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Clinical Trial Results

Summaries of Newsworthy Clinical Trial Results

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    Posted: 09/20/2006
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Search for Clinical Trials 1
NCI's PDQ® Cancer Clinical Trials Registry.

Lung Cancer Home Page 2
NCI's gateway for information about lung cancer.
ERCC1 Expression in Lung Cancer May Predict Survival Benefit from Cisplatin

Reprinted from the NCI Cancer Bulletin, vol. 3/no. 35, Sept. 12, 2006 (see the current issue 3).

A new substudy from the International Adjuvant Lung Cancer Trial (IALT) - the IALT Bio study - has identified lack of expression of the DNA-repair protein ERCC1 as a possible predictor of increased survival after cisplatin-based chemotherapy. The results, published in the September 7, 2006, New England Journal of Medicine (see the journal abstract), showed that patients whose tumors lacked ERCC1 expression derived a significant survival benefit from adjuvant cisplatin-based chemotherapy, but patients with ERCC1-positive tumors did not.

The IALT Bio investigators used immunostaining to evaluate ERCC1 expression in tumor and control tissue taken from 761 patients who participated in the IALT trial; 389 had received adjuvant cisplatin-based chemotherapy, and 372 were followed without further treatment after surgery. The investigators then compared overall survival within the chemotherapy and control groups based on ERCC1 status.

Expression of ERCC1 correlated with age, tumor histology, and whether the tumor had spread into the pleura. For patients with ERCC1-negative tumors, the addition of chemotherapy significantly improved five-year overall survival, which was 47 percent in the chemotherapy group and 39 percent in the control group. The addition of chemotherapy did not significantly improve survival for patients with ERCC1-positive tumors.

"Our results suggest that determination of ERCC1 expression in non-small-cell lung cancer cells before chemotherapy can make a contribution as an independent predictor of the effect of adjuvant chemotherapy," stated the authors. The next question for researchers, explained Dr. Eddie Reed of the Centers for Disease Control and Prevention in an accompanying editorial, "is whether this information can be used prospectively."

(Results from the original IALT trial were published in the Jan. 22, 2004, New England Journal of Medicine; see the journal abstract.)



Glossary Terms

adjuvant therapy (A-joo-vant THAYR-uh-pee)
Additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back. Adjuvant therapy may include chemotherapy, radiation therapy, hormone therapy, targeted therapy, or biological therapy.
cisplatin (sis-PLA-tin)
A drug used to treat many types of cancer. Cisplatin contains the metal platinum. It kills cancer cells by damaging their DNA and stopping them from dividing. Cisplatin is a type of alkylating agent. Also called Platinol.
control group
In a clinical trial, the group that does not receive the new treatment being studied. This group is compared to the group that receives the new treatment, to see if the new treatment works.
prospective (proh-SPEK-tiv)
In medicine, a study or clinical trial in which participants are identified and then followed forward in time.
protein (PRO-teen)
A molecule made up of amino acids that are needed for the body to function properly. Proteins are the basis of body structures such as skin and hair and of substances such as enzymes, cytokines, and antibodies.
statistically significant
Describes a mathematical measure of difference between groups. The difference is said to be statistically significant if it is greater than what might be expected to happen by chance alone. Also called significant.


Table of Links

1http://www.cancer.gov/clinicaltrials/search
2http://www.cancer.gov/cancertopics/types/lung
3http://www.cancer.gov/ncicancerbulletin