Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Study of cancer trials finds significant safety improvement

03.11.2004


Risk of dying from experimental cancer treatment drops by 90 percent over 12 years



The chance that patients participating in early-stage cancer research studies will die from the experimental treatments has dropped dramatically over the past decade, according to a study from the Massachusetts General Hospital (MGH) Cancer Center and the Massachusetts Institute of Technology (MIT). In an analysis of more than 200 Phase 1 research trials from 1991 through 2002, the researchers found that treatment-related deaths decreased by 90 percent during the study period. The report appears in the November 3 Journal of the American Medical Association.

"We undertook this study because there has been so much concern in recent years about the safety of clinical trials. We wanted to see if the increased attention to patient safety had made a difference and if the addition of targeted therapies, which tend to be less toxic, had also helped," says Thomas Roberts Jr., MD, of the MGH Cancer Center, the paper’s lead author. "Now we can tell patients with cancer that, compared with 10 years ago, they can expect a higher level of safety when they enroll in early-stage clinical trials."


Representing the first time potential new drugs are tested in humans, phase 1 trials have a goal of assuring drug safety and determining the best dosage. While most of these early-stage studies enroll healthy volunteers, cancer studies have several important differences. Phase 1 cancer studies are usually restricted to patients with cancer who have exhausted established therapeutic options. While identifying toxic effects is the primary goal of most Phase 1 studies, cancer trials also have a secondary goal of evaluating anti-tumor effects.

Since there had been no comprehensive analysis of Phase 1 trials since the mid-1980s, the researchers compiled a database of Phase 1 trial results reported at the annual meeting of the American Society for Clinical Oncology from 1991 through 2002. In order to insure that the studies were comparable, the investigators focused on published studies of single agents that had not yet received FDA approval and excluded those involving radiation therapy or treatment of leukemia or lymphoma. This strategy narrowed the study group down to 213 trials, enrolling aproximately 6,500 patients. For these studies, the researchers analyzed how often participants died from drug toxicity, cancer-related deaths, other toxic treatment effects, and whether or not the treatment caused the tumor to shrink, as measured by CT scanning.

The most significant change during the study period was the more than 90 percent drop in the risk of drug-related deaths – from a risk of about 1 percent in the first four years of the study to .06 percent in the last four years. The chance that the tested drug would have a measurable anti-tumor effect also dropped during the study period but by only 50 percent, suggesting a possible improvement in the overall risk/benefit ratio.

The researchers cite several possible reasons for the improvements in safety, including increased attention to patient safety regulations, the use of less-toxic targeted therapies, and improvements in supportive care, such as new treatments for chemotherapy-induced anemia and neutropenia. While they were surprised and concerned about the reduced chance of a therapeutic benefit, Roberts explains several potential underlying reasons. "We have gotten more systematic in the determination of response rates, so the later results may be more accurate," he says. "In addition, some of the newer agents like angiogenesis inhibitors, could be stopping cancer progression without actually shrinking the tumor. We may need to find new ways to measure treatment success."

Roberts continues, "Many investigators feel frustrated about the regulatory hurdles they have to go through to initiate and conduct clinical trials. There will always be a balance between optimizing patient safety and conducting research efficiently. We need to be aware of that balance and to find ways to monitor patient safety in real time." Roberts is an instructor in Medicine at Harvard Medical School and visiting scientist at MIT.

Roberts’ co-authors are Bernardo Goulart, MD, Bruce Chabner, MD, and Jeffrey Clark, MD of the MGH Cancer Center; Elkan Halpern, PhD, and G. Scott Gazelle, MD, MPH, PhD, of the MGH Institute of Technology Assessment; and Sarah Stallings, PhD, Stan Finkelstein, MD, and Lee Squitieri of Massachusetts Institute of Technology. The study was supported by grants from the Alfred P. Sloan Foundation and the National Cancer Institute.

Sue McGreevey | EurekAlert!
Further information:
http://www.mgh.harvard.edu

More articles from Studies and Analyses:

nachricht Study relating to materials testing Detecting damages in non-magnetic steel through magnetism
23.07.2018 | Technische Universität Kaiserslautern

nachricht Innovative genetic tests for children with developmental disorders and epilepsy
11.07.2018 | Christian-Albrechts-Universität zu Kiel

All articles from Studies and Analyses >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Future electronic components to be printed like newspapers

A new manufacturing technique uses a process similar to newspaper printing to form smoother and more flexible metals for making ultrafast electronic devices.

The low-cost process, developed by Purdue University researchers, combines tools already used in industry for manufacturing metals on a large scale, but uses...

Im Focus: First evidence on the source of extragalactic particles

For the first time ever, scientists have determined the cosmic origin of highest-energy neutrinos. A research group led by IceCube scientist Elisa Resconi, spokesperson of the Collaborative Research Center SFB1258 at the Technical University of Munich (TUM), provides an important piece of evidence that the particles detected by the IceCube neutrino telescope at the South Pole originate from a galaxy four billion light-years away from Earth.

To rule out other origins with certainty, the team led by neutrino physicist Elisa Resconi from the Technical University of Munich and multi-wavelength...

Im Focus: Magnetic vortices: Two independent magnetic skyrmion phases discovered in a single material

For the first time a team of researchers have discovered two different phases of magnetic skyrmions in a single material. Physicists of the Technical Universities of Munich and Dresden and the University of Cologne can now better study and understand the properties of these magnetic structures, which are important for both basic research and applications.

Whirlpools are an everyday experience in a bath tub: When the water is drained a circular vortex is formed. Typically, such whirls are rather stable. Similar...

Im Focus: Breaking the bond: To take part or not?

Physicists working with Roland Wester at the University of Innsbruck have investigated if and how chemical reactions can be influenced by targeted vibrational excitation of the reactants. They were able to demonstrate that excitation with a laser beam does not affect the efficiency of a chemical exchange reaction and that the excited molecular group acts only as a spectator in the reaction.

A frequently used reaction in organic chemistry is nucleophilic substitution. It plays, for example, an important role in in the synthesis of new chemical...

Im Focus: New 2D Spectroscopy Methods

Optical spectroscopy allows investigating the energy structure and dynamic properties of complex quantum systems. Researchers from the University of Würzburg present two new approaches of coherent two-dimensional spectroscopy.

"Put an excitation into the system and observe how it evolves." According to physicist Professor Tobias Brixner, this is the credo of optical spectroscopy....

All Focus news of the innovation-report >>>

Anzeige

Anzeige

VideoLinks
Industry & Economy
Event News

Leading experts in Diabetes, Metabolism and Biomedical Engineering discuss Precision Medicine

13.07.2018 | Event News

Conference on Laser Polishing – LaP: Fine Tuning for Surfaces

12.07.2018 | Event News

11th European Wood-based Panel Symposium 2018: Meeting point for the wood-based materials industry

03.07.2018 | Event News

 
Latest News

Detecting damage in non-magnetic steel with the help of magnetism

23.07.2018 | Materials Sciences

Researchers move closer to completely optical artificial neural network

23.07.2018 | Information Technology

Enabling technology in cell-based therapies: Scale-up, scale-out or program in-place

23.07.2018 | Health and Medicine

VideoLinks
Science & Research
Overview of more VideoLinks >>>