in Colorado

Pot-Infused Edibles Raise Concerns in Colorado

AFP (Oct. 30, 2014) Colorado may have legalized marijuana for recreational use, but the debate around the decision still continues, with a recent - failed - attempt to ban cannabis-infused edibles. Duration: 01:53 Video provided by AFP
Powered by NewsLook.com
British Navy Ship Arrives in Sierra Leone With Ebola Aid

British Navy Ship Arrives in Sierra Leone With Ebola Aid

AFP (Oct. 30, 2014) The British ship RFA ARGUS arrived in Sierra Leone to deliver supplies and equipment to help the fight against Ebola. Duration: 00:42 Video provided by AFP
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