Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Clinical trial of gefitinib for advanced lung cancer closes early

20.04.2005


Researchers have closed a randomized clinical trial comparing gefitinib (IressaTM) vs. placebo following chemotherapy and radiation for patients with non-small cell lung cancer (NSCLC) that had spread only to nearby tissues or lymph nodes. Review of interim data indicated that gefitinib would not improve survival.

The clinical trial was sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health in Bethesda, Md., and was conducted by a network of researchers led by the Southwest Oncology Group (SWOG), Ann Arbor, Mich. AstraZeneca Pharmaceuticals LP, Wilmington, Del., which manufactures gefitinib, provided the agent for the trial under the Clinical Trials Agreement with NCI for the development of gefitinib. Iressa is a drug that inhibits an enzyme (tyrosine kinase) present in lung cancer cells, as well as other cancers and normal tissues, that appears to be important to the growth of cancer cells.

Based on a review of the limited data available from the Phase III clinical trial, the Data Monitoring Committee overseeing the trial (known as S0023*) recommended the closure, as the trial would not meet its primary endpoint of improved survival. Detailed results from the study will be presented at the American Society of Clinical Oncology Annual Meeting (ASCO) on May 14, 2005.



The study was designed to assess whether maintenance therapy with gefitinib -- gefitinib given to help keep cancer in control -- would improve overall survival and progression-free survival as compared to placebo in patients with stable or responding disease. These patients had inoperable stage III NSCLC and already had completed the combined chemotherapy regimen of cisplatin and etoposide with radiation, followed by docetaxel. A total of 672 patients in this study were to be randomized to one of two treatment arms following chemotherapy and radiation: one arm would receive gefitinib daily and the other arm would receive a placebo daily. As of March 10, 2005, 611 patients were entered and 276 were randomized to one of the two arms.

"The interim analysis indicates that even with accrual of more patients or with longer follow-up, the gefitinib arm would not improve survival," said Laurence Baker, D.O., chairman of SWOG and professor of internal medicine and pharmacology at the University of Michigan in Ann Arbor. This analysis did confirm, however, the favorable survival seen with the chemotherapy and radiation regimen previously reported by SWOG**, and thus patients currently entered in the trial are being advised to complete this part of their treatment.

"Based on the analysis, the use of gefitinib following chemotherapy and radiation should not be prescribed for this group of patients," said Scott Saxman, M.D., who oversees lung cancer clinical trials for NCI.

An estimated 172,570 people will be diagnosed with lung cancer in the United States in 2005. Lung cancer is the second most commonly diagnosed cancer and the leading cause of cancer-related death in both men and women in this country. An estimated 163,510 deaths from lung cancer will occur in 2005 in the United States, accounting for about 29 percent of all cancer-related deaths in the nation.

NCI Press Officers | EurekAlert!
Further information:
http://www.nih.gov
http://www.cancer.gov

More articles from Health and Medicine:

nachricht Investigators may unlock mystery of how staph cells dodge the body's immune system
22.09.2017 | Cedars-Sinai Medical Center

nachricht Monitoring the heart's mitochondria to predict cardiac arrest?
21.09.2017 | Boston Children's Hospital

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

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

Im Focus: The pyrenoid is a carbon-fixing liquid droplet

Plants and algae use the enzyme Rubisco to fix carbon dioxide, removing it from the atmosphere and converting it into biomass. Algae have figured out a way to increase the efficiency of carbon fixation. They gather most of their Rubisco into a ball-shaped microcompartment called the pyrenoid, which they flood with a high local concentration of carbon dioxide. A team of scientists at Princeton University, the Carnegie Institution for Science, Stanford University and the Max Plank Institute of Biochemistry have unravelled the mysteries of how the pyrenoid is assembled. These insights can help to engineer crops that remove more carbon dioxide from the atmosphere while producing more food.

A warming planet

Im Focus: Highly precise wiring in the Cerebral Cortex

Our brains house extremely complex neuronal circuits, whose detailed structures are still largely unknown. This is especially true for the so-called cerebral cortex of mammals, where among other things vision, thoughts or spatial orientation are being computed. Here the rules by which nerve cells are connected to each other are only partly understood. A team of scientists around Moritz Helmstaedter at the Frankfiurt Max Planck Institute for Brain Research and Helene Schmidt (Humboldt University in Berlin) have now discovered a surprisingly precise nerve cell connectivity pattern in the part of the cerebral cortex that is responsible for orienting the individual animal or human in space.

The researchers report online in Nature (Schmidt et al., 2017. Axonal synapse sorting in medial entorhinal cortex, DOI: 10.1038/nature24005) that synapses in...

Im Focus: Tiny lasers from a gallery of whispers

New technique promises tunable laser devices

Whispering gallery mode (WGM) resonators are used to make tiny micro-lasers, sensors, switches, routers and other devices. These tiny structures rely on a...

Im Focus: Ultrafast snapshots of relaxing electrons in solids

Using ultrafast flashes of laser and x-ray radiation, scientists at the Max Planck Institute of Quantum Optics (Garching, Germany) took snapshots of the briefest electron motion inside a solid material to date. The electron motion lasted only 750 billionths of the billionth of a second before it fainted, setting a new record of human capability to capture ultrafast processes inside solids!

When x-rays shine onto solid materials or large molecules, an electron is pushed away from its original place near the nucleus of the atom, leaving a hole...

Im Focus: Quantum Sensors Decipher Magnetic Ordering in a New Semiconducting Material

For the first time, physicists have successfully imaged spiral magnetic ordering in a multiferroic material. These materials are considered highly promising candidates for future data storage media. The researchers were able to prove their findings using unique quantum sensors that were developed at Basel University and that can analyze electromagnetic fields on the nanometer scale. The results – obtained by scientists from the University of Basel’s Department of Physics, the Swiss Nanoscience Institute, the University of Montpellier and several laboratories from University Paris-Saclay – were recently published in the journal Nature.

Multiferroics are materials that simultaneously react to electric and magnetic fields. These two properties are rarely found together, and their combined...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

“Lasers in Composites Symposium” in Aachen – from Science to Application

19.09.2017 | Event News

I-ESA 2018 – Call for Papers

12.09.2017 | Event News

EMBO at Basel Life, a new conference on current and emerging life science research

06.09.2017 | Event News

 
Latest News

Rainbow colors reveal cell history: Uncovering β-cell heterogeneity

22.09.2017 | Life Sciences

Penn first in world to treat patient with new radiation technology

22.09.2017 | Medical Engineering

Calculating quietness

22.09.2017 | Physics and Astronomy

VideoLinks
B2B-VideoLinks
More VideoLinks >>>